A Study Comparing Upadacitinib (ABT-494) to Placebo in Adults With Rheumatoid Arthritis on a Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who Have an Inadequate Response to csDMARDs Alone

• Register: ClinicalTrials.gov
• Last refreshed on: 10 August 2021
• Main ID: NCT02675426
• Date of registration: 11/12/2015
• Prospective Registration: Yes
• Primary sponsor: AbbVie
• Public title: A Study Comparing Upadacitinib (ABT-494) to Placebo in Adults With Rheumatoid Arthritis on a Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who Have an Inadequate Response to csDMARDs Alone SELECT-NEXT
• Scientific title: A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) to Placebo in Subjects With Moderately to Severely Active Rheumatoid Arthritis Who Are on a Stable Dose of Conventional Synthetic Disease-Modifying Anti-Rheumatic Drugs (csDMARDs) and Have an Inadequate Response to csDMARDs
• Date of first enrolment: December 17, 2015
• Target sample size: 661
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/show/NCT02675426
• 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, Colombia, Croatia, Czech Republic, Czechia, Denmark, Estonia, Finland, France, Germany, Greece, Hong Kong, Hungary, Ireland, Israel, Italy, Kazakhstan, Korea, Republic of, Latvia, Lithuania, Mexico, Netherlands, New Zealand, Norway, Poland, Portugal, Puerto Rico, Romania, Russian Federation, Serbia, Singapore, Slovakia, South Africa, Spain, Switzerland, 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 Rheumatoid Arthritis (RA) for greater than or equal to 3 months.

- Subjects have been receiving conventional synthetic DMARD (csDMARD) therapy for
greater than or equal to 3 months and on a stable dose for greater than or equal to 4
weeks prior to the first dose of study drug. The following csDMARDs are allowed:
Methotrexate (MTX), sulfasalazine, hydroxychloroquine, chloroquine, and leflunomide.

- 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.

- Subjects with prior exposure to at most one biologic DMARD (bDMARD) may be enrolled
(up to 20% of study population) if they have documented evidence of intolerance to
bDMARDs or limited exposure (less than 3 months) and have satisfied required washout
periods.

Exclusion Criteria:

- Prior exposure to any Janus kinase (JAK) inhibitor (including but not limited to
tofacitinib, baricitinib, and filgotinib).

- History of inflammatory joint disease other than RA. History of secondary Sjogren's
Syndrome is permitted.

- Subjects who are considered inadequate responders to bDMARD therapy as determined by
the Investigator.



Age minimum: 18 Years
Age maximum: 99 Years
Gender: All

Health Condition(s) or Problem(s) studied

Rheumatoid Arthritis

Intervention(s)

Drug: Upadacitinib

Drug: Placebo

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

Secondary Outcome(s)

Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) 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]

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

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

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

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

Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 1 [Time Frame: Baseline and week 1]

Change From Baseline in in Disease Activity Score 28 (CRP) 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 Short-Form 36 (SF-36) Physical Component Score (PCS) at Week 12 [Time Frame: Baseline and Week 12]

Secondary ID(s)

M13-549

2015-003332-13

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/NCT02675426