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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT01885078
Registration number
NCT01885078
Ethics application status
Date submitted
19/06/2013
Date registered
24/06/2013
Titles & IDs
Public title
An Extension Study in Participants With Moderate to Severe Rheumatoid Arthritis
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Scientific title
A Phase 3, Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients With Rheumatoid Arthritis
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Secondary ID [1]
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I4V-MC-JADY
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Secondary ID [2]
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14060
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Universal Trial Number (UTN)
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Trial acronym
RA-BEYOND
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Rheumatoid Arthritis
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Condition category
Condition code
Musculoskeletal
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Osteoarthritis
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Inflammatory and Immune System
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Rheumatoid arthritis
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Baricitinib
Treatment: Drugs - Placebo
Experimental: 4 milligram (mg) Baricitinib - 4 mg Baricitinib administered orally once daily.
Participants received baricitinib doses according to the dose received at the completion of the originating study. Participants may continue to receive the background non-investigational, open-label conventional disease-modifying antirheumatic drugs (cDMARD), nonsteroidal anti-inflammatory drug (NSAID), corticosteroid, and other analgesic therapies they were receiving at completion of the originating study.
Experimental: 2 mg Baricitinib - 2 mg Baricitinib administered orally once daily.
Participants received baricitinib doses according to the dose received at the completion of the originating study. Participants may continue to receive the background non-investigational, open-label cDMARD, NSAID, corticosteroid, and other analgesic therapies they were receiving at completion of the originating study.
Experimental: 2 mg Baricitinib Step-down - 2 mg Baricitinib administered orally once daily in the 96-week Step-down period.
Participants may continue to receive the background non-investigational, open-label cDMARD, NSAID, corticosteroid, and other analgesic therapies they were receiving at completion of the originating study.
Experimental: 4 mg Baricitinib Step-down - 4 mg Baricitinib administered orally once daily in the 96-week Step-down period.
Participants may continue to receive the background non-investigational, open-label cDMARD, NSAID, corticosteroid, and other analgesic therapies they were receiving at completion of the originating study.
Treatment: Drugs: Baricitinib
Administered orally
Treatment: Drugs: Placebo
Administered orally
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Number of Participants Who Experienced Adverse Events (AEs) or Serious AE
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Assessment method [1]
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An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can be any unfavorable and unintended sign (i.e., abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. Non-serious AEs are reported at a threshold of 5%.
An SAE is an AE from this study that results in any of the following: death, initial or prolonged inpatient hospitalization, a life-threatening experience, persistent or significant disability/incapacity, congenital anomaly/birth defect, considered significant by the investigator for any other reason
A summary of serious adverse events (SAEs) and other non-serious adverse events (AEs), regardless of causality, were reported in the Reported Adverse Events module.
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Timepoint [1]
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Baseline through 84 Months
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Secondary outcome [1]
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Percentage of Participants Maintaining an American College of Rheumatology (ACR) Response of ACR20
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Assessment method [1]
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ACR20 Responder Index is a composite of clinical, laboratory, and functional measures in rheumatoid arthritis (RA). An ACR20 Responder is a participant who had =20% improvement from baseline in both 68 tender and 66 swollen joint counts and =20% improvement in at least 3 of 5 criteria: Patient's and Physician's Global Assessment of Disease Activity, Health Assessment Questionnaire-Disability Index (HAQ-DI) (assessment of participant's physical function), pain due to RA, and hsCRP. Percentage of participants achieving ACR20 response = (number of ACR20 responders) / (number of participants analyzed) \* 100
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Timepoint [1]
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Year 1 after entry into JADY
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Secondary outcome [2]
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Percentage of Participants Maintaining an American College of Rheumatology (ACR) Response of ACR20
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Assessment method [2]
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ACR20 Responder Index is a composite of clinical, laboratory, and functional measures in rheumatoid arthritis (RA). An ACR20 Responder is a participant who had =20% improvement from baseline in both 68 tender and 66 swollen joint counts and =20% improvement in at least 3 of 5 criteria: Patient's and Physician's Global Assessment of Disease Activity, Health Assessment Questionnaire-Disability Index (HAQ-DI) (assessment of participant's physical function), pain due to RA, and hsCRP. Percentage of participants achieving ACR20 response = (number of ACR20 responders) / (number of participants analyzed) \* 100
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Timepoint [2]
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Year 3 after entry into JADY
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Secondary outcome [3]
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Percentage of Participants Maintaining an American College of Rheumatology (ACR) Response of ACR20
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Assessment method [3]
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ACR20 Responder Index is a composite of clinical, laboratory, and functional measures in rheumatoid arthritis (RA). An ACR20 Responder is a participant who had =20% improvement from baseline in both 68 tender and 66 swollen joint counts and =20% improvement in at least 3 of 5 criteria: Patient's and Physician's Global Assessment of Disease Activity, Health Assessment Questionnaire-Disability Index (HAQ-DI) (assessment of participant's physical function), pain due to RA, and hsCRP. Percentage of participants achieving ACR20 response = (number of ACR20 responders) / (number of participants analyzed) \* 100
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Timepoint [3]
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0
Year 5 after entry into JADY
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Secondary outcome [4]
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Percentage of Participants Maintaining an American College of Rheumatology (ACR) Response of ACR50
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Assessment method [4]
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ACR50 Responder Index is a composite of clinical, laboratory, and functional measures in rheumatoid arthritis (RA). An ACR50 Responder is a participant who had =50% improvement from baseline in both 68 tender and 66 swollen joint counts and =50% improvement in at least 3 of 5 criteria: Patient's and Physician's Global Assessment of Disease Activity, Health Assessment Questionnaire-Disability Index (HAQ-DI) (assessment of participant's physical function), pain due to RA, and hsCRP. Percentage of participants achieving ACR50 response = (number of ACR50 responders) / (number of participants analyzed) \* 100
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Timepoint [4]
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Year 1 after entry into JADY
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Secondary outcome [5]
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Percentage of Participants Maintaining an American College of Rheumatology (ACR) Response of ACR50
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Assessment method [5]
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ACR50 Responder Index is a composite of clinical, laboratory, and functional measures in rheumatoid arthritis (RA). An ACR50 Responder is a participant who had =50% improvement from baseline in both 68 tender and 66 swollen joint counts and =50% improvement in at least 3 of 5 criteria: Patient's and Physician's Global Assessment of Disease Activity, Health Assessment Questionnaire-Disability Index (HAQ-DI) (assessment of participant's physical function), pain due to RA, and hsCRP. Percentage of participants achieving ACR50 response = (number of ACR50 responders) / (number of participants analyzed) \* 100
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Timepoint [5]
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Year 3 after entry into JADY
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Secondary outcome [6]
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Percentage of Participants Maintaining an American College of Rheumatology (ACR) Response of ACR50
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Assessment method [6]
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ACR50 Responder Index is a composite of clinical, laboratory, and functional measures in rheumatoid arthritis (RA). An ACR50 Responder is a participant who had =50% improvement from baseline in both 68 tender and 66 swollen joint counts and =50% improvement in at least 3 of 5 criteria: Patient's and Physician's Global Assessment of Disease Activity, Health Assessment Questionnaire-Disability Index (HAQ-DI) (assessment of participant's physical function), pain due to RA, and hsCRP. Percentage of participants achieving ACR50 response = (number of ACR50 responders) / (number of participants analyzed) \* 100
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Timepoint [6]
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Year 5 after entry into JADY
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Secondary outcome [7]
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Percentage of Participants Maintaining an American College of Rheumatology (ACR) Response of ACR70
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Assessment method [7]
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ACR70 Responder Index is a composite of clinical, laboratory, and functional measures in rheumatoid arthritis (RA). An ACR70 Responder is a participant who had =70% improvement from baseline in both 68 tender and 66 swollen joint counts and =70% improvement in at least 3 of 5 criteria: Patient's and Physician's Global Assessment of Disease Activity, Health Assessment Questionnaire-Disability Index (HAQ-DI) (assessment of participant's physical function), pain due to RA, and hsCRP. Percentage of participants achieving ACR70 response = (number of ACR70 responders) / (number of participants analyzed) \* 100
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Timepoint [7]
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Year 1 after entry into JADY
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Secondary outcome [8]
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Percentage of Participants Maintaining an American College of Rheumatology (ACR) Response of ACR70
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Assessment method [8]
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ACR70 Responder Index is a composite of clinical, laboratory, and functional measures in rheumatoid arthritis (RA). An ACR70 Responder is a participant who had =70% improvement from baseline in both 68 tender and 66 swollen joint counts and =70% improvement in at least 3 of 5 criteria: Patient's and Physician's Global Assessment of Disease Activity, Health Assessment Questionnaire-Disability Index (HAQ-DI) (assessment of participant's physical function), pain due to RA, and hsCRP. Percentage of participants achieving ACR70 response = (number of ACR70 responders) / (number of participants analyzed) \* 100
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Timepoint [8]
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Year 3 after entry into JADY
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Secondary outcome [9]
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Percentage of Participants Maintaining an American College of Rheumatology (ACR) Response of ACR70
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Assessment method [9]
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ACR70 Responder Index is a composite of clinical, laboratory, and functional measures in rheumatoid arthritis (RA). An ACR70 Responder is a participant who had =70% improvement from baseline in both 68 tender and 66 swollen joint counts and =70% improvement in at least 3 of 5 criteria: Patient's and Physician's Global Assessment of Disease Activity, Health Assessment Questionnaire-Disability Index (HAQ-DI) (assessment of participant's physical function), pain due to RA, and hsCRP. Percentage of participants achieving ACR70 response = (number of ACR70 responders) / (number of participants analyzed) \* 100
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Timepoint [9]
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Year 5 after entry into JADY
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Secondary outcome [10]
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Percentage of Participants Maintaining a Disease Activity Score (DAS28) High-Sensitivity C-Reactive Protein (hsCRP) =3.2
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Assessment method [10]
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Disease Activity Score (DAS) modified to include 28 joint count (DAS28) consisted of composite score of following variables: tender joint count-28 (TJC28), swollen joint count-28 (SJC28), CRP (mg/L), and Patient's Global Assessment of Disease Activity using VAS (patient's global VAS). DAS28-CRP=0.56\*square root (sqrt)(TJC28)+0.28\*sqrt(SJC28)+0.36\*natural log(CRP+1)+0.014\*patient's global VAS+0.96. Scores ranged from 1.0-9.4, where lower scores indicated less disease activity, low disease activity was DAS28-CRP =3.2 and remission was DAS28-CRP \<2.6. A decrease in DAS28-CRP indicated an improvement in participant's condition.
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Timepoint [10]
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0
Year 1 after entry into JADY
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Secondary outcome [11]
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Percentage of Participants Maintaining a Disease Activity Score (DAS28) High-Sensitivity C-Reactive Protein (hsCRP) =3.2
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Assessment method [11]
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Disease Activity Score (DAS) modified to include 28 joint count (DAS28) consisted of composite score of following variables: tender joint count-28 (TJC28), swollen joint count-28 (SJC28), CRP (mg/L), and Patient's Global Assessment of Disease Activity using VAS (patient's global VAS). DAS28-CRP=0.56\*square root (sqrt)(TJC28)+0.28\*sqrt(SJC28)+0.36\*natural log(CRP+1)+0.014\*patient's global VAS+0.96. Scores ranged from 1.0-9.4, where lower scores indicated less disease activity, low disease activity was DAS28-CRP =3.2 and remission was DAS28-CRP \<2.6. A decrease in DAS28-CRP indicated an improvement in participant's condition.
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Timepoint [11]
0
0
Year 3 after entry into JADY
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Secondary outcome [12]
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Percentage of Participants Maintaining a Disease Activity Score (DAS28) High-Sensitivity C-Reactive Protein (hsCRP) =3.2
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Assessment method [12]
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0
Disease Activity Score (DAS) modified to include 28 joint count (DAS28) consisted of composite score of following variables: tender joint count-28 (TJC28), swollen joint count-28 (SJC28), CRP (mg/L), and Patient's Global Assessment of Disease Activity using VAS (patient's global VAS). DAS28-CRP=0.56\*square root (sqrt)(TJC28)+0.28\*sqrt(SJC28)+0.36\*natural log(CRP+1)+0.014\*patient's global VAS+0.96. Scores ranged from 1.0-9.4, where lower scores indicated less disease activity, low disease activity was DAS28-CRP =3.2 and remission was DAS28-CRP \<2.6. A decrease in DAS28-CRP indicated an improvement in participant's condition.
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Timepoint [12]
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0
Year 5 after entry into JADY
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Secondary outcome [13]
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Percentage of Participants Maintaining a Disease Activity Score (DAS28) High-Sensitivity C-Reactive Protein (hsCRP)<2.6
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Assessment method [13]
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0
Disease Activity Score (DAS) modified to include 28 joint count (DAS28) consisted of composite score of following variables: tender joint count-28 (TJC28), swollen joint count-28 (SJC28), CRP (mg/L), and Patient's Global Assessment of Disease Activity using VAS (patient's global VAS). DAS28-CRP=0.56\*square root (sqrt)(TJC28)+0.28\*sqrt(SJC28)+0.36\*natural log(CRP+1)+0.014\*patient's global VAS+0.96. Scores ranged from 1.0-9.4, where lower scores indicated less disease activity, low disease activity was DAS28-CRP =3.2 and remission was DAS28-CRP \<2.6. A decrease in DAS28-CRP indicated an improvement in participant's condition.
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Timepoint [13]
0
0
Year 1 after entry into JADY
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Secondary outcome [14]
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0
Percentage of Participants Maintaining a Disease Activity Score (DAS28) High-Sensitivity C-Reactive Protein (hsCRP)<2.6
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Assessment method [14]
0
0
Disease Activity Score (DAS) modified to include 28 joint count (DAS28) consisted of composite score of following variables: tender joint count-28 (TJC28), swollen joint count-28 (SJC28), CRP (mg/L), and Patient's Global Assessment of Disease Activity using VAS (patient's global VAS). DAS28-CRP=0.56\*square root (sqrt)(TJC28)+0.28\*sqrt(SJC28)+0.36\*natural log(CRP+1)+0.014\*patient's global VAS+0.96. Scores ranged from 1.0-9.4, where lower scores indicated less disease activity, low disease activity was DAS28-CRP =3.2 and remission was DAS28-CRP \<2.6. A decrease in DAS28-CRP indicated an improvement in participant's condition.
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Timepoint [14]
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Year 3 after entry into JADY
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Secondary outcome [15]
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Percentage of Participants Maintaining a Disease Activity Score (DAS28) High-Sensitivity C-Reactive Protein (hsCRP)<2.6
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Assessment method [15]
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0
Disease Activity Score (DAS) modified to include 28 joint count (DAS28) consisted of composite score of following variables: tender joint count-28 (TJC28), swollen joint count-28 (SJC28), CRP (mg/L), and Patient's Global Assessment of Disease Activity using VAS (patient's global VAS). DAS28-CRP=0.56\*square root (sqrt)(TJC28)+0.28\*sqrt(SJC28)+0.36\*natural log(CRP+1)+0.014\*patient's global VAS+0.96. Scores ranged from 1.0-9.4, where lower scores indicated less disease activity, low disease activity was DAS28-CRP =3.2 and remission was DAS28-CRP \<2.6. A decrease in DAS28-CRP indicated an improvement in participant's condition.
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Timepoint [15]
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Year 5 after entry into JADY
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Secondary outcome [16]
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Percentage of Participants Maintaining a DAS28-Erythrocyte Sedimentation Rate (ESR) Score of =3.2
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Assessment method [16]
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DAS28 consisted of composite score of following variables: tender joint count (TJC28), swollen joint count (SJC28), ESR (millimeters per hour), and Patient's Global Assessment of Disease Activity. DAS28 was calculated using following formula: DAS28-ESR=0.56\*square root (sqrt)(TJC28)+0.28\*sqrt(SJC28)+0.70\*natural log(ESR)+0.014\*Patient's Global VAS. Total scores ranged from 1.0-9.4, where lower scores indicated less disease activity.
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Timepoint [16]
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0
Year 1 after entry into JADY
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Secondary outcome [17]
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Percentage of Participants Maintaining a DAS28-Erythrocyte Sedimentation Rate (ESR) Score of =3.2
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Assessment method [17]
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0
DAS28 consisted of composite score of following variables: tender joint count (TJC28), swollen joint count (SJC28), ESR (millimeters per hour), and Patient's Global Assessment of Disease Activity. DAS28 was calculated using following formula: DAS28-ESR=0.56\*square root (sqrt)(TJC28)+0.28\*sqrt(SJC28)+0.70\*natural log(ESR)+0.014\*Patient's Global VAS. Total scores ranged from 1.0-9.4, where lower scores indicated less disease activity.
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Timepoint [17]
0
0
Year 3 after entry into JADY
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Secondary outcome [18]
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Percentage of Participants Maintaining a DAS28-Erythrocyte Sedimentation Rate (ESR) Score of =3.2
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Assessment method [18]
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0
DAS28 consisted of composite score of following variables: tender joint count (TJC28), swollen joint count (SJC28), ESR (millimeters per hour), and Patient's Global Assessment of Disease Activity. DAS28 was calculated using following formula: DAS28-ESR=0.56\*square root (sqrt)(TJC28)+0.28\*sqrt(SJC28)+0.70\*natural log(ESR)+0.014\*Patient's Global VAS. Total scores ranged from 1.0-9.4, where lower scores indicated less disease activity.
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Timepoint [18]
0
0
Year 5 after entry into JADY
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Secondary outcome [19]
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Percentage of Participants Maintaining a DAS28-Erythrocyte Sedimentation Rate (ESR) Sore of <2.6
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Assessment method [19]
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DAS28 consisted of composite score of following variables: tender joint count (TJC28), swollen joint count (SJC28), ESR (millimeters per hour), and Patient's Global Assessment of Disease Activity. DAS28 was calculated using following formula: DAS28-ESR=0.56\*square root (sqrt)(TJC28)+0.28\*sqrt(SJC28)+0.70\*natural log(ESR)+0.014\*Patient's Global VAS. Total scores ranged from 1.0-9.4, where lower scores indicated less disease activity.
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Timepoint [19]
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0
Year 1 after entry into JADY
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Secondary outcome [20]
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Percentage of Participants Maintaining a DAS28-Erythrocyte Sedimentation Rate (ESR) Sore of <2.6
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Assessment method [20]
0
0
DAS28 consisted of composite score of following variables: tender joint count (TJC28), swollen joint count (SJC28), ESR (millimeters per hour), and Patient's Global Assessment of Disease Activity. DAS28 was calculated using following formula: DAS28-ESR=0.56\*square root (sqrt)(TJC28)+0.28\*sqrt(SJC28)+0.70\*natural log(ESR)+0.014\*Patient's Global VAS. Total scores ranged from 1.0-9.4, where lower scores indicated less disease activity.
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Timepoint [20]
0
0
Year 3 after entry into JADY
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Secondary outcome [21]
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0
Percentage of Participants Maintaining a DAS28-Erythrocyte Sedimentation Rate (ESR) Sore of <2.6
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Assessment method [21]
0
0
DAS28 consisted of composite score of following variables: tender joint count (TJC28), swollen joint count (SJC28), ESR (millimeters per hour), and Patient's Global Assessment of Disease Activity. DAS28 was calculated using following formula: DAS28-ESR=0.56\*square root (sqrt)(TJC28)+0.28\*sqrt(SJC28)+0.70\*natural log(ESR)+0.014\*Patient's Global VAS. Total scores ranged from 1.0-9.4, where lower scores indicated less disease activity.
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Timepoint [21]
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Year 5 after entry into JADY
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Secondary outcome [22]
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Percentage of Participants Maintaining American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) Boolean Remission Response
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Assessment method [22]
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Boolean-based definition of remission, all 4 criteria below must be met: tender joint count (TJC28 ) \<=1, swollen joint count (SJC28) \<=1, hsCRP \<=1 milligram per deciliter (mg/dL), Patient Global Assessment of Disease Activity using visual analog scale (VAS) \<=1 cm.
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Timepoint [22]
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0
Year 1 after entry into JADY
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Secondary outcome [23]
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Percentage of Participants Maintaining American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) Boolean Remission Response
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Assessment method [23]
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0
Boolean-based definition of remission, all 4 criteria below must be met: tender joint count (TJC28 ) \<=1, swollen joint count (SJC28) \<=1, hsCRP \<=1 milligram per deciliter (mg/dL), Patient Global Assessment of Disease Activity using visual analog scale (VAS) \<=1 cm.
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Timepoint [23]
0
0
Year 3 after entry into JADY
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Secondary outcome [24]
0
0
Percentage of Participants Maintaining American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) Boolean Remission Response
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Assessment method [24]
0
0
Boolean-based definition of remission, all 4 criteria below must be met: tender joint count (TJC28 ) \<=1, swollen joint count (SJC28) \<=1, hsCRP \<=1 milligram per deciliter (mg/dL), Patient Global Assessment of Disease Activity using visual analog scale (VAS) \<=1 cm.
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Timepoint [24]
0
0
Year 5 after entry into JADY
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Secondary outcome [25]
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0
Change From Baseline of Originating Study in Modified Total Sharp Score (mTSS)
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Assessment method [25]
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0
X-rays of the hands/wrists and feet were scored for structural progression as measured using the mTSS. This methodology quantified the extent of bone erosions and joint space narrowing (JSN) for 44 and 42 joints, with higher scores representing greater damage. The mTSS at a time point is the sum of the erosion (range from 0 to 280) and JSN (range from 0 to 168) scores, for a maximum score of 448. Least Squares Mean (LSM) was calculated using a mixed model for repeated measures (MMRM) with treatment, visit, treatment-by-visit-interactions as fixed categorical effects and baseline and baseline-by-visit-interactions as fixed continuous effects.
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Timepoint [25]
0
0
Baseline, Year 1
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Secondary outcome [26]
0
0
Change From Baseline of Originating Study in Modified Total Sharp Score (mTSS)
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Assessment method [26]
0
0
X-rays of the hands/wrists and feet were scored for structural progression as measured using the mTSS. This methodology quantified the extent of bone erosions and joint space narrowing (JSN) for 44 and 42 joints, with higher scores representing greater damage. The mTSS at a time point is the sum of the erosion (range from 0 to 280) and JSN (range from 0 to 168) scores, for a maximum score of 448. Least Squares Mean (LSM) was calculated using a mixed model for repeated measures (MMRM) with treatment, visit, treatment-by-visit-interactions as fixed categorical effects and baseline and baseline-by-visit-interactions as fixed continuous effects.
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Timepoint [26]
0
0
Baseline, Year 3
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Secondary outcome [27]
0
0
Change From Baseline of Originating Study in Modified Total Sharp Score (mTSS)
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Assessment method [27]
0
0
X-rays of the hands/wrists and feet were scored for structural progression as measured using the mTSS. This methodology quantified the extent of bone erosions and joint space narrowing (JSN) for 44 and 42 joints, with higher scores representing greater damage. The mTSS at a time point is the sum of the erosion (range from 0 to 280) and JSN (range from 0 to 168) scores, for a maximum score of 448. Least Squares Mean (LSM) was calculated using a mixed model for repeated measures (MMRM) with treatment, visit, treatment-by-visit-interactions as fixed categorical effects and baseline and baseline-by-visit-interactions as fixed continuous effects.
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Timepoint [27]
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0
Baseline, Year 5
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Secondary outcome [28]
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0
Percentage of Participants With mTSS Change =0
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Assessment method [28]
0
0
X-rays of the hands/wrists and feet were scored for structural progression as measured using the mTSS. This methodology quantified the extent of bone erosions and joint space narrowing (JSN) for 44 and 42 joints, with higher scores representing greater damage. The mTSS at a time point is the sum of the erosion (range from 0 to 280) and JSN (range from 0 to 168) scores, for a maximum score of 448, with higher scores representing greater damage.
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Timepoint [28]
0
0
Year 1 after entry into JADY
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Secondary outcome [29]
0
0
Percentage of Participants With mTSS Change =0
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Assessment method [29]
0
0
X-rays of the hands/wrists and feet were scored for structural progression as measured using the mTSS. This methodology quantified the extent of bone erosions and joint space narrowing (JSN) for 44 and 42 joints, with higher scores representing greater damage. The mTSS at a time point is the sum of the erosion (range from 0 to 280) and JSN (range from 0 to 168) scores, for a maximum score of 448, with higher scores representing greater damage.
Query!
Timepoint [29]
0
0
Year 3 after entry into JADY
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Secondary outcome [30]
0
0
Percentage of Participants With mTSS Change =0
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Assessment method [30]
0
0
X-rays of the hands/wrists and feet were scored for structural progression as measured using the mTSS. This methodology quantified the extent of bone erosions and joint space narrowing (JSN) for 44 and 42 joints, with higher scores representing greater damage. The mTSS at a time point is the sum of the erosion (range from 0 to 280) and JSN (range from 0 to 168) scores, for a maximum score of 448, with higher scores representing greater damage.
Query!
Timepoint [30]
0
0
Year 5 after entry into JADY
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Secondary outcome [31]
0
0
Change From Baseline of Originating Study in Joint Space Narrowing at Year 1
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Assessment method [31]
0
0
X-rays of the hands/wrists and feet were assessed for joint space narrowing (JSN) and bone erosions. Assessment of JSN for each hand (15 joints per hand) and foot (6 joints per foot), including subluxation, is scored from 0 to 4, with 0 indicating no (normal) JSN and 4 indicating complete loss of joint space, bony ankylosis or luxation. JSN scores ranged from 0-168. A score of 0 would indicate no change and higher scores represent a worsening of joint space narrowing.
Query!
Timepoint [31]
0
0
Baseline, Year 1
Query!
Secondary outcome [32]
0
0
Change From Baseline of Originating Study in Joint Space Narrowing at Year 3
Query!
Assessment method [32]
0
0
X-rays of the hands/wrists and feet were assessed for joint space narrowing (JSN) and bone erosions. Assessment of JSN for each hand (15 joints per hand) and foot (6 joints per foot), including subluxation, is scored from 0 to 4, with 0 indicating no (normal) JSN and 4 indicating complete loss of joint space, bony ankylosis or luxation. JSN scores ranged from 0-168. A score of 0 would indicate no change and higher scores represent a worsening of joint space narrowing.
Query!
Timepoint [32]
0
0
Baseline, Year 3
Query!
Secondary outcome [33]
0
0
Change From Baseline of Originating Study in Joint Space Narrowing at Year 5
Query!
Assessment method [33]
0
0
X-rays of the hands/wrists and feet were assessed for joint space narrowing (JSN) and bone erosions. Assessment of JSN for each hand (15 joints per hand) and foot (6 joints per foot), including subluxation, is scored from 0 to 4, with 0 indicating no (normal) JSN and 4 indicating complete loss of joint space, bony ankylosis or luxation. JSN scores ranged from 0-168. A score of 0 would indicate no change and higher scores represent a worsening of joint space narrowing
Query!
Timepoint [33]
0
0
Baseline, Year 5
Query!
Secondary outcome [34]
0
0
Change From Baseline of Originating Study in Duration of Morning Stiffness
Query!
Assessment method [34]
0
0
Participants reported the duration of their morning joint stiffness (MJS) in hours and minutes. The participants were asked about their duration of morning joint stiffness on the day prior to the study visit to capture actual symptoms, since the participant may have had an atypical morning routine on the day of the study visit. If morning joint stiffness duration was longer than 12 hours (720 minutes), it was truncated to 720 minutes for statistical presentations and analyses. A decrease in duration of morning joint stiffness indicated an improvement in the participant's condition.
Query!
Timepoint [34]
0
0
Baseline, Year 1
Query!
Secondary outcome [35]
0
0
Change From Baseline of Originating Study in Duration of Morning Stiffness
Query!
Assessment method [35]
0
0
Participants reported the duration of their morning joint stiffness (MJS) in hours and minutes. The participants were asked about their duration of morning joint stiffness on the day prior to the study visit to capture actual symptoms, since the participant may have had an atypical morning routine on the day of the study visit. If morning joint stiffness duration was longer than 12 hours (720 minutes), it was truncated to 720 minutes for statistical presentations and analyses. A decrease in duration of morning joint stiffness indicated an improvement in the participant's condition.
Query!
Timepoint [35]
0
0
Baseline, Year 3
Query!
Secondary outcome [36]
0
0
Change From Baseline of Originating Study in Duration of Morning Stiffness
Query!
Assessment method [36]
0
0
Participants reported the duration of their morning joint stiffness (MJS) in hours and minutes. The participants were asked about their duration of morning joint stiffness on the day prior to the study visit to capture actual symptoms, since the participant may have had an atypical morning routine on the day of the study visit. If morning joint stiffness duration was longer than 12 hours (720 minutes), it was truncated to 720 minutes for statistical presentations and analyses. A decrease in duration of morning joint stiffness indicated an improvement in the participant's condition.
Query!
Timepoint [36]
0
0
Baseline, Year 5
Query!
Secondary outcome [37]
0
0
Change From Baseline of Originating Study in European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) Health State Scores
Query!
Assessment method [37]
0
0
The European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) is a standardized measure of health status of the participant. The first component is a descriptive system of the respondent's health comprised of the following 5 participant-reported dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The responses are used to derive the health state index scores using the United Kingdom (UK) algorithm, with scores ranging from -0.594 to 1, and the United States (US) algorithm, with scores ranging from -0.109 to 1. A higher score indicates better health state.
Query!
Timepoint [37]
0
0
Baseline, Year 1
Query!
Secondary outcome [38]
0
0
Change From Baseline of Originating Study in European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) Health State Scores
Query!
Assessment method [38]
0
0
The European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) is a standardized measure of health status of the participant. The first component is a descriptive system of the respondent's health comprised of the following 5 participant-reported dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The responses are used to derive the health state index scores using the United Kingdom (UK) algorithm, with scores ranging from -0.594 to 1, and the United States (US) algorithm, with scores ranging from -0.109 to 1. A higher score indicates better health state.
Query!
Timepoint [38]
0
0
Baseline, Year 3
Query!
Secondary outcome [39]
0
0
Change From Baseline of Originating Study in European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) Health State Scores
Query!
Assessment method [39]
0
0
The European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) is a standardized measure of health status of the participant. The first component is a descriptive system of the respondent's health comprised of the following 5 participant-reported dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The responses are used to derive the health state index scores using the United Kingdom (UK) algorithm, with scores ranging from -0.594 to 1, and the United States (US) algorithm, with scores ranging from -0.109 to 1. A higher score indicates better health state.
Query!
Timepoint [39]
0
0
Baseline, Year 5
Query!
Secondary outcome [40]
0
0
Change From Baseline of Originating Study in European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) Scores (Self-Perceived Health)
Query!
Assessment method [40]
0
0
The European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) is a standardized measure of health status of the participant. The second component is a self-perceived health score which is assessed using a VAS that ranged from 0 to 100 millimeter (mm), where 0 mm indicated the worst health you can imagine and 100 mm indicated the best health you can imagine.
Query!
Timepoint [40]
0
0
Baseline, Year 1
Query!
Secondary outcome [41]
0
0
Change From Baseline of Originating Study in European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) Scores (Self-Perceived Health)
Query!
Assessment method [41]
0
0
The European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) is a standardized measure of health status of the participant. The second component is a self-perceived health score which is assessed using a VAS that ranged from 0 to 100 millimeter (mm), where 0 mm indicated the worst health you can imagine and 100 mm indicated the best health you can imagine.
Query!
Timepoint [41]
0
0
Baseline, Year 3
Query!
Secondary outcome [42]
0
0
Change From Baseline of Originating Study in European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) Scores (Self-Perceived Health)
Query!
Assessment method [42]
0
0
The European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) is a standardized measure of health status of the participant. The second component is a self-perceived health score which is assessed using a VAS that ranged from 0 to 100 millimeter (mm), where 0 mm indicated the worst health you can imagine and 100 mm indicated the best health you can imagine.
Query!
Timepoint [42]
0
0
Baseline, Year 5
Query!
Secondary outcome [43]
0
0
Percentage of Participants Maintaining a Clinical Disease Activity Index Score (CDAI) =10
Query!
Assessment method [43]
0
0
The CDAI is a tool for measurement of disease activity in RA that does not require a laboratory component and was scored by the investigative site. It integrates TJC28 (scored 0-28 with higher scores indicating higher disease activity), SJC28 (scored 0-28 with higher scores indicating higher disease activity), Patient's Global Assessment of Disease Activity (scored on a visual analogue scale from 0-10 cm with higher scores indicating higher disease activity), and Physician's Global Assessment of Disease Activity (scored on a visual analogue scale from 0-10 cm with higher scores indicating higher disease activity). The CDAI is calculated by summing the values of the 4 components. CDAI scores range from 0 to 76; lower scores indicated lower disease activity. A negative change from baseline indicates improvement in condition.
Query!
Timepoint [43]
0
0
Year 1 after entry into JADY
Query!
Secondary outcome [44]
0
0
Percentage of Participants Maintaining a Clinical Disease Activity Index Score (CDAI) =10
Query!
Assessment method [44]
0
0
The CDAI is a tool for measurement of disease activity in RA that does not require a laboratory component and was scored by the investigative site. It integrates TJC28 (scored 0-28 with higher scores indicating higher disease activity), SJC28 (scored 0-28 with higher scores indicating higher disease activity), Patient's Global Assessment of Disease Activity (scored on a visual analogue scale from 0-10 cm with higher scores indicating higher disease activity), and Physician's Global Assessment of Disease Activity (scored on a visual analogue scale from 0-10 cm with higher scores indicating higher disease activity). The CDAI is calculated by summing the values of the 4 components. CDAI scores range from 0 to 76; lower scores indicated lower disease activity. A negative change from baseline indicates improvement in condition.
Query!
Timepoint [44]
0
0
Year 3 after entry into JADY
Query!
Secondary outcome [45]
0
0
Percentage of Participants Maintaining a Clinical Disease Activity Index Score (CDAI) =10
Query!
Assessment method [45]
0
0
The CDAI is a tool for measurement of disease activity in RA that does not require a laboratory component and was scored by the investigative site. It integrates TJC28 (scored 0-28 with higher scores indicating higher disease activity), SJC28 (scored 0-28 with higher scores indicating higher disease activity), Patient's Global Assessment of Disease Activity (scored on a visual analogue scale from 0-10 cm with higher scores indicating higher disease activity), and Physician's Global Assessment of Disease Activity (scored on a visual analogue scale from 0-10 cm with higher scores indicating higher disease activity). The CDAI is calculated by summing the values of the 4 components. CDAI scores range from 0 to 76; lower scores indicated lower disease activity. A negative change from baseline indicates improvement in condition.
Query!
Timepoint [45]
0
0
Years 5 after entry into JADY
Query!
Secondary outcome [46]
0
0
Percentage of Participants Maintaining a Clinical Disease Activity Index Score (CDAI) = 2.8
Query!
Assessment method [46]
0
0
The CDAI is a tool for measurement of disease activity in RA that does not require a laboratory component and was scored by the investigative site. It integrates TJC28 (scored 0-28 with higher scores indicating higher disease activity), SJC28 (scored 0-28 with higher scores indicating higher disease activity), Patient's Global Assessment of Disease Activity (scored on a visual analogue scale from 0-10 cm with higher scores indicating higher disease activity), and Physician's Global Assessment of Disease Activity (scored on a visual analogue scale from 0-10 cm with higher scores indicating higher disease activity). The CDAI is calculated by summing the values of the 4 components. CDAI scores range from 0 to 76; lower scores indicated lower disease activity. A negative change from baseline indicates improvement in condition.
Query!
Timepoint [46]
0
0
Year 1 after entry into JADY
Query!
Secondary outcome [47]
0
0
Percentage of Participants Maintaining a Clinical Disease Activity Index Score (CDAI) =2.8
Query!
Assessment method [47]
0
0
The CDAI is a tool for measurement of disease activity in RA that does not require a laboratory component and was scored by the investigative site. It integrates TJC28 (scored 0-28 with higher scores indicating higher disease activity), SJC28 (scored 0-28 with higher scores indicating higher disease activity), Patient's Global Assessment of Disease Activity (scored on a visual analogue scale from 0-10 cm with higher scores indicating higher disease activity), and Physician's Global Assessment of Disease Activity (scored on a visual analogue scale from 0-10 cm with higher scores indicating higher disease activity). The CDAI is calculated by summing the values of the 4 components. CDAI scores range from 0 to 76; lower scores indicated lower disease activity. A negative change from baseline indicates improvement in condition.
Query!
Timepoint [47]
0
0
Year 3 after entry into JADY
Query!
Secondary outcome [48]
0
0
Percentage of Participants Maintaining a Clinical Disease Activity Index Score (CDAI) =2.8
Query!
Assessment method [48]
0
0
The CDAI is a tool for measurement of disease activity in RA that does not require a laboratory component and was scored by the investigative site. It integrates TJC28 (scored 0-28 with higher scores indicating higher disease activity), SJC28 (scored 0-28 with higher scores indicating higher disease activity), Patient's Global Assessment of Disease Activity (scored on a visual analogue scale from 0-10 cm with higher scores indicating higher disease activity), and Physician's Global Assessment of Disease Activity (scored on a visual analogue scale from 0-10 cm with higher scores indicating higher disease activity). The CDAI is calculated by summing the values of the 4 components. CDAI scores range from 0 to 76; lower scores indicated lower disease activity. A negative change from baseline indicates improvement in condition.
Query!
Timepoint [48]
0
0
Year 5 after entry into JADY
Query!
Secondary outcome [49]
0
0
Percentage of Participants Maintaining a Health Assessment Questionnaire Disability Index (HAQ-DI) Improvement =0.22
Query!
Assessment method [49]
0
0
The HAQ-DI questionnaire assesses the participant's self-perception on the degree of difficulty \[0 (without any difficulty), 1 (with some difficulty), 2 (with much difficulty), and 3 (unable to do)\] when dressing and grooming, arising, eating, walking, hygiene, reaching, gripping, and performing other daily activities. Scores for each functional area were averaged to calculate HAQ-DI scores, which ranged from 0 (no disability) to 3 (worst disability). A decrease in HAQ-DI score indicated an improvement in the participant's condition. An improvement of 0.22 or 0.3 points on the HAQ-DI has been identified as a minimal clinically important difference in Rheumatoid Arthritis participants.
Query!
Timepoint [49]
0
0
Year 1 after entry into JADY
Query!
Secondary outcome [50]
0
0
Percentage of Participants Maintaining a Health Assessment Questionnaire Disability Index (HAQ-DI) Improvement =0.22
Query!
Assessment method [50]
0
0
The HAQ-DI questionnaire assesses the participant's self-perception on the degree of difficulty \[0 (without any difficulty), 1 (with some difficulty), 2 (with much difficulty), and 3 (unable to do)\] when dressing and grooming, arising, eating, walking, hygiene, reaching, gripping, and performing other daily activities. Scores for each functional area were averaged to calculate HAQ-DI scores, which ranged from 0 (no disability) to 3 (worst disability). A decrease in HAQ-DI score indicated an improvement in the participant's condition. An improvement of 0.22 or 0.3 points on the HAQ-DI has been identified as a minimal clinically important difference in Rheumatoid Arthritis participants.
Query!
Timepoint [50]
0
0
Year 3 after entry into JADY
Query!
Secondary outcome [51]
0
0
Percentage of Participants Maintaining a Health Assessment Questionnaire Disability Index (HAQ-DI) Improvement =0.22
Query!
Assessment method [51]
0
0
The HAQ-DI questionnaire assesses the participant's self-perception on the degree of difficulty \[0 (without any difficulty), 1 (with some difficulty), 2 (with much difficulty), and 3 (unable to do)\] when dressing and grooming, arising, eating, walking, hygiene, reaching, gripping, and performing other daily activities. Scores for each functional area were averaged to calculate HAQ-DI scores, which ranged from 0 (no disability) to 3 (worst disability). A decrease in HAQ-DI score indicated an improvement in the participant's condition. An improvement of 0.22 or 0.3 points on the HAQ-DI has been identified as a minimal clinically important difference in Rheumatoid Arthritis participants.
Query!
Timepoint [51]
0
0
Year 5 after entry into JADY
Query!
Secondary outcome [52]
0
0
Percentage of Participants Maintaining a Health Assessment Questionnaire Disability Index (HAQ-DI) Improvement =0.3
Query!
Assessment method [52]
0
0
The HAQ-DI questionnaire assesses the participant's self-perception on the degree of difficulty \[0 (without any difficulty), 1 (with some difficulty), 2 (with much difficulty), and 3 (unable to do)\] when dressing and grooming, arising, eating, walking, hygiene, reaching, gripping, and performing other daily activities. Scores for each functional area were averaged to calculate HAQ-DI scores, which ranged from 0 (no disability) to 3 (worst disability). A decrease in HAQ-DI score indicated an improvement in the participant's condition.
An improvement of 0.22 or 0.3 points on the HAQ-DI has been identified as a minimal clinically important difference in Rheumatoid Arthritis participants.
Query!
Timepoint [52]
0
0
Year 1 after entry into JADY
Query!
Secondary outcome [53]
0
0
Percentage of Participants Maintaining a Health Assessment Questionnaire Disability Index (HAQ-DI) Improvement =0.3
Query!
Assessment method [53]
0
0
The HAQ-DI questionnaire assesses the participant's self-perception on the degree of difficulty \[0 (without any difficulty), 1 (with some difficulty), 2 (with much difficulty), and 3 (unable to do)\] when dressing and grooming, arising, eating, walking, hygiene, reaching, gripping, and performing other daily activities. Scores for each functional area were averaged to calculate HAQ-DI scores, which ranged from 0 (no disability) to 3 (worst disability). A decrease in HAQ-DI score indicated an improvement in the participant's condition.
An improvement of 0.22 or 0.3 points on the HAQ-DI has been identified as a minimal clinically important difference in Rheumatoid Arthritis participants.
Query!
Timepoint [53]
0
0
Year 3 after entry into JADY
Query!
Secondary outcome [54]
0
0
Percentage of Participants Maintaining a Health Assessment Questionnaire Disability Index (HAQ-DI) Improvement =0.3
Query!
Assessment method [54]
0
0
The HAQ-DI questionnaire assesses the participant's self-perception on the degree of difficulty \[0 (without any difficulty), 1 (with some difficulty), 2 (with much difficulty), and 3 (unable to do)\] when dressing and grooming, arising, eating, walking, hygiene, reaching, gripping, and performing other daily activities. Scores for each functional area were averaged to calculate HAQ-DI scores, which ranged from 0 (no disability) to 3 (worst disability). A decrease in HAQ-DI score indicated an improvement in the participant's condition.
An improvement of 0.22 or 0.3 points on the HAQ-DI has been identified as a minimal clinically important difference in Rheumatoid Arthritis participants.
Query!
Timepoint [54]
0
0
Year 5 after entry into JADY
Query!
Secondary outcome [55]
0
0
Change From Baseline of Originating Study in Bone Erosion Score
Query!
Assessment method [55]
0
0
The joint erosion score is a summary of erosion severity in 32 joints of the hands and 12 joints of the feet. The maximum erosion score for a hand joint is 5 and for a foot joint is 10. Thus, the maximal erosion score is 280 for a timepoint (160 for both hands/ wrists and 120 for both feet).
Each joint is scored according to the surface area involved from 0 to 5 for hand joints and 0 to 10 for the foot joints. The highest score (5 for the hand and 10 for the foot) indicates extensive loss of bone from more than one half of the articulating bone. A score of 0 in either the hand or foot joints indicates no erosion.
LSM was calculated using an MMRM model with treatment, baseline value, visit, and the interactions of baseline-by-visit and treatment-by-visit as fixed factors.
Query!
Timepoint [55]
0
0
Baseline, Year 1
Query!
Secondary outcome [56]
0
0
Change From Baseline of Originating Study in Bone Erosion Score
Query!
Assessment method [56]
0
0
The joint erosion score is a summary of erosion severity in 32 joints of the hands and 12 joints of the feet. The maximum erosion score for a hand joint is 5 and for a foot joint is 10. Thus, the maximal erosion score is 280 for a timepoint (160 for both hands/ wrists and 120 for both feet). Each joint is scored according to the surface area involved from 0 to 5 for hand joints and 0 to 10 for the foot joints. The highest score (5 for the hand and 10 for the foot) indicates extensive loss of bone from more than one half of the articulating bone. A score of 0 in either the hand or foot joints indicates no erosion.
LSM was calculated using an MMRM model with treatment, baseline value, visit, and the interactions of baseline-by-visit and treatment-by-visit as fixed factors.
Query!
Timepoint [56]
0
0
Baseline, Year 3
Query!
Secondary outcome [57]
0
0
Change From Baseline of Originating Study in Bone Erosion Score
Query!
Assessment method [57]
0
0
The joint erosion score is a summary of erosion severity in 32 joints of the hands and 12 joints of the feet. The maximum erosion score for a hand joint is 5 and for a foot joint is 10. Thus, the maximal erosion score is 280 for a timepoint (160 for both hands/ wrists and 120 for both feet). Each joint is scored according to the surface area involved from 0 to 5 for hand joints and 0 to 10 for the foot joints. The highest score (5 for the hand and 10 for the foot) indicates extensive loss of bone from more than one half of the articulating bone. A score of 0 in either the hand or foot joints indicates no erosion.
LSM was calculated using an MMRM model with treatment, baseline value, visit, and the interactions of baseline-by-visit and treatment-by-visit as fixed factors.
Query!
Timepoint [57]
0
0
Baseline, Year 5
Query!
Secondary outcome [58]
0
0
Healthcare Resource Utilization
Query!
Assessment method [58]
0
0
Number of visits to medical care providers related to treatment of Rheumatoid Arthritis (RA) outside of the clinical study. Reported here are healthcare consultations and emergency room consultations from end of originating study to end of participation in study JADY.
Query!
Timepoint [58]
0
0
Baseline up to 84 Months
Query!
Secondary outcome [59]
0
0
Percentage of Participants Maintaining a Simplified Disease Activity Index (SDAI) =11
Query!
Assessment method [59]
0
0
SDAI is a tool for measurement of disease activity in RA that integrates TJC28, SJC28, acute phase response using C-reactive protein (milligrams per liter), Patient's Global Assessment of Disease Activity using visual analog scale (cm), and Physician's Global Assessment of Disease Activity using visual analog scale (cm). The SDAI is calculated by summing the values of the 5 components. Lower scores indicated less disease activity.
The SDAI is expressed as a score on a scale with the minimum score=0 (best) to maximum score=86 (worst). Low disease activity is defined as a SDAI score =11.
Query!
Timepoint [59]
0
0
Year 1 after entry into JADY
Query!
Secondary outcome [60]
0
0
Percentage of Participants Maintaining a Simplified Disease Activity Index (SDAI) =11
Query!
Assessment method [60]
0
0
SDAI is a tool for measurement of disease activity in RA that integrates TJC28, SJC28, acute phase response using C-reactive protein (milligrams per liter), Patient's Global Assessment of Disease Activity using visual analog scale (cm), and Physician's Global Assessment of Disease Activity using visual analog scale (cm). The SDAI is calculated by summing the values of the 5 components. Lower scores indicated less disease activity.
The SDAI is expressed as a score on a scale with the minimum score=0 (best) to maximum score=86 (worst). Low disease activity is defined as a SDAI score =11.
Query!
Timepoint [60]
0
0
Year 3 after entry into JADY
Query!
Secondary outcome [61]
0
0
Percentage of Participants Maintaining a Simplified Disease Activity Index (SDAI) =11
Query!
Assessment method [61]
0
0
SDAI is a tool for measurement of disease activity in RA that integrates TJC28, SJC28, acute phase response using C-reactive protein (milligrams per liter), Patient's Global Assessment of Disease Activity using visual analog scale (cm), and Physician's Global Assessment of Disease Activity using visual analog scale (cm). The SDAI is calculated by summing the values of the 5 components. Lower scores indicated less disease activity.
The SDAI is expressed as a score on a scale with the minimum score=0 (best) to maximum score=86 (worst). Low disease activity is defined as a SDAI score =11.
Query!
Timepoint [61]
0
0
Year 5 after entry into JADY
Query!
Secondary outcome [62]
0
0
Percentage of Participants Maintaining a Simplified Disease Activity Index (SDAI) =3.3
Query!
Assessment method [62]
0
0
SDAI is a tool for measurement of disease activity in RA that integrates TJC28, SJC28, acute phase response using C-reactive protein (milligrams per liter), Patient's Global Assessment of Disease Activity using visual analog scale (cm), and Physician's Global Assessment of Disease Activity using visual analog scale (cm). The SDAI is calculated by summing the values of the 5 components. Lower scores indicated less disease activity.
The SDAI is expressed as a score on a scale with the minimum score=0 (best) to maximum score=86 (worst). Disease remission is defined as an SDAI score of =3.3.
Query!
Timepoint [62]
0
0
Year 1 after entry into JADY
Query!
Secondary outcome [63]
0
0
Percentage of Participants Maintaining a Simplified Disease Activity Index (SDAI) =3.3
Query!
Assessment method [63]
0
0
SDAI is a tool for measurement of disease activity in RA that integrates TJC28, SJC28, acute phase response using C-reactive protein (milligrams per liter), Patient's Global Assessment of Disease Activity using visual analog scale (cm), and Physician's Global Assessment of Disease Activity using visual analog scale (cm). The SDAI is calculated by summing the values of the 5 components. Lower scores indicated less disease activity.
The SDAI is expressed as a score on a scale with the minimum score=0 (best) to maximum score=86 (worst). Disease remission is defined as an SDAI score of =3.3.
Query!
Timepoint [63]
0
0
Year 3 after entry into JADY
Query!
Secondary outcome [64]
0
0
Percentage of Participants Maintaining a Simplified Disease Activity Index (SDAI) =3.3
Query!
Assessment method [64]
0
0
SDAI is a tool for measurement of disease activity in RA that integrates TJC28, SJC28, acute phase response using C-reactive protein (milligrams per liter), Patient's Global Assessment of Disease Activity using visual analog scale (cm), and Physician's Global Assessment of Disease Activity using visual analog scale (cm). The SDAI is calculated by summing the values of the 5 components. Lower scores indicated less disease activity.
The SDAI is expressed as a score on a scale with the minimum score=0 (best) to maximum score=86 (worst). Disease remission is defined as an SDAI score of =3.3.
Query!
Timepoint [64]
0
0
Year 5 after entry into JADY
Query!
Secondary outcome [65]
0
0
Percentage of Participants With Relapse Event During the 96-Week Step-Down Period
Query!
Assessment method [65]
0
0
Relapse is defined as a Clinical Disease Activity Index score \> 10. The CDAI is a tool for measurement of disease activity in RA that does not require a laboratory component and was scored by the investigative site. It integrates TJC28 (scored 0-28 with higher scores indicating higher disease activity), SJC28 (scored 0-28 with higher scores indicating higher disease activity), Patient's Global Assessment of Disease Activity (scored on a visual analogue scale from 0-10 cm with higher scores indicating higher disease activity), and Physician's Global Assessment of Disease Activity (scored on a visual analogue scale from 0-10 cm with higher scores indicating higher disease activity). The CDAI is calculated by summing the values of the 4 components. CDAI scores range from 0 to 76; lower scores indicated lower disease activity.
Total number of participants at risk multiplied by estimate of cumulative event probability would need to be rounded up or down to get a whole number.
Query!
Timepoint [65]
0
0
Week 0 through Week 96 of Step-down
Query!
Eligibility
Key inclusion criteria
* Have completed the final active treatment in study JADV (NCT01710358), JADZ (NCT01711359), JADX (NCT01721057), JADW (NCT01721044), JADA (NCT01185353) or JAGS (NCT02265705)
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
* Have significant uncontrolled cerebro-cardiovascular (eg, myocardial infarction [MI], unstable angina, unstable arterial hypertension, severe heart failure, or cerebrovascular accident), respiratory, hepatic, renal, gastrointestinal, endocrine, hematologic, neuropsychiatric disorders, or abnormal laboratory values that developed during a previous baricitinib study that, in the opinion of the investigator, pose an unacceptable risk to the participant if investigational product continues to be administered
* Have a known hypersensitivity to baricitinib or any component of this investigational product
* Had investigational product permanently discontinued at any time during a previous baricitinib study
* Had temporary investigational product interruption at the final study visit of a previous baricitinib study and, in the opinion of the investigator, this poses an unacceptable risk for participation in the study
* Have any other condition that, in the opinion of the investigator, renders the participant unable to understand the nature, scope, and possible consequences of the study or precludes the participant from following and completing the protocol
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
27/06/2013
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
12/11/2020
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
2877
Query!
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,VIC
Query!
Recruitment hospital [1]
0
0
Canberra Hospital - Garran
Query!
Recruitment hospital [2]
0
0
Royal Prince Alfred Hospital - Camperdown
Query!
Recruitment hospital [3]
0
0
Combined Rheumatology Practice (CRP) - Kogarah
Query!
Recruitment hospital [4]
0
0
Coast Joint Care - Maroochydore
Query!
Recruitment hospital [5]
0
0
Emeritus Research - Camberwell
Query!
Recruitment hospital [6]
0
0
St Vincents Hospital Melbourne - Fitzroy
Query!
Recruitment postcode(s) [1]
0
0
2605 - Garran
Query!
Recruitment postcode(s) [2]
0
0
2050 - Camperdown
Query!
Recruitment postcode(s) [3]
0
0
2217 - Kogarah
Query!
Recruitment postcode(s) [4]
0
0
4558 - Maroochydore
Query!
Recruitment postcode(s) [5]
0
0
3124 - Camberwell
Query!
Recruitment postcode(s) [6]
0
0
3065 - Fitzroy
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Arizona
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
California
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
Colorado
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Connecticut
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Delaware
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Florida
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Idaho
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Illinois
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Indiana
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
Maryland
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
Michigan
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
Mississippi
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
Missouri
Query!
Country [14]
0
0
United States of America
Query!
State/province [14]
0
0
Nevada
Query!
Country [15]
0
0
United States of America
Query!
State/province [15]
0
0
New Jersey
Query!
Country [16]
0
0
United States of America
Query!
State/province [16]
0
0
New Mexico
Query!
Country [17]
0
0
United States of America
Query!
State/province [17]
0
0
New York
Query!
Country [18]
0
0
United States of America
Query!
State/province [18]
0
0
North Carolina
Query!
Country [19]
0
0
United States of America
Query!
State/province [19]
0
0
Ohio
Query!
Country [20]
0
0
United States of America
Query!
State/province [20]
0
0
Oklahoma
Query!
Country [21]
0
0
United States of America
Query!
State/province [21]
0
0
Oregon
Query!
Country [22]
0
0
United States of America
Query!
State/province [22]
0
0
Pennsylvania
Query!
Country [23]
0
0
United States of America
Query!
State/province [23]
0
0
South Carolina
Query!
Country [24]
0
0
United States of America
Query!
State/province [24]
0
0
Texas
Query!
Country [25]
0
0
United States of America
Query!
State/province [25]
0
0
Virginia
Query!
Country [26]
0
0
United States of America
Query!
State/province [26]
0
0
Washington
Query!
Country [27]
0
0
United States of America
Query!
State/province [27]
0
0
Wisconsin
Query!
Country [28]
0
0
Argentina
Query!
State/province [28]
0
0
Buenos Aires
Query!
Country [29]
0
0
Argentina
Query!
State/province [29]
0
0
Ciudad Autonoma Buenos Aires
Query!
Country [30]
0
0
Argentina
Query!
State/province [30]
0
0
Ciudad Autonoma De Buenos Aire
Query!
Country [31]
0
0
Argentina
Query!
State/province [31]
0
0
Santa Fe
Query!
Country [32]
0
0
Argentina
Query!
State/province [32]
0
0
Tucuman
Query!
Country [33]
0
0
Argentina
Query!
State/province [33]
0
0
Tucumán
Query!
Country [34]
0
0
Argentina
Query!
State/province [34]
0
0
Ciudad Autonoma de Buenos Aire
Query!
Country [35]
0
0
Argentina
Query!
State/province [35]
0
0
Cordoba
Query!
Country [36]
0
0
Argentina
Query!
State/province [36]
0
0
San Juan
Query!
Country [37]
0
0
Austria
Query!
State/province [37]
0
0
Steiermark
Query!
Country [38]
0
0
Austria
Query!
State/province [38]
0
0
Wien
Query!
Country [39]
0
0
Belgium
Query!
State/province [39]
0
0
Brussel
Query!
Country [40]
0
0
Belgium
Query!
State/province [40]
0
0
Oost-Vlaanderen
Query!
Country [41]
0
0
Belgium
Query!
State/province [41]
0
0
Vlaams Gewest
Query!
Country [42]
0
0
Belgium
Query!
State/province [42]
0
0
Genk
Query!
Country [43]
0
0
Belgium
Query!
State/province [43]
0
0
Mons
Query!
Country [44]
0
0
Brazil
Query!
State/province [44]
0
0
SP
Query!
Country [45]
0
0
Brazil
Query!
State/province [45]
0
0
São Paulo
Query!
Country [46]
0
0
Canada
Query!
State/province [46]
0
0
Alberta
Query!
Country [47]
0
0
Canada
Query!
State/province [47]
0
0
British Columbia
Query!
Country [48]
0
0
Canada
Query!
State/province [48]
0
0
Manitoba
Query!
Country [49]
0
0
Canada
Query!
State/province [49]
0
0
Ontario
Query!
Country [50]
0
0
Canada
Query!
State/province [50]
0
0
Quebec
Query!
Country [51]
0
0
Canada
Query!
State/province [51]
0
0
Saskatchewan
Query!
Country [52]
0
0
China
Query!
State/province [52]
0
0
Anhui
Query!
Country [53]
0
0
China
Query!
State/province [53]
0
0
Beijing
Query!
Country [54]
0
0
China
Query!
State/province [54]
0
0
Guangdong
Query!
Country [55]
0
0
China
Query!
State/province [55]
0
0
Guangzhou
Query!
Country [56]
0
0
China
Query!
State/province [56]
0
0
Hunan
Query!
Country [57]
0
0
China
Query!
State/province [57]
0
0
Jiangsu
Query!
Country [58]
0
0
China
Query!
State/province [58]
0
0
Jiangxi
Query!
Country [59]
0
0
China
Query!
State/province [59]
0
0
Shandong
Query!
Country [60]
0
0
China
Query!
State/province [60]
0
0
Shanghai
Query!
Country [61]
0
0
China
Query!
State/province [61]
0
0
Sichuan
Query!
Country [62]
0
0
China
Query!
State/province [62]
0
0
Yunnan
Query!
Country [63]
0
0
China
Query!
State/province [63]
0
0
Zhejiang
Query!
Country [64]
0
0
Croatia
Query!
State/province [64]
0
0
Osijek
Query!
Country [65]
0
0
Croatia
Query!
State/province [65]
0
0
Zagreb
Query!
Country [66]
0
0
Czechia
Query!
State/province [66]
0
0
Praha, Hlavní Mešto
Query!
Country [67]
0
0
Czechia
Query!
State/province [67]
0
0
Brno
Query!
Country [68]
0
0
Czechia
Query!
State/province [68]
0
0
Bruntal
Query!
Country [69]
0
0
Czechia
Query!
State/province [69]
0
0
Hustopece
Query!
Country [70]
0
0
Czechia
Query!
State/province [70]
0
0
Ostrava
Query!
Country [71]
0
0
Czechia
Query!
State/province [71]
0
0
Pardubice
Query!
Country [72]
0
0
Czechia
Query!
State/province [72]
0
0
Uherske Hradiste
Query!
Country [73]
0
0
Czechia
Query!
State/province [73]
0
0
Zlin
Query!
Country [74]
0
0
Denmark
Query!
State/province [74]
0
0
Hovedstaden
Query!
Country [75]
0
0
Denmark
Query!
State/province [75]
0
0
Syd
Query!
Country [76]
0
0
France
Query!
State/province [76]
0
0
Haute-Vienne
Query!
Country [77]
0
0
France
Query!
State/province [77]
0
0
Cahors CEDEX 9
Query!
Country [78]
0
0
France
Query!
State/province [78]
0
0
Chambray-lès-Tours
Query!
Country [79]
0
0
France
Query!
State/province [79]
0
0
Montpellier Cedex 5
Query!
Country [80]
0
0
France
Query!
State/province [80]
0
0
Nantes Cedex 1
Query!
Country [81]
0
0
France
Query!
State/province [81]
0
0
Orleans CEDEX 2
Query!
Country [82]
0
0
France
Query!
State/province [82]
0
0
Paris CEDEX 13
Query!
Country [83]
0
0
France
Query!
State/province [83]
0
0
Paris CEDEX 14
Query!
Country [84]
0
0
France
Query!
State/province [84]
0
0
Poitiers
Query!
Country [85]
0
0
France
Query!
State/province [85]
0
0
Rennes CEDEX 2
Query!
Country [86]
0
0
France
Query!
State/province [86]
0
0
Thionville
Query!
Country [87]
0
0
Germany
Query!
State/province [87]
0
0
Baden-Württemberg
Query!
Country [88]
0
0
Germany
Query!
State/province [88]
0
0
Bayern
Query!
Country [89]
0
0
Germany
Query!
State/province [89]
0
0
Nordrhein-Westfalen
Query!
Country [90]
0
0
Germany
Query!
State/province [90]
0
0
Sachsen-Anhalt
Query!
Country [91]
0
0
Germany
Query!
State/province [91]
0
0
Sachsen
Query!
Country [92]
0
0
Germany
Query!
State/province [92]
0
0
Berlin
Query!
Country [93]
0
0
Germany
Query!
State/province [93]
0
0
Hamburg
Query!
Country [94]
0
0
Greece
Query!
State/province [94]
0
0
Attiki
Query!
Country [95]
0
0
Greece
Query!
State/province [95]
0
0
Crete
Query!
Country [96]
0
0
Greece
Query!
State/province [96]
0
0
Larissa
Query!
Country [97]
0
0
Hungary
Query!
State/province [97]
0
0
Bacs-Kiskun
Query!
Country [98]
0
0
Hungary
Query!
State/province [98]
0
0
Bekes
Query!
Country [99]
0
0
Hungary
Query!
State/province [99]
0
0
Fejer
Query!
Country [100]
0
0
Hungary
Query!
State/province [100]
0
0
Pest
Query!
Country [101]
0
0
Hungary
Query!
State/province [101]
0
0
Szabolcs-Szatmar-Bereg
Query!
Country [102]
0
0
Hungary
Query!
State/province [102]
0
0
Budapest
Query!
Country [103]
0
0
Hungary
Query!
State/province [103]
0
0
Veszprem
Query!
Country [104]
0
0
India
Query!
State/province [104]
0
0
Andhra Pradesh
Query!
Country [105]
0
0
India
Query!
State/province [105]
0
0
Delhi
Query!
Country [106]
0
0
India
Query!
State/province [106]
0
0
Gujarat
Query!
Country [107]
0
0
India
Query!
State/province [107]
0
0
Haryana
Query!
Country [108]
0
0
India
Query!
State/province [108]
0
0
Karnataka
Query!
Country [109]
0
0
India
Query!
State/province [109]
0
0
Maharashtra
Query!
Country [110]
0
0
India
Query!
State/province [110]
0
0
Rajasthan
Query!
Country [111]
0
0
India
Query!
State/province [111]
0
0
Telangana
Query!
Country [112]
0
0
India
Query!
State/province [112]
0
0
Telengana
Query!
Country [113]
0
0
India
Query!
State/province [113]
0
0
Uttar Pradesh
Query!
Country [114]
0
0
India
Query!
State/province [114]
0
0
West Bengal
Query!
Country [115]
0
0
Israel
Query!
State/province [115]
0
0
HaDarom
Query!
Country [116]
0
0
Israel
Query!
State/province [116]
0
0
Haifa
Query!
Country [117]
0
0
Israel
Query!
State/province [117]
0
0
Jerusalem
Query!
Country [118]
0
0
Israel
Query!
State/province [118]
0
0
Kfar Saba
Query!
Country [119]
0
0
Israel
Query!
State/province [119]
0
0
Petah Tiqva
Query!
Country [120]
0
0
Israel
Query!
State/province [120]
0
0
Tel Aviv
Query!
Country [121]
0
0
Israel
Query!
State/province [121]
0
0
Zerifin
Query!
Country [122]
0
0
Israel
Query!
State/province [122]
0
0
?eifa
Query!
Country [123]
0
0
Italy
Query!
State/province [123]
0
0
Firenze
Query!
Country [124]
0
0
Italy
Query!
State/province [124]
0
0
Milano
Query!
Country [125]
0
0
Italy
Query!
State/province [125]
0
0
Pisa
Query!
Country [126]
0
0
Italy
Query!
State/province [126]
0
0
Roma
Query!
Country [127]
0
0
Italy
Query!
State/province [127]
0
0
Torino
Query!
Country [128]
0
0
Italy
Query!
State/province [128]
0
0
Verona
Query!
Country [129]
0
0
Japan
Query!
State/province [129]
0
0
Aichi
Query!
Country [130]
0
0
Japan
Query!
State/province [130]
0
0
Chiba
Query!
Country [131]
0
0
Japan
Query!
State/province [131]
0
0
Fukuoka
Query!
Country [132]
0
0
Japan
Query!
State/province [132]
0
0
Hokkaido
Query!
Country [133]
0
0
Japan
Query!
State/province [133]
0
0
Hyogo
Query!
Country [134]
0
0
Japan
Query!
State/province [134]
0
0
Ibaragi
Query!
Country [135]
0
0
Japan
Query!
State/province [135]
0
0
Ibaraki
Query!
Country [136]
0
0
Japan
Query!
State/province [136]
0
0
Iwate
Query!
Country [137]
0
0
Japan
Query!
State/province [137]
0
0
Kagawa
Query!
Country [138]
0
0
Japan
Query!
State/province [138]
0
0
Kagoshima
Query!
Country [139]
0
0
Japan
Query!
State/province [139]
0
0
Kanagawa
Query!
Country [140]
0
0
Japan
Query!
State/province [140]
0
0
Kumamoto
Query!
Country [141]
0
0
Japan
Query!
State/province [141]
0
0
Mie
Query!
Country [142]
0
0
Japan
Query!
State/province [142]
0
0
Nagasaki
Query!
Country [143]
0
0
Japan
Query!
State/province [143]
0
0
Niigata
Query!
Country [144]
0
0
Japan
Query!
State/province [144]
0
0
Okayama
Query!
Country [145]
0
0
Japan
Query!
State/province [145]
0
0
Okinawa
Query!
Country [146]
0
0
Japan
Query!
State/province [146]
0
0
Saga
Query!
Country [147]
0
0
Japan
Query!
State/province [147]
0
0
Saitama
Query!
Country [148]
0
0
Japan
Query!
State/province [148]
0
0
Shizuoka
Query!
Country [149]
0
0
Japan
Query!
State/province [149]
0
0
Tochigi
Query!
Country [150]
0
0
Japan
Query!
State/province [150]
0
0
Tokyo
Query!
Country [151]
0
0
Japan
Query!
State/province [151]
0
0
Toyama
Query!
Country [152]
0
0
Japan
Query!
State/province [152]
0
0
Yamaguchi
Query!
Country [153]
0
0
Japan
Query!
State/province [153]
0
0
Hiroshima
Query!
Country [154]
0
0
Japan
Query!
State/province [154]
0
0
Nagano
Query!
Country [155]
0
0
Japan
Query!
State/province [155]
0
0
Oita
Query!
Country [156]
0
0
Japan
Query!
State/province [156]
0
0
Osaka
Query!
Country [157]
0
0
Korea, Republic of
Query!
State/province [157]
0
0
Gyeonggi-do
Query!
Country [158]
0
0
Korea, Republic of
Query!
State/province [158]
0
0
Korea
Query!
Country [159]
0
0
Korea, Republic of
Query!
State/province [159]
0
0
Seoul-teukbyeolsi [Seoul]
Query!
Country [160]
0
0
Latvia
Query!
State/province [160]
0
0
Liepaja
Query!
Country [161]
0
0
Latvia
Query!
State/province [161]
0
0
Riga
Query!
Country [162]
0
0
Latvia
Query!
State/province [162]
0
0
Valmiera
Query!
Country [163]
0
0
Lithuania
Query!
State/province [163]
0
0
Kaunas
Query!
Country [164]
0
0
Lithuania
Query!
State/province [164]
0
0
Klaipeda
Query!
Country [165]
0
0
Lithuania
Query!
State/province [165]
0
0
Siauliai
Query!
Country [166]
0
0
Mexico
Query!
State/province [166]
0
0
Baja California
Query!
Country [167]
0
0
Mexico
Query!
State/province [167]
0
0
Distrito Federal
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Funding & Sponsors
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Commercial sector/industry
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Name
Eli Lilly and Company
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Ethics approval
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Summary
Brief summary
The purpose of this study is to investigate the long-term safety and any side effects of baricitinib in participants who have completed a previous baricitinib rheumatoid arthritis study. The study provides 7 years of additional treatment with baricitinib.
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Trial website
https://clinicaltrials.gov/study/NCT01885078
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Trial related presentations / publications
Taylor PC, Takeuchi T, Burmester GR, Durez P, Smolen JS, Deberdt W, Issa M, Terres JR, Bello N, Winthrop KL. Safety of baricitinib for the treatment of rheumatoid arthritis over a median of 4.6 and up to 9.3 years of treatment: final results from long-term extension study and integrated database. Ann Rheum Dis. 2022 Mar;81(3):335-343. doi: 10.1136/annrheumdis-2021-221276. Epub 2021 Oct 27. Wells AF, Jia B, Xie L, Valenzuela GJ, Keystone EC, Li Z, Quebe AK, Griffing K, Otawa S, Haraoui B. Efficacy of Long-Term Treatment with Once-Daily Baricitinib 2 mg in Patients with Active Rheumatoid Arthritis: Post Hoc Analysis of Two 24-Week, Phase III, Randomized, Controlled Studies and One Long-Term Extension Study. Rheumatol Ther. 2021 Jun;8(2):987-1001. doi: 10.1007/s40744-021-00317-9. Epub 2021 May 24. Fleischmann R, Takeuchi T, Schiff M, Schlichting D, Xie L, Issa M, Stoykov I, Lisse J, Martinez-Osuna P, Rooney T, Zerbini CAF. Efficacy and Safety of Long-Term Baricitinib With and Without Methotrexate for the Treatment of Rheumatoid Arthritis: Experience With Baricitinib Monotherapy Continuation or After Switching From Methotrexate Monotherapy or Baricitinib Plus Methotrexate. Arthritis Care Res (Hoboken). 2020 Aug;72(8):1112-1121. doi: 10.1002/acr.24007. Tanaka Y, Fautrel B, Keystone EC, Ortmann RA, Xie L, Zhu B, Issa M, Patel H, Gaich CL, de Bono S, Rooney TP, Taylor PC. Clinical outcomes in patients switched from adalimumab to baricitinib due to non-response and/or study design: phase III data in patients with rheumatoid arthritis. Ann Rheum Dis. 2019 Jul;78(7):890-898. doi: 10.1136/annrheumdis-2018-214529. Epub 2019 Apr 30. Winthrop KL, Bingham CO 3rd, Komocsar WJ, Bradley J, Issa M, Klar R, Kartman CE. Evaluation of pneumococcal and tetanus vaccine responses in patients with rheumatoid arthritis receiving baricitinib: results from a long-term extension trial substudy. Arthritis Res Ther. 2019 Apr 18;21(1):102. doi: 10.1186/s13075-019-1883-1. Smolen JS, Genovese MC, Takeuchi T, Hyslop DL, Macias WL, Rooney T, Chen L, Dickson CL, Riddle Camp J, Cardillo TE, Ishii T, Winthrop KL. Safety Profile of Baricitinib in Patients with Active Rheumatoid Arthritis with over 2 Years Median Time in Treatment. J Rheumatol. 2019 Jan;46(1):7-18. doi: 10.3899/jrheum.171361. Epub 2018 Sep 15. Erratum In: J Rheumatol. 2019 Dec;46(12):1648-1649. doi: 10.3899/jrheum.171361.C1. Tanaka Y, McInnes IB, Taylor PC, Byers NL, Chen L, de Bono S, Issa M, Macias WL, Rogai V, Rooney TP, Schlichting DE, Zuckerman SH, Emery P. Characterization and Changes of Lymphocyte Subsets in Baricitinib-Treated Patients With Rheumatoid Arthritis: An Integrated Analysis. Arthritis Rheumatol. 2018 Dec;70(12):1923-1932. doi: 10.1002/art.40680. Epub 2018 Oct 22. Taylor PC, Kremer JM, Emery P, Zuckerman SH, Ruotolo G, Zhong J, Chen L, Witt S, Saifan C, Kurzawa M, Otvos JD, Connelly MA, Macias WL, Schlichting DE, Rooney TP, de Bono S, McInnes IB. Lipid profile and effect of statin treatment in pooled phase II and phase III baricitinib studies. Ann Rheum Dis. 2018 Jul;77(7):988-995. doi: 10.1136/annrheumdis-2017-212461. Epub 2018 Feb 20.
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Public notes
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Contacts
Principal investigator
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Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
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Eli Lilly and Company
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR)
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When will data be available (start and end dates)?
Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
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Available to whom?
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
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Available for what types of analyses?
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How or where can data be obtained?
IPD available at link: https://vivli.org/
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What supporting documents are/will be available?
No Supporting Document Provided
Type
Other Details
Attachment
Study protocol
https://cdn.clinicaltrials.gov/large-docs/78/NCT01885078/Prot_000.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/78/NCT01885078/SAP_001.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT01885078