CI

At a glance

ClinicalIndex Comparison Record
Phase 3Active· 1,629 enrolled
Drug / intervention
Placebo for Adalimumab +3 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02629159
NCT02629159Phase 3Active
CompareCT.gov

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)

AbbVie·interventional·Posted Dec 14, 2015·Updated Aug 5, 2025

In Brief

A Phase 3 clinical trial evaluating Placebo for Adalimumab, Adalimumab, and 2 other interventions for Rheumatoid Arthritis. Active but no longer recruiting, targeting 1,629 participants across 370 sites in 44 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRheumatoid Arthritis
CountriesArgentina, 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, United States
Collaborators--

Timeline

Phase 3Active
2016201720182019202020212022202320242025202620272028
First PostedDec 14, 2015
Enrollment StartDec 1, 2015
Primary CompletionOct 27, 2017
Study CompletionSep 30, 2027
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 10.5 years ago

Interventions

Placebo for Adalimumabdrug

Administered by subcutaneous injection once every other week

Adalimumabdrug

Administered by subcutaneous injection once every other week

Placebo for Upadacitinibdrug

Tablets taken orally once a day

Upadacitinibdrug

Tablets taken orally once a day