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

Phase 4

• Conditions: Rheumatoid Arthritis
• Interventions: Drug: Iguratimod; Drug: Leflunomide; Drug: Methotrexate

• Registration Number: NCT02275299
• Lead Sponsor: Jiangsu Simcere Pharmaceutical Co., Ltd.

Brief Summary

This study is intended to evaluate the efficacy and safety of Iguratimod Plus Methotrexate Compared to Leflunomid Plus Methotrexate in patients with active Rheumatoid Arthritis (RA).

Detailed Description

Not available

Study Timeline

• Study Start: 2013-09
• Status Verified: 2014-10
• Study First Submitted: 2014-10-23
• Study First Submitted QC: 2014-10-23
• Last Update Submitted: 2014-10-23
• Study First Posted: 2014-10-27
• Last Update Posted: 2014-10-27
• Primary Completion: 2016-02
• Study Completion: 2016-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 240

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 more than 3 months from the time of the initial diagnosis
• Functional Class II-III
• Subjects have active RA at the time of screening
• Subjects with inadequate response to biologics should have a washout period before the initiation of study. For etanercept, washout period should be 2-week, and 8-week for infliximab and adalimumab.
• For firstly diagnostic RA patients, the disease activity should be moderate to severe, with DAS28>3.2
• Must have at least 4 tender joints (66 join count) and 8 swollen joints( 68 join count) at screening and baseline
• Has a C-reactive protein ≥ 10 mg/L(or 1.0 mg/dL) OR Erythrocyte Sedimentation Rate (ESR) ≥ 28 mm/hr
• Must have a negative Pregnancy test and use adequate method of contraception throughout the trial
• Written informed consent

Exclusion Criteria

• Preceding treatment with DMARDs, immunosuppressants (cyclophosphamide, cyclosporine, azathioprine, etc.), or Tripterygium within 4 weeks prior to study entry
• Subjects have been treated with iguratimod or leflunomide combined with MTX before screening.
• Subjects combined with other autoimmune disease, such as systemic lupus erythematosus (SLE), mixed connective tissue disease (MCTD), scleriasis and polymyositis, except for Sjögren syndrome.
• Chest x-ray abnormalities, such as tuberculosis, interstitial pulmonary fibrosis, etc.
• ALT >1.5×ULN, AST >1.5×ULN, Cr >135umol/L, total bilirubin>1.5×ULN
• WBC<4×109/L，HGB<85g/L，PLT<100×109/L
• Subjects with serious cardiovascular, renal, hematologic, endocrine diseases or malignant
• Women of Pregnant or breastfeeding, and male or female with recent plan to conception
• Subjects with immunodeficiency, uncontrolled infection and active gastrointestinal disease
• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Iguratimod and MTX combination	Iguratimod	Drug:Iguratimod 25 mg/tablet, taken orally, 2 tablets/day (bid) Drug:MTX 2.5 mg/tablet, taken orally once a week, 4 tablets/week
Iguratimod and MTX combination	Methotrexate	Drug:Iguratimod 25 mg/tablet, taken orally, 2 tablets/day (bid) Drug:MTX 2.5 mg/tablet, taken orally once a week, 4 tablets/week
Leflunomide and MTX combination	Leflunomide	Drug: Leflunomide 10 mg/tablet, taken orally, 2 tablets/day (bid) Drug: Methotrexate 2.5 mg/tablet, taken orally once a week, 4 tablets/week
Leflunomide and MTX combination	Methotrexate	Drug: Leflunomide 10 mg/tablet, taken orally, 2 tablets/day (bid) Drug: Methotrexate 2.5 mg/tablet, taken orally once a week, 4 tablets/week

Primary Outcome Measures

Name	Time	Method
Percentage of patients with ACR 20 response and Change in Disease Activity as measured by the DAS28	week 52

Secondary Outcome Measures

Name	Time	Method
Change from baseline in modified Total Sharp Score (mTSS)	week 52
Change from baseline in number of swollen and tender joins, Erythrocyte sedimentation rate (ESR) ,C-reactive protein (CRP),anti-citrullinated-protein antibody (ACPA) and heumatoid factor(RF)	week 24, week 52
Time to achieve the ACR20, ACR50 and ACR70	week 12, week 24, week 40, week 52
Percentage of patients with Simplified Disease Activity Index (SDAI) ≤ 3.3 and change from baseline in Health Assessment Questionnaire (HAQ)	week 12, week 24, week 40, week 52
Percentage of patients with ACR 50 response and ACR70 response	week 24,week 52
Incidence of adverse events	up to 52 weeks

Trial Locations

Locations (1)

Peking Union Medical College Hospital; 🇨🇳 Beijing, Beijing, China