Efficacy and Safety Study of ABP 501 Compared to Adalimumab in Subjects With Moderate to Severe Rheumatoid Arthritis
Completed · Phase 3
Conditions studied: Arthritis, Rheumatoid
In brief
The purpose of this study is to compare the effectiveness and safety of ABP 501 against adalimumab (HUMIRA®) in adults with moderate to severe rheumatoid arthritis (RA) who have an inadequate response to methotrexate (MTX).
Key facts
- Study ID
- NCT01970475
- Run by
- Amgen
- People needed
- 526
- Starts
- 2013-10-01
- Expected to finish
- 2014-11-01
- Last updated by the study team
- 2016-12-13
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Men or women ≥ 18 and ≤ 80 years old
- Subjects must be diagnosed with rheumatoid arthritis for at least 3 months before baseline
- Active RA defined as ≥ 6 swollen joints and ≥ 6 tender joints at screening and baseline
- Subjects must be taking MTX for ≥ 12 consecutive weeks and on a stable dose of 7.5 to 25 mg/week for > 8 weeks prior to receiving the study drug and be willing to remain on stable dose throughout the study
- Subject has no known history of active tuberculosis
You may not qualify if…
- Class IV RA, Felty's syndrome or history of prosthetic or native joint infection
- Major chronic inflammatory disease or connective tissue disease other than RA, with the exception of secondary Sjögren's syndrome
- Prior use of 2 or more biologic therapies for RA
- Previous receipt of HUMIRA® (adalimumab) or a biosimilar of adalimumab
- Ongoing use of prohibited treatments
- Other Inclusion/Exclusion criteria may apply
Where it is running
- Research Site — Victorville, California, United States
- Research Site — Jupiter, Florida, United States
- Research Site — Sandy Springs, Georgia, United States
- Research Site — Lansing, Michigan, United States
- Research Site — Middleburg Heights, Ohio, United States
- Research Site — Winnipeg, Manitoba, Canada
- Research Site — Hattingen, North Rhine-Westphalia, Germany
- Research Site — Barnsley, England, United Kingdom
- Research Site — North Shields, England, United Kingdom
- Research Site — Suffolk, England, United Kingdom
- Research Site — Cardiff, Wales, United Kingdom
Full record on ClinicalTrials.gov
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