Last updated: 04/11/2025 13:20:10

SLE disease control in the United States (US) OBSErve study

GSK study ID
213502
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: Evaluating SLE disease control at 12 months in the US OBSErve study
Trial description: Systemic Lupus Erythematosus (SLE) is a chronic autoimmune disease characterized by autoreactive T- and B-cells. GlaxoSmithKline (GSK) is currently testing whether both belimumab and rituximab can be used sequentially to reduce SLE disease activity to a state of SLE disease control and/or disease remission in Belimumab International Systemic Lupus Erythematosus Studies (BLISS)-BELIEVE study (NCT03312907). The current study aims to use previously collected real world data from the US OBSErve study to characterize the extent to which belimumab initiators achieve SLE disease control or remission at 12 months; this work will further aid in contextualizing BLISS-BELIEVE findings.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:

Percentage of participants in a state of SLE disease control at Month 12

Timeframe: Month 12

Secondary outcomes:

Percentage of participants in a state of SLE disease remission at Month 12

Timeframe: Month 12

Percentage of participants in a state of SLE disease control or remission at 12 months receiving no or lower corticosteroids at 6 and 12 months of follow-up

Timeframe: Month 12

Percentage of participants in a state of SLE disease control or remission at 12 months stratified by Baseline immunosuppressant use

Timeframe: Month 12

Percentage of participants in a state of SLE disease control or remission at 12 months stratified by Baseline corticosteroid use

Timeframe: Month 12

SLE treatment patterns

Timeframe: Baseline, Month 6 and Month 12

Interventions:
Not applicable
Enrollment:
0
Primary completion date:
2020-16-04
Observational study model:
Cohort
Time perspective:
Retrospective
Clinical publications:
Jacob N Hunnicutt; Jolyon Fairburn-Beech; Mary Elizabeth Georgiou; Anna Richards; Yun Irene Gregan; Holly Quasny; Deven Chauhan.Evaluating disease control following belimumab treatment in patients with SLE enrolled in the US OBSErve study.Lupus Sci Med.2022;9(1):e000710 DOI: 10.1136/lupus-2022-000710
Medical condition
Systemic Lupus Erythematosus
Product
belimumab
Collaborators
Not applicable
Study date(s)
February 2020 to April 2020
Type
Observational
Phase
Not applicable

Participation criteria

Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
  • Participants with documented SLE diagnosis.
  • Participants with >=18 years of age at study entry.
  • Participants who enrolled in an SLE-related clinical trial.
  • Participants who did not have >=6 months of medical history available with the participating study physician prior to belimumab initiation.
Inclusion and exclusion criteria
Inclusion criteria:
  • Participants with documented SLE diagnosis.
  • Participants with >=18 years of age at study entry.
  • Initiated belimumab and continued it for at least 8 infusions of drug at time of study enrollment.
Exclusion criteria:
  • Participants who enrolled in an SLE-related clinical trial.
  • Participants who did not have >=6 months of medical history available with the participating study physician prior to belimumab initiation.
  • Participants who did not have SELENA-SLEDAI measured on the index date or at 12 months of follow-up.
  • Participants who did not have a SELENA-SLEDAI score >=6 at 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)
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
2020-16-04
Actual study completion date
2020-16-04

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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