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The efficacy of Iguratimod, and adding Adalimumab in patients with active rheumatoid arthritis: an open label multicenter randomized parallel study.

The efficacy of Iguratimod, and adding Adalimumab in patients with active rheumatoid arthritis: an open label multicenter randomized parallel study. - The efficacy of Iguratimod, and adding Adalimumab in patients with active rheumatoid arthritis.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000020833
Enrollment
240
Registered
2016-02-01
Start date
2015-10-09
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

Administer MTX 6-16mg/week for 12 weeks to patients with MDA-RA. If patients can&#39
t take MTX, administer IGU 25-50mg/day or Tac 1.5-3.0mg/day for 12 weeks. Administer ADA 40mg/2weeks for 24weeks additionally, in case of MDA taking MTX or IGU, Tac for 12 weeks. If patients maintai

Sponsors

Zenjinkai Shimin-no-mori Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients with MDA-RA who take other csDMARDs and Steroid more than 3months.

Exclusion criteria

Exclusion criteria: Patients who contraindicate for IGU, Tac or ADA. In case of MTX group, patients who contraindicate for MTX. Patients who can't provide informed concent. Patients who have malignancy. Patients who judged to be disqualified by the physician.

Design outcomes

Primary

MeasureTime frame
DAS28-CRP remission rate at 12weeks, 36weeks and 108weeks

Secondary

MeasureTime frame
1) DAS28-CRP LDA rate at 12weeks, 36weeks and 108weeks 2) Change of ADL(Delta HAQ-DI) 3) Adverse event 4) The factors for each outcomes

Countries

Japan

Contacts

Public ContactToshihiko Hidaka MD. PhD.

Zenjinkai Shimin-no-mori Hospital Insutitution of Rheumatology

tosirin@d4.dion.ne.jp+81-985-39-7630

Outcome results

None listed

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