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:
  Planned

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

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