A Study of Iguratimod in Patients With Active Rheumatoid Arthritis

Rheumatoid Arthritis Clinical Trial

Official title:

A Phase IV Study of Iguratimod in Patients With Active Rheumatoid Arthritis (RA)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01554917
• Other study ID #: SIM-109
• Status: Completed
• Phase: Phase 4
• Start date: May 2012
• Est. completion date: August 2015

Study information

• Verified date: October 2020
• Source: Jiangsu Simcere Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1759
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• Iguratimod
taken orally, 2 tablets/day (bid)

Locations

Country	Name	City	State
China	Peking University People's Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu Simcere Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of patients meeting the American College of Rheumatology 20% response criteria (ACR20)		week 24
Primary	Incidence of adverse events		up to 28 weeks
Secondary	Percentage of patients meeting the American College of Rheumatology 50% response criteria (ACR50)		week 24
Secondary	Percentage of patients meeting the American College of Rheumatology 70% response criteria (ACR70)		week 24
Secondary	Change from baseline in Disease Activity Score 28 (DAS28)		week 24
Secondary	Change from baseline in Health Assessment Questionnaire (HAQ)		week 24