An Open-label Extension Study Evaluating the Safety and Efficacy of Upadacitinib (ABT-494) in Adults With Rheumatoid Arthritis

Completed · Phase 2

Conditions studied: Rheumatoid Arthritis

In brief

The primary objective of the study is to evaluate the long-term safety, tolerability, and efficacy of upadacitinib in adults with rheumatoid arthritis (RA) who have completed a preceding randomized controlled trial with upadacitinib.

Key facts

Study ID

NCT02049138

Run by

AbbVie

People needed

493

Starts

2014-01-24

Expected to finish

2021-07-29

Last updated by the study team

2022-07-12

Who can join

Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subjects who have completed Study M13-550 (NCT01960855) or Study M13-537 (NCT02066389) with upadacitinib (ABT-494) and did not develop any discontinuation criteria.
• If the subject has evidence of new latent tuberculosis (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 before continuing to receive study drug.
• If female, subject must be postmenopausal, OR permanently surgically sterile, OR for women of childbearing potential practicing at least one protocol-specified method of birth control, that is effective from Study Day 1 through at least 30 days after the last dose of study drug.
• Subjects must voluntarily sign and date an informed consent, approved by an Independent Ethics Committee (IEC)/Institutional Review Board (IRB), prior to the initiation of any screening or study specific procedures.
• Substudy:
• Must currently be enrolled in the main study.
• Must have been receiving a stable dose of upadacitinib (either 15 mg QD or 30 mg QD) for a minimum of 4 weeks prior to the Vaccination visit.
• Must have been on a stable dose of background methotrexate (no change in dose or frequency) for a minimum of 4 weeks prior to the Vaccination visit.
• If subject is on corticosteroids, must remain on a stable dose of ≤ 10 mg/day of prednisone or equivalent corticosteroid therapy for at least 4 weeks after the vaccination visit.
• Must meet the prescribing specifications as per local label requirements to receive Prevnar 13® vaccine.
• Willing to receive Prevnar13® vaccine.

You may not qualify if…

• Pregnant or breastfeeding female.
• Ongoing infections at Week 0 that have not been successfully treated. Subjects with ongoing infections undergoing treatment may be enrolled but not dosed until the infection has been successfully treated.
• Anticipated requirement or receipt of any live vaccine during study participation including up to 30 days after the last dose of study drug.
• Laboratory values from the visit immediately prior to Baseline Visit (local requirements may apply) meeting the following criteria:
• Serum aspartate transaminase (AST) or alanine transaminase (ALT) > 3.0 × upper limit of normal (ULN)
• Estimated glomerular filtration rate by simplified 4-variable Modification of Diet in Renal Disease (MDRD) formula < 40 mL/min/1.73m\^2
• Total white blood cell count (WBC) < 2,000/μL
• Absolute neutrophil count (ANC) < 1,000/μL
• Platelet count < 50,000/μL
• Absolute lymphocytes count < 500/μL
• Hemoglobin < 8 g/dL
• Enrollment in another interventional clinical study while participating in this study.
• Consideration by the investigator, for any reason, that the subject is an unsuitable candidate to receive study drug.
• Substudy:
• Receiving any conventional synthetic disease modifying antirheumatic drugs (csDMARDs) other than methotrexate
• Receiving > 10 mg/day of prednisone or equivalent corticosteroid therapy.
• Receipt of any steroid injection within 4 weeks prior to Vaccination visit.
• History of severe allergic reaction (e.g., anaphylaxis) to any component of Prevnar 13®.
• History of any documented pneumococcal infection within the last 6 months prior to the vaccination visit.
• Receipt of any vaccine 4 weeks prior to the vaccination visit and/or anticipation of any vaccination for 4 weeks after the vaccination visit.
• Receipt of any pneumococcal vaccine.
• Subject is not suitable for the sub-study as per the Investigator's judgment.

Where it is running

• AZ Arthritis and Rheumotology Research, PLLC /ID# 135902 — Phoenix, Arizona, United States
• AZ Arthritis and Rheumotology Research, PLLC /ID# 135931 — Phoenix, Arizona, United States
• C.V. Mehta MD, Med Corporation /ID# 124092 — Hemet, California, United States
• Moores Cancer Center at UC San Diego /ID# 128747 — La Jolla, California, United States
• Desert Medical Advances - Palm Desert /ID# 135911 — Palm Desert, California, United States
• Orrin Troum, M.D. and Medical /ID# 135933 — Santa Monica, California, United States
• Duplicate_Robin K. Dore MD, Inc /ID# 135906 — Tustin, California, United States
• Inland Rheum Clin Trials Inc. /ID# 136716 — Upland, California, United States
• Duplicate_Desert Valley Medical Group /ID# 135932 — Victorville, California, United States
• Denver Arthritis Clinic /ID# 135901 — Denver, Colorado, United States
• New England Research Associates, LLC /ID# 124085 — Bridgeport, Connecticut, United States
• Arthritis & Rheumatic Disease Specialties /ID# 135910 — Aventura, Florida, United States
• Rheumatology Associates of South Florida (RASF) - Clinical Research /ID# 124082 — Boca Raton, Florida, United States
• Omega Research Maitland, LLC /ID# 124094 — DeBary, Florida, United States
• University of Florida /ID# 124087 — Jacksonville, Florida, United States
• Suncoast Research Group /ID# 137774 — Miami, Florida, United States
• Omega Research Maitland, LLC /ID# 137398 — Orlando, Florida, United States
• Millennium Research /ID# 135917 — Ormond Beach, Florida, United States
• Arthritis Center, Inc. /ID# 124090 — Palm Harbor, Florida, United States
• IRIS Research and Development, LLC /ID# 140362 — Plantation, Florida, United States
• Lovelace Scientific Resources /ID# 128745 — Venice, Florida, United States
• North Georgia Rheumatology Group /ID# 128746 — Lawrenceville, Georgia, United States
• Kansas City Internal Medicine /ID# 135916 — Overland Park, Kansas, United States
• PRN Professional Research Network of Kansas, LLC /ID# 124091 — Wichita, Kansas, United States
• Rheum Assoc of North Alabama /ID# 135926 — Huntsville, Alabama, United States

Full record on ClinicalTrials.gov

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