Disease-Modifying Antirheumatic Drugs Cycle Combination Therapy Research

Not Applicable

• Conditions: Rheumatoid Arthritis
• Interventions: Drug: methotrexate; Drug: leflunomide

• Registration Number: NCT01617590
• Lead Sponsor: Shanxi Medical University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-05
• Study First Submitted: 2012-05-28
• Status Verified: 2012-06
• Study First Submitted QC: 2012-06-11
• Study First Posted: 2012-06-12
• Last Update Submitted: 2012-06-12
• Last Update Posted: 2012-06-14
• Primary Completion: 2013-12
• Study Completion: 2014-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 500

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
methotrexate	methotrexate	MTX 7.5-15 mg/week
leflunomide	leflunomide	Leflunomide 10-20 mg/d

Primary Outcome Measures

Name	Time	Method
ACR20	48 weeks	Percentage of subjects who meet the response rate of ACR20 at each post-dose visit

Secondary Outcome Measures

Name	Time	Method
ACR50	48 weeks	Percentage of subjects who meet the response rate of ACR 50 at week 48
ACR70	48week	Percentage of subjects who meet the response rate of ACR 70 at week 48
EULAR response：good response	48 week	Percentage of subjects who meet the EULAR response criteria of good response at week 48
EULAR response ：moderate response	48 week	Percentage of subjects who meet the EULAR response criteria of moderate response at week 48

Trial Locations

Locations (1)

rheumatism department,Second hospital of Shanxi medical university; 🇨🇳 TaiYuan, Shanxi, China