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UPFIRST Study

The investigation of treatment methods using upadacitinib for long-term remission maintenance in patients with rheumatoid arthritis: A cohort observational study (UPFIRST Study)

Status
Recruiting
Phases
Phase 4
Study type
Observational
Source
JPRN
Registry ID
JPRN-jRCT1071240137
Enrollment
200
Registered
2025-03-28
Start date
2025-03-25
Completion date
Unknown
Last updated
2026-06-29

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

Conditions

Rheumatoid arthritis

Interventions

None listed

Sponsors

Kanda Ryuichiro
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Register patients who meet all of the following criteria. 1) Patients with rheumatoid arthritis are 15 years of age or older. 2) Patients who started upadacitinib at UOEH from April 2020 to December 2026.

Exclusion criteria

Exclusion criteria: Patients who meet any of the following criteria will be excluded: 1) Patients who fall under the contraindications listed in the package insert (patients with a history of hypersensitivity to Rinvoq, patients with severe infections, patients with active tuberculosis, patients with severe liver dysfunction, patients with a neutrophil count of less than 1000/mm3, patients with a lymphocyte count of less than 500/mm3, patients with a hemoglobin level of less than 8g/dL, pregnant women or women who may be pregnant). 2) Patients deemed inappropriate for this study by the principal investigator.

Design outcomes

Primary

MeasureTime frame
The proportion of all RA patients initiated with UPA who achieve clinical remission (measured by CDAI <=2.8) at six months following initiation.

Secondary

MeasureTime frame
Secondary outcomes will be assessed up to two years of follow up in the following: 1. Effectiveness of UPA Numbers and proportions of patients who achieved clinical remission/sustained remission and LDA at every three months up to two years from baseline. Total time that patients are in remission within the two years follow up period Changes from baseline at every three months up to two years: EGA (evaluator global assessment), PGA (patient global assessment), Pain VAS, HAQ-DI, EQ-5D Numbers and proportions of patients who achieved normalization of physical function (HAQ-DI4.5 on the scale of the CDAI. Numbers and proportions of the first flared patients Median time to the first flare Description of how flares are managed Number and proportions of patients who increased or re-initiated on MTX or UPA Dose changes of MTX or UPA after flare Median time to increase or re-initiation of MTX or UPA b) Patients in whom treatment is escalated following treatment change, but who do not meet CDAI criteria for flare. Numbers and proportions of the patients who escalate UPA and/or MTX Median time to UPA and/or MTX Reason for treatment escalation Dose changes of MTX or UPA

Contacts

Public ContactRyuichiro Kanda

University of Occupational and Environmental Health (UOEH), Japan

ryuichiro0120@med.uoeh-u.ac.jp+81-936031611

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026