Safety and Effectiveness of Belimumab in Systemic Lupus Erythematosus Registry (SABLE)
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Purpose
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 | Intervention |
|---|---|
|
Systemic Lupus Erythematosus |
Biological: BENLYSTA Other: SLE treatment |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| 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) |
- Incidence of adverse events of special interest [ Time Frame: Up to 5 years ] [ Designated as safety issue: Yes ]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.
- Change in organ damage [ Time Frame: Baseline, 6 month intervals up to 5 years ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]Concomitant SLE medications including steroids
- Change in disease activity [ Time Frame: Baseline, 6 month intervals up to 5 years ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]Severe flares as derived by a severe flare algorithm.
- Change in quality of life [ Time Frame: Baseline, 6 month intervals up to 5 years ] [ Designated as safety issue: No ]Quality of life as assessed by SF-12v2® Health Survey
- Change in fatigue [ Time Frame: Baseline, 6 month intervals up to 5 years ] [ Designated as safety issue: No ]Fatigue as assessed by FACIT-Fatigue Scale
- Rate of hospitalizations [ Time Frame: Baseline, 6 month intervals up to 5 years ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 3000 |
| Study Start Date: | February 2013 |
| Estimated Study Completion Date: | April 2023 |
| Estimated Primary Completion Date: | April 2023 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
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. |
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
General population: patients with active autoantibody-positive SLE.
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.
Contacts and Locations More Information
No publications provided
| Responsible Party: | GlaxoSmithKline ( Human Genome Sciences Inc., a GSK Company ) |
| ClinicalTrials.gov Identifier: | NCT01729455 History of Changes |
| Other Study ID Numbers: | 116543, HGS1006-C1124 |
| Study First Received: | November 14, 2012 |
| Last Updated: | April 5, 2013 |
| Health Authority: | United States: No Health Authority |
Keywords provided by GlaxoSmithKline:
|
Belimumab Connective Tissue Diseases Lupus Additional relevant MeSH terms: Lupus Erythematosus, Systemic Autoimmune Diseases |
SLE Systemic Lupus Erythematosus Autoimmune Disease Antibodies Immune System Diseases |
Additional relevant MeSH terms:
|
Lupus Erythematosus, Systemic Connective Tissue Diseases Autoimmune Diseases Immune System Diseases |
ClinicalTrials.gov processed this record on May 23, 2013