Last updated: 02/04/2020 14:40:15
Study 201223 - Interim Meta-analysis of BEL112233, BEL112234, BEL110751 and BEL110752
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
Trial overview
Official title: Study 201223 - Interim Meta-analysis of BEL112233, BEL112234, BEL110751 and BEL110752
Trial description: Study 201223 is a pooled Analysis of BEL112233 and BEL112234, long term extension studies of BEL110751 (BLISS 76) and BEL110752 (BLISS 52), for the treatment of Systemic Lupus Erythematosus (SLE). The purpose of this interim reporting effort is to pool these datasets to assess the long term safety and SDI scores of subjects treated with belimumab plus standard care in SLE patients .
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
the change in SDI from baseline to the 5-6 year interval of belimumab treatment
Timeframe: year 5-6
Secondary outcomes:
Time to First SDI Worsening
Timeframe: any
Transition Analysis (multi-state modelling) ) to explore transitions in SDI scores, including covariate analysis
Timeframe: any
Interventions:
Drug: belimumab
Enrollment:
0
Observational study model:
Other
Primary completion date:
2014-15-12
Time perspective:
Prospective
Clinical publications:
Bruce I, Urowitz M, van Vollenhoven R, Aranow C, Fettiplace J, Oldham M, Wilson B, Molta C, Roth D, Gordon D. Long-term Organ Damage Accrual and Safety in Patients with SLE Treated with Belimumab Plus Standard of Care. Lupus. 2016;25(7):699-709
Medical condition
Systemic Lupus Erythematosus
Product
belimumab
Collaborators
Not applicable
Study date(s)
April 2014 to December 2014
Type
Observational
Phase
3
Participation criteria
Sex
Female & Male
Age
Not applicable
Accepts healthy volunteers
none
- n/a
- n/a
- There were no specific inclusion or exclusion criteria - patients were required to have entered the long-term extension stduies BEL112233 or BEL112234
Inclusion and exclusion criteria
Inclusion criteria:
- n/a
Exclusion criteria:
- n/a There were no specific inclusion or exclusion criteria
- patients were required to have entered the long-term extension stduies BEL112233 or BEL112234
Trial location(s)
No location data available.
Study documents
Statistical analysis plan
Available language(s): English
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
Refer to study documents
Recruitment status
Finalized
Actual primary completion date
2014-15-12
Actual study completion date
2014-15-12
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
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