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Completed

NCT Number: NCT01554917

A Study of Iguratimod in Patients With Active Rheumatoid Arthritis

This study is intended to evaluate the safety and efficacy of Iguratimod in patients with active Rheumatoid Arthritis.

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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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Peking University People's Hospital

Beijing, China

About this study

This is a multi-center, open, single arm study.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Subjects with a diagnosis of RA
  • Subjects who have active RA at the time of screening
  • Subjects who haven't used any antirheumatic drugs or have used antirheumatic drugs for more than 3 months at the time of screening
  • Written informed consent

Exclusion criteria

  • Subjects with serious cardiovascular, renal, hematologic or endocrine diseases
  • Pregnant or lactating women
  • ALT>1.5×ULN, AST>1.5×ULN, Cr>135umol/L
  • WBC<4×109/L，HGB<85g/L，PLT<100×109/L
  • Subjects with uncontrolled infection
  • Patients with active gastrointestinal diseases (such as gastric ulcer, etc.)
  • Allergic to any of the study drugs
  • History of alcoholism
  • Subjects receiving live vaccines within 3 months prior to study entry
  • Subjects participating in other clinical study within 3 months prior to study entry

Treatment and study plan

Iguratimod

Drug

taken orally, 2 tablets/day (bid)

Primary outcomes

  1. Percentage of patients meeting the American College of Rheumatology 20% response criteria (ACR20)

    Time frame: week 24

  2. Incidence of adverse events

    Time frame: up to 28 weeks

Secondary outcomes

  1. Percentage of patients meeting the American College of Rheumatology 50% response criteria (ACR50)

    Time frame: week 24

  2. Percentage of patients meeting the American College of Rheumatology 70% response criteria (ACR70)

    Time frame: week 24

  3. Change from baseline in Disease Activity Score 28 (DAS28)

    Time frame: week 24

  4. Change from baseline in Health Assessment Questionnaire (HAQ)

    Time frame: week 24

Sponsors and collaborators

Lead sponsor

Jiangsu Simcere Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

A Phase IV Study of Iguratimod in Patients With Active Rheumatoid Arthritis (RA)

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Mar 15, 2012
Registry last updated
Oct 14, 2020

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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