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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
Sponsor:
Information provided by (Responsible Party):
Eisai Inc. ( Eisai Co., Ltd. )

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

Condition or disease Intervention/treatment
Rheumatoid Arthritis Drug: Iguratimod

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Study Type : Observational
Actual Enrollment : 2747 participants
Observational Model: Case-Control
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Iguratimod 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.




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Number of Participants with Adverse Events [ Time Frame: 52 weeks ]


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Hospitals and clinics in Japan
Criteria

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

Information from the National Library of Medicine

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
Sponsors and Collaborators
Eisai Co., Ltd.
Investigators
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Study Director: Akiko Yoshimura Drug Fostering and Evolution Coordination Department, Eisai Co., Ltd.

Publications of Results:
Mod Rheumatol. 2017;27:755-65.
Rheumatology. 2018;59: 222-32.

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Responsible Party: Eisai Co., Ltd.
ClinicalTrials.gov Identifier: NCT01850966     History of Changes
Other Study ID Numbers: CRM01T
First Posted: May 10, 2013    Key Record Dates
Last Update Posted: November 5, 2018
Last Verified: January 2017
Keywords provided by Eisai Inc. ( Eisai Co., Ltd. ):
Arthritis, Rheumatoid, Iguratimod
Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases