Last updated: 03/10/2025 09:10:16

Study to evaluate use of Belimumab in participants with Systemic lupus erythematosus (SLE) in Clinical practice settings in Russia and Saudi Arabia

GSK study ID
215349
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: Evaluation Of Use of Belimumab in Clinical Practice SEttings (OBSErve): Observations from a retrospective, observational study on patients with SLE in Russia and Saudi Arabia
Trial description: This observational study aims to collect standard of care clinical information from participant medical records on the short-term clinical benefit attributable to belimumab use in adult SLE participants.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Physician-assessed overall clinical response for overall disease activity using the physicians’ judgment scale

Timeframe: 6 months post belimumab initiation

Secondary outcomes:

Baseline and clinical characteristics of participants receiving belimumab at Baseline

Timeframe: At Baseline

Clinical response for specific manifestations

Timeframe: 6 months post belimumab initiation

Change from Baseline in Safety of Estrogens in Lupus Erythematosus, National Assessment-SLE Disease Activity Index (SELENA-SLEDAI) score

Timeframe: Baseline and up to 6 months post belimumab treatment

Treatment patterns with concomitant medication (particularly steroids) in the course of the therapy

Timeframe: 6 months post belimumab initiation

Reasons for initiation and discontinuation of belimumab

Timeframe: Index date (Belimumab initiation) and up to 6 months post belimumab treatment

Healthcare resource utilization among users of belimumab

Timeframe: 6 months pre belimumab and up to 6 months post belimumab treatment

Interventions:
Not applicable
Enrollment:
0
Primary completion date:
2022-01-07
Observational study model:
Cohort
Time perspective:
Retrospective
Clinical publications:
Ibrahim Al-Homood, Ibrahim Almaghlouth, Alhussain Asiri, Hanan Hamdy, Ali Alhammad, Alaa Mustafa, Mohamed Othman, Munther Khamashta, Tamer Elfishawy, Lindsey Teichman, Debora dos Santos, Juliana Queiroz, Saeed Noibi. Real-World Effectiveness of Intravenous Belimumab on Clinical Outcomes in Patients With Systemic Lupus Erythematosus in Saudi Arabia: The OBSErve Observational Study. Open Access Rheumatology: Research and Reviews. 2025-2;Volume 17: 33-45. doi:10.2147/OARRR.S497802 https://doi.org/10.2147/oarrr.s497802 PMID: 39973976 DOI: 10.2147/OARRR.S497802
Medical condition
Systemic Lupus Erythematosus
Product
belimumab
Collaborators
Not applicable
Study date(s)
September 2021 to July 2022
Type
Observational
Phase
4

Participation criteria

Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
  • Physician inclusion criteria:
  • Must currently manage and/or treat at least 10 SLE participants.
Inclusion and exclusion criteria
Inclusion criteria:
  • Physician inclusion criteria:
  • Must currently manage and/or treat at least 10 SLE participants.
  • Must be treating SLE for at least 5 years.
  • Must have treated at least 2 participants with belimumab as part of standard care and currently have at least 1 participant on belimumab (as standard care).
  • Must agree to all rules of the study including resolution of data validation queries. Participant inclusion criteria:
  • Adult participants more than or equal to (>=)18 years old diagnosed with SLE.
  • Participant was belimumab naïve, and the initial prescription of Intravenous (IV) belimumab was part of standard care.
  • Participant’s first dose of IV belimumab was administered at least 6-months prior to inclusion into the study.
  • The participant received at least one dose of IV belimumab in cases of discontinuation of treatment.
  • Medical history must be available for data extraction as defined by the study period/participant observational period. Participant exclusion criteria:
  • Participant was initiated on or treated with subcutaneous belimumab at any point during the treatment observational period (index date to 6-months post-index date).
  • Enrolled in an SLE-related clinical trial during the 12-month participant observational period.
  • Started IV belimumab as part of a clinical trial.
  • Participants with documented record of severe active Lupus Nephritis (LN) (or kidney disease) within 90 days of the index date (IV belimumab initiation).
  • Participants with documented record of severe active Central Nervous System (CNS) Lupus within 60 days of the index date (IV belimumab initiation).

Trial location(s)

This study does not involve prospective enrollment of participants.

Study documents

Study report synopsis
Available language(s): English
Download document(s)
Protocol
Available language(s): English
Download document(s)
Statistical analysis plan
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
2022-01-07
Actual study completion date
2022-01-07

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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