Clinical Trials in France / NCT02629159
Active, not recruiting
Phase 3
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 France tracker
Condition(s) studied
Rheumatoid Arthritis
Investigational drug(s) / intervention(s)
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
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 | Status |
|---|---|---|---|
| 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.
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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 France