Phase 3
Completed N=467
Long-term Safety and Efficacy of ABP 501 in Subjects With Moderate to Severe Rheumatoid Arthritis
Arthritis, Rheumatoid
Source: ClinicalTrials.gov NCT02114931 ↗
Enrolled (actual)
467
Serious AEs
9.9%
Results posted
Apr 2017
Primary outcomePrimary: Number of Participants With Adverse Events — 143; 154; 26; 16 participants
◆ Published Evidence
Established
53citations · ~11 / year
Adalimumab Biosimilars in the Treatment of Rheumatoid Arthritis: A Systematic Review of the Evidence for Biosimilarity.
Summary
The purpose of this open-label study is to evaluate the long-term safety and efficacy of ABP 501 in adults with moderate to severe rheumatoid arthritis (RA).
Linked Publications (2)
-
Adalimumab Biosimilars in the Treatment of Rheumatoid Arthritis: A Systematic Review of the Evidence for Biosimilarity.
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An open-label extension study to demonstrate long-term safety and efficacy of ABP 501 in patients with rheumatoid arthritis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Events |
143; 154; 26; 16; 37; 43 | — |
| PRIMARY Number of Participants With Grade ≥ 3 Hematology and Chemistry Laboratory Results |
1; 0; 1; 0; 1; 0 | — |
| PRIMARY Percentage of Participants Who Developed Antibodies to ABP 501 |
32.3; 34.2; 5.7; 8.9; 21.8; 14.8 | — |
| SECONDARY Percentage of Participants With an American College of Rheumatology (ACR) 20 Response |
73.2; 73.3; 77.6; 77.6; 74.0; 74.3 | — |
| SECONDARY Change From Parent Study Baseline in Disease Activity Score 28-C-reactive Protein (DAS28-CRP) |
-2.26; -2.25; -2.40; -2.32; -2.49; -2.33 | — |
Eligibility Criteria
Inclusion Criteria
- Subject was randomized into protocol 20120262 (NCT01970475) and completed the week 26 visit
Exclusion Criteria
- Subject experienced a serious adverse event (SAE) or an adverse event (AE) in the 20120262 study that could cause extension treatment to be detrimental
- Subject completed study 20120262 but cannot be dosed within 4 weeks of the week 26 visit of study 20120262
- Current infection requiring the use of oral or intravenous antibiotics
Other Inclusion/Exclusion criteria may apply
Data sourced from ClinicalTrials.gov (NCT02114931) 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.