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A Study of Iguratimod in Patients With Active Rheumatoid Arthritis

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ClinicalTrials.gov Identifier: NCT01554917
Recruitment Status : Completed
First Posted : March 15, 2012
Last Update Posted : February 23, 2016
Sponsor:
Information provided by (Responsible Party):
Jiangsu Simcere Pharmaceutical Co., Ltd.

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

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Drug: Iguratimod Phase 4

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1759 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase IV Study of Iguratimod in Patients With Active Rheumatoid Arthritis (RA)
Study Start Date : May 2012
Actual Primary Completion Date : August 2015
Actual Study Completion Date : August 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Iguratimod Drug: Iguratimod
taken orally, 2 tablets/day (bid)



Primary Outcome Measures :
  1. Percentage of patients meeting the American College of Rheumatology 20% response criteria (ACR20) [ Time Frame: week 24 ]

Secondary Outcome Measures :
  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 ]
  5. Incidence of adverse events [ Time Frame: up to 28 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT01554917


Locations
China
Peking University People's Hospital
Beijing, China
Sponsors and Collaborators
Jiangsu Simcere Pharmaceutical Co., Ltd.
Investigators
Principal Investigator: Zhanguo Li, MD/PhD Peking University People's Hospital

Responsible Party: Jiangsu Simcere Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT01554917     History of Changes
Other Study ID Numbers: SIM-109
First Posted: March 15, 2012    Key Record Dates
Last Update Posted: February 23, 2016
Last Verified: February 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Jiangsu Simcere Pharmaceutical Co., Ltd.:
Rheumatoid Arthritis
Iguratimod

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases