Last updated: 11/04/2018 00:18:46
Efficacy and Safety of Belimumab in a Subgroup of Systemic Lupus Erythematosus (SLE) Patients with High Disease Activity (anti-dsDNA positive and low complement and SELENA-SLEDAI score >=10): A Pooled Analysis of the HGS1006-C1056 (BLISS-76) and HGS1006-C1057 (BLISS-52) Studies
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
Trial overview
Official title: Efficacy and Safety of Belimumab in a Subgroup of Systemic Lupus Erythematosus (SLE) Patients with High Disease Activity (anti-dsDNA positive and low complement and SELENA-SLEDAI score >=10): A Pooled Analysis of the HGS1006-C1056 (BLISS-76) and HGS1006-C1057 (BLISS-52) Studies
Trial description: This pooled analysis will assess data from the Phase III belimumab clinical studies HGS1006-C1056 (BLISS-76) and HGS1006-C1057 (BLISS-52). The objective of this study is to evaluate the impact of belimumab treatment on a subgroup of SLE subjects with high disease activity, to provide physicians with the information regarding belimumab treatment for appropriate subjects and to aid payers in making decisions regarding reimbursement and market access.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Assessment of response rate by SLE response index (SRI) at Week 52
Timeframe: Week 52
Secondary outcomes:
SRI Response Rate at Week 76
Timeframe: Week 76
Number of subjects with reduction of prednisone dose by >=25% from Baseline to <= 7.5 milligram per day (mg/day) during Weeks 40 through 52
Timeframe: Up to Week 52
Time to first flare by SLE Flare Index
Timeframe: Up to Week 52
Time to first severe SLE flare
Timeframe: Up to Week 52
Change from baseline in Short Form Health Survey (SF-36) physical component summary (PCS)
Timeframe: Up to Week 24
Interventions:
Drug: Belimumab
Drug: Placebo
Enrollment:
1
Observational study model:
Other
Primary completion date:
Not applicable
Time perspective:
Retrospective
Clinical publications:
Not applicable
Medical condition
Systemic Lupus Erythematosus
Product
belimumab
Collaborators
Not applicable
Study date(s)
June 2010 to December 2010
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
None
- Clinical diagnosis of SLE by ACR criteria.
- Active SLE disease (SELENA_SLEDAI>=10).
- Pregnant or nursing
- Have received treatment with any B cell targeted therapy.
Inclusion and exclusion criteria
Inclusion criteria:
- Clinical diagnosis of SLE by ACR criteria.
- Active SLE disease (SELENA_SLEDAI>=10).
- Autoantibody-positive
- On stable SLE treatment regimen.
Exclusion criteria:
- Pregnant or nursing
- Have received treatment with any B cell targeted therapy.
- Have received treatment with a biological investigational agent in the past year.
- Have received IV cyclophosphamide within 180 days of Day 0.
- Have severe lupus kidney disease.
- Have active central nervous system (CNS) lupus.
- Have required management of acute or chronic infections within the past 60 days.
- Have current drug or alcohol abuse or dependence.
- Have a historically positive test or test positive at screening for HIV, hepatitis B, or hepatitis C.
Trial location(s)
No location data available.
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Finalized
Actual primary completion date
Not applicable
Actual study completion date
2010-01-12
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
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