Last updated: 08/24/2020 15:50:05

Evaluation Of Use of Belimumab in Clinical Practice SEttings (OBSErve)Observe

GSK study ID
201282
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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)
Trial description: Multicenter, cohort study, observational and retrospective of patients with diagnosis of SLE to whom belimumab was prescribed, in selected sites of Argentina.
20-30 rheumatologists/physicians from Argentina will be recruited who treat SLE patients with belimumab as part of their clinical practice.
70-80 patients will be recruited.
Data will be collected retrospectively (from medical charts) for a 18 month period of time. 6 months prior and 6 and 12 months after having started treatment with belimumab.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Global Clinical Response

Timeframe: 6 and 12 months after starting belimumab therapy

Secondary outcomes:
Not applicable
Interventions:
Not applicable
Enrollment:
81
Primary completion date:
2017-30-11
Observational study model:
Cohort
Time perspective:
Retrospective
Clinical publications:
Babini A, Cappuccio AM, Caprarulo C, Casado G, Eimon A, Figueredo H, Garcia MA, Magri S, Mannucci P, Perez Rodriguez S, Pons Estel BA, Velozo EJ, Iglesias-Rodriguez M, Streger G. Evaluation of belimumab treatment in patients with systemic lupus erythematosus in a clinical practice setting: results from a 24-month OBSErve study in Argentina. Lupus. 2020; DOI: 10.1177/0961203320947814
Medical condition
Systemic Lupus Erythematosus
Product
belimumab
Collaborators
Not applicable
Study date(s)
May 2014 to November 2017
Type
Observational
Phase
4

Participation criteria

Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
Not applicable
  • SLE diagnosis according to physician’s criteria (usually ACR 82/97 and/or SLICC)
  • Adults (> or = 18 years)
  • Patient is currently participating in an interventional clinical study related to SLE
  • Patient has started treatment with belimumab as part of an interventional clinical trial
Inclusion and exclusion criteria
Inclusion criteria:
  • SLE diagnosis according to physician’s criteria (usually ACR 82/97 and/or SLICC)
  • Adults (> or = 18 years)
  • belimumab prescription as part of regular clinical practice (patients not priorly treated with belimumab)
  • By the moment of the trial, the patients has received 6 months of treatment with belimumab, and in cases where treatment was withdrawn, having received at least one dose.
  • the reason for starting belimumab can be identified
  • in patients where belimumab was withdrawn, this reason can be identified
  • Physician is capable of describing changes after use of belimumab after 6 or 12 months of treatment or after treatment was withdrawn
  • clinical data is available in the medical chart
Exclusion criteria:
  • Patient is currently participating in an interventional clinical study related to SLE
  • Patient has started treatment with belimumab as part of an interventional clinical trial

Trial location(s)

Location
Status
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Location
GSK Investigational Site
Buenos Aires, Buenos Aires, Argentina, C1280AEB
Status
Study Complete
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Location
GSK Investigational Site
Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1416CSD
Status
Study Complete
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Location
GSK Investigational Site
Ciudad Autónoma de Buenos Aires, Argentina, C1426BOR
Status
Study Complete
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Location
GSK Investigational Site
Concordia, Entre Ríos, Argentina, E3200ELD
Status
Study Complete
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Location
GSK Investigational Site
Cordoba, Argentina, 5004
Status
Study Complete
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Location
GSK Investigational Site
General Roca, Río Negro, Argentina, 8332
Status
Study Complete
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Study documents

Clinical study report
Available language(s): English
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Protocol
Available language(s): English
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Scientific result summary
Available language(s): English
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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
2017-30-11
Actual study completion date
2017-30-11

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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