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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT02629159
Registration number
NCT02629159
Ethics application status
Date submitted
10/12/2015
Date registered
14/12/2015
Titles & IDs
Public title
A Study Comparing Upadacitinib (ABT-494) to Placebo and to Adalimumab in Adults With Rheumatoid Arthritis Who Are on a Stable Dose of Methotrexate and Who Have an Inadequate Response to Methotrexate
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Scientific title
A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) to Placebo and to Adalimumab in Subjects With Moderately to Severely Active Rheumatoid Arthritis Who Are on a Stable Background of Methotrexate (MTX) and Who Have an Inadequate Response to MTX (MTX-IR)
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Secondary ID [1]
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2022-501017-31-00
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Secondary ID [2]
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M14-465
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Universal Trial Number (UTN)
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Trial acronym
SELECT-COMPARE
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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 - Placebo for Adalimumab
Treatment: Drugs - Adalimumab
Treatment: Drugs - Placebo for Upadacitinib
Treatment: Drugs - Upadacitinib
Placebo comparator: Placebo followed by ABT-494 - Participants were to receive placebo to upadacitinib orally once daily (QD) and placebo to adalimumab by subcutaneous injection once every two weeks (eow) for up to 26 weeks. Participants who did not achieve a = 20% improvement in tender joint count (TJC) and swollen joint count (SJC) at Weeks 14, 18, or 22 compared to Baseline were to be switched to 15 mg upadacitinib orally QD. At Week 26, all remaining participants were to be switched to 15 mg upadacitinib QD until Week 48 (end of Period 1).
Participants who complete Period 1 will continue to receive 15 mg upadacitinib orally QD for up to 5 years in Period 2.
Active comparator: Adalimumab - Participants were to receive placebo to upadacitinib orally QD and 40 mg adalimumab by subcutaneous injection eow for up to 48 weeks in Period 1. Participants who did not achieve a = 20% improvement in TJC and SJC at Weeks 14, 18, or 22 compared to Baseline were to be switched to 15 mg upadacitinib orally QD. At Week 26 remaining participants who did not achieve low disease activity (defined as Clinical Disease Activity Index \[CDAI\] = 10) were to be switched to 15 mg upadacitinib orally QD until Week 48.
Participants who complete Period 1 will continue to receive the same treatment assigned at the end of Period 1 (15 mg upadacitinib QD or 40 mg adalimumab eow) for up to 5 years in Period 2.
Experimental: Upadacitinib - Participants were to receive 15 mg upadacitinib orally QD and placebo to adalimumab by subcutaneous injection eow for up to 48 weeks in Period 1. Participants who did not achieve a = 20% improvement in TJC and SJC at Weeks 14, 18, or 22 compared to Baseline were to be switched to 40 mg adalimumab eow. At Week 26 remaining participants who did not achieve low disease activity (defined as CDAI = 10) were to be switched to 40 mg adalimumab eow until Week 48.
Participants who complete Period 1 will continue to receive the same treatment assigned at the end of Period 1 (15 mg upadacitinib QD or 40 mg adalimumab eow) for up to 5 years in Period 2.
Treatment: Drugs: Placebo for Adalimumab
Administered by subcutaneous injection once every other week
Treatment: Drugs: Adalimumab
Administered by subcutaneous injection once every other week
Treatment: Drugs: Placebo for Upadacitinib
Tablets taken orally once a day
Treatment: Drugs: Upadacitinib
Tablets taken orally once a day
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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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Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 12
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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 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:
1. = 20% improvement in 68-tender joint count;
2. = 20% improvement in 66-swollen joint count; and
3. = 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 [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 12
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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 12.
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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Week 12
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Secondary outcome [1]
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Change From Baseline in DAS28 (CRP) at Week 12
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Assessment method [1]
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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 and Week 12
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Secondary outcome [2]
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Change From Baseline in Modified Total Sharp Score (mTSS) at Week 26
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Assessment method [2]
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The mTSS measures the level of joint damage from radiographs of the hands and feet, assessed by 2 independent, blinded readers. mTSS is calculated as the sum of the total joint erosion score and total joint space narrowing (JSN) score.
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).
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 negative change from Baseline in mTSS indicates improvement in joint damage whereas a change from Baseline greater than 0 indicates progression.
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Timepoint [2]
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Baseline and Week 26
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Secondary outcome [3]
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Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 12
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Assessment method [3]
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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 [3]
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Baseline and Week 12
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Secondary outcome [4]
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Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response at Week 12
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Assessment method [4]
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Participants who met the following 3 conditions for improvement from baseline were classified as meeting the ACR50 response criteria:
1. = 50% improvement in 68-tender joint count;
2. = 50% improvement in 66-swollen joint count; and
3. = 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 [4]
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Baseline and Week 12
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Secondary outcome [5]
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Change From Baseline in Short-Form 36 (SF-36) Physical Component Score (PCS) at Week 12
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Assessment method [5]
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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 [5]
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Baseline and Week 12
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Secondary outcome [6]
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Percentage of Participants Achieving Low Disease Activity (LDA) Based on DAS28(CRP) at Week 12
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Assessment method [6]
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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 [6]
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Week 12
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Secondary outcome [7]
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Percentage of Participants Achieving Low Disease Activity Based on CDAI at Week 12
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Assessment method [7]
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Low disease activity based on the clinical disease activity index (CDAI) is defined as a CDAI score = 10.
CDAI is a composite index for assessing disease activity based on the summation of the total tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity.
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Timepoint [7]
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Week 12
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Secondary outcome [8]
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Change From Baseline in Duration of Morning Stiffness at Week 12
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Assessment method [8]
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Participants were asked to indicate the time it took for them to get as limber as possible after awakening with morning stiffness over the past 7 days. A negative change from Baseline indicates improvement.
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Timepoint [8]
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Baseline and Week 12
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Secondary outcome [9]
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Change From Baseline in in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F)
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Assessment method [9]
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The FACIT Fatigue scale is a 13-item tool that measures an individual's level of fatigue during their usual daily activities over the past 7 days. Each of the fatigue and impact of fatigue items are measured on a four point Likert scale. The FACIT Fatigue Scale is the sum of the individual 13 scores and ranges from 0 to 52 where higher scores indicate better the quality of life. A positive change from Baseline indicates improvement.
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Timepoint [9]
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Baseline and Week 12
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Secondary outcome [10]
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Change From Baseline in Patient's Assessment of Pain at Week 12
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Assessment method [10]
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Participants were asked to indicate the severity of their arthritis pain within the previous week on a visual analog scale (VAS) from 0 to 100. A score of 0 indicates "no pain" and a score of 100 indicates "worst possible pain." A negative change from Baseline indicates improvement.
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Timepoint [10]
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Baseline and Week 12
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Secondary outcome [11]
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Percentage of Participants With No Radiographic Progression at Week 26
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Assessment method [11]
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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, which were assessed by 2 independent, blinded readers. mTSS is calculated as the sum of the total joint erosion score and total joint space narrowing (JSN) score and ranges from 0 (normal) to 448 (worst).
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).
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Timepoint [11]
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Baseline and Week 26
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Secondary outcome [12]
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Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response at Week 12
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Assessment method [12]
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Participants who met the following 3 conditions for improvement from baseline were classified as meeting the ACR70 response criteria:
1. = 70% improvement in 68-tender joint count;
2. = 70% improvement in 66-swollen joint count; and
3. = 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 [12]
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Baseline and Week 12
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Eligibility
Key inclusion criteria
* Adult male or female, at least 18 years old.
* Diagnosis of RA for greater than or equal to 3 months.
* Subjects must have been on oral or parenteral methotrexate (MTX) therapy greater than or equal to 3 months and on a stable prescription of greater than or equal to 15 to 25 mg/week (or greater than or equal to 10 mg/week in subjects intolerant of MTX at doses greater than or equal to 12.5 mg/week) for at least 4 weeks prior to the first dose of study drug. In addition all subjects should take a dietary supplement of folic acid or folinic acid throughout the study participation.
* Meets the following minimum disease activity criteria: greater than or equal to 6 swollen joints (based on 66 joint counts) and greater than or equal to 6 tender joints (based on 68 joint counts) at Screening and Baseline Visits.
* At least one of the following at Screening: greater than or equal to 3 bone erosions on x-ray OR greater than or equal to 1 bone erosion and a positive rheumatoid factor OR greater than or equal to 1 bone erosion and a positive anti-cyclic citrullinated peptide autoantibodies.
* Subjects with prior exposure to only one biological disease-modifying anti-rheumatic drugs (bDMARD) (except adalimumab) may be enrolled (up to 20% of total study population) if they have documented evidence of intolerance to the bDMARD or limited exposure (less than 3 months), but required washout periods need to be satisfied.
* Except for MTX, subject must have discontinued all conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDs).
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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
* Prior exposure to any Janus kinase (JAK) inhibitor (including but not limited to tofacitinib, baricitinib, and filgotinib).
* Subjects who have been exposed to adalimumab or who are considered inadequate responders to bDMARD therapy as determined by the Investigator.
* History of inflammatory joint disease other than RA. History of secondary Sjogren's Syndrome is permitted.
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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
Active, not recruiting
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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
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Actual
1/12/2015
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
30/09/2027
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Actual
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Sample size
Target
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Accrual to date
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Final
1629
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Recruitment in Australia
Recruitment state(s)
NSW,VIC
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Recruitment hospital [1]
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Royal Prince Alfred Hospital /ID# 144857 - Camperdown
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Recruitment hospital [2]
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Emeritus Research /ID# 142848 - Camberwell
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Recruitment postcode(s) [1]
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2050 - Camperdown
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Recruitment postcode(s) [2]
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3124 - Camberwell
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Recruitment outside Australia
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Alabama
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0
0
Santiago
Query!
Country [63]
0
0
Chile
Query!
State/province [63]
0
0
Temuco
Query!
Country [64]
0
0
Chile
Query!
State/province [64]
0
0
Vina Del Mar
Query!
Country [65]
0
0
Colombia
Query!
State/province [65]
0
0
Cundinamarca
Query!
Country [66]
0
0
Colombia
Query!
State/province [66]
0
0
Barranquilla
Query!
Country [67]
0
0
Colombia
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State/province [67]
0
0
Bogota DC
Query!
Country [68]
0
0
Colombia
Query!
State/province [68]
0
0
Bogota
Query!
Country [69]
0
0
Colombia
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State/province [69]
0
0
Bucaramanga
Query!
Country [70]
0
0
Colombia
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State/province [70]
0
0
Medellín
Query!
Country [71]
0
0
Croatia
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State/province [71]
0
0
Primorsko-goranska Zupanija
Query!
Country [72]
0
0
Croatia
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State/province [72]
0
0
Split
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Country [73]
0
0
Croatia
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State/province [73]
0
0
Zagreb
Query!
Country [74]
0
0
Czechia
Query!
State/province [74]
0
0
Moravskoslezsky Kraj
Query!
Country [75]
0
0
Czechia
Query!
State/province [75]
0
0
Olomoucky Kraj
Query!
Country [76]
0
0
Czechia
Query!
State/province [76]
0
0
Praha 2
Query!
Country [77]
0
0
Czechia
Query!
State/province [77]
0
0
Praha 4
Query!
Country [78]
0
0
Czechia
Query!
State/province [78]
0
0
Brno
Query!
Country [79]
0
0
Czechia
Query!
State/province [79]
0
0
Bruntál
Query!
Country [80]
0
0
Czechia
Query!
State/province [80]
0
0
Kladno
Query!
Country [81]
0
0
Czechia
Query!
State/province [81]
0
0
Ostrava
Query!
Country [82]
0
0
Czechia
Query!
State/province [82]
0
0
Pardubice
Query!
Country [83]
0
0
Denmark
Query!
State/province [83]
0
0
Midtjylland
Query!
Country [84]
0
0
Denmark
Query!
State/province [84]
0
0
Silkeborg
Query!
Country [85]
0
0
Estonia
Query!
State/province [85]
0
0
Harjumaa
Query!
Country [86]
0
0
Estonia
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State/province [86]
0
0
Tartumaa
Query!
Country [87]
0
0
Estonia
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State/province [87]
0
0
Pärnu
Query!
Country [88]
0
0
Estonia
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State/province [88]
0
0
Tallinn
Query!
Country [89]
0
0
France
Query!
State/province [89]
0
0
Haute-Garonne
Query!
Country [90]
0
0
France
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State/province [90]
0
0
Hauts-de-France
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Country [91]
0
0
France
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State/province [91]
0
0
Herault
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Country [92]
0
0
France
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State/province [92]
0
0
Bordeaux
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Country [93]
0
0
France
Query!
State/province [93]
0
0
Caen
Query!
Country [94]
0
0
France
Query!
State/province [94]
0
0
Clermont Ferrand
Query!
Country [95]
0
0
France
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State/province [95]
0
0
Marseille
Query!
Country [96]
0
0
France
Query!
State/province [96]
0
0
Paris
Query!
Country [97]
0
0
France
Query!
State/province [97]
0
0
Rennes
Query!
Country [98]
0
0
France
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State/province [98]
0
0
Strasbourg
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Country [99]
0
0
Germany
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State/province [99]
0
0
Nordrhein-Westfalen
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Country [100]
0
0
Germany
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State/province [100]
0
0
Schleswig-Holstein
Query!
Country [101]
0
0
Germany
Query!
State/province [101]
0
0
Chemnitz
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Country [102]
0
0
Germany
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State/province [102]
0
0
Hamburg
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Country [103]
0
0
Germany
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State/province [103]
0
0
Munich
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Country [104]
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0
Greece
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State/province [104]
0
0
Attiki
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Country [105]
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0
Greece
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State/province [105]
0
0
Athens
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Country [106]
0
0
Hong Kong
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State/province [106]
0
0
Hong Kong
Query!
Country [107]
0
0
Hong Kong
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State/province [107]
0
0
Tuen Mun
Query!
Country [108]
0
0
Hungary
Query!
State/province [108]
0
0
Borsod-Abauj-Zemplen
Query!
Country [109]
0
0
Hungary
Query!
State/province [109]
0
0
Pest
Query!
Country [110]
0
0
Hungary
Query!
State/province [110]
0
0
Vas
Query!
Country [111]
0
0
Hungary
Query!
State/province [111]
0
0
Veszprem
Query!
Country [112]
0
0
Hungary
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State/province [112]
0
0
Budapest
Query!
Country [113]
0
0
Hungary
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State/province [113]
0
0
Debrecen
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Country [114]
0
0
Hungary
Query!
State/province [114]
0
0
Heviz
Query!
Country [115]
0
0
Hungary
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State/province [115]
0
0
Kiskunhalas
Query!
Country [116]
0
0
Hungary
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State/province [116]
0
0
Kistarcsa
Query!
Country [117]
0
0
Ireland
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State/province [117]
0
0
Dublin
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Country [118]
0
0
Israel
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State/province [118]
0
0
Tel-Aviv
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Country [119]
0
0
Israel
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State/province [119]
0
0
Haifa
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Country [120]
0
0
Israel
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State/province [120]
0
0
Ramat Gan
Query!
Country [121]
0
0
Italy
Query!
State/province [121]
0
0
Milano
Query!
Country [122]
0
0
Italy
Query!
State/province [122]
0
0
Piemonte
Query!
Country [123]
0
0
Italy
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State/province [123]
0
0
Milan
Query!
Country [124]
0
0
Italy
Query!
State/province [124]
0
0
Verona
Query!
Country [125]
0
0
Kazakhstan
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State/province [125]
0
0
Astana
Query!
Country [126]
0
0
Kazakhstan
Query!
State/province [126]
0
0
Karaganda
Query!
Country [127]
0
0
Kazakhstan
Query!
State/province [127]
0
0
Semey
Query!
Country [128]
0
0
Kazakhstan
Query!
State/province [128]
0
0
Shymkent
Query!
Country [129]
0
0
Korea, Republic of
Query!
State/province [129]
0
0
Daegu Gwang Yeogsi
Query!
Country [130]
0
0
Korea, Republic of
Query!
State/province [130]
0
0
Daejeon Gwang Yeogsi
Query!
Country [131]
0
0
Korea, Republic of
Query!
State/province [131]
0
0
Incheon Gwang Yeogsi
Query!
Country [132]
0
0
Korea, Republic of
Query!
State/province [132]
0
0
Jeonranamdo
Query!
Country [133]
0
0
Korea, Republic of
Query!
State/province [133]
0
0
Seoul Teugbyeolsi
Query!
Country [134]
0
0
Korea, Republic of
Query!
State/province [134]
0
0
Daegu
Query!
Country [135]
0
0
Korea, Republic of
Query!
State/province [135]
0
0
Seoul
Query!
Country [136]
0
0
Latvia
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State/province [136]
0
0
Adazi
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Country [137]
0
0
Latvia
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State/province [137]
0
0
Daugavpils
Query!
Country [138]
0
0
Latvia
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State/province [138]
0
0
Liepaja
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Country [139]
0
0
Latvia
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State/province [139]
0
0
Riga
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Country [140]
0
0
Lithuania
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State/province [140]
0
0
Kaunas
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Country [141]
0
0
Lithuania
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State/province [141]
0
0
Vilnius
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Country [142]
0
0
Malaysia
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State/province [142]
0
0
Kelantan
Query!
Country [143]
0
0
Malaysia
Query!
State/province [143]
0
0
Batu Caves
Query!
Country [144]
0
0
Malaysia
Query!
State/province [144]
0
0
Kuching
Query!
Country [145]
0
0
Malaysia
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State/province [145]
0
0
Putrajaya
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Country [146]
0
0
Malaysia
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State/province [146]
0
0
Seremban
Query!
Country [147]
0
0
Mexico
Query!
State/province [147]
0
0
Ciudad De Mexico
Query!
Country [148]
0
0
Mexico
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State/province [148]
0
0
Nuevo Leon
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Country [149]
0
0
Mexico
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State/province [149]
0
0
Chihuahua
Query!
Country [150]
0
0
Mexico
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State/province [150]
0
0
Mexico City
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Country [151]
0
0
Mexico
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State/province [151]
0
0
Mérida
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Country [152]
0
0
New Zealand
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State/province [152]
0
0
Waikato
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Country [153]
0
0
New Zealand
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State/province [153]
0
0
Nelson
Query!
Country [154]
0
0
New Zealand
Query!
State/province [154]
0
0
Timaru
Query!
Country [155]
0
0
Poland
Query!
State/province [155]
0
0
Dolnoslaskie
Query!
Country [156]
0
0
Poland
Query!
State/province [156]
0
0
Kujawsko-pomorskie
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Country [157]
0
0
Poland
Query!
State/province [157]
0
0
Lubelskie
Query!
Country [158]
0
0
Poland
Query!
State/province [158]
0
0
Malopolskie
Query!
Country [159]
0
0
Poland
Query!
State/province [159]
0
0
Mazowieckie
Query!
Country [160]
0
0
Poland
Query!
State/province [160]
0
0
Podlaskie
Query!
Country [161]
0
0
Poland
Query!
State/province [161]
0
0
Pomorskie
Query!
Country [162]
0
0
Poland
Query!
State/province [162]
0
0
Slaskie
Query!
Country [163]
0
0
Poland
Query!
State/province [163]
0
0
Bialystok
Query!
Country [164]
0
0
Poland
Query!
State/province [164]
0
0
Poznan
Query!
Country [165]
0
0
Poland
Query!
State/province [165]
0
0
Warsaw
Query!
Country [166]
0
0
Portugal
Query!
State/province [166]
0
0
Lisboa
Query!
Country [167]
0
0
Portugal
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State/province [167]
0
0
Porto
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Country [168]
0
0
Portugal
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State/province [168]
0
0
Braga
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Country [169]
0
0
Portugal
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State/province [169]
0
0
Lisbon
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Country [170]
0
0
Portugal
Query!
State/province [170]
0
0
Viana Do Castelo
Query!
Country [171]
0
0
Puerto Rico
Query!
State/province [171]
0
0
Ponce
Query!
Country [172]
0
0
Puerto Rico
Query!
State/province [172]
0
0
San Juan
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Country [173]
0
0
Romania
Query!
State/province [173]
0
0
Bucuresti
Query!
Country [174]
0
0
Romania
Query!
State/province [174]
0
0
Iasi
Query!
Country [175]
0
0
Romania
Query!
State/province [175]
0
0
Oradea
Query!
Country [176]
0
0
Russian Federation
Query!
State/province [176]
0
0
Moskva
Query!
Country [177]
0
0
Russian Federation
Query!
State/province [177]
0
0
Permskiy Kray
Query!
Country [178]
0
0
Russian Federation
Query!
State/province [178]
0
0
Stavropol Skiy Kray
Query!
Country [179]
0
0
Russian Federation
Query!
State/province [179]
0
0
Tatarstan, Respublika
Query!
Country [180]
0
0
Russian Federation
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State/province [180]
0
0
Tverskaya Oblast
Query!
Country [181]
0
0
Russian Federation
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State/province [181]
0
0
Ivanovo
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Country [182]
0
0
Russian Federation
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State/province [182]
0
0
Moscow
Query!
Country [183]
0
0
Russian Federation
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State/province [183]
0
0
Nizhnij Novgorod
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Country [184]
0
0
Russian Federation
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State/province [184]
0
0
Orenburg
Query!
Country [185]
0
0
Russian Federation
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State/province [185]
0
0
Ryazan
Query!
Country [186]
0
0
Russian Federation
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State/province [186]
0
0
St. Petersburg
Query!
Country [187]
0
0
Russian Federation
Query!
State/province [187]
0
0
UFA
Query!
Country [188]
0
0
Russian Federation
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State/province [188]
0
0
Ulyanovsk
Query!
Country [189]
0
0
Serbia
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State/province [189]
0
0
Beograd
Query!
Country [190]
0
0
Serbia
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State/province [190]
0
0
Vojvodina
Query!
Country [191]
0
0
Slovakia
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State/province [191]
0
0
Martin
Query!
Country [192]
0
0
Slovakia
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State/province [192]
0
0
Nové Mesto Nad Váhom
Query!
Country [193]
0
0
Slovakia
Query!
State/province [193]
0
0
Partizanske
Query!
Country [194]
0
0
Slovakia
Query!
State/province [194]
0
0
Pieštany
Query!
Country [195]
0
0
Slovakia
Query!
State/province [195]
0
0
Rimavska Sobota
Query!
Country [196]
0
0
Slovakia
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State/province [196]
0
0
Sabinov
Query!
Country [197]
0
0
Slovakia
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State/province [197]
0
0
Stará Lubovna
Query!
Country [198]
0
0
Slovakia
Query!
State/province [198]
0
0
Topolcany
Query!
Country [199]
0
0
Slovakia
Query!
State/province [199]
0
0
Zvolen
Query!
Country [200]
0
0
South Africa
Query!
State/province [200]
0
0
Eastern Cape
Query!
Country [201]
0
0
South Africa
Query!
State/province [201]
0
0
Gauteng
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Country [202]
0
0
South Africa
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State/province [202]
0
0
Kwazulu-Natal
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Country [203]
0
0
South Africa
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State/province [203]
0
0
Western Cape
Query!
Country [204]
0
0
Spain
Query!
State/province [204]
0
0
Cantabria
Query!
Country [205]
0
0
Spain
Query!
State/province [205]
0
0
A Coruna
Query!
Country [206]
0
0
Spain
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State/province [206]
0
0
Cordoba
Query!
Country [207]
0
0
Spain
Query!
State/province [207]
0
0
Santiago de Compostela
Query!
Country [208]
0
0
Taiwan
Query!
State/province [208]
0
0
Taichung
Query!
Country [209]
0
0
Taiwan
Query!
State/province [209]
0
0
Taipei
Query!
Country [210]
0
0
Taiwan
Query!
State/province [210]
0
0
Kaohsiung
Query!
Country [211]
0
0
Taiwan
Query!
State/province [211]
0
0
New Taipei City
Query!
Country [212]
0
0
Taiwan
Query!
State/province [212]
0
0
Taichung City
Query!
Country [213]
0
0
Taiwan
Query!
State/province [213]
0
0
Taipei City
Query!
Country [214]
0
0
Taiwan
Query!
State/province [214]
0
0
Taoyuan City
Query!
Country [215]
0
0
Turkey
Query!
State/province [215]
0
0
Cerrahpasa
Query!
Country [216]
0
0
Turkey
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State/province [216]
0
0
Istanbul
Query!
Country [217]
0
0
Turkey
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State/province [217]
0
0
Izmir
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Country [218]
0
0
Ukraine
Query!
State/province [218]
0
0
Kyiv
Query!
Country [219]
0
0
Ukraine
Query!
State/province [219]
0
0
Lvivska Oblast
Query!
Country [220]
0
0
Ukraine
Query!
State/province [220]
0
0
Vinnytska Oblast
Query!
Country [221]
0
0
Ukraine
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State/province [221]
0
0
Ivano-frankivsk
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Country [222]
0
0
Ukraine
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State/province [222]
0
0
Kiev
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Country [223]
0
0
Ukraine
Query!
State/province [223]
0
0
Lviv
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Country [224]
0
0
Ukraine
Query!
State/province [224]
0
0
Odesa
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Country [225]
0
0
Ukraine
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State/province [225]
0
0
Zaporizhia
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Country [226]
0
0
United Kingdom
Query!
State/province [226]
0
0
London, City Of
Query!
Country [227]
0
0
United Kingdom
Query!
State/province [227]
0
0
Portsmouth
Query!
Country [228]
0
0
United Kingdom
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State/province [228]
0
0
Warrington
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Query!
Name
AbbVie
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Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
The purpose of this study was to assess efficacy, including inhibition of radiographic progression, and safety with upadacitinib versus placebo and versus an active comparator, adalimumab, in adults with with moderately to severely active rheumatoid arthritis (RA) who are on a stable background of methotrexate (MTX and who have an inadequate response to MTX.
Query!
Trial website
https://clinicaltrials.gov/study/NCT02629159
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Trial related presentations / publications
Fleischmann R, Pangan AL, Song IH, Mysler E, Bessette L, Peterfy C, Durez P, Ostor AJ, Li Y, Zhou Y, Othman AA, Genovese MC. Upadacitinib Versus Placebo or Adalimumab in Patients With Rheumatoid Arthritis and an Inadequate Response to Methotrexate: Results of a Phase III, Double-Blind, Randomized Controlled Trial. Arthritis Rheumatol. 2019 Nov;71(11):1788-1800. doi: 10.1002/art.41032. Epub 2019 Aug 28. Bergman M, Buch MH, Tanaka Y, Citera G, Bahlas S, Wong E, Song Y, Zueger P, Ali M, Strand V. Routine Assessment of Patient Index Data 3 (RAPID3) in Patients with Rheumatoid Arthritis Treated with Long-Term Upadacitinib Therapy in Five Randomized Controlled Trials. Rheumatol Ther. 2022 Dec;9(6):1517-1529. doi: 10.1007/s40744-022-00483-4. Epub 2022 Sep 20. Mysler E, Tanaka Y, Kavanaugh A, Aletaha D, Taylor PC, Song IH, Shaw T, Song Y, DeMasi R, Ali M, Fleischmann R. Impact of initial therapy with upadacitinib or adalimumab on achievement of 48-week treatment goals in patients with rheumatoid arthritis: post hoc analysis of SELECT-COMPARE. Rheumatology (Oxford). 2023 May 2;62(5):1804-1813. doi: 10.1093/rheumatology/keac477. Peterfy CG, Strand V, Friedman A, Hall S, Mysler E, Durez P, Baraliakos X, Enejosa JV, Shaw T, Li Y, Chen S, Song IH. Inhibition of structural joint damage progression with upadacitinib in rheumatoid arthritis: 1-year outcomes from the SELECT phase 3 program. Rheumatology (Oxford). 2022 Aug 3;61(8):3246-3256. doi: 10.1093/rheumatology/keab861. Yamaoka K, Tanaka Y, Kameda H, Khan N, Sasaki N, Harigai M, Song Y, Zhang Y, Takeuchi T. The Safety Profile of Upadacitinib in Patients with Rheumatoid Arthritis in Japan. Drug Saf. 2021 Jun;44(6):711-722. doi: 10.1007/s40264-021-01067-x. Epub 2021 May 27. Strand V, Tundia N, Bergman M, Ostor A, Durez P, Song IH, Enejosa J, Schlacher C, Song Y, Fleischmann R. Upadacitinib improves patient-reported outcomes vs placebo or adalimumab in patients with rheumatoid arthritis: results from SELECT-COMPARE. Rheumatology (Oxford). 2021 Dec 1;60(12):5583-5594. doi: 10.1093/rheumatology/keab158. Fleischmann RM, Blanco R, Hall S, Thomson GTD, Van den Bosch FE, Zerbini C, Bessette L, Enejosa J, Li Y, Song Y, DeMasi R, Song IH. Switching between Janus kinase inhibitor upadacitinib and adalimumab following insufficient response: efficacy and safety in patients with rheumatoid arthritis. Ann Rheum Dis. 2021 Apr;80(4):432-439. doi: 10.1136/annrheumdis-2020-218412. Epub 2020 Nov 4. Cohen SB, van Vollenhoven RF, Winthrop KL, Zerbini CAF, Tanaka Y, Bessette L, Zhang Y, Khan N, Hendrickson B, Enejosa JV, Burmester GR. Safety profile of upadacitinib in rheumatoid arthritis: integrated analysis from the SELECT phase III clinical programme. Ann Rheum Dis. 2021 Mar;80(3):304-311. doi: 10.1136/annrheumdis-2020-218510. Epub 2020 Oct 28. Erratum In: Ann Rheum Dis. 2021 May;80(5):e83. doi: 10.1136/annrheumdis-2020-218510corr1. Nader A, Mohamed MF, Winzenborg I, Doelger E, Noertersheuser P, Pangan AL, Othman AA. Exposure-Response Analyses of Upadacitinib Efficacy and Safety in Phase II and III Studies to Support Benefit-Risk Assessment in Rheumatoid Arthritis. Clin Pharmacol Ther. 2020 Apr;107(4):994-1003. doi: 10.1002/cpt.1671. Epub 2019 Nov 30. Fleischmann RM, Genovese MC, Enejosa JV, Mysler E, Bessette L, Peterfy C, Durez P, Ostor A, Li Y, Song IH. Safety and effectiveness of upadacitinib or adalimumab plus methotrexate in patients with rheumatoid arthritis over 48 weeks with switch to alternate therapy in patients with insufficient response. Ann Rheum Dis. 2019 Nov;78(11):1454-1462. doi: 10.1136/annrheumdis-2019-215764. Epub 2019 Jul 30.
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AbbVie Inc.
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AbbVie
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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?
AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR), Analytic code
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When will data be available (start and end dates)?
For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
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Available to whom?
Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
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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/ourmember/abbvie/
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What supporting documents are/will be available?
No Supporting Document Provided
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Attachment
Study protocol
https://cdn.clinicaltrials.gov/large-docs/59/NCT02629159/Prot_000.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/59/NCT02629159/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/NCT02629159