Investigation of the Safety and Efficacy of Iguratimod in Patients With Rheumatoid Arthritis

Rheumatoid Arthritis Clinical Trial

Official title:

Investigation of the Safety and Efficacy of Iguratimod in Patients With Rheumatoid Arthritis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01850966
• Other study ID #: CRM01T
• Status: Completed
• Start date: September 12, 2012
• Est. completion date: April 13, 2014

Study information

• Verified date: January 2017
• Source: Eisai Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

To investigate the safety and efficacy of the administration of Iguratimod (CRM01T) for 52 weeks in patients with rheumatoid arthritis in clinical practice

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• Iguratimod
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Eisai Co., Ltd.

Country where clinical trial is conducted

Japan, 

References & Publications (2)

Mod Rheumatol. 2017;27:755-65.

Rheumatology. 2018;59: 222-32.

Outcome

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