A Study of Iguratimod in Patients With Active Rheumatoid Arthritis

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01554917

Enrollment

1759

Registered

2012-03-15

Start date

2012-05-31

Completion date

2015-08-31

Last updated

2020-10-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid Arthritis

Keywords

Rheumatoid Arthritis, Iguratimod

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.

Interventions

DRUGIguratimod

taken orally, 2 tablets/day (bid)

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
Change from baseline in Health Assessment Questionnaire (HAQ)	week 24
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

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 23, 2026