Disease-Modifying Antirheumatic Drugs Cycle Combination Therapy Research

• Status: Unknown status
• Trial end date: 2014-05-01
• Target enrollment: 0
• Participant gender: All

Summary

This study was intended to assess the efficacy and safety of different Disease-Modifying Antirheumatic Drugs cycle combination regimen using the American College of Rheumatology (ACR) criteria of 20% improvement in symptoms (ACR20) in managing active adult rheumatoid arthritis.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shanxi Medical University
• Treatments: Antirheumatic Agents; Leflunomide; Methotrexate

Criteria

Inclusion Criteria:

RA patients：

• Male and female patients aged 18 - 75 years (inclusive).

• Body weight between 50 and 100 kg (inclusive).

• Post menopausal or surgically sterile female patients are allowed. Female patients of child-bearing potential may participate if they are already on a stable dose of methotrexate. Additional birth control details to be provided at screening. Male patients must use an effective contraception method during the study and at least for 2 months following the completion/discontinuation of the study.

• Diagnosis of RA, classified by American Rheumatism Association 1987 revised criteria.

• Active disease evaluation (DAS 28 > 3.2).

• Patients who using steroids before enrollment, the dose should not be more than 30mg/d, and remain unchanged for more than 30days.

• Without use of other disease activity controlling drugs.

• Get the informed consent.

Exclusion Criteria:

• Advanced patients with severe joints disability.

• Pregnant or breast- feeding female patients.

• Patients with severe primary disease or impairment of heart, brain, lung, liver (ALT or AST > 1.5 normal value), kidney (sCr > normal value), endocrine, and hematology system.

• Concomitant with other rheumatic disease.

• Alcohol taken or drug abusing patients.

• Patients with congestive heart failure, QT prolongation syndrome or poorly controlled diabetes mellitus. Patients with a history of QTc prolongation will be excluded.

• Patients who have received intra-articular or systemic corticosteroid injections having been required for treatment of acute RA flare (not being part of a regular therapeutic regimen) within 4 weeks prior to randomization.