Disease-Modifying Antirheumatic Drugs Cycle Combination Therapy Research

Rheumatoid Arthritis Clinical Trial

— DCCT  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01617590
• Other study ID #: DMARD-RA
• Status: Recruiting
• Phase: N/A
• First received: May 28, 2012
• Last updated: June 12, 2012
• Start date: May 2012
• Est. completion date: May 2014

Study information

• Verified date: June 2012
• Source: Shanxi Medical University
• Contact: Li xiao feng
• Phone: 086-0351-3074231
• Email: lixiaofeng_sxey[@]163.com
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: May 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

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.
• 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

Locations

Country	Name	City	State
China	rheumatism department,Second hospital of Shanxi medical university	TaiYuan	Shanxi

Sponsors (1)

Lead Sponsor	Collaborator
Shanxi Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ACR20	Percentage of subjects who meet the response rate of ACR20 at each post-dose visit	48 weeks	No
Secondary	ACR50	Percentage of subjects who meet the response rate of ACR 50 at week 48	48 weeks	No
Secondary	ACR70	Percentage of subjects who meet the response rate of ACR 70 at week 48	48week	No
Secondary	EULAR response:good response	Percentage of subjects who meet the EULAR response criteria of good response at week 48	48 week	No
Secondary	EULAR response :moderate response	Percentage of subjects who meet the EULAR response criteria of moderate response at week 48	48 week	No