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

NCT ID: NCT02275299

Last Updated: 2014-10-27

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 240 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-09-30
• Study Completion Date: 2016-02-29

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).

Conditions

Rheumatoid Arthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Iguratimod and MTX combination

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

Group Type: EXPERIMENTAL

Iguratimod

Intervention Type: DRUG

Iguratimod 25 mg/tablet, taken orally, 2 tablets/day (bid),52 weeks

Methotrexate

Intervention Type: DRUG

Methotrexate 2.5 mg/tablet, taken orally once a week, 4 tablets/week,52 weeks

Leflunomide and MTX combination

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

Group Type: ACTIVE_COMPARATOR

Leflunomide

Intervention Type: DRUG

Leflunomide 10 mg/tablet, taken orally, 2 tablets/day (bid),52 weeks

Methotrexate

Intervention Type: DRUG

Methotrexate 2.5 mg/tablet, taken orally once a week, 4 tablets/week,52 weeks

Interventions

Iguratimod

Iguratimod 25 mg/tablet, taken orally, 2 tablets/day (bid),52 weeks

Intervention Type: DRUG

Leflunomide

Leflunomide 10 mg/tablet, taken orally, 2 tablets/day (bid),52 weeks

Intervention Type: DRUG

Methotrexate

Methotrexate 2.5 mg/tablet, taken orally once a week, 4 tablets/week,52 weeks

Intervention Type: DRUG

Other Intervention Names

Iremod

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jiangsu Simcere Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

weihong zhao, doctor

Role: CONTACT

zhaoweihong@simcere.com

+86(25) 8556 6666 ext. 8701

Facility Contacts

Fengchun Zhang, doctor

Role: primary

zhangfccra@yahoo.com.cn

+86（10）6915 6114

Other Identifiers

Tranmod

Identifier Type: -

Identifier Source: org_study_id