A Non-interventional, observational Post Marketing Surveillance (PMS) Study of AdaliRelTM (Adalimumab) in Patients With Active Rheumatoid arthritis.
- Conditions
- Health Condition 1: M04-M04- Autoinflammatory syndromes
- Registration Number
- CTRI/2020/04/024644
- Lead Sponsor
- Reliance Life Sciences Pv Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Diagnosis of Rheumatoid Arthritis according to the criteria based on American College of Rheumatology (ACR)/ European League against Rheumatism (EULAR) classification criteria for Rheumatoid Arthritis according to routine clinical practice
1.Pregnant women, nursing mothers or a planned pregnancy within 18 months of selection.Allergy to any of the excipients of adalimumab.Active TB. Also excluded are patients who have evidence of latent TB [evidence of tuberculosis based on standard hospital practice of TB screening]. Also excluded are patients with opportunistic infections including, but not limited to, evidence of active cytomegalovirus, active pneumocystis carinii, aspergillosis, or atypical mycobacterial infection, etc., within the previous 6 months.Patients with warnings / contraindications to AdaliRel® (see warnings in full prescribing information in Appendix )
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence of adverse events (AEs) and Serious Adverse Events (SAEs) up to 5 yearsTimepoint: Incidence of adverse events (AEs) and Serious Adverse Events (SAEs) up to 5 years
- Secondary Outcome Measures
Name Time Method Incidence of adverse events (AEs) and Serious Adverse Events (SAEs) up to 5 yearsTimepoint: Incidence of adverse events (AEs) and Serious Adverse Events (SAEs) up to 5 years