Disease-Modifying Antirheumatic Drugs Cycle Combination Therapy Research (DCCT)

Shanxi Medical University

Status: Unknown

Conditions: Rheumatoid Arthritis

Treatments: Drug: methotrexate; Drug: leflunomide

Study type: Interventional

Funder types: Other

Identifiers

NCT01617590

DMARD-RA

Details and patient eligibility

About

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.

Enrollment: 500 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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500 participants in 2 patient groups

leflunomide

Experimental group

Description:

Leflunomide 10-20 mg/d

Treatment:

Drug: leflunomide

methotrexate

Active Comparator group

Description:

MTX 7.5-15 mg/week

Treatment:

Drug: methotrexate