Investigation of the Safety and Efficacy of Iguratimod in Patients With Rheumatoid Arthritis
Overview
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Eisai Co., Ltd.
- Enrollment
- 2,747
- Primary Endpoint
- Disease Activity Score (DAS28) for Rheumatoid Arthritis (EULAR Response Criteria)
Overview
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
Study Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Prospective
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Iguratimod
Intervention: Iguratimod (Drug)
Outcomes
Primary Outcomes
Disease Activity Score (DAS28) for Rheumatoid Arthritis (EULAR Response Criteria)
Time Frame: 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 Outcomes
- Number of Participants with Adverse Events(52 weeks)