CTRI/2020/04/024644
Not yet recruiting
Phase 4
A Prospective Multi-centre, Non-interventional, observational Post Marketing Surveillance (PMS) Study of AdaliRelTM (Adalimumab) to Evaluate long-term safety in Patients With Active Rheumatoid arthritis in Routine Clinical Practice
Reliance Life Sciences Pv Ltd0 sites0 target enrollmentTBD
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Reliance Life Sciences Pv Ltd
- Status
- Not yet recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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 )
Outcomes
Primary Outcomes
Not specified
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