Investigation of the Safety and Efficacy of Iguratimod in Patients With Rheumatoid Arthritis
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|ClinicalTrials.gov Identifier: NCT01850966|
Recruitment Status : Completed
First Posted : May 10, 2013
Last Update Posted : November 5, 2018
|Condition or disease||Intervention/treatment|
|Rheumatoid Arthritis||Drug: Iguratimod|
|Study Type :||Observational|
|Actual Enrollment :||2747 participants|
|Official Title:||Investigation of the Safety and Efficacy of Iguratimod in Patients With Rheumatoid Arthritis|
|Actual Study Start Date :||September 12, 2012|
|Actual Primary Completion Date :||April 13, 2014|
|Actual Study Completion Date :||April 13, 2014|
The usual adult dosage for oral use of 25 mg tablet of iguratimod once daily for 4 weeks or more, after which the dosage should be increased to one 25 mg tablet taken twice daily.
- 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
- Number of Participants with Adverse Events [ Time Frame: 52 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01850966
Show 453 Study Locations
|Study Director:||Akiko Yoshimura||Drug Fostering and Evolution Coordination Department, Eisai Co., Ltd.|