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

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/107874
• EU PAS number:
  EUPAS103727
• Study ID:
  107874
• Official title and acronym:
  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
• DARWIN EU® study:
  No
• Study countries:
  India
• Study description:
  This multicenter prospective study of patient charts evaluates treatment persistence, time until drug discontinuation (drug survival), effectiveness and safety of advanced therapies in Rheumatoid arthritis patients. ; Patients will be enrolled in this study if they were diagnosed with Rheumatoid arthritis and are eligible for treatment with biological or targeted synthetic Disease Modifying Anti-Rheumatic Drugs as per the routine clinical practice.
• Study status:
  Ongoing

Research institution and networks

Institutions

Pfizer

Centre for Rheumatic Diseases and Regenerative Clinical Medicine

Mumbai Arthritis Clinic and Research Center
Institute of Post-Graduate Medical Education and Research
Kalinga Institute of Medical Sciences (KIMS)
Optima Arthritis and Rheumatology Clinic
Stanley Medical College
Shanti Wellness Care
Sri Deepti Rheumatology Center
A B Rheumatology Centre
Center for Rheumatic Diseases
Max Super Specialty Hospital
Kokilaben Dhirubhai Ambani Hospital & Medical Research Institution
Krishna Institute of Medical Sciences Ltd.
Amrita Institute of Medical Sciences & Research Centre
Artemis Hospital
Institute of Postgraduate Medical Education & Research

Networks

Insignia

Study timelines

Date when funding contract was signed

Planned: 19/12/2022

Study start date

Planned: 15/06/2024

Actual: 25/09/2024

Data analysis start date

Planned: 15/06/2026

Date of final study report

Planned: 15/05/2027

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Pfizer

Study protocol

Initial protocol

A3921433 Non-Interventional Study Protocol_Amendment 1_(clean)_Version 2.0_26JAN2024)_Redacted.pdf

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable