Disease-Modifying Antirheumatic Drugs Cycle Combination Therapy Research - Full Text View

Purpose

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.

Condition	Intervention
Rheumatoid Arthritis	Drug: leflunomide Drug: methotrexate

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A 48-week, Multi-center, Randomized, Open-lable, Controlled Study to Assess the Response (ACR20) Using Different Disease-Modifying Antirheumatic Drugs Cycle Combination Regimen in Adult Patients With Active Rheumatoid Arthritis

Resource links provided by NLM:

MedlinePlus related topics: Rheumatoid Arthritis

Drug Information available for: Methotrexate Methotrexate sodium Leflunomide

U.S. FDA Resources

Further study details as provided by Shanxi Medical University:

Primary Outcome Measures:

ACR20 [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
Percentage of subjects who meet the response rate of ACR20 at each post-dose visit

Secondary Outcome Measures:

ACR50 [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
Percentage of subjects who meet the response rate of ACR 50 at week 48
ACR70 [ Time Frame: 48week ] [ Designated as safety issue: No ]
Percentage of subjects who meet the response rate of ACR 70 at week 48
EULAR response：good response [ Time Frame: 48 week ] [ Designated as safety issue: No ]
Percentage of subjects who meet the EULAR response criteria of good response at week 48
EULAR response ：moderate response [ Time Frame: 48 week ] [ Designated as safety issue: No ]
Percentage of subjects who meet the EULAR response criteria of moderate response at week 48

Estimated Enrollment:	500
Study Start Date:	May 2012
Estimated Study Completion Date:	May 2014
Estimated Primary Completion Date:	December 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: leflunomide Leflunomide 10-20 mg/d	Drug: 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.
Active Comparator: methotrexate MTX 7.5-15 mg/week	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

Arms

Assigned Interventions

Experimental: leflunomide

Leflunomide 10-20 mg/d

Drug: 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.

Active Comparator: methotrexate

MTX 7.5-15 mg/week

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

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01617590

Contacts

Contact: Li xiao feng

086-0351-3074231

lixiaofeng_sxey@163.com

Locations

China, Shanxi
rheumatism department,Second hospital of Shanxi medical university	Recruiting
TaiYuan, Shanxi, China, 030001
Contact: li xiao feng 086-0351-3074231 lixiaofeng_sxey@163.com

Sponsors and Collaborators

Shanxi Medical University

Investigators

Principal Investigator:

li xiao feng

Second hospital of Shanxi medical university

More Information

No publications provided

Responsible Party:	Li Xiaofeng, dean, Shanxi Medical University
ClinicalTrials.gov Identifier:	NCT01617590 History of Changes
Other Study ID Numbers:	DMARD-RA
Study First Received:	May 28, 2012
Last Updated:	June 12, 2012
Health Authority:	China: Ethics Committee

Keywords provided by Shanxi Medical University:

RA
Leflunomide
Methotrexate

Additional relevant MeSH terms:

Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Leflunomide
Antirheumatic Agents
Methotrexate
Therapeutic Uses
Pharmacologic Actions
Abortifacient Agents, Nonsteroidal

Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on May 19, 2013

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