A Study of Belimumab Administered Subcutaneously in Subjects with Systemic Lupus Erythematosus (SLE)

• Conditions: Systemic lupus erythematosis (SLE); MedDRA version: 14.1Level: LLTClassification code 10042944Term: Systemic lupus erythematosisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2011-003814-18-IT
• Lead Sponsor: HUMAN GENOME SCIENCES INC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-06-08
• Last Update Posted: 11 April 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 816

Inclusion Criteria

1. At least 18 years of age. 2. Clinical diagnosis of Systemic Lupus Erythematosus (SLE) by ACR criteria. 3. Active SLE disease. 4. Autoantibody-positive. 5. On stable SLE treatment regimen which may include corticosteroids (for example, prednisone), antimalarial (for example, hydroxychloroquine) and/or immunosuppressants (for example, azathioprine, methotrexate, mycophenolate, etc.)
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 800
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 16

Exclusion Criteria

1. Pregnant or nursing. 2. Have received treatment with an B cell targeted therapy (for example, rituximab or belimumab). 3. Have received treatment an investigational biological agent in the past year. 4. Have received IV cyclophosphamide within 90 days of Day 0. 5. Have severe active lupus kidney disease. 6. Have severe active central nervous system (CNS) lupus. 7. Have required management of acute or chronic infections within the past 60 days. 8. Have current drug or alcohol abuse or dependence. 9. Have a positive test for HIV, hepatitis B, or hepatitis C. 10. Have a history of hypersensitivity reactions to contrast agents or biological medicines.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: • To evaluate the efficacy of belimumab administered SC in adult subjects with SLE. • To evaluate the safety and tolerability of belimumab administered SC in adult subjects with SLE.;Secondary Objective: Not applicable;Primary end point(s): Primary Outcome Measure: SLE Responder Index (SRI) response rate; [Time Frame: Baseline, 52 Weeks]. A patient that has an SRI response has all 3 of the following: - >=4 point reduction from baseline in SELENA SLEDAI score, AND - No worsening (increase of <0.30 points from baseline) in Physician's Global Assessment (PGA), AND - No new BILAG A organ domain score or 2 new BILAG B organ domain scores compared with baseline at the time of assessment (ie, at Week 52).;Timepoint(s) of evaluation of this end point: baseline 52 weeks

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Secondary Outcome Measures: • Time to first severe flare (SLE Flare Index); [Time Frame: Baseline to 52 weeks] • Reduction in prednisone dose. Percent of subjects whose average prednisone dose has been reduced by >= 25% from baseline to <=7.5 mg/day during Weeks 40 through 52 in subjects receiving greater than 7.5 mg/day at baseline ; [Time Frame: Baseline, Weeks 40-52];Timepoint(s) of evaluation of this end point: 1.Time Frame: Baseline to 52 weeks; 2.Time Frame: Baseline, Weeks 40-52.