Phase 3
Completed N=526
Efficacy and Safety Study of ABP 501 Compared to Adalimumab in Subjects With Moderate to Severe Rheumatoid Arthritis
Arthritis, Rheumatoid
Source: ClinicalTrials.gov NCT01970475 ↗
Enrolled (actual)
526
Serious AEs
4.4%
Results posted
Dec 2016
Primary outcomePrimary: Percentage of Participants With an American College of Rheumatology (ACR) 20 Response at Week 24 — 74.6; 72.4 percentage of participants
◆ Published Evidence
Highly cited
186citations · ~21 / year
Efficacy and safety of the biosimilar ABP 501 compared with adalimumab in patients with moderate to severe rheumatoid arthritis: a randomised, double-blind, phase III equivalence study.
Summary
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).
Linked Publications (2)
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Efficacy and safety of the biosimilar ABP 501 compared with adalimumab in patients with moderate to severe rheumatoid arthritis: a randomised, double-blind, phase III equivalence study.
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Adalimumab Biosimilars in the Treatment of Rheumatoid Arthritis: A Systematic Review of the Evidence for Biosimilarity.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With an American College of Rheumatology (ACR) 20 Response at Week 24 |
74.6; 72.4 | — |
| SECONDARY Change From Baseline in Disease Activity Score 28-C-reactive Protein (DAS28-CRP) |
-1.01; -0.96; -1.45; -1.42; -1.79; -1.70 | — |
| SECONDARY Percentage of Participants With an ACR20 Response at Week 2 and Week 8 |
35.4; 24.5; 63.5; 62.5 | — |
| SECONDARY Percentage of Participants With an ACR50 Response at Week 24 |
49.2; 52.0 | — |
| SECONDARY Percentage of Participants With an ACR70 Response at Week 24 |
26.0; 22.9 | — |
| SECONDARY Number of Participants With Adverse Events |
132; 143; 9; 17; 50; 55 | — |
| SECONDARY Percentage of Participants Who Developed Antibodies to ABP 501 or Adalimumab |
38.3; 38.2; 9.1; 11.1 | — |
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT01970475) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.