A Safety and Efficacy Study of LymphoStat-B™ (Monoclonal Anti-BLyS Antibody) in Subjects With Rheumatoid Arthritis (RA)

Human Genome Sciences

Status and phase: Completed; Phase 2

Conditions: Arthritis, Rheumatoid

Treatments: Drug: Belimumab 1 mg/kg; Drug: Belimumab 4 mg/kg; Drug: Placebo; Drug: Belimumab 10 mg/kg

Study type: Interventional

Funder types: Industry

Identifiers

NCT00071812

LBRA01

Details and patient eligibility

About

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).

Full description

The purpose of this study is to evaluate the safety and efficacy of three different doses of belimumab (1 mg/kg, 4 mg/kg, and 10 mg/kg), administered in addition to standard therapy, compared to placebo plus standard therapy in patients with RA. All patients were to be dosed on Days 0, 14, and 28, then every 28 days for the remainder of 24 weeks. Patients completing the 24-week period could enter a 24-week open-label extension; belimumab patients received the same dose or were switched to 10 mg/kg at the investigator's discretion and former placebo patients received belimumab 10 mg/kg.

Enrollment: 283 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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283 participants in 4 patient groups, including a placebo group

Placebo plus SOC

Placebo Comparator group

Treatment:

Drug: Placebo

Belimumab 1 mg/kg plus SOC

Experimental group

Treatment:

Drug: Belimumab 1 mg/kg

Belimumab 4 mg/kg plus SOC

Experimental group

Treatment:

Drug: Belimumab 4 mg/kg

Belimumab 10 mg/kg plus SOC

Experimental group

Treatment:

Drug: Belimumab 10 mg/kg