A Study to Compare Upadacitinib (ABT-494) Monotherapy to Methotrexate (MTX) Monotherapy in Adults With Rheumatoid Arthritis (RA) Who Have Not Previously Taken Methotrexate

Completed · Phase 3 · Has a placebo group

Conditions studied: Rheumatoid Arthritis

In brief

The objectives of Period 1 were the following: * To compare the safety and efficacy of upadacitinib 7.5 mg once daily (QD) monotherapy (for participants in Japan only), 15 mg QD monotherapy, and 30 mg QD monotherapy versus weekly methotrexate monotherapy for the treatment of signs and symptoms of RA in methotrexate-naïve adults with moderately to severely active RA; * To compare the efficacy of upadacitinib 15 mg QD monotherapy and upadacitinib 30 mg QD monotherapy versus weekly methotrexate monotherapy for prevention of structural progression in methotrexate-naïve adults with moderately to severely active RA. The objective of Period 2 is to evaluate the long-term safety, tolerability, and efficacy of upadacitinib 7.5 mg QD (for participants in Japan only), 15 mg QD, and 30 mg QD in adults with RA who have completed Period 1.

Key facts

Study ID

NCT02706873

Run by

AbbVie

People needed

1002

Starts

2016-02-23

Expected to finish

2022-11-10

Last updated by the study team

2023-07-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Duration of symptoms consistent with RA for ≥ 6 weeks who also fulfill the 2010 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) classification criteria for RA.
• Naïve to Methotrexate (MTX) or, if already on MTX, have received no more than 3 weekly MTX doses with requirement to complete a 4-week MTX washout before the first dose of study drug.
• Participants with prior exposure to conventional synthetic disease-modifying anti-rheumatic drugs(csDMARDs) other than MTX may be enrolled if completed the washout period.
• Participant meets both of the following minimum disease activity criteria:
• ≥ 6 swollen joints (based on 66 joint counts) and ≥ 6 tender joints (based on 68 joint counts) at Screening and Baseline Visits.
• high sensitivity C reactive protein (hsCRP) ≥ 5 mg/L (central lab, upper limit of normal [ULN] 2.87 mg/L at Screening Visit.
• Greater than or equal to 1 bone erosion on x-ray (by local reading) OR in the absence of documented bone erosion, both positive rheumatoid factor (RF) and positive anti-cyclic citrullinated peptide (anti CCP) autoantibodies are required at Screening.
• Stable dose of non-steroidal anti-inflammatory drugs (NSAIDs), acetaminophen, oral corticosteroids (equivalent to prednisone ≤ 10 mg/day), or inhaled corticosteroids for stable medical conditions are allowed but must have been at a stable dose ≥ 1 week prior to the first dose of study drug.

You may not qualify if…

• Intolerant to Methotrexate (MTX).
• Prior exposure to any Janus kinase (JAK) inhibitor (including but not limited to tofacitinib, baricitinib, and filgotinib).
• Prior exposure to any biologic disease-modifying anti-rheumatic drugs (bDMARDs).
• History of any arthritis with onset prior to age 17 years or current diagnosis, inflammatory joint disease other than RA (including but not limited to gout, systemic lupus erythematosus, psoriatic arthritis, axial spondyloarthritis including ankylosing spondylitis and non-radiographic axial spondyloarthritis, reactive arthritis, overlap connective tissue diseases, scleroderma, polymyositis, dermatomyositis, fibromyalgia [currently with active symptoms]. Current diagnosis of secondary Sjogren's Syndrome is permitted.
• Has been treated with intra-articular, intramuscular, intravenous, trigger point or tender point, intra-bursa, or intra-tendon sheath corticosteroids in the preceding 8 weeks prior to the first dose of study drug.

Where it is running

• Desert Medical Advances /ID# 143730 — Palm Desert, California, United States
• International Medical Research - Daytona /ID# 143748 — Daytona Beach, Florida, United States
• FL Med Ctr and Research, Inc. /ID# 143724 — Miami, Florida, United States
• Millennium Research /ID# 143736 — Ormond Beach, Florida, United States
• Arthritis Research of Florida /ID# 143743 — Palm Harbor, Florida, United States
• Sarasota Arthritis Center /ID# 145978 — Sarasota, Florida, United States
• FL Med Clinic, PA /ID# 143744 — Zephyrhills, Florida, United States
• Deerbrook Medical Associates /ID# 143728 — Vernon Hills, Illinois, United States
• Four Rivers Clinical Research /ID# 143741 — Paducah, Kentucky, United States
• Ocean Rheumatology, PA /ID# 143737 — Toms River, New Jersey, United States
• Arthritis Rheumatic Back Disorder /ID# 143733 — Voorhees Township, New Jersey, United States
• Trinity Health Med Arts Clinic /ID# 143727 — Minot, North Dakota, United States
• STAT Research, Inc. /ID# 143750 — Vandalia, Ohio, United States
• Healthcare Research Consultant /ID# 143747 — Tulsa, Oklahoma, United States
• Advanced Rheumatology & Arthri /ID# 147947 — Wexford, Pennsylvania, United States
• Articularis Healthcare Group, Inc d/b/a Low Country Rheumatology /ID# 145653 — Summerville, South Carolina, United States
• West Tennessee Research Inst /ID# 143723 — Jackson, Tennessee, United States
• Dr. Ramesh Gupta /ID# 143732 — Memphis, Tennessee, United States
• Diagnostic Group Integrated He /ID# 152921 — Beaumont, Texas, United States
• Adriana Pop-Moody MD Clinic PA /ID# 147626 — Corpus Christi, Texas, United States
• Doctor's Hosp at Renaissance /ID# 156407 — Edinburg, Texas, United States
• MedResearch Inc. /ID# 156409 — El Paso, Texas, United States
• Rheumatic Disease Clin Res Ctr /ID# 151103 — Houston, Texas, United States
• Accurate Clinical Research /ID# 143749 — Houston, Texas, United States
• TriWest Research Associates- La Mesa /ID# 143738 — La Mesa, California, United States

Full record on ClinicalTrials.gov

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