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

UMIN ID: UMIN000020833

Registered date:01/02/2016

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Rheumatoid arthritis
• Date of first enrollment: 2015/10/09
• Target sample size: 240
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Administer MTX 6-16mg/week for 12 weeks to patients with MDA-RA. If patients can'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 maintain remission for 24weeks, discontinue ADA by their own will, after 48 weeks administering ADA.

Outcome(s)

• Primary Outcome: DAS28-CRP remission rate at 12weeks, 36weeks and 108weeks
• Secondary Outcome: 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

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude 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.

Related Information

• Primary Sponsor: Zenjinkai Shimin-no-mori Hospital
• Source(s) of Monetary Support: None