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)
18 Years
N/A
Both
Systemic Lupus Erythematosus
Trial Information
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 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.
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.
Type of Study:
Observational
Study Design:
Observational Model: Cohort, Time Perspective: Prospective
Outcome Measure:
Incidence of adverse events of special interest
Outcome Description:
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.
Outcome Time Frame:
Up to 5 years
Safety Issue:
Yes
Principal Investigator
GSK Clinical Trials
Investigator Role:
Study Director
Investigator Affiliation:
GlaxoSmithKline
Authority:
United States: No Health Authority
Study ID:
116543
NCT ID:
NCT01729455
Start Date:
February 2013
Completion Date:
April 2023
Related Keywords:
- Systemic Lupus Erythematosus
- Belimumab
- Connective Tissue Diseases
- Lupus
- Additional relevant MeSH terms:
- Lupus Erythematosus, Systemic
- Autoimmune Diseases
- SLE
- Systemic Lupus Erythematosus
- Autoimmune Disease
- Antibodies
- Immune System Diseases
- Lupus Erythematosus, Systemic
Name | Location |
|---|---|
| GSK Investigational Site | Pittsburgh, Pennsylvania 15213 |
