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A Non-interventional, observational Post Marketing Surveillance (PMS) Study of AdaliRelTM (Adalimumab) in Patients With Active Rheumatoid arthritis.

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

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
CTRI
Registry ID
CTRI/2020/04/024644
Enrollment
200
Registered
2020-04-15
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: M04-M04- Autoinflammatory syndromes

Interventions

None listed

Sponsors

Reliance Life Sciences Pv Ltd
Lead Sponsor

Eligibility

Inclusion 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

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 )

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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

Countries

India

Contacts

Public ContactDr Jaysing Salve

Prakurti Care Hospital

jksalve@yahoo.com9920013944

Outcome results

None listed

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