Last updated: 10/09/2024 06:00:12

Pooled analysis of OBSErve data

GSK study ID
206351
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: Pooled analysis of the real-world effectiveness of belimumab using multi-country data from the OBSErve studies
Trial description: This is subject-level meta-analysis of multi-center retrospective observational studies. In this study all subjects enrolled to the OBSErve studies in Canada, Spain, Argentina, United States (US), Germany and Switzerland will be included. The aim of the current study is to combine the OBSErve data from these countries, thereby generating a larger cohort in which to evaluate the effectiveness of belimumab in clinical practice setting.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Overall clinical response to belimumab therapy using the physician judgment scale

Timeframe: Up to 6 months

Secondary outcomes:

Age group of subjects at treatment initiation

Timeframe: Baseline (Day 1)

Gender of subjects at treatment initiation

Timeframe: Baseline (Day1)

Ethnicityof subjects at treatment initiation

Timeframe: Baseline (Day1)

Duration of SLE disease at treatment initiation

Timeframe: Baseline (Day1)

Number of subjects with SLE severity assessed by physician

Timeframe: Baseline (Day1)

Number of prior immunosuppressant

Timeframe: Baseline (Day1)

Number of subjects with comorbidities

Timeframe: Baseline (Day1)

Reasons of belimumab initiation as per physician decision

Timeframe: Baseline (Day1)

Reasons of belimumab discontinuation as per physician decision

Timeframe: Baseline (Day1)

Number of subjects with 1 versus 2 or more prior immunosuppressant at belimumab treatment initiated

Timeframe: Baseline (Day1)

Mean change in steroid dosage

Timeframe: Up to 6 months

Percentage of subjects who experienced change in steroid dose

Timeframe: Up to 6 months

Percentage of subjects with reduction to <=7.5 milligram/day (mg/day) prednisolone

Timeframe: Up to 6 months

Overall clinical response to belimumab therapy amongst subjects with a high degree of disease activity at belimumab initiation

Timeframe: Up to 6 months

Change from Baseline in SLE Disease Activity Index (SLEDAI) score

Timeframe: Baseline and up to 6 months

Interventions:
Not applicable
Enrollment:
0
Primary completion date:
2019-16-05
Observational study model:
Cohort
Time perspective:
Retrospective
Clinical publications:
Christopher E Collins, Josefina Cortes-Hernández, Mercedes A Garcia, Johannes von Kempis, Andreas Schwarting, Zahi Touma, Milena Kurtinecz, Kerry Gairy. Real-World Effectiveness of Belimumab in the Treatment of Systemic Lupus Erythematosus: Pooled Analysis of Multi- Country Data from the OBSErve Studies. Rheumatol Ther. 2020; DOI: 10.1007/s40744-020-00243-2 PMID: 33206344
Medical condition
Systemic Lupus Erythematosus
Product
belimumab
Collaborators
Not applicable
Study date(s)
December 2017 to May 2019
Type
Observational
Phase
Not applicable

Participation criteria

Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
  • All subjects enrolled in the OBSErve studies in US, Germany, Canada, Argentina, Spain and Switzerland are eligible for inclusion in the meta-analysis.
  • The eligibility criteria of the OBSErve studies are: Subject diagnosed with SLE.
  • Currently enrolled in an SLE-related clinical trial.
  • Started belimumab as part of a clinical trial in an interventional arm
Inclusion and exclusion criteria
Inclusion criteria:
  • All subjects enrolled in the OBSErve studies in US, Germany, Canada, Argentina, Spain and Switzerland are eligible for inclusion in the meta-analysis.
  • The eligibility criteria of the OBSErve studies are: Subject diagnosed with SLE.
  • Adults >= 18 years old.
  • Prescribed belimumab by treating physician as part of usual care.
  • Belimumab initiation at least 6 months prior to study enrollment for OBSErve Argentina, OBSErve Germany, OBSErve Spain, OBSErve Switzerland. Received at least 8 belimumab infusions for OBSErve Canada and OBSErve US.
  • Reason for belimumab initiation can be identified.
  • Medical history was available for chart abstraction as defined by the study period.
Exclusion criteria:
  • Currently enrolled in an SLE-related clinical trial.
  • Started belimumab as part of a clinical trial in an interventional arm

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
2019-16-05
Actual study completion date
2019-16-05

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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