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A Study of Iguratimod in Patients With Active Rheumatoid Arthritis

This study is currently recruiting participants.
Verified April 2013 by Jiangsu Simcere Pharmaceutical R&D Co. Ltd.
Sponsor:
Information provided by (Responsible Party):
Jiangsu Simcere Pharmaceutical R&D Co. Ltd.
ClinicalTrials.gov Identifier:
NCT01554917
First received: March 12, 2012
Last updated: April 22, 2013
Last verified: April 2013
History of Changes
  Purpose

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


Condition Intervention Phase
Rheumatoid Arthritis
 Drug: Iguratimod
 Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase IV Study of Iguratimod in Patients With Active Rheumatoid Arthritis (RA)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Jiangsu Simcere Pharmaceutical R&D Co. Ltd.:

Primary Outcome Measures:
  • Percentage of patients meeting the American College of Rheumatology 20% response criteria (ACR20) [ Time Frame: week 24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percentage of patients meeting the American College of Rheumatology 50% response criteria (ACR50) [ Time Frame: week 24 ] [ Designated as safety issue: No ]
  • Percentage of patients meeting the American College of Rheumatology 70% response criteria (ACR70) [ Time Frame: week 24 ] [ Designated as safety issue: No ]
  • Change from baseline in Disease Activity Score 28 (DAS28) [ Time Frame: week 24 ] [ Designated as safety issue: No ]
  • Change from baseline in Health Assessment Questionnaire (HAQ) [ Time Frame: week 24 ] [ Designated as safety issue: No ]
  • Incidence of adverse events [ Time Frame: up to 28 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 2400
Study Start Date: May 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Iguratimod Drug: Iguratimod
taken orally, 2 tablets/day (bid)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01554917

Locations
China
Peking University People's Hospital Recruiting
Beijing, China
Contact: Zhanguo Li, MD/PhD     86-010-88325222        
Sponsors and Collaborators
Jiangsu Simcere Pharmaceutical R&D Co. Ltd.
Investigators
Principal Investigator: Zhanguo Li, MD/PhD Peking University People's Hospital
  More Information

No publications provided

Responsible Party: Jiangsu Simcere Pharmaceutical R&D Co. Ltd.
ClinicalTrials.gov Identifier: NCT01554917     History of Changes
Other Study ID Numbers: SIM-109
Study First Received: March 12, 2012
Last Updated: April 22, 2013
Health Authority: China: Food and Drug Administration

Keywords provided by Jiangsu Simcere Pharmaceutical R&D 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

ClinicalTrials.gov processed this record on May 16, 2013