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NCT04340115
Study To Assess Frequency Of Serious Infections In Clinical Practice In Japan For Adult Participants With Rheumatoid Arthritis Receiving Oral RINVOQ Tablets
trial in Rheumatoid Arthritis (RA) in 4,211 participants. Completed in 15 August 2025.
15 August 2025
Quick facts
| Lead sponsor | AbbVie |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 4,211 |
| Start date | 24 April 2020 |
| Primary completion | 15 August 2025 |
| Estimated completion | 15 August 2025 |
| Sites | 1017 locations across Japan |
Conditions studied
- Rheumatoid Arthritis (RA) — all drugs for Rheumatoid Arthritis (RA) →
Sponsor
AbbVie — full company profile →
Who can join
15 and older, any sex, with Rheumatoid Arthritis (RA). Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Rheumatoid Arthritis (RA) is a chronic inflammatory disease causing pain, stiffness, swelling and loss of joint function. RA can reduce the ability to perform everyday tasks. The purpose of this study is to observe the incidence of serious infections, regardless of their relationship to RINVOQ, in Japanese daily practice. RINVOQ is an approved drug for the treatment of adults with moderately to severely active RA. This study evaluates medical records from institutions participating in the study to identify any adverse events (untoward medical occurrence), and reasons for discontinuation of RINVOQ in participants taking the study drug. A target of 1000 Japanese participants' data will be observed for 3 years. Participants will receive RINVOQ per their physicians' usual prescription. Individual data will be collected for three years. No additional study-related tests will be conducted during routine clinic visits. Only data which are routinely collected during clinic visits will be utilized for this study.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT04340115
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Rheumatoid Arthritis (RA)
Currently open trials in the same condition.
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- NCT07264101 — Validity And Reliability Of The Four Square Step Test In Individuals With Rheumatoid Arthritis · recruiting
- NCT07221890 — A Trial of Academic Detailing to Promote Prescribing of Biosimilars · NA · active not recruiting
- NCT07100873 — A Phase 1 Study of ADI-001 in Rheumatoid Arthritis · Phase 1 · recruiting
Other AbbVie trials
Trials by the same sponsor.
- NCT07219017 — A Study to Assess the Mass Balance of Oral ABBV-1354 in Healthy Adult Male Participants · Phase 1 · completed
- NCT05316220 — A Study to Assess Adverse Events and Change in Disease Condition of Mesalamine Capsules in Children Aged 5 to 17 Years W · Phase 3 · withdrawn
- NCT07024797 — Study to Assess the Adverse Events, Tolerability, and How Oral Doses of ABBV-932 Moves Through the Body in Healthy Adult · Phase 1 · completed
- NCT07058051 — Cross-sectional Study to Characterize Real World Burden of Disease in Patients With Vitiligo in China · completed
- NCT07007091 — A Study to Assess the Relative Bioavailability of Risankizumab Following Subcutaneous Administrations With a Pre-Filled · Phase 1 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04340115 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by AbbVie
- Last refreshed: 17 November 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04340115.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing