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

Simcere

Status and phase: Unknown; Phase 4

Conditions: Rheumatoid Arthritis

Treatments: Drug: Iguratimod; Drug: Methotrexate; Drug: Leflunomide

Study type: Interventional

Funder types: Industry

Identifiers

NCT02275299

Tranmod

Details and patient eligibility

About

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).

Enrollment: 240 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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240 participants in 2 patient groups

Iguratimod and MTX combination

Experimental group

Description:

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

Treatment:

Drug: Methotrexate

Drug: Iguratimod

Leflunomide and MTX combination

Active Comparator group

Description:

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

Treatment:

Drug: Methotrexate

Drug: Leflunomide