Observing serious infections in Japanese adults with rheumatoid arthritis taking RINVOQ

Special Drug Use - Results Survey Of Evaluating Safety And Effectiveness Of RINVOQ In Patients With Rheumatoid Arthritis

Observational AbbVie · NCT04340115

This study looks at how often serious infections happen in Japanese adults with rheumatoid arthritis who are taking RINVOQ to see how safe the medication is in real-life use.

Quick facts

Study typeObservational
Enrollment1000 (estimated)
Ages15 Years and up
SexAll
SponsorAbbVie Industry-sponsored
Locations1004 sites (Gamagori, Aichi and 1003 other locations)
Trial IDNCT04340115 on ClinicalTrials.gov

What this trial studies

This study aims to observe the frequency of serious infections among Japanese adults with rheumatoid arthritis who are receiving RINVOQ tablets. It will analyze medical records from approximately 1000 participants over a three-year period to identify any adverse events and reasons for discontinuation of the medication. The study does not involve additional tests; instead, it relies on data collected during routine clinic visits. The goal is to understand the safety profile of RINVOQ in everyday clinical practice.

Who should consider this trial

Good fit: Ideal candidates for this study are adults in Japan who are currently being treated with RINVOQ for rheumatoid arthritis.

Not a fit: Patients who are not taking RINVOQ or those with conditions unrelated to rheumatoid arthritis may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide valuable insights into the safety of RINVOQ, helping to inform treatment decisions for patients with rheumatoid arthritis.

How similar studies have performed: While this study focuses on observational data, similar studies evaluating the safety of RA treatments have shown success in providing critical safety information.

Eligibility criteria

Show full inclusion / exclusion criteria
Inclusion Criteria:

- All participants treated with RINVOQ.

Exclusion Criteria:

- Participants not taking RINVOQ.

Where this trial is running

Gamagori, Aichi and 1003 other locations

+954 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions Rheumatoid ArthritisRINVOQUpadacitinibABT-494
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.