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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

March 12, 2012
April 22, 2013
May 2012
December 2015   (final data collection date for primary outcome measure)
Percentage of patients meeting the American College of Rheumatology 20% response criteria (ACR20) [ Time Frame: week 24 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01554917 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
A Study of Iguratimod in Patients With Active Rheumatoid Arthritis
A Phase IV Study of Iguratimod in Patients With Active Rheumatoid Arthritis (RA)

This study is intended to evaluate the safety and efficacy of Iguratimod in patients with active Rheumatoid Arthritis.
Not Provided
Interventional
Phase 4
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Rheumatoid Arthritis
Drug: Iguratimod
taken orally, 2 tablets/day (bid)
Experimental: Iguratimod
Intervention: Drug: Iguratimod
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
2400
December 2015
December 2015   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Not Provided
China
 
NCT01554917
SIM-109
No
Jiangsu Simcere Pharmaceutical R&D Co. Ltd.
Jiangsu Simcere Pharmaceutical R&D Co. Ltd.
Not Provided
Principal Investigator: Zhanguo Li, MD/PhD Peking University People's Hospital
Jiangsu Simcere Pharmaceutical R&D Co. Ltd.
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP