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

• Conditions: Systemic lupus erythematosis (SLE); MedDRA version: 18.0Level: LLTClassification code 10042944Term: Systemic lupus erythematosisSystem Organ Class: 100000004859; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2011-003814-18-DE
• Lead Sponsor: Human Genome Sciences, Inc. (a wholly owned subsidiary of GlaxoSmithKline PLC)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-12-16
• Last Update Posted: 19 October 2015

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:
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