Comparison of effects between higher dosages of infliximab and switching to other biologics for rheumatoid arthritis patients with less responsiveness to infliximab therapy (cHAMLET)

UMIN ID: UMIN000002340

Registered date:20/08/2009

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Rheumatoid Arthritis
• Date of first enrollment: 2009/08/01
• Target sample size: 60
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Treatment with higher dosages of infliximab (3-10 mg/Kg) Every 2 months Follow-up to 54 weeks
Treatment with one of other biologics (etanercept, adalimumab, tocilizumab) in standard protocol Follow-up to 54 weeks

Outcome(s)

• Primary Outcome: DAS28, EULAR responsiveness
• Secondary Outcome: mHAQ, The number and dosages of concomitant medication

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: Patients whose DAS28-ESR are below 3.2 (DAS28-CRP>2.7) after low-dose infliximab (3mg/Kg) therapy at least 5 times

Related Information

• Primary Sponsor: Department of Rheumatosurgery, Osaka City University Medical School
• Source(s) of Monetary Support: Department of Rheumatosurgery, Osaka City University Medical School