Disease-Modifying Antirheumatic Drugs Cycle Combination Therapy Research

NCT01617590 | Unknown DMC

• 1 other identifier: DMARD-RA
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

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

Keywords

RA; Leflunomide; Methotrexate

Outcome Measures

Primary Outcomes (1)

• ACR20

  Percentage of subjects who meet the response rate of ACR20 at each post-dose visit

  48 weeks

Secondary Outcomes (4)

• ACR50

  48 weeks

• ACR70

  48week

• EULAR response：good response

  48 week

• EULAR response ：moderate response

  48 week

Study Arms (2)

leflunomide

EXPERIMENTAL

Leflunomide 10-20 mg/d

Drug: leflunomide

methotrexate

ACTIVE COMPARATOR

MTX 7.5-15 mg/week

Drug: methotrexate

Interventions

leflunomide 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.

leflunomide

methotrexate 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

methotrexate

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanxi Medical University: lead

Study Sites (1)

rheumatism department,Second hospital of Shanxi medical university

Taiyuan, Shanxi, 030001, China

RECRUITING

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Leflunomide; Methotrexate

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Isoxazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• li xiao feng

  Second Hospital of Shanxi Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Li xiao feng

CONTACT

086-0351-3074231; lixiaofeng_sxey@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: dean

Study Record Dates

• First Submitted: May 28, 2012
• First Posted: June 12, 2012
• Study Start: May 1, 2012
• Primary Completion: December 1, 2013
• Study Completion: May 1, 2014
• Last Updated: June 14, 2012

Record last verified: 2012-06

Locations

CN (1)