CTRI/2024/09/073987Not yet recruitingNot Applicable
A multicenter evaluation of the treatment persistence of advanced therapies (Biological disease-modifying agents and Targeted synthetic Disease Modifying Anti-Rheumatic Drugs) in the treatment of rheumatoid arthritis (RA): A Real World Evidence (RWE) study from India.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Pfizer Limited
- Enrollment
- 225
- Locations
- 10
- Primary Endpoint
- Evaluate the treatment persistence/drug survival in patients on the advanced therapies
Study Overview
Brief Summary
The aim of this study is to define treatment persistence, the parameters to change the therapy, the prescribing patterns of advanced therapies and to evaluate the effectiveness and safety of persistence of these therapies in the management of rheumatoid arthritis in a real world setting.
Study Design
- Study Type
- Observational
Eligibility Criteria
- Ages
- 18.00 Year(s) to 99.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Patients aged 18 years and over diagnosed with RA eligible for treatment with advanced therapies (bDMARDs as well as tsDMARDs)
- •Agree to a minimum of 3 follow up visits with the rheumatologist.
- •Evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study.
Exclusion Criteria
- •Patients not willing to sign the informed consent document
- •Participation in a clinical trial during the past 6 months before enrolment into the study
- •Patients on therapy with bDMARDs/tsDMARDs for over 3 months.
Outcomes
Primary Outcomes
Evaluate the treatment persistence/drug survival in patients on the advanced therapies
Time Frame: 1 year
for rheumatoid arthritis.
Time Frame: 1 year
Secondary Outcomes
- To study the effectiveness parameters as per the routine clinical practice and understand the real-world practice towards management of rheumatological disorders (DAS 28 scores, HAQ-DI scores or any other routine parameters evaluated).(Record the adverse events including serious adverse events, non-serious adverse events while on treatment during the study inclusion.)
Investigators
Amod Tilak
Pfizer Limited
Study Sites (10)
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