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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01729455
Recruitment Status : Recruiting
First Posted : November 20, 2012
Last Update Posted : January 18, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

November 14, 2012
November 20, 2012
January 18, 2017
February 2013
April 2025   (Final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01729455 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Safety and Effectiveness of Belimumab in Systemic Lupus Erythematosus Registry
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)
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.
The registry will enroll 2 groups of patients. One group will include patients who are currently taking lupus medicines along with intravenous 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.
Observational [Patient Registry]
Observational Model: Cohort
Time Perspective: Prospective
12 Years
Not Provided
Non-Probability Sample
General population: patients with active autoantibody-positive SLE.
Systemic Lupus Erythematosus
  • 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.

  • 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
Not Provided
 
Recruiting
3000
April 2025
April 2025   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com
Argentina,   Austria,   Belgium,   Canada,   France,   Germany,   Israel,   Italy,   Portugal,   Slovakia,   Spain,   Sweden,   United States
 
 
NCT01729455
116543
HGS1006-C1124 ( Other Identifier: Human Genome Sciences Inc. )
Yes
Not Provided
Not Provided
GlaxoSmithKline ( Human Genome Sciences Inc., a GSK Company )
Human Genome Sciences Inc., a GSK Company
GlaxoSmithKline
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
January 2017