Last updated: 11/03/2022 06:44:29
Summary Document Analysis Plan for GSK1550188 Study BEL116559 Pooled Analysis of Belimumab Elderly Patients
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Recruiting
Recruiting
Trial overview
Official title: Summary Document Analysis Plan for GSK1550188 Study BEL116559 Pooled Analysis of Belimumab Elderly Patients
Trial description: The primary objective of this meta-analysis is to evaluate the safety of belimumab treatment on elderly patients with Systemic Lupus Erythematosus (SLE). A secondary objective is to evaluate the efficacy of belimumab in elderly SLE subjects. Additionally, the safety and efficacy of subjects with vasculitis and lupus nephritis will be assessed. Data from 13 studies will be analyzed: LBSL02, C1056, C1057, BEL113750, C1115, C1112, C1113, LBSL99, C1066, C1074, SABLE (BEL116543), C1100 and C1121. Subjects aged >=65 years will be included.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Adverse events
Timeframe: At least 8 weeks post-treatment (unless continuing treatment in an extension study in which case follow-up is 4 weeks)
Secondary outcomes:
SLE Responder Index (SRI) response rate
Timeframe: At Week 52
Interventions:
Not applicable
Enrollment:
351
Primary completion date:
2025-31-12
Observational study model:
Other
Time perspective:
Retrospective
Clinical publications:
Gladman DD, Ibanez D, and Urowitz MB. Systemic lupus erythematosus disease activity index 2000. J Rheumatol 2002;29:288-91.
Hay EM, Bacon PA, Gordon C, et al. The BILAG index: a reliable and valid instrument for measuring clinical disease activity in systemic lupus erythematosus. Q J Med 1993;86:447-58.
Isenberg DA and Gordon C. From BILAG to BLIPS - disease activity assessment in lupus past, present and future. Lupus 2000;9:651-4.
Daniel J Wallace, Tatsuya Atsumi, Mark Daniels, Anne Hammer, Paige Meizlik, Holly Quasny, Andreas Schwarting, Fengchun Zhang, David A Roth.Safety of belimumab in adult patients with systemic lupus erythematosus: Results of a large integrated analysis of controlled clinical trial data.Lupus .2022;
DOI: 10.1177/09612033221131183
PMID: 36206400
David D'Cruz, Gina Eriksson, Yulia Green, Anne Hammer, Beulah Ji, Paige Meizlik, David A Roth. Safety and efficacy of belimumab in older adults with SLE: results of an integrated analysis of clinical trial data. Lupus science & medicine. 2023-Mar;10(1): e000830.
DOI:10.1136/lupus-2022-000830
PMID: 36963777
Medical condition
Systemic Lupus Erythematosus
Product
belimumab
Collaborators
Not applicable
Study date(s)
May 2013 to December 2025
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
65+ years
Accepts healthy volunteers
Not applicable
- Studies included in the meta-analysis will be LBSL02, C1056, C1057, BEL113750, C1115, C1112, C1113, SLE Continution Trials (LBSL99, C1066, C1074), SABLE (BEL116543), C1100 and C1121. Subjects aged >=65 years of age at baseline will be included.
Inclusion and exclusion criteria
Inclusion criteria:
- Studies included in the meta-analysis will be LBSL02, C1056, C1057, BEL113750, C1115, C1112, C1113, SLE Continution Trials (LBSL99, C1066, C1074), SABLE (BEL116543), C1100 and C1121. Subjects aged >=65 years of age at baseline will be included.
Trial location(s)
This study does not involve prospective enrollment of participants.
Study documents
Statistical analysis plan
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
No study documents available
Recruitment status
Recruiting
Actual primary completion date
Not applicable
Actual study completion date
Not applicable
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Additional information
Not applicable
Participate in clinical trial
Access to clinical trial data by researchers
Visit website