Back to resultsA Study of Iguratimod in Patients With Active Rheumatoid Arthritis
Primary Purpose
Rheumatoid Arthritis
Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Iguratimod
Sponsored by
About this trial
This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring Rheumatoid Arthritis, Iguratimod
Eligibility Criteria
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
Sites / Locations
- Peking University People's Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Iguratimod
Arm Description
Outcomes
Primary Outcome Measures
Percentage of patients meeting the American College of Rheumatology 20% response criteria (ACR20)
Incidence of adverse events
Secondary Outcome Measures
Percentage of patients meeting the American College of Rheumatology 50% response criteria (ACR50)
Percentage of patients meeting the American College of Rheumatology 70% response criteria (ACR70)
Change from baseline in Disease Activity Score 28 (DAS28)
Change from baseline in Health Assessment Questionnaire (HAQ)
Full Information
NCT ID
NCT01554917
First Posted
March 12, 2012
Last Updated
October 9, 2020
Sponsor
Jiangsu Simcere Pharmaceutical Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT01554917
Brief Title
A Study of Iguratimod in Patients With Active Rheumatoid Arthritis
Official Title
A Phase IV Study of Iguratimod in Patients With Active Rheumatoid Arthritis (RA)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
May 2012 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
August 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jiangsu Simcere Pharmaceutical Co., Ltd.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
Keywords
Rheumatoid Arthritis, Iguratimod
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1759 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Iguratimod
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Iguratimod
Intervention Description
taken orally, 2 tablets/day (bid)
Primary Outcome Measure Information:
Title
Percentage of patients meeting the American College of Rheumatology 20% response criteria (ACR20)
Time Frame
week 24
Title
Incidence of adverse events
Time Frame
up to 28 weeks
Secondary Outcome Measure Information:
Title
Percentage of patients meeting the American College of Rheumatology 50% response criteria (ACR50)
Time Frame
week 24
Title
Percentage of patients meeting the American College of Rheumatology 70% response criteria (ACR70)
Time Frame
week 24
Title
Change from baseline in Disease Activity Score 28 (DAS28)
Time Frame
week 24
Title
Change from baseline in Health Assessment Questionnaire (HAQ)
Time Frame
week 24
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhanguo Li, MD/PhD
Organizational Affiliation
Peking University People's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Peking University People's Hospital
City
Beijing
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
34327344
Citation
Mu R, Li C, Li X, Ke Y, Zhao L, Chen L, Wu R, Wu Z, Zuo X, Xie Y, Chen J, Wei W, Liu Y, Li Z, Dai L, Sun L, Liu X, Li Z. Effectiveness and safety of iguratimod treatment in patients with active rheumatoid arthritis in Chinese: A nationwide, prospective real-world study. Lancet Reg Health West Pac. 2021 Mar 22;10:100128. doi: 10.1016/j.lanwpc.2021.100128. eCollection 2021 May.
Results Reference
derived
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A Study of Iguratimod in Patients With Active Rheumatoid Arthritis
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