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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT02706873
Registration number
NCT02706873
Ethics application status
Date submitted
18/02/2016
Date registered
11/03/2016
Date last updated
7/07/2023
Titles & IDs
Public title
A Study to Compare Upadacitinib (ABT-494) Monotherapy to Methotrexate (MTX) Monotherapy in Adults With Rheumatoid Arthritis (RA) Who Have Not Previously Taken Methotrexate
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Scientific title
A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) Once Daily Monotherapy to Methotrexate (MTX) Monotherapy in MTX-Naïve Subjects With Moderately to Severely Active Rheumatoid Arthritis
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Secondary ID [1]
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2015-003334-27
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Secondary ID [2]
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M13-545
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Universal Trial Number (UTN)
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Trial acronym
SELECT-EARLY
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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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0
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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 - Placebo to Upadacitinib
Treatment: Drugs - Methotrexate
Treatment: Drugs - Placebo to Methotrexate
Treatment: Drugs - Upadacitinib
Active Comparator: Methotrexate - Period 1: Participants will receive placebo to upadacitinib once daily and methotrexate once weekly for 48 weeks.
Period 2: Participants will continue on placebo to upadacitinib once daily and methotrexate once weekly until the study is unblinded, after which participants will receive open-label methotrexate up to Week 260.
Experimental: Upadacitinib 7.5 mg (Japan-only) - Period 1: Participants will receive upadacitinib 7.5 mg once daily and placebo to methotrexate once weekly for 48 weeks.
Period 2: Participants will continue on upadacitinib 7.5 mg once daily and placebo to methotrexate once weekly until the study is unblinded, after which participants will receive open-label upadacitinib 7.5 mg up to Week 260.
Experimental: Upadacitinib 15 mg - Period 1: Participants will receive upadacitinib 15 mg once daily and placebo to methotrexate once weekly for 48 weeks.
Period 2: Participants will continue on upadacitinib 15 mg once daily and placebo to methotrexate once weekly until the study is unblinded, after which participants will receive open-label upadacitinib 15 mg up to Week 260.
Experimental: Upadacitinib 30 mg - Period 1: Participants will receive upadacitinib 30 mg once daily and placebo to methotrexate once weekly for 48 weeks.
Period 2: Participants will continue on upadacitinib 30 mg once daily and placebo to methotrexate once weekly until the study is unblinded, after which participants will receive open-label upadacitinib 30 mg once daily. After implementation of Protocol Amendment 6 participants will receive upadacitinib 15 mg once daily up to Week 260.
Treatment: Drugs: Placebo to Upadacitinib
Tablet; Oral
Treatment: Drugs: Methotrexate
Capsule or Tablet; Oral
Treatment: Drugs: Placebo to Methotrexate
Capsule or Tablet; Oral
Treatment: Drugs: Upadacitinib
Tablet; Oral
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Intervention code [1]
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0
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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Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response at Week 12 - Global Analysis
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Assessment method [1]
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The primary endpoint for United States (US)/Food and Drug Administration (FDA) regulatory purposes was ACR 50% response (ACR50) at Week 12. Participants who met the following 3 conditions for improvement from Baseline were classified as meeting the ACR50 response criteria:
= 50% improvement in 68-tender joint count;
= 50% improvement in 66-swollen joint count; and
= 50% improvement in at least 3 of the 5 following parameters:
Physician global assessment of disease activity
Patient global assessment of disease activity
Patient assessment of pain
Health Assessment Questionnaire - Disability Index (HAQ-DI)
High-sensitivity C-reactive protein (hsCRP).
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Timepoint [1]
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Baseline and Week 12
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Primary outcome [2]
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Percentage of Participants Achieving Clinical Remission (CR) Based on DAS28(CRP) at Week 24 - Global Analysis
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Assessment method [2]
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The primary endpoint for European Union (EU)/European Medicines Agency (EMA) regulatory purposes was clinical remission, based on a Disease Activity Score 28 (DAS28)-CRP score of < 2.6 at Week 24.
The DAS28 is a composite index used to assess rheumatoid arthritis disease activity, calculated based on the tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity (0-100 mm), and hsCRP (in mg/L). Scores on the DAS28 range from 0 to approximately 10, where higher scores indicate more disease activity.
A DAS28 score less than 2.6 indicates clinical remission.
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Timepoint [2]
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0
Week 24
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Primary outcome [3]
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Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 12 - Global Analysis
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Assessment method [3]
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The primary endpoint for Japan/Pharmaceuticals and Medical Devices Agency (PMDA) regulatory purposes was ACR 20% response (ACR20) at Week 12. Participants who met the following 3 conditions for improvement from Baseline were classified as meeting the ACR20 response criteria:
= 20% improvement in 68-tender joint count;
= 20% improvement in 66-swollen joint count; and
= 20% improvement in at least 3 of the 5 following parameters:
Physician global assessment of disease activity
Patient global assessment of disease activity
Patient assessment of pain
Health Assessment Questionnaire - Disability Index (HAQ-DI)
High-sensitivity C-reactive protein (hsCRP).
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Timepoint [3]
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0
Baseline and Week 12
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Primary outcome [4]
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Change From Baseline in Modified Total Sharp Score (mTSS) at Week 24 - Global Analysis
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Assessment method [4]
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The second primary endpoint for Japan/PMDA regulatory purposes was change from baseline in mTSS at Week 24.
The mTSS measures the level of joint damage from radiographs of the hands and feet. Joint erosion and joint space narrowing (JSN) were assessed by two independent, blinded readers.
Joint erosion was assessed in 16 joints in each hand/wrist and 6 joints in each foot. Each joint was scored from 0 (no erosion) to 5 for hands/wrists or to 10 for feet (complete collapse). The total erosion score ranges from 0 to 280 (worst).
JSN was assessed in 15 joints of each hand and wrist, and 6 joints of each foot, including subluxation, from 0 (normal) to 4 (complete loss of joint space, bony ankylosis, or luxation). The total JSN score ranges from 0 to 168 (worst).
The mTSS is the sum of the joint erosion and JSN scores and ranges from 0 (normal) to 448 (worst). A change from Baseline greater than 0 indicates progression.
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Timepoint [4]
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0
Baseline to Week 24
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Secondary outcome [1]
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Change From Baseline in DAS28 (CRP) at Week 12 - Global Analysis
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Assessment method [1]
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0
The DAS28 is a composite index used to assess rheumatoid arthritis disease activity, calculated based on the tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity (0-100 mm), and hsCRP (in mg/L). Scores on the DAS28 range from 0 to approximately 10, where higher scores indicate more disease activity. A negative change from Baseline in DAS28 (CRP) indicates improvement in disease activity.
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Timepoint [1]
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Baseline to Week 12
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Secondary outcome [2]
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Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 12 - Global Analysis
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Assessment method [2]
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0
The Health Assessment Questionnaire - Disability Index is a patient-reported questionnaire that measures the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and errands and chores) over the past week. Participants assessed their ability to do each task on a scale from 0 (without any difficulty) to 3 (unable to do). Scores were averaged to provide an overall score ranging from 0 to 3, where 0 represents no disability and 3 represents very severe, high-dependency disability.
A negative change from Baseline in the overall score indicates improvement.
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Timepoint [2]
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0
Baseline to week 12
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Secondary outcome [3]
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Percentage of Participants Achieving Low Disease Activity (LDA) Based on DAS28(CRP) at Week 12 - Global Analysis
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Assessment method [3]
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0
The DAS28(CRP) is a composite index used to assess rheumatoid arthritis disease activity, calculated based on the tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity (0-100 mm), and hsCRP (in mg/L). Scores on the DAS28 range from 0 to approximately 10, where higher scores indicate more disease activity.
A DAS28(CRP) score less than or equal to 3.2 indicates low disease activity.
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Timepoint [3]
0
0
Week 12
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Secondary outcome [4]
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0
Change From Baseline in Short-Form 36 (SF-36) Physical Component Score (PCS) at Week 12 - Global Analysis
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Assessment method [4]
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0
The Short Form 36-Item Health Survey (SF-36) Version 2 is a self-administered questionnaire that measures the impact of disease on overall quality of life during the past 4 weeks. The SF-36 consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health).
The physical component score is a weighted combination of the 8 subscales with positive weighting for physical functioning, role-physical, bodily pain, and general health. The PCS was calculated using norm-based scoring so that 50 is the average score and the standard deviation equals 10. Higher scores are associated with better functioning/quality of life; a positive change from baseline score indicates an improvement.
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Timepoint [4]
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0
Baseline to week 12
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Secondary outcome [5]
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Change From Baseline in DAS28 (CRP) at Week 24 - Global Analysis
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Assessment method [5]
0
0
The DAS28 is a composite index used to assess rheumatoid arthritis disease activity, calculated based on the tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity (0-100 mm), and hsCRP (in mg/L). Scores on the DAS28 range from 0 to approximately 10, where higher scores indicate more disease activity. A negative change from Baseline in DAS28 (CRP) indicates improvement in disease activity.
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Timepoint [5]
0
0
Baseline to Week 24
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Secondary outcome [6]
0
0
Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 24 - Global Analysis
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Assessment method [6]
0
0
The Health Assessment Questionnaire - Disability Index is a patient-reported questionnaire that measures the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and errands and chores) over the past week. Participants assessed their ability to do each task on a scale from 0 (without any difficulty) to 3 (unable to do). Scores were averaged to provide an overall score ranging from 0 to 3, where 0 represents no disability and 3 represents very severe, high-dependency disability.
A negative change from Baseline in the overall score indicates improvement.
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Timepoint [6]
0
0
Baseline to Week 24
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Secondary outcome [7]
0
0
Percentage of Participants With an ACR50 Response at Week 24 - Global Analysis
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Assessment method [7]
0
0
Participants who met the following 3 conditions for improvement from Baseline were classified as meeting the ACR50 response criteria:
= 50% improvement in 68-tender joint count;
= 50% improvement in 66-swollen joint count; and
= 50% improvement in at least 3 of the 5 following parameters:
Physician global assessment of disease activity
Patient global assessment of disease activity
Patient assessment of pain
Health Assessment Questionnaire - Disability Index (HAQ-DI)
High-sensitivity C-reactive protein (hsCRP).
Query!
Timepoint [7]
0
0
Baseline and Week 24
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Secondary outcome [8]
0
0
Percentage of Participants Achieving Low Disease Activity (LDA) Based on DAS28(CRP) at Week 24 - Global Analysis
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Assessment method [8]
0
0
The DAS28(CRP) is a composite index used to assess rheumatoid arthritis disease activity, calculated based on the tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity (0-100 mm), and hsCRP (in mg/L). Scores on the DAS28 range from 0 to approximately 10, where higher scores indicate more disease activity.
A DAS28(CRP) score less than or equal to 3.2 indicates low disease activity.
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Timepoint [8]
0
0
Week 24
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Secondary outcome [9]
0
0
Change From Baseline in Short-Form 36 (SF-36) Physical Component Score (PCS) at Week 24 - Global Analysis
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Assessment method [9]
0
0
The Short Form 36-Item Health Survey (SF-36) Version 2 is a self-administered questionnaire that measures the impact of disease on overall quality of life during the past 4 weeks. The SF-36 consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health).
The physical component score is a weighted combination of the 8 subscales with positive weighting for physical functioning, role-physical, bodily pain, and general health. The PCS was calculated using norm-based scoring so that 50 is the average score and the standard deviation equals 10. Higher scores are associated with better functioning/quality of life; a positive change from baseline score indicates an improvement.
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Timepoint [9]
0
0
Baseline to Week 24
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Secondary outcome [10]
0
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Percentage of Participants With No Radiographic Progression at Week 24 - Global Analysis
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Assessment method [10]
0
0
No radiographic progression is defined as a change from Baseline in mTSS = 0. The mTSS measures the level of joint damage from radiographs of the hands and feet. Joint erosion and joint space narrowing (JSN) were assessed by two independent, blinded readers.
Joint erosion severity was assessed in 16 joints in each hand and wrist and 6 joints in each foot. Each joint was scored from 0 (no erosion) to 5 for hands/wrists or to 10 for feet (complete collapse). The total erosion score ranges from 0 to 280 (worst).
Joint space narrowing (JSN) was assessed in 15 joints of each hand and wrist, and 6 joints of each foot, including subluxation, from 0 (normal) to 4 (complete loss of joint space, bony ankylosis, or luxation). The total JSN score ranges from 0 to 168 (worst).
The mTSS is the sum of the joint erosion and JSN scores and ranges from 0 (normal) to 448 (worst).
Query!
Timepoint [10]
0
0
Week 24
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Secondary outcome [11]
0
0
Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response at Week 12 - Global Analysis
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Assessment method [11]
0
0
Participants who met the following 3 conditions for improvement from Baseline were classified as meeting the ACR70 response criteria:
= 70% improvement in 68-tender joint count;
= 70% improvement in 66-swollen joint count; and
= 70% improvement in at least 3 of the 5 following parameters:
Physician global assessment of disease activity
Patient global assessment of disease activity
Patient assessment of pain
Health Assessment Questionnaire - Disability Index (HAQ-DI)
High-sensitivity C-reactive protein (hsCRP).
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Timepoint [11]
0
0
Baseline and Week 12
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Secondary outcome [12]
0
0
Percentage of Participants With an ACR20 Response at Week 24 - Global Analysis
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Assessment method [12]
0
0
Participants who met the following 3 conditions for improvement from Baseline were classified as meeting the ACR20 response criteria:
= 20% improvement in 68-tender joint count;
= 20% improvement in 66-swollen joint count; and
= 20% improvement in at least 3 of the 5 following parameters:
Physician global assessment of disease activity
Patient global assessment of disease activity
Patient assessment of pain
Health Assessment Questionnaire - Disability Index (HAQ-DI)
High-sensitivity C-reactive protein (hsCRP).
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Timepoint [12]
0
0
Baseline and Week 24
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Secondary outcome [13]
0
0
Percentage of Participants With an ACR70 Response at Week 24 - Global Analysis
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Assessment method [13]
0
0
Participants who met the following 3 conditions for improvement from Baseline were classified as meeting the ACR70 response criteria:
= 70% improvement in 68-tender joint count;
= 70% improvement in 66-swollen joint count; and
= 70% improvement in at least 3 of the 5 following parameters:
Physician global assessment of disease activity
Patient global assessment of disease activity
Patient assessment of pain
Health Assessment Questionnaire - Disability Index (HAQ-DI)
High-sensitivity C-reactive protein (hsCRP).
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Timepoint [13]
0
0
Baseline and Week 24
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Secondary outcome [14]
0
0
Percentage of Participants With an ACR20 Response at Week 12 - Japan Sub-study
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Assessment method [14]
0
0
Participants who met the following 3 conditions for improvement from Baseline were classified as meeting the ACR20 response criteria:
= 20% improvement in 68-tender joint count;
= 20% improvement in 66-swollen joint count; and
= 20% improvement in at least 3 of the 5 following parameters:
Physician global assessment of disease activity
Patient global assessment of disease activity
Patient assessment of pain
Health Assessment Questionnaire - Disability Index (HAQ-DI)
High-sensitivity C-reactive protein (hsCRP).
Query!
Timepoint [14]
0
0
Baseline and Week 12
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Secondary outcome [15]
0
0
Percentage of Participants With an ACR50 Response at Week 12 - Japan Sub-study
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Assessment method [15]
0
0
Participants who met the following 3 conditions for improvement from Baseline were classified as meeting the ACR50 response criteria:
= 50% improvement in 68-tender joint count;
= 50% improvement in 66-swollen joint count; and
= 50% improvement in at least 3 of the 5 following parameters:
Physician global assessment of disease activity
Patient global assessment of disease activity
Patient assessment of pain
Health Assessment Questionnaire - Disability Index (HAQ-DI)
High-sensitivity C-reactive protein (hsCRP).
Query!
Timepoint [15]
0
0
Baseline and Week 12
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Secondary outcome [16]
0
0
Percentage of Participants With an ACR70 Response at Week 12 - Japan Sub-study
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Assessment method [16]
0
0
Participants who met the following 3 conditions for improvement from Baseline were classified as meeting the ACR70 response criteria:
= 70% improvement in 68-tender joint count;
= 70% improvement in 66-swollen joint count; and
= 70% improvement in at least 3 of the 5 following parameters:
Physician global assessment of disease activity
Patient global assessment of disease activity
Patient assessment of pain
Health Assessment Questionnaire - Disability Index (HAQ-DI)
High-sensitivity C-reactive protein (hsCRP).
Query!
Timepoint [16]
0
0
Baseline and Week 12
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Secondary outcome [17]
0
0
Change From Baseline in DAS28 (CRP) at Week 12 - Japan Sub-study
Query!
Assessment method [17]
0
0
The DAS28 is a composite index used to assess rheumatoid arthritis disease activity, calculated based on the tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity (0-100 mm), and hsCRP (in mg/L). Scores on the DAS28 range from 0 to approximately 10, where higher scores indicate more disease activity. A negative change from Baseline in DAS28 (CRP) indicates improvement in disease activity.
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Timepoint [17]
0
0
Baseline to Week 12
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Secondary outcome [18]
0
0
Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 12 - Japan Sub-study
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Assessment method [18]
0
0
The Health Assessment Questionnaire - Disability Index is a patient-reported questionnaire that measures the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and errands and chores) over the past week. Participants assessed their ability to do each task on a scale from 0 (without any difficulty) to 3 (unable to do). Scores were averaged to provide an overall score ranging from 0 to 3, where 0 represents no disability and 3 represents very severe, high-dependency disability.
A negative change from Baseline in the overall score indicates improvement.
Query!
Timepoint [18]
0
0
Baseline to week 12
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Secondary outcome [19]
0
0
Change From Baseline in Short-Form 36 (SF-36) Physical Component Score (PCS) at Week 12 - Japan Sub-study
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Assessment method [19]
0
0
The Short Form 36-Item Health Survey (SF-36) Version 2 is a self-administered questionnaire that measures the impact of disease on overall quality of life during the past 4 weeks. The SF-36 consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health).
The physical component score is a weighted combination of the 8 subscales with positive weighting for physical functioning, role-physical, bodily pain, and general health. The PCS was calculated using norm-based scoring so that 50 is the average score and the standard deviation equals 10. Higher scores are associated with better functioning/quality of life; a positive change from baseline score indicates an improvement.
Query!
Timepoint [19]
0
0
Baseline to Week 12
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Secondary outcome [20]
0
0
Percentage of Participants Achieving Low Disease Activity (LDA) Based on DAS28(CRP) at Week 12 - Japan Sub-study
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Assessment method [20]
0
0
The DAS28(CRP) is a composite index used to assess rheumatoid arthritis disease activity, calculated based on the tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity (0-100 mm), and hsCRP (in mg/L). Scores on the DAS28 range from 0 to approximately 10, where higher scores indicate more disease activity.
A DAS28(CRP) score less than or equal to 3.2 indicates low disease activity.
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Timepoint [20]
0
0
Week 12
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Secondary outcome [21]
0
0
Percentage of Participants Achieving Clinical Remission (CR) Based on DAS28(CRP) at Week 24 - Japan Sub-study
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Assessment method [21]
0
0
The DAS28(CRP) is a composite index used to assess rheumatoid arthritis disease activity, calculated based on the tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity (0-100 mm), and hsCRP (in mg/L). Scores on the DAS28 range from 0 to approximately 10, where higher scores indicate more disease activity.
A DAS28 score less than 2.6 indicates clinical remission.
Query!
Timepoint [21]
0
0
Week 24
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Secondary outcome [22]
0
0
Change From Baseline in Modified Total Sharp Score (mTSS) at Week 24 - Japan Sub-study
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Assessment method [22]
0
0
The mTSS measures the level of joint damage from radiographs of the hands and feet. Joint erosion and joint space narrowing (JSN) were assessed by two independent, blinded readers.
Joint erosion was assessed in 16 joints in each hand/wrist and 6 joints in each foot. Each joint was scored from 0 (no erosion) to 5 for hands/wrists or to 10 for feet (complete collapse). The total erosion score ranges from 0 to 280 (worst).
JSN was assessed in 15 joints of each hand and wrist, and 6 joints of each foot, including subluxation, from 0 (normal) to 4 (complete loss of joint space, bony ankylosis, or luxation). The total JSN score ranges from 0 to 168 (worst).
The mTSS is the sum of the joint erosion and JSN scores and ranges from 0 (normal) to 448 (worst). A change from Baseline greater than 0 indicates progression.
Query!
Timepoint [22]
0
0
Baseline to Week 24
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Secondary outcome [23]
0
0
Percentage of Participants With No Radiographic Progression at Week 24 - Japan Sub-study
Query!
Assessment method [23]
0
0
No radiographic progression is defined as a change from Baseline in mTSS = 0. The mTSS measures the level of joint damage from radiographs of the hands and feet. Joint erosion and joint space narrowing (JSN) were assessed by two independent, blinded readers.
Joint erosion severity was assessed in 16 joints in each hand and wrist and 6 joints in each foot. Each joint was scored from 0 (no erosion) to 5 for hands/wrists or to 10 for feet (complete collapse). The total erosion score ranges from 0 to 280 (worst).
Joint space narrowing (JSN) was assessed in 15 joints of each hand and wrist, and 6 joints of each foot, including subluxation, from 0 (normal) to 4 (complete loss of joint space, bony ankylosis, or luxation). The total JSN score ranges from 0 to 168 (worst).
The mTSS is the sum of the joint erosion and JSN scores and ranges from 0 (normal) to 448 (worst).
Query!
Timepoint [23]
0
0
Week 24
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Eligibility
Key inclusion criteria
- Duration of symptoms consistent with RA for = 6 weeks who also fulfill the 2010
American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR)
classification criteria for RA.
- Naïve to Methotrexate (MTX) or, if already on MTX, have received no more than 3 weekly
MTX doses with requirement to complete a 4-week MTX washout before the first dose of
study drug.
- Participants with prior exposure to conventional synthetic disease-modifying
anti-rheumatic drugs(csDMARDs) other than MTX may be enrolled if completed the washout
period.
- Participant meets both of the following minimum disease activity criteria:
-= 6 swollen joints (based on 66 joint counts) and = 6 tender joints (based on 68
joint counts) at Screening and Baseline Visits.
- high sensitivity C reactive protein (hsCRP) = 5 mg/L (central lab, upper limit of
normal [ULN] 2.87 mg/L at Screening Visit.
- Greater than or equal to 1 bone erosion on x-ray (by local reading) OR in the absence
of documented bone erosion, both positive rheumatoid factor (RF) and positive
anti-cyclic citrullinated peptide (anti CCP) autoantibodies are required at Screening.
- Stable dose of non-steroidal anti-inflammatory drugs (NSAIDs), acetaminophen, oral
corticosteroids (equivalent to prednisone = 10 mg/day), or inhaled corticosteroids for
stable medical conditions are allowed but must have been at a stable dose = 1 week
prior to the first dose of study drug.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Intolerant to Methotrexate (MTX).
- Prior exposure to any Janus kinase (JAK) inhibitor (including but not limited to
tofacitinib, baricitinib, and filgotinib).
- Prior exposure to any biologic disease-modifying anti-rheumatic drugs (bDMARDs).
- History of any arthritis with onset prior to age 17 years or current diagnosis,
inflammatory joint disease other than RA (including but not limited to gout, systemic
lupus erythematosus, psoriatic arthritis, axial spondyloarthritis including ankylosing
spondylitis and non-radiographic axial spondyloarthritis, reactive arthritis, overlap
connective tissue diseases, scleroderma, polymyositis, dermatomyositis, fibromyalgia
[currently with active symptoms]. Current diagnosis of secondary Sjogren's Syndrome is
permitted.
- Has been treated with intra-articular, intramuscular, intravenous, trigger point or
tender point, intra-bursa, or intra-tendon sheath corticosteroids in the preceding 8
weeks prior to the first dose of study drug.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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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
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
Query!
Actual
23/02/2016
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
10/11/2022
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
1002
Query!
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,TAS,VIC
Query!
Recruitment hospital [1]
0
0
Royal Prince Alfred Hospital /ID# 143149 - Camperdown
Query!
Recruitment hospital [2]
0
0
Rheumatology Research Unit /ID# 143147 - Maroochydore
Query!
Recruitment hospital [3]
0
0
The Queen Elizabeth Hospital /ID# 143148 - Woodville
Query!
Recruitment hospital [4]
0
0
Southern Clinical Research Pty /ID# 143150 - Hobart
Query!
Recruitment hospital [5]
0
0
Emeritus Research /ID# 143146 - Camberwell
Query!
Recruitment postcode(s) [1]
0
0
2050 - Camperdown
Query!
Recruitment postcode(s) [2]
0
0
4558 - Maroochydore
Query!
Recruitment postcode(s) [3]
0
0
5011 - Woodville
Query!
Recruitment postcode(s) [4]
0
0
7000 - Hobart
Query!
Recruitment postcode(s) [5]
0
0
3124 - Camberwell
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
California
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Florida
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
Illinois
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Kentucky
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
New Jersey
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
North Dakota
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Ohio
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Oklahoma
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Pennsylvania
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
South Carolina
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
Tennessee
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
Texas
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
Virginia
Query!
Country [14]
0
0
Argentina
Query!
State/province [14]
0
0
Buenos Aires
Query!
Country [15]
0
0
Argentina
Query!
State/province [15]
0
0
Santa FE
Query!
Country [16]
0
0
Argentina
Query!
State/province [16]
0
0
Cordoba
Query!
Country [17]
0
0
Argentina
Query!
State/province [17]
0
0
San Miguel de Tucuman
Query!
Country [18]
0
0
Belarus
Query!
State/province [18]
0
0
Minsk
Query!
Country [19]
0
0
Belgium
Query!
State/province [19]
0
0
Hainaut
Query!
Country [20]
0
0
Belgium
Query!
State/province [20]
0
0
Oost-Vlaanderen
Query!
Country [21]
0
0
Belgium
Query!
State/province [21]
0
0
Genk
Query!
Country [22]
0
0
Belgium
Query!
State/province [22]
0
0
Mons
Query!
Country [23]
0
0
Bosnia and Herzegovina
Query!
State/province [23]
0
0
Republika Srpska
Query!
Country [24]
0
0
Bosnia and Herzegovina
Query!
State/province [24]
0
0
Sarajevo
Query!
Country [25]
0
0
Brazil
Query!
State/province [25]
0
0
Goias
Query!
Country [26]
0
0
Brazil
Query!
State/province [26]
0
0
Parana
Query!
Country [27]
0
0
Brazil
Query!
State/province [27]
0
0
Rio Grande Do Sul
Query!
Country [28]
0
0
Brazil
Query!
State/province [28]
0
0
Sao Paulo
Query!
Country [29]
0
0
Brazil
Query!
State/province [29]
0
0
Rio de Janeiro
Query!
Country [30]
0
0
Bulgaria
Query!
State/province [30]
0
0
Plovdiv
Query!
Country [31]
0
0
Bulgaria
Query!
State/province [31]
0
0
Sofia
Query!
Country [32]
0
0
Canada
Query!
State/province [32]
0
0
Alberta
Query!
Country [33]
0
0
Canada
Query!
State/province [33]
0
0
Manitoba
Query!
Country [34]
0
0
Canada
Query!
State/province [34]
0
0
Ontario
Query!
Country [35]
0
0
Canada
Query!
State/province [35]
0
0
Quebec
Query!
Country [36]
0
0
Chile
Query!
State/province [36]
0
0
Araucania
Query!
Country [37]
0
0
Chile
Query!
State/province [37]
0
0
Santiago
Query!
Country [38]
0
0
Chile
Query!
State/province [38]
0
0
Puerto Varas
Query!
Country [39]
0
0
Chile
Query!
State/province [39]
0
0
Vina Del Mar
Query!
Country [40]
0
0
China
Query!
State/province [40]
0
0
Anhui
Query!
Country [41]
0
0
China
Query!
State/province [41]
0
0
Fujian
Query!
Country [42]
0
0
China
Query!
State/province [42]
0
0
Guangdong
Query!
Country [43]
0
0
Colombia
Query!
State/province [43]
0
0
Cundinamarca
Query!
Country [44]
0
0
Colombia
Query!
State/province [44]
0
0
Barranquilla
Query!
Country [45]
0
0
Colombia
Query!
State/province [45]
0
0
Bogota
Query!
Country [46]
0
0
Colombia
Query!
State/province [46]
0
0
Bogotá
Query!
Country [47]
0
0
Colombia
Query!
State/province [47]
0
0
Bucaramanga
Query!
Country [48]
0
0
Croatia
Query!
State/province [48]
0
0
Split
Query!
Country [49]
0
0
Croatia
Query!
State/province [49]
0
0
Zagreb
Query!
Country [50]
0
0
Czechia
Query!
State/province [50]
0
0
Moravskoslezsky Kraj
Query!
Country [51]
0
0
Czechia
Query!
State/province [51]
0
0
Olomoucky Kraj
Query!
Country [52]
0
0
Czechia
Query!
State/province [52]
0
0
Praha 4
Query!
Country [53]
0
0
Czechia
Query!
State/province [53]
0
0
Zlin
Query!
Country [54]
0
0
Czechia
Query!
State/province [54]
0
0
Breclav
Query!
Country [55]
0
0
Czechia
Query!
State/province [55]
0
0
Brno
Query!
Country [56]
0
0
Czechia
Query!
State/province [56]
0
0
Bruntál
Query!
Country [57]
0
0
Czechia
Query!
State/province [57]
0
0
Slany
Query!
Country [58]
0
0
Czechia
Query!
State/province [58]
0
0
Uherské Hradište
Query!
Country [59]
0
0
Estonia
Query!
State/province [59]
0
0
Harjumaa
Query!
Country [60]
0
0
Estonia
Query!
State/province [60]
0
0
Pärnu
Query!
Country [61]
0
0
Estonia
Query!
State/province [61]
0
0
Tallinn
Query!
Country [62]
0
0
Germany
Query!
State/province [62]
0
0
Nordrhein-Westfalen
Query!
Country [63]
0
0
Germany
Query!
State/province [63]
0
0
Schleswig-Holstein
Query!
Country [64]
0
0
Germany
Query!
State/province [64]
0
0
Hamburg
Query!
Country [65]
0
0
Germany
Query!
State/province [65]
0
0
Munich
Query!
Country [66]
0
0
Greece
Query!
State/province [66]
0
0
Attiki
Query!
Country [67]
0
0
Guatemala
Query!
State/province [67]
0
0
Ciudad de Guatemala
Query!
Country [68]
0
0
Hong Kong
Query!
State/province [68]
0
0
Hong Kong
Query!
Country [69]
0
0
Hong Kong
Query!
State/province [69]
0
0
Tuen Mun
Query!
Country [70]
0
0
Hungary
Query!
State/province [70]
0
0
Borsod-Abauj-Zemplen
Query!
Country [71]
0
0
Hungary
Query!
State/province [71]
0
0
Pest
Query!
Country [72]
0
0
Hungary
Query!
State/province [72]
0
0
Vas
Query!
Country [73]
0
0
Hungary
Query!
State/province [73]
0
0
Heviz
Query!
Country [74]
0
0
Hungary
Query!
State/province [74]
0
0
Kistarcsa
Query!
Country [75]
0
0
Hungary
Query!
State/province [75]
0
0
Szekesfehervar
Query!
Country [76]
0
0
Ireland
Query!
State/province [76]
0
0
Dublin
Query!
Country [77]
0
0
Israel
Query!
State/province [77]
0
0
Ashkelon
Query!
Country [78]
0
0
Israel
Query!
State/province [78]
0
0
Haifa
Query!
Country [79]
0
0
Israel
Query!
State/province [79]
0
0
Ramat Gan
Query!
Country [80]
0
0
Italy
Query!
State/province [80]
0
0
Milano
Query!
Country [81]
0
0
Italy
Query!
State/province [81]
0
0
Milan
Query!
Country [82]
0
0
Italy
Query!
State/province [82]
0
0
Pavia
Query!
Country [83]
0
0
Italy
Query!
State/province [83]
0
0
Verona
Query!
Country [84]
0
0
Japan
Query!
State/province [84]
0
0
Aichi
Query!
Country [85]
0
0
Japan
Query!
State/province [85]
0
0
Chiba
Query!
Country [86]
0
0
Japan
Query!
State/province [86]
0
0
Fukuoka
Query!
Country [87]
0
0
Japan
Query!
State/province [87]
0
0
Hokkaido
Query!
Country [88]
0
0
Japan
Query!
State/province [88]
0
0
Hyogo
Query!
Country [89]
0
0
Japan
Query!
State/province [89]
0
0
Kanagawa
Query!
Country [90]
0
0
Japan
Query!
State/province [90]
0
0
Kawachinagano-shi
Query!
Country [91]
0
0
Japan
Query!
State/province [91]
0
0
Kochi
Query!
Country [92]
0
0
Japan
Query!
State/province [92]
0
0
Kumamoto
Query!
Country [93]
0
0
Japan
Query!
State/province [93]
0
0
Nagasaki
Query!
Country [94]
0
0
Japan
Query!
State/province [94]
0
0
Niigata
Query!
Country [95]
0
0
Japan
Query!
State/province [95]
0
0
Okayama
Query!
Country [96]
0
0
Japan
Query!
State/province [96]
0
0
Osaka
Query!
Country [97]
0
0
Japan
Query!
State/province [97]
0
0
Saitama
Query!
Country [98]
0
0
Japan
Query!
State/province [98]
0
0
Tochigi
Query!
Country [99]
0
0
Japan
Query!
State/province [99]
0
0
Tokyo
Query!
Country [100]
0
0
Japan
Query!
State/province [100]
0
0
Yamaguchi
Query!
Country [101]
0
0
Japan
Query!
State/province [101]
0
0
Beppu
Query!
Country [102]
0
0
Japan
Query!
State/province [102]
0
0
Fukui
Query!
Country [103]
0
0
Japan
Query!
State/province [103]
0
0
Kato
Query!
Country [104]
0
0
Japan
Query!
State/province [104]
0
0
Kurume
Query!
Country [105]
0
0
Japan
Query!
State/province [105]
0
0
Kyoto
Query!
Country [106]
0
0
Japan
Query!
State/province [106]
0
0
Miyagi
Query!
Country [107]
0
0
Japan
Query!
State/province [107]
0
0
Nagoya
Query!
Country [108]
0
0
Japan
Query!
State/province [108]
0
0
Nishimura
Query!
Country [109]
0
0
Japan
Query!
State/province [109]
0
0
Oita
Query!
Country [110]
0
0
Japan
Query!
State/province [110]
0
0
Sanuki
Query!
Country [111]
0
0
Japan
Query!
State/province [111]
0
0
Sapporo
Query!
Country [112]
0
0
Japan
Query!
State/province [112]
0
0
Sayama
Query!
Country [113]
0
0
Japan
Query!
State/province [113]
0
0
Sendai
Query!
Country [114]
0
0
Japan
Query!
State/province [114]
0
0
Takaoka
Query!
Country [115]
0
0
Japan
Query!
State/province [115]
0
0
Yotsukaido
Query!
Country [116]
0
0
Kazakhstan
Query!
State/province [116]
0
0
Astana
Query!
Country [117]
0
0
Kazakhstan
Query!
State/province [117]
0
0
Karaganda
Query!
Country [118]
0
0
Kazakhstan
Query!
State/province [118]
0
0
Semey
Query!
Country [119]
0
0
Kazakhstan
Query!
State/province [119]
0
0
Shymkent
Query!
Country [120]
0
0
Latvia
Query!
State/province [120]
0
0
Adazi
Query!
Country [121]
0
0
Lithuania
Query!
State/province [121]
0
0
Kovno
Query!
Country [122]
0
0
Lithuania
Query!
State/province [122]
0
0
Klaipeda
Query!
Country [123]
0
0
Lithuania
Query!
State/province [123]
0
0
Vilnius
Query!
Country [124]
0
0
Mexico
Query!
State/province [124]
0
0
Ciudad De Mexico
Query!
Country [125]
0
0
Mexico
Query!
State/province [125]
0
0
Chihuahua
Query!
Country [126]
0
0
Mexico
Query!
State/province [126]
0
0
Mexico City
Query!
Country [127]
0
0
Mexico
Query!
State/province [127]
0
0
Queretaro
Query!
Country [128]
0
0
New Zealand
Query!
State/province [128]
0
0
Waikato
Query!
Country [129]
0
0
New Zealand
Query!
State/province [129]
0
0
Auckland
Query!
Country [130]
0
0
New Zealand
Query!
State/province [130]
0
0
Nelson
Query!
Country [131]
0
0
New Zealand
Query!
State/province [131]
0
0
Timaru
Query!
Country [132]
0
0
Poland
Query!
State/province [132]
0
0
Dolnoslaskie
Query!
Country [133]
0
0
Poland
Query!
State/province [133]
0
0
Mazowieckie
Query!
Country [134]
0
0
Poland
Query!
State/province [134]
0
0
Pomorskie
Query!
Country [135]
0
0
Poland
Query!
State/province [135]
0
0
Slaskie
Query!
Country [136]
0
0
Poland
Query!
State/province [136]
0
0
Warminsko-mazurskie
Query!
Country [137]
0
0
Poland
Query!
State/province [137]
0
0
Wielkopolskie
Query!
Country [138]
0
0
Portugal
Query!
State/province [138]
0
0
Lisboa
Query!
Country [139]
0
0
Portugal
Query!
State/province [139]
0
0
Porto
Query!
Country [140]
0
0
Portugal
Query!
State/province [140]
0
0
Viana Do Castelo
Query!
Country [141]
0
0
Portugal
Query!
State/province [141]
0
0
Viseu
Query!
Country [142]
0
0
Puerto Rico
Query!
State/province [142]
0
0
Ponce
Query!
Country [143]
0
0
Puerto Rico
Query!
State/province [143]
0
0
San Juan
Query!
Country [144]
0
0
Romania
Query!
State/province [144]
0
0
Bucuresti
Query!
Country [145]
0
0
Romania
Query!
State/province [145]
0
0
Iasi
Query!
Country [146]
0
0
Romania
Query!
State/province [146]
0
0
Oradea
Query!
Country [147]
0
0
Russian Federation
Query!
State/province [147]
0
0
Moskva
Query!
Country [148]
0
0
Russian Federation
Query!
State/province [148]
0
0
Novosibirskaya Oblast
Query!
Country [149]
0
0
Russian Federation
Query!
State/province [149]
0
0
Stavropol Skiy Kray
Query!
Country [150]
0
0
Russian Federation
Query!
State/province [150]
0
0
Tatarstan, Respublika
Query!
Country [151]
0
0
Russian Federation
Query!
State/province [151]
0
0
Tverskaya Oblast
Query!
Country [152]
0
0
Russian Federation
Query!
State/province [152]
0
0
Moscow
Query!
Country [153]
0
0
Russian Federation
Query!
State/province [153]
0
0
Orenburg
Query!
Country [154]
0
0
Russian Federation
Query!
State/province [154]
0
0
Petrozavodsk
Query!
Country [155]
0
0
Russian Federation
Query!
State/province [155]
0
0
Ryazan
Query!
Country [156]
0
0
Russian Federation
Query!
State/province [156]
0
0
Samara
Query!
Country [157]
0
0
Russian Federation
Query!
State/province [157]
0
0
UFA
Query!
Country [158]
0
0
Russian Federation
Query!
State/province [158]
0
0
Ulyanovsk
Query!
Country [159]
0
0
Russian Federation
Query!
State/province [159]
0
0
Voronezh
Query!
Country [160]
0
0
Serbia
Query!
State/province [160]
0
0
Beograd
Query!
Country [161]
0
0
Serbia
Query!
State/province [161]
0
0
Vojvodina
Query!
Country [162]
0
0
Slovakia
Query!
State/province [162]
0
0
Martin
Query!
Country [163]
0
0
Slovakia
Query!
State/province [163]
0
0
Nové Mesto Nad Váhom
Query!
Country [164]
0
0
Slovakia
Query!
State/province [164]
0
0
Partizanske
Query!
Country [165]
0
0
Slovakia
Query!
State/province [165]
0
0
Pieštany
Query!
Country [166]
0
0
Slovakia
Query!
State/province [166]
0
0
Puchov
Query!
Country [167]
0
0
Slovakia
Query!
State/province [167]
0
0
Stará Lubovna
Query!
Country [168]
0
0
Slovakia
Query!
State/province [168]
0
0
Topolcany
Query!
Country [169]
0
0
Slovakia
Query!
State/province [169]
0
0
Trencin
Query!
Country [170]
0
0
Slovakia
Query!
State/province [170]
0
0
Trnava
Query!
Country [171]
0
0
Slovakia
Query!
State/province [171]
0
0
Zvolen
Query!
Country [172]
0
0
Slovakia
Query!
State/province [172]
0
0
Žiar nad Hronom
Query!
Country [173]
0
0
Slovenia
Query!
State/province [173]
0
0
Ljubljana
Query!
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Taichung
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Taipei
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Dalin
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La Marsa
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Manouba
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Sousse
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Tunis
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Turkey
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Izmir
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Ukraine
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Lvivska Oblast
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Ukraine
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Vinnytska Oblast
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Ukraine
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Ivano-frankivsk
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Ukraine
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Kiev
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Ukraine
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Kyiv
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Ukraine
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Lviv
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Ukraine
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Odesa
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Ukraine
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Zaporizhia
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United Kingdom
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England
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United Kingdom
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London, City Of
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United Kingdom
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Leeds
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Portsmouth
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United Kingdom
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Southampton
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Funding & Sponsors
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Commercial sector/Industry
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AbbVie
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Summary
Brief summary
The objectives of Period 1 were the following:
- To compare the safety and efficacy of upadacitinib 7.5 mg once daily (QD) monotherapy
(for participants in Japan only), 15 mg QD monotherapy, and 30 mg QD monotherapy versus
weekly methotrexate monotherapy for the treatment of signs and symptoms of RA in
methotrexate-naïve adults with moderately to severely active RA;
- To compare the efficacy of upadacitinib 15 mg QD monotherapy and upadacitinib 30 mg QD
monotherapy versus weekly methotrexate monotherapy for prevention of structural
progression in methotrexate-naïve adults with moderately to severely active RA.
The objective of Period 2 is to evaluate the long-term safety, tolerability, and efficacy of
upadacitinib 7.5 mg QD (for participants in Japan only), 15 mg QD, and 30 mg QD in adults
with RA who have completed Period 1.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02706873
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Trial related presentations / publications
van Vollenhoven R, Takeuchi T, Pangan AL, Friedman A, Mohamed MF, Chen S, Rischmueller M, Blanco R, Xavier RM, Strand V. Efficacy and Safety of Upadacitinib Monotherapy in Methotrexate-Naive Patients With Moderately-to-Severely Active Rheumatoid Arthritis (SELECT-EARLY): A Multicenter, Multi-Country, Randomized, Double-Blind, Active Comparator-Controlled Trial. Arthritis Rheumatol. 2020 Oct;72(10):1607-1620. doi: 10.1002/art.41384. Epub 2020 Sep 8.
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Public notes
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Contacts
Principal investigator
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AbbVie Inc.
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AbbVie
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Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02706873
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