Last updated: 11/03/2018 17:29:59
A Pooled Analysis of the HGS1006-C1056 (BLISS-52) and HGS1006-C1057 (BLISS-76) Studies
Clinicaltrials.gov ID
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 Higher Disease Activity (anti-dsDNA positive and low complement): A Pooled Analysis of the HGS1006-C1056 (BLISS-52) and HGS1006-C1057 (BLISS-76) Studies
Trial description: Efficacy and Safety of Belimumab in a Subgroup of Systemic Lupus Erythematosus (SLE) Patients with Higher Disease Activity (anti-dsDNA positive and low complement): A Pooled Analysis of the HGS1006-C1056 (BLISS-52) and HGS1006-C1057 (BLISS-76) Studies
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
SLE (systemic lupus erythematosus) Response Index (SRI) at Week 52
Timeframe: Response rate by visit through Week 52 for the pooled studies and through Week 76 for Study C1056
Secondary outcomes:
The response rate by visit modified to exclude anti-dsDNA and complement items in the determination of a 4-point reduction in SELENA SLEDAI (Safety of Oestrogen in Lupus National Assessment Systemic Lupus Erythematosus Disease Activity Index).
Timeframe: By visit up to Week 52 for pooled studies.
The percent of subjects with no new BILAG A (British Isles Lupus Assessment Group) organ domain score or 2 new BILAG B organ domain scores
Timeframe: By visit up to Week 52 for pooled studies
Percent of subjects with greater than 4 point reduction from baseline in SELENA SLEDAI (Safety of Oestrogen in Lupus National Assessment Systemic Lupus Erythematosus Disease Activity Index)
Timeframe: By visit up to Week 52
Mean change in PGA (Physician’s Global Assessment)
Timeframe: At Week 24, and by visit up to week 52 (population a only).
All Flares and Severe Flares will be assessed for population a
Timeframe: In periods of Weeks 0-52 and weeks 24-52
All BILAG A (British Isles Lupus Assessment Group) Flares will be assessed for population a
Timeframe: In periods of Weeks 0-52 and Weeks 24-52
Percent of Subjects with Daily Prednisone Dose Reduced to ≤ 7.5 mg/day from > 7.5 mg/day at Baseline by Visit
Timeframe: For pooled studies through Week 52
Mean change in SF-36 (Short Form 36 Health Survey questionnaire) domains (population a only), Physical Component Summary (PCS) and Mental Component Summary MCS (population a only)
Timeframe: By visit up to Week 52
Mean change in FACIT (Functional Assessment of Chronic Illness Therapy) Fatigue Scale score
Timeframe: By visit up to Week 52
EQ-5D (EuroQol five dimension self-reported health state questionnaire) individual item score (mobility, self-care, usual activities, pain/discomfort, anxiety/depression)
Timeframe: Change from baseline by visit up to Week 52
Improvement in each SELENA SLEDAI (Safety of Oestrogen in Lupus National Assessment Systemic Lupus Erythematosus Disease Activity Index) organ domain
Timeframe: At week 52
Percent of subjects with no worsening in PGA (Physician’s Global Assessment)
Timeframe: By visit up to Week 52
Percent of Subjects with Daily Prednisone Dose Increased to > 7.5 mg/day from ≤7.5 mg/day at Baseline by Visit
Timeframe: For pooled studies through Week 52.
Percent of Subjects with Daily Prednisone Dose Reduced by ≥25% and to ≤ 7.5 mg/day from > 7.5 mg/day at Baseline by Visit
Timeframe: For pooled studies through Week 52
Time to first SELENA SLEDAI (Safety of Oestrogen in Lupus National Assessment Systemic Lupus Erythematosus Disease Activity Index) organ improvement by organ domain, among subjects with involvement at baseline
Timeframe: Over Weeks 0-52
Time to first BILAG organ improvement by organ domain, among subjects with involvement at baseline
Timeframe: Over Weeks 0-52
EQ-5D (EuroQol five dimension self-reported health state questionnaire) index score using value set for the UK
Timeframe: Change from baseline by visit up to Week 52
EQ-5D (EuroQol five dimension self-reported health state questionnaire) visual analogue scale (VAS) score using value set for the UK
Timeframe: Change from baseline by visit up to Week 52
The response rate calculated without allowable and prohibited medication rules applied (population a only).
Timeframe: By visit up to Week 52
Interventions:
Drug: Belimumab 1 mg/kg
Drug: Belimumab 10 mg/kg
Other: Placebo
Enrollment:
1
Observational study model:
Other
Primary completion date:
Not applicable
Time perspective:
Other
Clinical publications:
R.F. van Vollenhoven,1 M.A. Petri,2 R. Cervera,3 D. Roth,4 B. Ji,5 C. Kleoudis,6 Z. John Zhong,7 W. Freimuth,7 for the BLISS-52 and BLISS-76 Study Groups. Response of Systemic Lupus Erythematosus Patients With High Disease Activity to Belimumab Treatment in the BLISS Trials . [Ann Rheum Dis]. 2012;71(8):1343-9.
R.F. van Vollenhoven, M.A. Petri, R. Cervera, D. Roth, B. Ji, C. Kleoudis, Z. John Zhong, W. Freimuth. Belimumab in the treatment of systemic lupus erythematosus: high disease activity predictors of response. Ann Rheum Dis. 2012;71(8):1343-9.
Medical condition
Lupus Erythematosus, Discoid
Product
belimumab
Collaborators
GSK
Study date(s)
May 2011 to May 2011
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
- Clinical diagnosis of SLE by ACR criteria.
- Active SLE disease.
- 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. -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
2011-31-05
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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