"Effect examination of infliximab to the effect insufficient example and the example of effect decrease of the 1st TNF inhibitor in rheumatoid arthritis "

UMIN ID: UMIN000007786

Registered date:19/04/2012

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Rheumatoid Arthritis
• Date of first enrollment: 2012/05/01
• Target sample size: 40
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): infliximab plus methotrexate

Outcome(s)

• Primary Outcome: the remission rate of 1-2years after(DAS28(4)-CRP<2.3 or DAS28(4)-ESR<2.6 or SDAI<3.3 or CDAI<2.8)
• Secondary Outcome: the low disease activity maintenance rate of 1-2 years after (DAS28(4)-ESR<3.2 or SDAI<11 or CDAI<10 the low disease activity maintenance rate of 1-2 years after (DAS28(4)-ESR<3.2 or SDAI<11 or CDAI<10

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 75years-old
• Gender: Male and Female
• Exclude criteria: "1) The patient who is having infliximab medical treatment already experienced 2) The patient who cannot prescribe a methotrexate tablet for the patient 3) The patient who is experienced in TNF inhibitors as for more than 2 agent 4) In addition, the patient who judged that a research doctor was unsuitable &quot

Related Information

• Primary Sponsor: Saitama Medical Center. Saitama Medical University
• Source(s) of Monetary Support: Saitama Medical Center, Saitama Medical Universitity