Last updated: 06/13/2022 12:20:05

Belimumab Effectiveness Literature Review

GSK study ID
213063
See study documents
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Systematic review and synthesis of real-world effectiveness of belimumab for the treatment of SLE
Trial description: Systemic lupus erythematosus (SLE) is an autoimmune disease, affecting the joints, skin, kidneys, blood cells, brain, heart, and lungs. The purpose of this study is to identify effectiveness and quality of life data reported in published real-world studies of belimumab for the treatment of SLE and estimate the overall effectiveness of belimumab in the real-world setting. This study used Systematic literature review following the Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) guidelines to identify published observational (prospective or retrospective) cohort studies reporting effectiveness outcomes in SLE participants using belimumab. The literature search plan will be carried out in EMBASE and MEDLINE databases (via ProQuest). Data of interest will be abstracted from each studies meeting study inclusion criteria.
Primary purpose:
Other
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

SLE-related outcomes measures as reported in published literature (e.g. SLE responder index (SRI), Physician Global Assessment (PGA), SLE flares, SF-36, prednisone utilization, SELENA-SLEDAI score, and British Isles Lupus Assessment Group (BILAG) score)

Timeframe: 2011 to 2020

Secondary outcomes:
Not applicable
Interventions:
Not applicable
Enrollment:
0
Primary completion date:
2020-15-06
Observational study model:
Cohort
Time perspective:
Retrospective
Clinical publications:
Shirley P. Huang, Sonya J. Snedecor, Sakina Nanji, Emily Lloyd, Christopher F. Bell. Real-World Effectiveness of Belimumab in Systemic Lupus Erythematosus: A Systematic Literature Review. Rheumatol Ther. 2022; DOI:10.1007/s40744-022-00454-9 PMID:35596922
Medical condition
Systemic Lupus Erythematosus
Product
belimumab
Collaborators
Not applicable
Study date(s)
April 2020 to June 2020
Type
Observational
Phase
4

Participation criteria

Sex
Female & Male
Age
5+ years
Accepts healthy volunteers
No
  • Inclusion criteria:
  • Adults/children aged 5 years or older with active, autoantibody-positive SLE; studies including participants with lupus nephritis will also be included.
Inclusion and exclusion criteria
Inclusion criteria:
  • Inclusion criteria:
  • Adults/children aged 5 years or older with active, autoantibody-positive SLE; studies including participants with lupus nephritis will also be included. Exclusion criteria:
  • Participants with central nervous system lupus.

Trial location(s)

This study does not involve prospective enrollment of participants.

Study documents

Clinical study report
Available language(s): English
Download document(s)
Protocol
Available language(s): English
Download document(s)
Scientific result summary
Available language(s): English
Download document(s)

If you wish to request for full study report, please contact - [email protected]

Results overview

Refer to study documents

Recruitment status
Study complete
Actual primary completion date
2020-15-06
Actual study completion date
2020-15-06

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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