A Study of Iguratimod in Patients With Active Rheumatoid Arthritis
A Phase IV Study of Iguratimod in Patients With Active Rheumatoid Arthritis (RA)
1 other identifier
interventional
1,759
1 country
1
Brief Summary
This study is intended to evaluate the safety and efficacy of Iguratimod in patients with active Rheumatoid Arthritis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4 rheumatoid-arthritis
Started May 2012
Typical duration for phase_4 rheumatoid-arthritis
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 12, 2012
CompletedFirst Posted
Study publicly available on registry
March 15, 2012
CompletedStudy Start
First participant enrolled
May 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2015
CompletedOctober 14, 2020
October 1, 2020
3.3 years
March 12, 2012
October 9, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Percentage of patients meeting the American College of Rheumatology 20% response criteria (ACR20)
week 24
Incidence of adverse events
up to 28 weeks
Secondary Outcomes (4)
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
Change from baseline in Health Assessment Questionnaire (HAQ)
week 24
Study Arms (1)
Iguratimod
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Peking University People's Hospital
Beijing, China
Related Publications (1)
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.
PMID: 34327344DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Zhanguo Li, MD/PhD
Peking University People's Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 12, 2012
First Posted
March 15, 2012
Study Start
May 1, 2012
Primary Completion
August 1, 2015
Study Completion
August 1, 2015
Last Updated
October 14, 2020
Record last verified: 2020-10
Data Sharing
- IPD Sharing
- Will not share