A Study of Iguratimod in Patients With Active Rheumatoid Arthritis

Phase 4

Completed

• Conditions: Rheumatoid Arthritis
• Interventions: Drug: Iguratimod

• Registration Number: NCT01554917
• Lead Sponsor: 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.

Detailed Description

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

Study Timeline

• Study First Submitted: 2012-03-12
• Study First Submitted QC: 2012-03-13
• Study First Posted: 2012-03-15
• Study Start: 2012-05
• Primary Completion: 2015-08
• Study Completion: 2015-08
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-09
• Last Update Posted: 2020-10-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1759

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Iguratimod	Iguratimod	-

Primary Outcome Measures

Name	Time	Method
Percentage of patients meeting the American College of Rheumatology 20% response criteria (ACR20)	week 24
Incidence of adverse events	up to 28 weeks

Secondary Outcome Measures

Name	Time	Method
Change from baseline in Health Assessment Questionnaire (HAQ)	week 24
Percentage of patients meeting the American College of Rheumatology 50% response criteria (ACR50)	week 24
Percentage of patients meeting the American College of Rheumatology 70% response criteria (ACR70)	week 24
Change from baseline in Disease Activity Score 28 (DAS28)	week 24

Trial Locations

Locations (1)

Peking University People's Hospital; 🇨🇳 Beijing, China