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 · tracked via the Priya Life Science UK tracker

Sponsor

AbbVie

Phase

Phase 3

Started

2015-12-01

Last updated

2025-08-05

Condition(s) studied

Rheumatoid Arthritis

Investigational drug(s) / intervention(s)

Placebo for AdalimumabAdalimumabPlacebo for UpadacitinibUpadacitinib

Placebo for Adalimumab: Administered by subcutaneous injection once every other week

Adalimumab: Administered by subcutaneous injection once every other week

Placebo for Upadacitinib: Tablets taken orally once a day

Upadacitinib: Tablets taken orally once a day

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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.

Primary outcome measure(s)

Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 12 — Baseline and Week 12
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).
Percentage of Participants Achieving Clinical Remission (CR) Based on DAS28(CRP) at Week 12 — Week 12
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.

Trial sites (370)

Facility	City	Region
Achieve Clinical Research, LLC /ID# 143136	Birmingham	Alabama
AZ Arthritis and Rheum Assoc /ID# 143130	Mesa	Arizona
SunValley Arthritis Center, Lt /ID# 143123	Peoria	Arizona
Elite Clinical Studies, LLC /ID# 144881	Phoenix	Arizona
AZ Arthritis and Rheum Researc /ID# 143080	Phoenix	Arizona
AZ Arthritis and Rheum Researc /ID# 143121	Phoenix	Arizona
AZ Arthritis & Rheuma Research /ID# 143131	Phoenix	Arizona
Arizona Research Center, Inc. /ID# 144877	Phoenix	Arizona
AZ Arthritis & Rheum Research /ID# 156093	Sun City	Arizona
University of Arizona Cancer Center - North Campus /ID# 143114	Tucson	Arizona
Osteoporosis Medical Center /ID# 153935	Beverly Hills	California
T. Joseph Raoof, MD, Inc. /ID# 144884	Encino	California
Rheumatology Ctr of San Diego /ID# 153747	Escondido	California
C.V. Mehta MD, Med Corporation /ID# 143116	Hemet	California
Allergy and Rheum Med Clin /ID# 146083	La Jolla	California
Kotha and Kotha /ID# 161046	La Mesa	California
TriWest Research Associates- La Mesa /ID# 143115	La Mesa	California
Valerius Med Grp & Res Ctr /ID# 143120	Los Alamitos	California
Discovery MM Services, Inc /ID# 163504	Los Angeles	California
Desert Medical Advances /ID# 143097	Palm Desert	California
Sierra Rheumatology /ID# 155672	Roseville	California
Robin K. Dore MD, Inc /ID# 143090	Tustin	California
Medvin Clinical Research /ID# 148362	Whittier	California
Arthritis Assoc & Osteo Ctr /ID# 143122	Colorado Springs	Colorado
Arthritis and Rheum Clin N. CO /ID# 156094	Fort Collins	Colorado
AARDS Research, Inc. /ID# 154190	Aventura	Florida
ZASA Clinical Research /ID# 143134	Boynton Beach	Florida
Clinical Res of West FL, Inc. /ID# 143112	Clearwater	Florida
International Medical Research /ID# 143132	Daytona Beach	Florida
Lakes Research, LLC /ID# 145630	Miami	Florida
FL Med Ctr and Research, Inc. /ID# 143081	Miami	Florida
Ctr Arthritis & Rheumatic Dise /ID# 143135	Miami	Florida
Precision Research Org, LLC /ID# 143092	Miami Lakes	Florida
Advanced Clin Res of Orlando /ID# 154617	Ocoee	Florida
Rheum Assoc of Central FL /ID# 145632	Orlando	Florida
Omega Research Consultants /ID# 145635	Orlando	Florida
HMD Research LLC /ID# 163292	Orlando	Florida
Arthritis Research of Florida /ID# 143125	Palm Harbor	Florida
Arthritis Center, Inc. /ID# 145647	Palm Harbor	Florida
St. Anthony Comprehsve Res Ins /ID# 143095	St. Petersburg	Florida

+ 330 more sites — see the full list on the official registry below.

On this site

📄 Humira (adalimumab) drug profile → 📄 Rinvoq (upadacitinib) drug profile →

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT02629159 on ClinicalTrials.gov ↗ ← All trials in the UK