A Study of Iguratimod in Patients With Active Rheumatoid Arthritis

• Sponsor: Jiangsu Simcere Pharmaceutical Co., Ltd. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01554917
• Collaborator: (none)
• Enrollment: 1,759
• Location: 1
• Arm: 1
• Duration (Months): 39
• Patients Per Site Per Month: 45.1

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Rheumatoid Arthritis	Drug: Iguratimod	Phase 4

Detailed Description

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

Study Design

• Study Type: Interventional
• Actual Enrollment: 1759 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase IV Study of Iguratimod in Patients With Active Rheumatoid Arthritis (RA)
• Study Start Date: May 1, 2012
• Actual Primary Completion Date: Aug 1, 2015
• Actual Study Completion Date: Aug 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Iguratimod	Drug: Iguratimod; taken orally, 2 tablets/day (bid)

Outcome Measures

Primary Outcome Measures

1. Percentage of patients meeting the American College of Rheumatology 20% response criteria (ACR20) [week 24]

2. Incidence of adverse events [up to 28 weeks]

Secondary Outcome Measures

1. Percentage of patients meeting the American College of Rheumatology 50% response criteria (ACR50) [week 24]

2. Percentage of patients meeting the American College of Rheumatology 70% response criteria (ACR70) [week 24]

3. Change from baseline in Disease Activity Score 28 (DAS28) [week 24]

4. Change from baseline in Health Assessment Questionnaire (HAQ) [week 24]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jiangsu Simcere Pharmaceutical Co., Ltd.
• ClinicalTrials.gov Identifier: NCT01554917
• Other Study ID Numbers: SIM-109
• First Posted: Mar 15, 2012
• Last Update Posted: Oct 14, 2020
• Last Verified: Oct 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Jiangsu Simcere Pharmaceutical Co., Ltd.: Rheumatoid Arthritis; Iguratimod
• Additional relevant MeSH terms: Arthritis; Arthritis, Rheumatoid

Study Results

No Results Posted as of Oct 14, 2020