Last updated: 07/17/2024 15:22:48
A Continuation Trial for Subjects with Systemic Lupus Erythematosus that have completed Protocol LBSL02
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: A Multi-Center, Open-Label, Continuation Trial LymphoStat-B™ Antibody (Monoclonal Anti-BLyS Antibody) in Subjects With Systemic Lupus Erythematosus (SLE) who Completed the Phase 2 Protocol LBSL02
Trial description: This is a continuation study to evaluate the long-term safety and efficacy of LymphoStat-B™ in subjects with SLE disease, that completed study LBSL02 and benefitted from treatment.
Primary purpose:
Treatment
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Not applicable
Primary outcomes:
Number of participants with the indicated type of adverse event (AEs) and serious adverse event (SAEs)
Timeframe: Approximately up to 13 years
Adverse event (AE) rates by system organ class (SOC) during the study
Timeframe: Approximately up to 13 years
SAE rates by system organ class (SOC) during the study
Timeframe: Approximately up to 13 years
Change from Baseline in activated partial thromboplastin time (APTT) and prothrombin time (PT) at the indicated time points
Timeframe: Baseline and approximately up to 13 years
Change from Baseline in basophils, eosinophils, lymphocytes, monocytes, neutrophils segmented and platelets at the indicated time points
Timeframe: Baseline and approximately up to 13 years
Change from Baseline in erythrocytes at the indicated time points
Timeframe: Baseline and approximately up to 13 years
Change from Baseline in hematocrit at the indicated time points
Timeframe: Baseline and approximately up to 13 years
Change from Baseline in hemoglobin at the indicated time points
Timeframe: Baseline and approximately up to 13 years
Change from Baseline in albumin and protein at the indicated time points
Timeframe: Baseline and approximately up to 13 years
Change from Baseline in blood urea nitrogen (BUN), glucose, calcium, carbon dioxide, chloride, magnesium, phosphate, potassium and sodium at the indicated time points
Timeframe: Baseline and approximately up to 13 years
Change from Baseline in creatinine, urate and bilirubin at the indicated time points
Timeframe: Baseline and approximately up to 13 years
Change from Baseline in BUN/creatinine at the indicated time points
Timeframe: Baseline and approximately up to 13 years
Change from Baseline in alanine aminotransferase (ALT), alkaline phosphatase (AP), aspartate aminotransferase (AST), gamma glutamyl transferase (GGT) and lactate dehydrogenase (LD) at the indicated time points
Timeframe: Baseline and approximately up to 13 years
Secondary outcomes:
Percentage of participants achieving SLE Responder Index (SRI) Response at indicated time points
Timeframe: Approximately up to 13 years
Observed anti-double stranded DNA levels in participants positive at Baseline at indicated time points
Timeframe: Approximately up to 13 years
Median percent change from Baseline in anti-double stranded DNA in participants positive at Baseline at indicated time points
Timeframe: Baseline and approximately up to 13 years
Observed complement C3 and C4 levels in participants low at Baseline at indicated time points
Timeframe: Approximately up to 13 years
Median percent change from Baseline in complement C3 and C4 levels in participants low at Baseline at indicated time points
Timeframe: Baseline and approximately up to 13 years
Percentage of participants with daily prednisone dose reduction at indicated time points
Timeframe: Approximately up to 13 years
Absolute serum immunoglobulin G values at indicated time points
Timeframe: Approximately up to 13 years
Median percent change from Baseline in Immunoglobulin G at indicated time points
Timeframe: Baseline and approximately up to 13 years
Interventions:
Enrollment:
298
Primary completion date:
2016-23-02
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Daniel J Wallace, Ellen M Ginzler, Joan T Merrill, Richard A Furie, William Stohl, W Winn Chatham, Arthur Weinstein, James McKay, W Joseph McCune, Michelle Petri, James Fettiplace, David Roth, Beulah Ji, Amy Heath. SAFETY AND EFFICACY OF BELIMUMAB PLUS STANDARD THERAPY FOR UP TO 13 YEARS IN PATIENTS WITH SYSTEMIC LUPUS ERYTHEMATOSUS. Arthritis Rheumatol. 2019;71(7):1125-1134
DOI: 10.1002/art.40861
PMID: 30771238
Medical condition
Systemic Lupus Erythematosus
Product
belimumab
Collaborators
GSK
Study date(s)
May 2005 to February 2016
Type
Interventional
Phase
2
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
- Primary Inclusion Criteria
- 1. Have completed the LBSL02 trial and achieved a satisfactory response.
Inclusion and exclusion criteria
Inclusion criteria:
- Other investigational agents.
- Biologic therapeutic agents: adalimumab (Humira™), etanercept (Enbrel™), infliximab (Remicade™), and rituximab (Rituxan™).
- Intravenous cyclophosphamide.
- Corticosteroids >100 mg/day prednisone equivalent for reasons other than severe SLE flare.
Primary Inclusion Criteria 1. Have completed the LBSL02 trial and achieved a satisfactory response. Primary Exclusion Criteria 1. Required more than 2 courses of corticosteroids for treatment of severe SLE flares in the last 5 months of LBSL02. 2. Had an SLE flare during the last 30 days of LBSL02 and through the 1st dose in LBSL99. 3. Used any of the following prohibited medications during their participation in LBSL02:
Trial location(s)
Location
GSK Investigational Site
Albany, New York, United States, 12206
Status
Study Complete
Location
GSK Investigational Site
Ann Arbor, Michigan, United States, 48109-5542
Status
Study Complete
Location
GSK Investigational Site
Arlington, Virginia, United States, 22205-3606
Status
Study Complete
Location
GSK Investigational Site
Atlanta, Georgia, United States, 30303
Status
Study Complete
Location
GSK Investigational Site
Aventura, Florida, United States, 33180
Status
Study Complete
Location
GSK Investigational Site
Baltimore, Maryland, United States, 21201
Status
Study Complete
Location
GSK Investigational Site
Baltimore, Maryland, United States, 21287
Status
Study Complete
Location
GSK Investigational Site
Baton Rouge, Louisiana, United States, 70809
Status
Study Complete
Location
GSK Investigational Site
Birmingham, Alabama, United States, 35294
Status
Study Complete
Location
GSK Investigational Site
Boston, Massachusetts, United States, 02111
Status
Study Complete
Location
GSK Investigational Site
Brooklyn, New York, United States, 11203
Status
Study Complete
Location
GSK Investigational Site
Charlotte, North Carolina, United States, 28210
Status
Study Complete
Location
GSK Investigational Site
Chicago, Illinois, United States, 60611
Status
Study Complete
Location
GSK Investigational Site
Chicago, Illinois, United States, 60612
Status
Study Complete
Location
GSK Investigational Site
Colorado Springs, Colorado, United States, 80920
Status
Study Complete
Location
GSK Investigational Site
Concord, New Hampshire, United States, 03301
Status
Study Complete
Location
GSK Investigational Site
Cumberland, Maryland, United States, 21502
Status
Study Complete
Location
GSK Investigational Site
Dallas, Texas, United States, 75390-8550
Status
Study Complete
Location
GSK Investigational Site
Dover, New Hampshire, United States, 03820
Status
Study Complete
Location
GSK Investigational Site
Great Neck, New York, United States, 11021
Status
Study Complete
Location
GSK Investigational Site
Idaho Falls, Idaho, United States, 83401
Status
Study Complete
Location
GSK Investigational Site
Kansas City, Kansas, United States, 66160
Status
Study Complete
Location
GSK Investigational Site
La Jolla, California, United States, 92037
Status
Study Complete
Location
GSK Investigational Site
Lincoln, Nebraska, United States, 68516
Status
Study Complete
Location
GSK Investigational Site
Los Angeles, California, United States, 90033
Status
Study Complete
Location
GSK Investigational Site
Los Angeles, California, United States, 90048
Status
Study Complete
Location
GSK Investigational Site
Louisville, Kentucky, United States, 40202
Status
Study Complete
Location
GSK Investigational Site
Manhasset, New York, United States, 11030
Status
Study Complete
Location
GSK Investigational Site
Milwaukee, Wisconsin, United States, 53226
Status
Study Complete
Location
GSK Investigational Site
Munster, Indiana, United States, 46321
Status
Study Complete
Location
GSK Investigational Site
New Orleans, Louisiana, United States, 70121
Status
Study Complete
Location
GSK Investigational Site
Oklahoma City, Oklahoma, United States, 73103
Status
Study Complete
Location
GSK Investigational Site
Oklahoma City, Oklahoma, United States, 73104
Status
Study Complete
Location
GSK Investigational Site
Onalaska, Wisconsin, United States, 54650
Status
Study Complete
Location
GSK Investigational Site
Orlando, Florida, United States, 32806-6264
Status
Study Complete
Location
GSK Investigational Site
Pittsburgh, Pennsylvania, United States, 15217
Status
Study Complete
Location
GSK Investigational Site
Rochester, New York, United States, 14618
Status
Study Complete
Location
GSK Investigational Site
Sacramento, California, United States, 95817
Status
Study Complete
Location
GSK Investigational Site
San Jose, California, United States, 95124
Status
Study Complete
Location
GSK Investigational Site
Scottsdale, Arizona, United States, 85260
Status
Study Complete
Location
GSK Investigational Site
Seattle, Washington, United States, 98133
Status
Study Complete
Location
GSK Investigational Site
Spokane, Washington, United States, 99204
Status
Study Complete
Location
GSK Investigational Site
St. Louis, Missouri, United States, 63110
Status
Study Complete
Location
GSK Investigational Site
Sugarland, Texas, United States, 77479
Status
Study Complete
Location
GSK Investigational Site
Upland, California, United States, 91786
Status
Study Complete
Location
GSK Investigational Site
Washington, District of Columbia, United States, 20010
Status
Study Complete
Location
GSK Investigational Site
Wheaton, Maryland, United States, 20902
Status
Study Complete
Location
GSK Investigational Site
Willow Grove, PA, Pennsylvania, United States, 19090
Status
Study Complete
Location
GSK Investigational Site
Winston-Salem, North Carolina, United States, 27157
Status
Study Complete
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Study complete
Actual primary completion date
2016-23-02
Actual study completion date
2016-23-02
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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Access to clinical trial data by researchers
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