Long-term Efficacy of Iguratimod Alone or Iguratimod in Combination With Methotrexate in Patients With Rheumatoid Arthritis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

910 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-05-31

Study Completion Date

2017-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study is intended to evaluate the efficacy and safety of Iguratimod alone or Iguratimod in combination with Methotrexate (MTX) versus Methotrexate alone in patients with Rheumatoid Arthritis (RA).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Study of Iguratimod in Patients With Active Rheumatoid Arthritis

NCT01554917

Rheumatoid Arthritis

COMPLETED PHASE4

Study of Iguratimod Plus Methotrexate Compared to Leflunomid Plus Methotrexate in Patients With Rheumatoid Arthritis

NCT02275299

Rheumatoid Arthritis

UNKNOWN PHASE4

The Clinical Efficacy and Safety of Iguratimod in RA and Early RA Patients for 6 Months Treatment

NCT03855007

Arthritis, Rheumatoid

COMPLETED PHASE4

The Clinical Efficacy of Immunomodulators in RA Patients

NCT05626348

Arthritis, Rheumatoid

RECRUITING PHASE4

An Efficacy and Safety Study of Infliximab in Participants With Rheumatoid Arthritis

NCT00896168

Arthritis, Rheumatoid

COMPLETED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Rheumatoid Arthritis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Iguratimod monotherapy

Group Type EXPERIMENTAL

Iguratimod

Intervention Type DRUG

25 mg/tablet, taken orally, 2 tablets/day (bid)

Iguratimod and MTX combination

Group Type EXPERIMENTAL

Iguratimod

Intervention Type DRUG

25 mg/tablet, taken orally, 2 tablets/day (bid)

Methotrexate

Intervention Type DRUG

2.5 mg/tablet, taken orally once a week, 4 tablets/week (week 1-week 4) , 6 tablets/week (week 5- week 52)

MTX monotherapy

Group Type ACTIVE_COMPARATOR

Methotrexate

Intervention Type DRUG

2.5 mg/tablet, taken orally once a week, 4 tablets/week (week 1-week 4) , 6 tablets/week (week 5- week 52)

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Iguratimod

25 mg/tablet, taken orally, 2 tablets/day (bid)

Intervention Type DRUG

Methotrexate

2.5 mg/tablet, taken orally once a week, 4 tablets/week (week 1-week 4) , 6 tablets/week (week 5- week 52)

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Subjects with a diagnosis of RA according to the diagnostic criteria of the American College of Rheumatology (ACR) (revised in 1987)
* Rheumatoid Arthritis for 3 months to 2 years from the time of the initial diagnosis
* Subjects have active RA at the time of screening
* Subjects are naive to MTX or RA related biologics
* Written informed consent

Exclusion Criteria

* Preceding treatment with DMARDs, immunosuppressants (cyclophosphamide, cyclosporine, azathioprine, etc.), or Tripterygium within 4 weeks prior to study entry
* Chest x-ray abnormalities, such as tuberculosis, interstitial pulmonary fibrosis, etc.
* ALT \>1.5×ULN, AST \>1.5×ULN, Cr \>135umol/L
* WBC\<4×109/L，HGB\<85g/L，PLT\<100×109/L
* Subjects with serious cardiovascular, renal, hematologic or endocrine diseases
* Pregnant or lactating women
* Allergic to any of the study drugs
* History of alcoholism
* Subjects with mental illness
* Subjects receiving live vaccines recently
* Subjects participating in other clinical study within 3 months prior to study entry

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No