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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01850966

Enrollment

2747

Registered

2013-05-10

Start date

2012-09-12

Completion date

2014-04-13

Last updated

2018-11-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid Arthritis

Keywords

Arthritis, Rheumatoid, Iguratimod

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

Interventions

DRUGIguratimod

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.

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame
Number of Participants with Adverse Events	52 weeks

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026