FindTrial
Sign In

A prospective study across 10 centers to evaluate persistence on treatment with advanced therapies in rheumatoid arthritis management in routine clinical practice.

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. - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2024/09/073987
Enrollment
225
Registered
2024-09-17
Start date
Unknown
Completion date
Unknown
Last updated
2024-10-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: M069- Rheumatoid arthritis, unspecified

Interventions

Intervention1: NON-INTERVENTIONAL STUDY: NIL

Sponsors

Pfizer Limited
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients aged 18 years and over diagnosed with RA eligible for treatment with advanced therapies (bDMARDs as well as tsDMARDs) 2. Agree to a minimum of 3 follow up visits with the rheumatologist. 3. 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

Exclusion criteria: 1. Patients not willing to sign the informed consent document 2. Patients not willing to follow up for a duration of 1 year 3. Participation in a clinical trial during the past 6 months before enrolment into the study 4. Patients on therapy with bDMARDs/tsDMARDs for over 3 months.

Design outcomes

Primary

MeasureTime frame
Evaluate the treatment persistence/drug survival in patients on the advanced therapies for rheumatoid arthritis.Timepoint: 1 year—

Secondary

MeasureTime frame
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. To study patient factors, disease factors or other determinants for treatment switch and time to first and subsequent switch to advanced therapies. Understand the use of branded and generic Tofacitinib in treatment of RA and persistence on the innovator versus the generic brands of Tofacitinib in India. Evaluation of the reduction in the need for concomitant therapies like NSAIDs, corticosteroids. Demographic characteristics of patients enrolled in the study.Timepoint: 1 year—

Countries

India

Contacts

Public ContactAmod Tilak

Pfizer Limited

amodmadhav.tilak@pfizer.com18008793477

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026