Iremod (iguratimod) - Simcere
A study of iguratimod in patients with active rheumatoid arthritis (clinicaltrials.gov) - Mar 13, 2012 - P4, N=2,400; Not yet recruiting; New P4 trial 
New trial • Immunology • Rheumatoid Arthritis
http://clinicaltrials.gov/ct2/show/NCT01554917
 
Mar 13, 2012
 
This study is not yet open for participant recruitment. Verified March 2012 by Jiangsu Simcere Pharmaceutical R&D Co. Ltd. First Received on March 12, 2012.   Last Updated on March 13, 2012   History of Changes Sponsor: Jiangsu Simcere Pharmaceutical R&D Co. Ltd. Information provided by (Responsible Party): Jiangsu Simcere Pharmaceutical R&D Co. Ltd. ClinicalTrials.gov Identifier: NCT01554917 Purpose This study is intended to evaluate the safety and efficacy of Iguratimod in patients with active Rheumatoid Arthritis. Condition Rheumatoid Arthritis Intervention Drug: Iguratimod Phase Phase IV 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: MedlinePlus related topics: Rheumatoid Arthritis Drug Information available for: Iguratimod 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)