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OpenTrials
Completed

NCT Number: NCT01850966

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

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

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Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Aisai, Aichi-ken, Japan

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Iguratimod

Drug

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 outcomes

  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 outcomes

  1. Number of Participants with Adverse Events

    Time frame: 52 weeks

Sponsors and collaborators

Lead sponsor

Eisai Co., Ltd.

Industry

Registry information

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
May 10, 2013
Registry last updated
Nov 5, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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