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A Study Investigating the Efficacy and Safety of Upadacitinib (ABT-494) Given With Methotrexate (MTX) in Adults With Rheumatoid Arthritis Who Have Had an Inadequate Response to MTX Alone

A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study to Investigate the Safety and Efficacy of ABT-494 With Background Methotrexate (MTX) in Subjects With Active Rheumatoid Arthritis (RA) Who Have Had an Inadequate Response to MTX Alone

NCT02066389•AbbVie

View on ClinicalTrials.gov

Summary

The primary objective of the study was to compare the safety and efficacy of multiple doses of upadacitinib versus placebo in adults with moderately to severely active rheumatoid arthritis (RA) on stable background methotrexate therapy who had not shown an adequate response to methotrexate alone.

Eligibility

Age

18 - 100 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Diagnosed with RA based on either the 1987-revised American College of Rheumatology (ACR) classification criteria or the 2010 ACR/European League against Rheumatism (EULAR) criteria for ≥ 3 months.
•2. Have active RA as defined by the following minimum disease activity criteria:
•* ≥ 6 swollen joints (based on 66 joint counts) at Screening and Baseline Visits.
•* ≥ 6 tender joints (based on 68 joint counts) at Screening and Baseline Visits.
•* high-sensitivity C-reactive protein (hsCRP) \> upper limit of normal (ULN) OR positive for both rheumatoid factor and anti-cyclic citrullinated peptide (CCP) at Screening.
•3. Subjects must have been receiving oral or parenteral methotrexate therapy ≥ 3 months and on a stable prescription of 7.5 to 25 mg/week for at least 4 weeks prior to Baseline Visit. Subjects should also be on a stable dose of folic acid (or equivalent) for at least 4 weeks prior to Baseline Visit. Subjects should continue with their stable doses of methotrexate and folic acid throughout the study.
•4. Except for MTX, subjects must have discontinued all oral disease-modifying anti-rheumatic drugs (DMARDs) prior to Baseline Visit as specified below or for at least five times the mean terminal elimination half-life of a drug, whichever is longer:
•* ≥ 4 weeks prior to Baseline Visit for minocycline, penicillamine, sulfasalazine, hydroxychloroquine, chloroquine, azathioprine, gold formulations, cyclophosphamide
•* ≥ 8 weeks prior to Baseline Visit for leflunomide if no elimination procedure was followed, or adhere to a washout procedure (i.e., 11 days washout with colestyramine, or 30 days washout with activated charcoal)
•5. Subject has a negative tuberculosis (TB) Screening Assessment. If the subject has evidence of a latent TB infection, the subject must initiate and complete a minimum of 2 weeks (or per local guidelines, whichever is longer) of an ongoing TB prophylaxis or have documented completion of a full course of TB prophylaxis, prior to Baseline Visit.
+2 more criteria

Exclusion Criteria

•1. Female who is pregnant or breastfeeding.
•2. Prior exposure to Janus activated kinase (JAK) inhibitor (e.g., tofacitinib, baricitinib).
•3. Prior exposure to any investigational or approved biologic RA therapy.
•4. Receipt of any investigational drug of chemical or biologic nature within a minimum of 30 days or 5 half-lives of the drug (whichever is longer) prior to Week 0 Visit.
•5. Current or expected need of other immunosuppressant medications, except methotrexate. Use of oral intake of \> 10 mg prednisone/day or equivalent corticosteroid therapy (see inclusion criterion 7).
•6. Subject has been treated with intra-articular or parenteral administration of corticosteroids in the preceding 8 weeks prior to the Week 0 Visit.
•7. Screening laboratory values meeting the following criteria:
•* Serum aspartate transaminase (AST) or alanine transaminase (ALT) \> 1.5 × ULN
•* Estimated glomerular filtration rate (eGRF) by simplified 4-variable Modification of Diet in Renal Disease (MDRD) formula \< 40 mL/min/1.73 m²
•* Total white blood cell count (WBC) \< 3,000/µL
+4 more criteria

Locations (63)

C.V. Mehta MD, Med Corporation /ID# 126380

Hemet, California, United States

Omega Research Consultants, LLC /ID# 125780

DeBary, Florida, United States

Lovelace Scientific Resources /ID# 127324

Venice, Florida, United States

North Georgia Rheumatology Grp /ID# 125779

Lawrenceville, Georgia, United States

PRN Professional Research Network of Kansas, LLC /ID# 126148

Wichita, Kansas, United States

The Center for Rheumatology & /ID# 127323

Wheaton, Maryland, United States

Summit Medical Group /ID# 125776

Clifton, New Jersey, United States

Arthritis and Osteo Assoc /ID# 134994

Las Cruces, New Mexico, United States

Altoona Ctr Clinical Res /ID# 125777

Duncansville, Pennsylvania, United States

Emkey Arthritis and Osteo Clin /ID# 134716

Wyomissing, Pennsylvania, United States

Key Dates

Start Date

March 26, 2014

Primary Completion Date

July 2, 2015

Completion Date

July 2, 2015

Last Updated

July 30, 2021

Enrollment

300

ACTUAL participants

Conditions

Rheumatoid Arthritis

Interventions

Placebo

DRUG

Upadacitinib

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 30, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study Investigating the Efficacy and Safety of Upadacitinib (ABT-494) Given With Methotrexate (MTX) in Adults With Rheumatoid Arthritis Who Have Had an Inadequate Response to MTX Alone

Inclusion Criteria

Exclusion Criteria

A Study to Evaluate the Safety and Activity of SAR448501/DR-0201 in Patients With Autoimmune Rheumatic Diseases

Clinical Cohort Construction and Therapeutic Effect Evaluation of Integrated Traditional Chinese and Western Medicine in the Treatment of Rheumatoid Arthritis

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