Disease-Modifying Antirheumatic Drugs Cycle Combination Therapy Research

NCT ID: NCT01617590

Last Updated: 2012-06-14

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 500 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-05-31
• Study Completion Date: 2014-05-31

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.

Conditions

Rheumatoid Arthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

leflunomide

Leflunomide 10-20 mg/d

Group Type: EXPERIMENTAL

leflunomide

Intervention Type: DRUG

Leflunomide 10-20 mg, orally, once daily for up to 48 weeks. Twelve weeks after the initial Leflunomide induction, patients were randomized into two groups (LEF+CTX:LEF+MTX=2:1) if the DAS 28 were higher than 2.6, or continuing leflunomide use without dosing change. Then, the disease activity was assessed using DAS 28 every 12 weeks. The regimen should remain unchanged if the DAS 28 reached to less than 2.6, otherwise, a third (24 weeks) or fourth (36 weeks) DMARs should be added.

Intravenous CTX was administrated once 200-400mg per 3 weeks.

methotrexate

MTX 7.5-15 mg/week

Group Type: ACTIVE_COMPARATOR

methotrexate

Intervention Type: DRUG

MTX 7.5-15 mg, orally, once weekly for up to 48 weeks. Twelve weeks after the initial MTX induction, patients were randomized into two groups (MTX+CTX:LEF+MTX=2:1) if the DAS 28 were higher than 2.6, or continuing MTX use without dosing change. Then, the disease activity was assessed using DAS 28 every 12 weeks. The regimen should remain unchanged if the DAS 28 reached to less than 2.6, otherwise, a third (24 weeks) or fourth (36 weeks) DMARs should be added.

Intravenous CTX was administrated once

Interventions

leflunomide

Leflunomide 10-20 mg, orally, once daily for up to 48 weeks. Twelve weeks after the initial Leflunomide induction, patients were randomized into two groups (LEF+CTX:LEF+MTX=2:1) if the DAS 28 were higher than 2.6, or continuing leflunomide use without dosing change. Then, the disease activity was assessed using DAS 28 every 12 weeks. The regimen should remain unchanged if the DAS 28 reached to less than 2.6, otherwise, a third (24 weeks) or fourth (36 weeks) DMARs should be added.

Intravenous CTX was administrated once 200-400mg per 3 weeks.

Intervention Type: DRUG

methotrexate

MTX 7.5-15 mg, orally, once weekly for up to 48 weeks. Twelve weeks after the initial MTX induction, patients were randomized into two groups (MTX+CTX:LEF+MTX=2:1) if the DAS 28 were higher than 2.6, or continuing MTX use without dosing change. Then, the disease activity was assessed using DAS 28 every 12 weeks. The regimen should remain unchanged if the DAS 28 reached to less than 2.6, otherwise, a third (24 weeks) or fourth (36 weeks) DMARs should be added.

Intravenous CTX was administrated once

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanxi Medical University

OTHER

Sponsor Role: lead

Responsible Party

Li Xiaofeng

dean

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

li xiao feng

Role: PRINCIPAL_INVESTIGATOR

Second Hospital of Shanxi Medical University

Locations

rheumatism department,Second hospital of Shanxi medical university

Taiyuan, Shanxi, China

Site Status: RECRUITING

Countries

China

Central Contacts

Li xiao feng

Role: CONTACT

lixiaofeng_sxey@163.com

086-0351-3074231

Facility Contacts

li xiao feng

Role: primary

lixiaofeng_sxey@163.com

086-0351-3074231

Other Identifiers

DMARD-RA

Identifier Type: -

Identifier Source: org_study_id