A Study of Iguratimod in Patients With Active Rheumatoid Arthritis

October 9, 2020 updated by: Jiangsu Simcere Pharmaceutical Co., Ltd.

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

1759

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China
        • Peking University People's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jiangsu Simcere Pharmaceutical Co., Ltd.

Investigators

  • Principal Investigator: Zhanguo Li, MD/PhD, Peking University People's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2012

Primary Completion (Actual)

August 1, 2015

Study Completion (Actual)

August 1, 2015

Study Registration Dates

First Submitted

March 12, 2012

First Submitted That Met QC Criteria

March 13, 2012

First Posted (Estimate)

March 15, 2012

Study Record Updates

Last Update Posted (Actual)

October 14, 2020

Last Update Submitted That Met QC Criteria

October 9, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SIM-109

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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