Phase 2
Completed N=283
A Safety and Efficacy Study of LymphoStat-B™ (Monoclonal Anti-BLyS Antibody) in Subjects With Rheumatoid Arthritis (RA)
Arthritis, Rheumatoid
Source: ClinicalTrials.gov NCT00071812 ↗
Enrolled (actual)
283
Serious AEs
9.0%
Results posted
Jun 2012
Primary outcomePrimary: Percentage of Patients With ACR20 (American College of Rheumatology) Response at Week 24, Based on Erythrocyte Sedimentation Rate (ESR) — 15.9; 34.7; 25.4; 28.2 percentage of participants — p=0.0097
Summary
The purpose of this study is to evaluate the safety and efficacy of 3 different doses of belimumab, administered in addition to standard therapy, in patients with rheumatoid arthritis (RA).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Patients With ACR20 (American College of Rheumatology) Response at Week 24, Based on Erythrocyte Sedimentation Rate (ESR) |
15.9; 34.7; 25.4; 28.2 | 0.0097 sig |
| SECONDARY Percentage of Patients With an ACR50 Response at Week 24, Based on ESR |
4.3; 9.7; 8.5; 14.1 | 0.2074 |
| SECONDARY Percentage of Patients With an ACR70 Response at Week 24, Based on ESR |
2.9; 5.6; 1.4; 2.8 | 0.4299 |
| SECONDARY Time to First ACR20 Response, Based on ESR |
112; 109; 112; 111 | 0.1752 |
| SECONDARY Time to First ACR50 Response, Based on ESR |
— | — |
| SECONDARY Time to First ACR70 Response, Based on ESR |
— | — |
| SECONDARY Mean Change in Disease Activity Score 28 (DAS28) at Week 24 |
-0.9; -1.3; -0.9; -1.5 | 0.0958 |
| SECONDARY Time to First DAS28 Response |
111; 82; 84; 57 | 0.0960 |
| SECONDARY Mean Change in Modified Total Sharp Score at Week 24 |
0.7; 0.3; 0.3; 0.6 | 0.1940 |
Eligibility Criteria
Primary Inclusion Criteria:
- Diagnosis of RA for at least 1 year
- Failed at least 1 disease modifying anti-rheumatic drug (DMARD) due to toxicity or lack of efficacy. These drugs must include 1 or more of the following: methotrexate, parenteral gold, sulfasalazine, leflunomide, and tumor necrosis factor-alpha (TNFα) inhibitors (infliximab, etanercept or adalimumab)
- Active RA disease of at least moderate disease activity
- Be on a stable RA treatment regimen for at least the past 60 days (for DMARDS); if on non-steroidal anti-inflammatory drugs (NSAIDs) or steroids these must be at a stable dose for the last 30 days
Primary Exclusion Criteria:
- Received a non-FDA approved investigational agent within the last 28 days
- Currently receiving or received within the last 60 days the following: TNFα-inhibitors (infliximab, etanercept, adalimumab) or interleukin-1 receptor antagonist (anakinra)
- Currently receiving or received within the last 6 months the following: anti-CD20 antibody (rituximab) or cyclophosphamide
- Steroid injection into any joint within the last 30 days
- History of hypogammaglobulinemia or immunoglobulin A (IgA) deficiency
- History of chronic infection that has been active within last 6 months, or herpes zoster within last 90 days, or any infection requiring hospitalization or intravenous medication within last 60 days
- Human immunodeficiency virus (HIV), Hepatitis-B, Hepatitis-C
Data sourced from ClinicalTrials.gov (NCT00071812). 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.