A Pooled Analysis of the HGS1006-C1056 (BLISS-52) and HGS1006-C1057 (BLISS-76) Studies

NCT01858792 | Completed DMC

• 1 other identifier: 115030
• Study Type: observational
• Target: 1
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Lupus Erythematosus, Discoid

Outcome Measures

Primary Outcomes (1)

• SLE (systemic lupus erythematosus) Response Index (SRI) at Week 52

  Composite endpoint resulting from the combination of three well-established tools for evaluating SLE disease activity which include an objective measure of the reduction in global disease activity for efficacy and two measures to ensure that the improvement in disease activity (score) is not offset by worsening of the subject's condition overall.

  Response rate by visit through Week 52 for the pooled studies and through Week 76 for Study C1056

Secondary Outcomes (19)

• 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).

  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

  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)

  By visit up to Week 52

• Mean change in PGA (Physician's Global Assessment)

  At Week 24, and by visit up to week 52 (population a only).

• All Flares and Severe Flares will be assessed for population a

  In periods of Weeks 0-52 and weeks 24-52

Study Arms (2)

Baseline Health-Related Quality of Life (HRQOL)

Quality of life assessment tools were similar across the treatment groups and indicated that there was impairment in quality of life of subjects in the Low C+anti-dsDNA Population

Drug: Belimumab 1 mg/kg; Drug: Belimumab 10 mg/kg; Other: Placebo

SLE Medication Usage at Baseline

All subjects in the Low C+anti-dsDNA Population

Drug: Belimumab 1 mg/kg; Drug: Belimumab 10 mg/kg; Other: Placebo

Interventions

Belimumab 1 mg/kg DRUG

Belimumab 1 mg/kg IV plus standard therapy; belimumab 1 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks.

Baseline Health-Related Quality of Life (HRQOL); SLE Medication Usage at Baseline

Belimumab 10 mg/kg DRUG

Belimumab 10 mg/kg IV plus standard therapy; belimumab 10 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks.

Baseline Health-Related Quality of Life (HRQOL); SLE Medication Usage at Baseline

Placebo OTHER

Placebo IV plus standard therapy; placebo administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks.

Baseline Health-Related Quality of Life (HRQOL); SLE Medication Usage at Baseline

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects who were anti-dsDNA positive and had low C3 and/or C4 at baseline (Low C+anti-dsDNA Population) Subjects with baseline SELENA SLEDAI score \>= 10 (SS \>=10 Population)

You may qualify if:

• Clinical diagnosis of SLE by ACR criteria.
• Active SLE disease.
• Autoantibody-positive.
• On stable SLE treatment regimen.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Human Genome Sciences Inc., a GSK Company: lead
• GlaxoSmithKline: collaborator

Related Publications (1)

• van Vollenhoven RF, Petri MA, Cervera R, Roth DA, Ji BN, Kleoudis CS, Zhong ZJ, Freimuth W. Belimumab in the treatment of systemic lupus erythematosus: high disease activity predictors of response. Ann Rheum Dis. 2012 Aug;71(8):1343-9. doi: 10.1136/annrheumdis-2011-200937. Epub 2012 Feb 15.

  PMID: 22337213 BACKGROUND

MeSH Terms

Conditions

Lupus Erythematosus, Discoid

Interventions

belimumab

Condition Hierarchy (Ancestors)

Lupus Erythematosus, Cutaneous; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2012
• First Posted: May 21, 2013
• Study Start: May 1, 2011
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: May 21, 2013

Record last verified: 2013-05