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Safety and Effectiveness of Belimumab in Systemic Lupus Erythematosus Registry (SABLE)

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ClinicalTrials.gov Identifier: NCT01729455
Recruitment Status : Recruiting
First Posted : November 20, 2012
Last Update Posted : June 28, 2019
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
GlaxoSmithKline ( Human Genome Sciences Inc., a GSK Company )

Tracking Information
First Submitted Date November 14, 2012
First Posted Date November 20, 2012
Last Update Posted Date June 28, 2019
Actual Study Start Date February 21, 2013
Estimated Primary Completion Date January 31, 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 14, 2012)
Incidence of adverse events of special interest [ Time Frame: Up to 5 years ]
Summary of the number and percentage of participants with adverse events within 6 prespecified categories: malignancies (excluding non-melanoma skin cancers), non-melanoma skin cancers, mortality, serious infections, opportunistic infections and other infections of interest, and serious psychiatric events.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT01729455 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: November 14, 2012)
  • Change in organ damage [ Time Frame: Baseline, 6 month intervals up to 5 years ]
    Organ damage as assessed by System Lupus International Collaborating Clinics/American College of Rheumatology (SLICC/ACR) Damage Index
  • Change in concomitant SLE medication use [ Time Frame: Baseline, 6 month intervals up to 5 years ]
    Concomitant SLE medications including steroids
  • Change in disease activity [ Time Frame: Baseline, 6 month intervals up to 5 years ]
    Disease activity as assessed by Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI 2000)
  • Change in severe flares [ Time Frame: Baseline, 6 month intervals up to 5 years ]
    Severe flares as derived by a severe flare algorithm.
  • Change in quality of life [ Time Frame: Baseline, 6 month intervals up to 5 years ]
    Quality of life as assessed by SF-12v2® Health Survey
  • Change in fatigue [ Time Frame: Baseline, 6 month intervals up to 5 years ]
    Fatigue as assessed by FACIT-Fatigue Scale
  • Rate of hospitalizations [ Time Frame: Baseline, 6 month intervals up to 5 years ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Safety and Effectiveness of Belimumab in Systemic Lupus Erythematosus Registry
Official Title A 5-Year Prospective Observational Registry to Assess Adverse Events of Interest and Effectiveness in Adults With Active, Autoantibody-Positive Systemic Lupus Erythematosus Treated With or Without BENLYSTA™ (Belimumab)
Brief Summary The purpose of this registry is to collect additional information regarding the side effects and effectiveness of BENLYSTA (belimumab) when given with other lupus medicines to adults with active systemic lupus erythematosus (SLE). Information will be collected on serious events that are not that common or may only be seen with long-term treatment. These events include death, cancers, serious infections and other infections of interest, and serious mental health problems. Information on the effectiveness of BENLYSTA will also be collected.
Detailed Description The registry will enroll 2 groups of patients. One group will include patients who are currently taking lupus medicines along with BENLYSTA (With BENLYSTA). The other group will include patients who are taking lupus medicines but do not take BENLYSTA (Without BENLYSTA). For every 3 participants enrolled in the registry, 2 will be taking BENLYSTA and 1 will not. After enrollment, changes in lupus medications, including starting or stopping BENLYSTA, are at the discretion of the physician, and all patients will continue to be followed regardless of changes in their lupus medicines until study completion. Physicians will manage the patient in accordance with their medical judgment and standard of care. Data will be collected at enrollment and at 6 month intervals for 5 years.
Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 12 Years
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population General population: patients with active autoantibody-positive SLE.
Condition Systemic Lupus Erythematosus
Intervention
  • Biological: BENLYSTA

    As prescribed.

    Belimumab is a recombinant, human, IgG1λ monoclonal antibody for the treatment of systemic lupus erythematosus.

    Other Name: belimumab
  • Other: SLE treatment

    As prescribed.

    At baseline, SLE treatment must include an immunosuppressant. During the registry, SLE treatment may include any of the following (alone or in combination): immunosuppressants, corticosteroids, antimalarials, other biologics, investigational agents for SLE, as clinically indicated.

Study Groups/Cohorts
  • With BENLYSTA
    SLE treatment including BENLYSTA at baseline
    Interventions:
    • Biological: BENLYSTA
    • Other: SLE treatment
  • Without BENLYSTA
    SLE treatment without BENLYSTA at baseline
    Intervention: Other: SLE treatment
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: November 14, 2012)
3000
Original Estimated Enrollment Same as current
Estimated Study Completion Date January 31, 2025
Estimated Primary Completion Date January 31, 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria

Key Inclusion Criteria:

  • Clinical diagnosis of active SLE.
  • Autoantibody-positive.
  • Current SLE treatment includes BENLYSTA and/or immunosuppressants (for example, azathioprine, methotrexate, cyclophosphamide, mycophenolate, and biologics).

Key Exclusion Criteria:

  • Have received treatment with an investigational agent within the past year.
  • Are currently enrolled in a placebo-controlled BENLYSTA (belimumab) clinical trial or a continuation trial in which belimumab is used as an investigational agent.
  • Have a history of BENLYSTA exposure, but are not currently receiving BENLYSTA.
  • Current SLE treatment includes only an antimalarial (for example, hydroxychloroquine) or only steroids.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com
Contact: EU GSK Clinical Trials Call Center +44 (0) 20 89904466 GSKClinicalSupportHD@gsk.com
Listed Location Countries Argentina,   Austria,   Belgium,   Canada,   France,   Germany,   Israel,   Italy,   Portugal,   Slovakia,   Spain,   Sweden,   United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01729455
Other Study ID Numbers 116543
HGS1006-C1124 ( Other Identifier: Human Genome Sciences Inc. )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party GlaxoSmithKline ( Human Genome Sciences Inc., a GSK Company )
Study Sponsor Human Genome Sciences Inc., a GSK Company
Collaborators GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
PRS Account GlaxoSmithKline
Verification Date June 2019