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

Simcere

Status and phase: Unknown; Phase 4

Conditions: Rheumatoid Arthritis

Treatments: Drug: Iguratimod; Drug: Methotrexate

Study type: Interventional

Funder types: Industry

Identifiers

NCT01548001

SIM-106

Details and patient eligibility

About

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).

Enrollment: 910 patients

Sex: All

Ages: 18 to 65 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 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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910 participants in 3 patient groups

Iguratimod monotherapy

Experimental group

Treatment:

Drug: Iguratimod

Iguratimod and MTX combination

Experimental group

Treatment:

Drug: Iguratimod

Drug: Methotrexate

MTX monotherapy

Active Comparator group

Treatment:

Drug: Methotrexate