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Study of the effect of addition of iguratimod (IGU) on clinical remission rate after biologic disease modified anti-rheumatic drugs (bDMARDs) discontinuation in patients with rheumatoid arthritis(RA) .

Study of the effect of addition of IGU on clinical remission rate after bDMARDs discontinuation in patients with RA. - Study of the effect of addition of IGU on clinical remission rate after bDMARDs discontinuation in patients with RA.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000044255
Enrollment
60
Registered
2021-05-19
Start date
2021-07-01
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

RA patients are divided into two groups by patient&#39
s decision.:bDMARDs discontinuation group(IGU- group) and IGU addition/bDMARDs discontinuation group(IGU+ group). The RA patients in the IGU addition group are treated with 25 mg/day of IGU for the
s decision.:bDMARDs discontinuation group(IGU- group) and IGU addition/bDMARDs discontinuation group(IGU+ group).

Sponsors

Osaka Medical and Pharmaceutical University Department of Internal Medicine (IV)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: RA patients who fulfilled the following criteria are included:(i)> 1-year of bDMARDs;(ii)> 6-months disease activity score (DAS) 28-erythrocyte sedimentation rate (ESR) 2.6 or clinical disease activity index (CDAI) score <2.8.

Exclusion criteria

Exclusion criteria: Patients with IGU contraindications, such as during warfarin potassium.

Design outcomes

Primary

MeasureTime frame
The primary endpoints of this study are DAS28-ESR, CDAI, and US-GLOESS score at 48 weeks.

Countries

Japan

Contacts

Public ContactAyaka Yoshikawa

Osaka Medical and Pharmaceutical University Department of Internal Medicine (IV)

in1362@osaka-med.ac.jp072-683-1221

Outcome results

None listed

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