Last updated: 01/29/2025 10:50:14

Changes in rheumatology-specific disease measures with belimumab treatment using real-world rheumatology provider network data

GSK study ID
214106
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: Changes in Rheumatology-Specific Disease Measures after Initiating Treatment with Belimumab using Data from a Real-World Rheumatology Provider Network
Trial description: The main objective of this study is to assess rheumatology disease activity measures pre and post-initiation of belimumab among participants with Systemic lupus erythematosus (SLE) in a real-world setting using a large rheumatology network electronic medical record (EMR) database. BENLYSTA® is the registered trademark of GlaxoSmithKline (GSK) group of companies.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Time to decrease in rheumatology specific disease measures below the minimally important difference (MID)

Timeframe: Baseline (12-months) and up to 24 months follow-up

Secondary outcomes:

Change from Baseline in routine assessment of patient index data 3 (RAPID3) score (Scores on a scale)

Timeframe: Baseline (12-months) and up to 24 months follow-up

Change from Baseline in patient pain index (PPI) (Scores on a scale)

Timeframe: Baseline (12-months) and up to 24 months follow-up

Change from Baseline in swollen joint count (Scores on a scale)

Timeframe: Baseline (12-months) and up to 24 months follow-up

Change from Baseline in tender joint count (Scores on a scale)

Timeframe: Baseline (12-months) and up to 24 months follow-up

Change from Baseline in complement 3 (C3) and complement 4 (C4)

Timeframe: Baseline (12-months) and up to 24 months follow-up

Change from Baseline in anti-double stranded deoxyribonucleic acid (dsDNA)

Timeframe: Baseline (12-months) and up to 24 months follow-up

Interventions:
Not applicable
Enrollment:
0
Primary completion date:
2022-23-11
Observational study model:
Cohort
Time perspective:
Retrospective
Clinical publications:
Germain G, Worley K, MacKnight S, Rubin B, Bell C, Laliberte F, et al. Evaluating the Real-World Effectiveness of Belimumab in Patients with SLE using SLE-Related Laboratory Values and Rheumatoid Arthritis-Derived Disease Activity Measures: RAPID3, Swollen Joint Count, and Tender Joint Count . Lupus Sci Med. DOI: 10.1136/lupus-2023-001111 PMID: 38575172
Medical condition
Systemic Lupus Erythematosus
Product
belimumab
Collaborators
Not applicable
Study date(s)
August 2022 to November 2022
Type
Observational
Phase
Not applicable

Participation criteria

Sex
Female & Male
Age
20+ years
Accepts healthy volunteers
No
  • Participants with greater than or equal to ( >=)1 prescription or treatment for belimumab between 01-January-2012 and 03-December-2019 (i.e., the identification period; the list of codes will be provided in the statistical analysis plan [SAP]). The index date will be defined as the date of the first prescription or treatment for belimumab during the identification period.
  • Participants with >=12 months of clinical activity prior to the index date. The baseline period will be defined as the 12 months prior to the index date.
  • Participants with >=1 prescription or treatment for belimumab prior to the index date (that is [i.e.], applicable only to prescriptions/treatments before 01-January-2012).
  • Participants with >=1 diagnosis of drug-induced SLE prior to or on the index date
Inclusion and exclusion criteria
Inclusion criteria:
  • Participants with greater than or equal to ( >=)1 prescription or treatment for belimumab between 01-January-2012 and 03-December-2019 (i.e., the identification period; the list of codes will be provided in the statistical analysis plan [SAP]). The index date will be defined as the date of the first prescription or treatment for belimumab during the identification period.
  • Participants with >=12 months of clinical activity prior to the index date. The baseline period will be defined as the 12 months prior to the index date.
  • Participants with >=24 months of clinical activity following the index date (>=12 or >=18 months could also be used, depending on data distribution).
  • Participants with >=6 prescriptions or treatments for belimumab during the 24-month follow-up period (including the index belimumab prescription/treatment).
  • Participants with >=1 diagnosis of SLE prior to or on the index date.
  • Participants with >=20 years of age at the index date.
Exclusion criteria:
  • Participants with >=1 prescription or treatment for belimumab prior to the index date (that is [i.e.], applicable only to prescriptions/treatments before 01-January-2012).
  • Participants with >=1 diagnosis of drug-induced SLE prior to or on the index date

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
2022-23-11
Actual study completion date
2022-23-11

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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