Rheumatoid Arthritis Clinical Trial
Official title:
Investigation of the Safety and Efficacy of Iguratimod in Patients With Rheumatoid Arthritis
NCT number | NCT01850966 |
Other study ID # | CRM01T |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | September 12, 2012 |
Est. completion date | April 13, 2014 |
Verified date | January 2017 |
Source | Eisai Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
To investigate the safety and efficacy of the administration of Iguratimod (CRM01T) for 52 weeks in patients with rheumatoid arthritis in clinical practice
Status | Completed |
Enrollment | 2747 |
Est. completion date | April 13, 2014 |
Est. primary completion date | April 13, 2014 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility |
Inclusion criteria - Participants with rheumatoid arthritis - Participants who take iguratimod Exclusion criteria - Participants registered for this survey previously - Pregnant women or women suspected of being pregnant - Participants with a serious liver disorder - Participants with peptic ulcer - Participants with known hypersensitivity to iguratimod or any of its excipients |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Eisai Co., Ltd. |
Japan,
Mod Rheumatol. 2017;27:755-65.
Rheumatology. 2018;59: 222-32.
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Disease Activity Score (DAS28) for Rheumatoid Arthritis (EULAR Response Criteria) | 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 |
52 weeks (0-24 weeks and 25-52 weeks) | |
Secondary | Number of Participants with Adverse Events | 52 weeks |
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