Investigation of the Safety and Efficacy of Iguratimod in Patients With Rheumatoid Arthritis
- Registration Number
- NCT01850966
- Lead Sponsor
- Eisai Co., Ltd.
- Brief Summary
To investigate the safety and efficacy of the administration of Iguratimod (CRM01T) for 52 weeks in patients with rheumatoid arthritis in clinical practice
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 2747
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Iguratimod Iguratimod -
- Primary Outcome Measures
Name Time Method Disease Activity Score (DAS28) for Rheumatoid Arthritis (EULAR Response Criteria) 52 weeks (0-24 weeks and 25-52 weeks) DAS28 is a quantitative tool used to measure and monitor disease activity and treatment of rheumatoid arthritis. DAS28 uses a formula that includes the number of tender joints and swollen joints for a maximum of 28 joints.
DAS28 is used to assess whether an individual participant has a significant improvement of the disease activity, compared to baseline.
* Good response: Baseline DAS28 less than or equal to 3.2 (low disease activity); DAS28 Improvement \>1.2
* Moderate response: Baseline DAS28 less than or equal to 3.2; DAS28 Improvement \>0.6 and less than or equal to 1.2
* or Baseline DAS28 \>3.2 and less than or equal to 5.1; DAS28 Improvement \>0.6
* or Baseline DAS28 \>5.1; DAS28 Improvement \>1.2
* No response: Baseline DAS28 \>5.1 (high disease activity); DAS28 Improvement less than or equal to 1.2 or DAS28 Improvement less than or equal to 0.6
- Secondary Outcome Measures
Name Time Method Number of Participants with Adverse Events 52 weeks
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