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
NCT02629159 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1629
Last updated 2025-08-05
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.
Conditions
Interventions
- DRUG
-
Placebo for Adalimumab
Administered by subcutaneous injection once every other week
- DRUG
-
Administered by subcutaneous injection once every other week
- DRUG
-
Placebo for Upadacitinib
Tablets taken orally once a day
- DRUG
-
Upadacitinib
Tablets taken orally once a day
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
AbbVie Inc. · AbbVie
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2015-12-01
- Primary Completion
- 2017-10-27
- Completion
- 2027-09-30
- FDA Drug
- Yes
Countries
- United States
- Argentina
- Australia
- Austria
- Belarus
- Belgium
- Bosnia and Herzegovina
- Brazil
- Bulgaria
- Canada
- Chile
- Colombia
- Croatia
- Czechia
- Denmark
- Estonia
- France
- Germany
- Greece
- Hong Kong
- Hungary
- Ireland
- Israel
- Italy
- Kazakhstan
- Latvia
- Lithuania
- Malaysia
- Mexico
- New Zealand
- Poland
- Portugal
- Puerto Rico
- Romania
- Russia
- Serbia
- Slovakia
- South Africa
- South Korea
- Spain
- Taiwan
- Turkey (Türkiye)
- Ukraine
- United Kingdom
Study Locations
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