Last updated: 03/10/2020 15:00:30

Evaluation Of Use of Belimumab in Clinical Practice Settings (OBSErve)- Observations from Brazil

GSK study ID
205065
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Other
Other
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 Brazil
Trial description: Systemic lupus erythematosus (SLE) is an autoimmune disease of unknown etiology with very different clinical manifestations involving periods of relapse and remission. In recent years, there has been significant interest in B cell-targeted therapies for the treatment of inflammatory and autoimmune diseases. B-lymphocyte stimulator (BLyS)-specific inhibitors are indicated as adjunctive therapy in adult subjects with active SLE, which have a high degree of disease activity and which use standard therapy, including corticosteroids, anti-malarials, Non-steroidal Anti-inflammatory Drugs (NSAIDs) or other immunosuppressive.
This study is a retrospective, cohort, multi-center observational study designed to collect real clinical practice information from subject medical records on the short term clinical benefit attributable to belimumab use in SLE subjects.
The study period included a treatment history period comprising the 6 months prior to the index date and a follow up period of treatment approximately 6 and 12 months after the index date (or at the time of discontinuation for any reason). Follow up duration may vary between subjects, considering cases of treatment discontinuation and/or dropout. The objectives of the study is to describe the changes on Safety of Estrogens in Lupus Erythematosus – National Assessment (SELENA)- SLE Disease Activity Index (SLEDAI) score, number and severity of relapses, corticosteroids dose changes, healthcare resource utilization, work condition/absenteeism ad the characteristics of the subjects after 6 months and 12 months of belimumab treatment compared with 6 months prior to belimumab treatment respectively.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Use of healthcare resources comparing the 6 and 12 months after the use of belimumab or at the time of discontinuation for any reason with the previous 6 months

Timeframe: From 6 months prior to belimumab treatment and up to18 months

Work condition or absenteeism of subjects in 6 and 12 months after the use of belimumab (or at the time of discontinuation for any reason) compared to the previous 6 months.

Timeframe: From 6 months prior to belimumab treatment and up to18 months

Change in SELENA-SLEDAI score after 6 and 12 months or at the time of discontinuation of belimumab treatment compared with 6 months prior to belimumab treatment.

Timeframe: From 6 months prior to belimumab treatment and up to18 months

Change in corticosteroid dose after 6 and 12 months of belimumab treatment (or at the time of discontinuation for any reason) compared with 6 months prior to belimumab treatment

Timeframe: From 6 months prior to belimumab treatment and up to18 months

The reasons to start the treatment and percentage of treatment dropout in subjects treated with belimumab

Timeframe: From 6 months prior to belimumab treatment and up to18 months

Evaluation of the standards of belimumab treatment with other concomitant medication before and after 6 and 12 months of use of belimumab (or at the time of discontinuation for any reason).

Timeframe: From 6 months prior to belimumab treatment and up to18 months

Number and severity of relapses (flare/disease exacerbation) after 6 and 12 months of belimumab treatment (or at the time of discontinuation for any reason) compared with 6 months prior to belimumab treatment

Timeframe: From 6 months prior to belimumab treatment and up to18 months

Secondary outcomes:
Not applicable
Interventions:
  • Other: Data Collection
    • Enrollment:
    0
    Primary completion date:
    Not applicable
    Observational study model:
    Cohort
    Time perspective:
    Retrospective
    Clinical publications:
    Not applicable
    Medical condition
    Systemic Lupus Erythematosus
    Product
    belimumab
    Collaborators
    Not applicable
    Study date(s)
    February 2017 to June 2017
    Type
    Observational
    Phase
    Not applicable

    Participation criteria

    Sex
    Female & Male
    Age
    18+ years
    Accepts healthy volunteers
    none
    • Diagnosed with SLE according to ACR 82/97 criteria.
    • Adults >=18 years old.
    • The subject is currently participating in a clinical trial with intervention related to SLE.
    • The subject started treatment with BLyS inhibitors as part of a clinical study in an intervention group.
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Diagnosed with SLE according to ACR 82/97 criteria.
    • Adults >=18 years old.
    • Treated by rheumatologist as part of usual medical care.
    • At the point or time of the study, subjects were treated with belimumab for up to 12 months after the index date, having received at least one dose in cases of treatment suspension or dropout.
    • The reason for the initiation of treatment with belimumab can be determined
    • In subjects who discontinued treatment with belimumab, the reason for such an interruption can be notified.
    • The physician is able to notify the results of treatment, preferably at defined times (for example, 6 and 12 months after the date of treatment start or upon discontinuation of treatment).
    • The medical history should be available for data extraction from clinical records during the study period, necessarily comprising the 6 months prior to the index date and up to 12 months post initiation of treatment with belimumab.
    Exclusion criteria:
    • The subject is currently participating in a clinical trial with intervention related to SLE.
    • The subject started treatment with BLyS inhibitors as part of a clinical study in an intervention group.
    • The subject started treatment with BLyS inhibitors not yet approved for use in humans.

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    Study documents

    No study documents available.

    Results overview

    No study documents available

    Recruitment status
    Other
    Actual primary completion date
    Not applicable
    Actual study completion date
    Not applicable

    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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