A Study of Iguratimod in Patients With Active Rheumatoid Arthritis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jiangsu Simcere Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01554917
First received: March 12, 2012
Last updated: February 22, 2016
Last verified: February 2016
  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:


Further study details as provided by Jiangsu Simcere Pharmaceutical 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 ]

Enrollment: 1759
Study Start Date: May 2012
Study Completion Date: August 2015
Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Iguratimod Drug: Iguratimod
taken orally, 2 tablets/day (bid)

Detailed Description:
This is a multi-center, open, single arm study.
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Responsible Party: Jiangsu Simcere Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT01554917     History of Changes
Other Study ID Numbers: SIM-109 
Study First Received: March 12, 2012
Last Updated: February 22, 2016
Health Authority: China: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on May 22, 2016