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

Study Overview
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Brief Summary
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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).

Official Title
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A Randomized, Double-blind Study to Evaluate the Efficacy and Safety of Iguratimod Alone or Iguratimod in Combination With Methotrexate Versus Methotrexate Alone in Patients With Rheumatoid Arthritis

Conditions
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Rheumatoid Arthritis

Intervention / Treatment
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* Drug: Iguratimod
* Drug: Methotrexate


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 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

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 monotherapy<br> | Drug: Iguratimod<br>* 25 mg/tablet, taken orally, 2 tablets/day (bid)<br>|
| Experimental: Iguratimod and MTX combination<br> | Drug: Iguratimod<br>* 25 mg/tablet, taken orally, 2 tablets/day (bid)<br>Drug: Methotrexate<br>* 2.5 mg/tablet, taken orally once a week, 4 tablets/week (week 1-week 4) , 6 tablets/week (week 5- week 52)<br>|
| Active Comparator: MTX monotherapy<br> | Drug: Methotrexate<br>* 2.5 mg/tablet, taken orally once a week, 4 tablets/week (week 1-week 4) , 6 tablets/week (week 5- week 52)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients with ACR 20 response |  | week 52 | 
| Change from baseline in modified Total Sharp Score (mTSS) |  | week 52 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in mTSS |  | week 24 | 
| Percentage of patients achieving radiographic non-progression |  | week 24, week 52 | 
| Percentage of patients with ACR 20 response |  | week 12, week 24, week 40 | 
| Percentage of patients with ACR 50 response |  | week 12, week 24, week 40, week 52 | 
| Percentage of patients with ACR 70 response |  | week 12, week 24, week 40, week 52 | 
| Percentage of patients with Simplified Disease Activity Index (SDAI) ≤ 3.3 |  | week 12, week 24, week 40, week 52 | 
| Change from baseline in Health Assessment Questionnaire (HAQ) |  | week 12, week 24, week 40, week 52 | 
| Incidence of adverse events |  | up to 2 years | 

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