PROFILE-J

Phase 4

• Conditions: Rheumatoid arthritis

• Registration Number: JPRN-jRCT1071190016
• Lead Sponsor: Tanaka Yoshiya

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-07-26
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 2000

Inclusion Criteria

1.Adult patients.
2.Patients with diagnosis of Rheumatoid Arthritis according to The 2010 American College of Rheumatology/European League Against Rheumatism classification criteria.
3.Patients for whom the treating physician has made the decision to initiate sarilumab before patient inclusion and independently of the purpose of the study.
4.Study enrollment is to be on the same day as the initiation of treatment or within a maximum of 4 weeks before the initiation of treatment.
5.Signed written informed consent.

Exclusion Criteria

1.Patients for whom sarilumab is contra-indicated as described in Japanese package insert.
2.Patients currently participating in any interventional clinical trials.
3.Previous experience with sarilumab through either a clinical trial.
4.Concomitant use of any bDMARDs or any tsDMARDs, including but not limited to etanercept, etanercept BS, adalimumab, adalimumab BS, infliximab, infliximab BS, anakinra, rituximab, rituximab BS, abatacept, tocilizumab, certolizumab, golimumab, tofacitinib, baricitinib, peficitinib, upadacitinib, filgotinib.
5.Previously treated with sarilumab.
6.Uncooperative, or any condition, that could make the patient potentially noncompliant to the study procedures, etc.

Study & Design

• Study Type: Observational
• Study Design: Not specified