Effectiveness of Iguratimod Versus Placebo to Treat Early Rheumatoid Arthritis on MRI

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the efficacy of Iguratimod versus placebo on synovial inflammation,bone erosion and bone edema as measured by MRI of wrist and Metacarpophalangeal joints in patients with early Rheumatoid Arthritis (RA).

Detailed Description
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Magnetic resonance imaging (MRI) is a powerful imaging modality that is now widely used in both scientific research and clinical settings to visualise joints of patients with RA. MRI is able to image structural damage and soft tissue changes, ie, synovitis, bone oedema, damage to cartilage and bone, as well as tendon pathology. MRI is more responsive to change in joint damage and can be used to monitor disease progression. In this studly,MRI of the dominant wrist was performed at baseline ,24 weeks and at 52 weeks, using a 1.5T or 3.0T MRI with a dedicated high-resolution wrist phased array coil.The same scanner and wrist coil were used for three examinations. The hand was placed in the wrist coil at the patient's side with the coil anchored to the base tray to reduce motion artefacts. The MRI sequences in this study included the OMERACT recommended MRI core set of sequences.

Official Title
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A Randomized, Double-blind Study to Evaluate the Efficacy of Iguratimod Versus Placebo in Patients With Rheumatoid Arthritis on Magnetic Resonance Imaging (MRI)

Conditions
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Rheumatoid Arthritis

Intervention / Treatment
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* Drug: Iguratimod
* Drug: Iguratimod placebo


Participation Criteria
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Eligibility Criteria
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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 Functional Class II-III Subjects have active RA at the time of screening Must have a negative Pregnancy test and use adequate method of contraception throughout the trial Must have at least 4 tender joints and 4 swollen joints(involved in DAS28) and among these,at least one swollen Metacarpophalangeal joint is essential Has a C-reactive protein ≥ 10 mg/L OR Erythrocyte Sedimentation Rate (ESR) ≥ 28 mm/hr Written informed consent Exclusion Criteria: Preceding treatment with DMARDs, immunosuppressants (cyclophosphamide, cyclosporine, azathioprine, etc.), biological agents or tripterygium within 12 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 or Cr >1.5mg WBC<4×109/L，HGB<85g/L，PLT<100×109/L Subjects with serious cardiovascular, renal, hematologic,endocrine diseases or malignant Subjects with immunodeficiency, uncontrolled infection and active gastrointestinal disease Pregnant, intend to become pregnant, or are breastfeeding Subjects with other rheumatological diseases such as SLE, mixed connective tissue disease, scleroderma, polymyositis, etc Subjects with inflammatory arthritis, such as gout, reactive arthritis, psoriatic arthritis, seronegative spondyloarthropathy, Lyme disease Subjects with intra-articular corticosteroid injections within 6 weeks prior to study entry 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Iguratimod<br>Iguratimod:25 mg/tablet, taken orally, 2 tablets/day (bid),52week | Drug: Iguratimod<br>* Iguratimod placebo:25 mg/tablet, taken orally, 2 tablets/day (bid),52week<br>* Other names: Iremod;|
| Placebo Comparator: Iguratimod placebo<br>Iguratimod placebo:25 mg/tablet, taken orally, 2 tablets/day (bid),24week;Iguratimod:25 mg/tablet, taken orally, 2 tablets/day (bid),28week | Drug: Iguratimod placebo<br>* Iguratimod placebo:25 mg/tablet, taken orally, 2 tablets/day (bid),24week; Iguratimod:25 mg/tablet, taken orally, 2 tablets/day (bid),28week.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in RA magnetic resonance imaging scoring system (RAMRIS) |  | week 52 | 
| Change from baseline in modified Total Sharp Score (mTSS) |  | week 52 | 
| Percentage of patients with ACR 20 response |  | week 52 | 
| Change in Disease Activity as measured by the DAS28 |  | week 52 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in RAMRIS |  | week 24 | 
| Change from baseline in mTSS |  | week 24 | 
| Percentage of patients with ACR 20 response |  | week 10, week 24, week 40 | 
| Change from baseline in Disease Activity Score 28 (DAS28) |  | : week 10, week 24, week 40 | 
| Percentage of patients with ACR 50 response |  | week 10, week 24, week 40, week 52 | 
| Percentage of patients with ACR 70 response |  | week 10, week 24, week 40, week 52 | 
| Percentage of patients with Simplified Disease Activity Index (SDAI) ≤ 3.3 |  | week 10, week 24, week 40, week 52 | 
| Change from baseline in Simplified Disease Activity Index (SDAI) |  | week 10, week 24, week 40, week 52 | 
| Change from baseline in Health Assessment Questionnaire (HAQ) |  | week 10, week 24, week 40, week 52 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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MRI, Iguratimod, Rheumatoid Arthritis