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

• Register: ClinicalTrials.gov
• Last refreshed on: 1 May 2023
• Main ID: NCT02629159
• Date of registration: 10/12/2015
• Prospective Registration: No
• Primary sponsor: AbbVie
• 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 SELECT-COMPARE
• 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)
• Date of first enrolment: December 1, 2015
• Target sample size: 1629
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/show/NCT02629159
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 3

Countries of recruitment

Argentina, Australia, Austria, Belarus, Belgium, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Chile, Colombia, Croatia, Czech Republic, Czechia, Denmark, Estonia, Finland, France, Germany, Greece, Hong Kong, Hungary, Ireland, Israel, Italy, Kazakhstan, Korea, Republic of, Latvia, Lithuania, Malaysia, Mexico, Netherlands, New Zealand, Poland, Portugal, Puerto Rico, Romania, Russian Federation, Serbia, Slovakia, South Africa, Spain, Taiwan, Turkey, Ukraine, United Kingdom, United States

Contacts

• Name: AbbVie Inc.
• Affiliation: AbbVie

Key inclusion & exclusion criteria

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).

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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Rheumatoid Arthritis

Intervention(s)

Drug: Placebo for Upadacitinib

Drug: Placebo for Adalimumab

Drug: Upadacitinib

Drug: Adalimumab

Primary Outcome(s)

Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 12 [Time Frame: Baseline and Week 12]

Percentage of Participants Achieving Clinical Remission (CR) Based on DAS28(CRP) at Week 12 [Time Frame: Week 12]

Secondary Outcome(s)

Percentage of Participants Achieving Low Disease Activity (LDA) Based on DAS28(CRP) at Week 12 [Time Frame: Week 12]

Percentage of Participants Achieving Low Disease Activity Based on CDAI at Week 12 [Time Frame: Week 12]

Change From Baseline in DAS28 (CRP) at Week 12 [Time Frame: Baseline and Week 12]

Change From Baseline in Patient's Assessment of Pain at Week 12 [Time Frame: Baseline and Week 12]

Change From Baseline in Short-Form 36 (SF-36) Physical Component Score (PCS) at Week 12 [Time Frame: Baseline and Week 12]

Change From Baseline in in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) [Time Frame: Baseline and Week 12]

Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 12 [Time Frame: Baseline and Week 12]

Change From Baseline in Duration of Morning Stiffness at Week 12 [Time Frame: Baseline and Week 12]

Change From Baseline in Modified Total Sharp Score (mTSS) at Week 26 [Time Frame: Baseline and Week 26]

Percentage of Participants With No Radiographic Progression at Week 26 [Time Frame: Baseline and Week 26]

Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response at Week 12 [Time Frame: Baseline and Week 12]

Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response at Week 12 [Time Frame: Baseline and Week 12]

Secondary ID(s)

M14-465

2022-501017-31-00

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 07/10/2019
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02629159