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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 : July 16, 2018
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
GlaxoSmithKline ( Human Genome Sciences Inc., a GSK Company )

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.

Condition or disease Intervention/treatment
Systemic Lupus Erythematosus Biological: BENLYSTA Other: SLE treatment

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]
Estimated Enrollment : 3000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 12 Years
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)
Actual Study Start Date : February 21, 2013
Estimated Primary Completion Date : January 31, 2025
Estimated Study Completion Date : January 31, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lupus
Drug Information available for: Belimumab

Group/Cohort Intervention/treatment
With BENLYSTA
SLE treatment including BENLYSTA at baseline
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.


Without BENLYSTA
SLE treatment without BENLYSTA at baseline
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.





Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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

  2. Change in concomitant SLE medication use [ Time Frame: Baseline, 6 month intervals up to 5 years ]
    Concomitant SLE medications including steroids

  3. 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)

  4. Change in severe flares [ Time Frame: Baseline, 6 month intervals up to 5 years ]
    Severe flares as derived by a severe flare algorithm.

  5. 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

  6. Change in fatigue [ Time Frame: Baseline, 6 month intervals up to 5 years ]
    Fatigue as assessed by FACIT-Fatigue Scale

  7. Rate of hospitalizations [ Time Frame: Baseline, 6 month intervals up to 5 years ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
General population: patients with active autoantibody-positive SLE.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01729455


Contacts
Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com

  Show 194 Study Locations
Sponsors and Collaborators
Human Genome Sciences Inc., a GSK Company
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline

Responsible Party: Human Genome Sciences Inc., a GSK Company
ClinicalTrials.gov Identifier: NCT01729455     History of Changes
Other Study ID Numbers: 116543
HGS1006-C1124 ( Other Identifier: Human Genome Sciences Inc. )
First Posted: November 20, 2012    Key Record Dates
Last Update Posted: July 16, 2018
Last Verified: July 2018

Keywords provided by GlaxoSmithKline ( Human Genome Sciences Inc., a GSK Company ):
Lupus Erythematosus, Systemic
Systemic Lupus Erythematosus
Belimumab
Connective Tissue Diseases
Lupus
Additional relevant MeSH terms:
Autoimmune Diseases
SLE
Autoimmune Disease
Antibodies
Immune System Diseases

Additional relevant MeSH terms:
Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Belimumab
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs