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

Primary Purpose

Rheumatoid Arthritis

Status

Unknown status

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

leflunomide

methotrexate

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring RA, Leflunomide, Methotrexate

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

rheumatism department,Second hospital of Shanxi medical universityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

leflunomide

methotrexate

Arm Description

Leflunomide 10-20 mg/d

MTX 7.5-15 mg/week

Outcomes

Primary Outcome Measures

ACR20

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

Secondary Outcome Measures

ACR50

Percentage of subjects who meet the response rate of ACR 50 at week 48

ACR70

Percentage of subjects who meet the response rate of ACR 70 at week 48

EULAR response：good response

Percentage of subjects who meet the EULAR response criteria of good response at week 48

EULAR response ：moderate response

Percentage of subjects who meet the EULAR response criteria of moderate response at week 48

Full Information

NCT ID

NCT01617590

First Posted

May 28, 2012

Last Updated

June 12, 2012

Sponsor

Shanxi Medical University

1. Study Identification

Unique Protocol Identification Number

NCT01617590

Brief Title

Disease-Modifying Antirheumatic Drugs Cycle Combination Therapy Research

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2012

Overall Recruitment Status

Unknown status

Study Start Date

May 2012 (undefined)

Primary Completion Date

December 2013 (Anticipated)

Study Completion Date

May 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Shanxi Medical University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Rheumatoid Arthritis

Keywords

RA, Leflunomide, Methotrexate

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

leflunomide

Arm Type

Experimental

Arm Description

Leflunomide 10-20 mg/d

Arm Title

methotrexate

Arm Type

Active Comparator

Arm Description

MTX 7.5-15 mg/week

Intervention Type

Drug

Intervention Name(s)

leflunomide

Intervention Description

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

Intervention Name(s)

methotrexate

Intervention Description

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

Primary Outcome Measure Information:

Title

ACR20

Description

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

Time Frame

48 weeks

Secondary Outcome Measure Information:

Title

ACR50

Description

Percentage of subjects who meet the response rate of ACR 50 at week 48

Time Frame

48 weeks

Title

ACR70

Description

Percentage of subjects who meet the response rate of ACR 70 at week 48

Time Frame

48week

Title

EULAR response：good response

Description

Percentage of subjects who meet the EULAR response criteria of good response at week 48

Time Frame

48 week

Title

EULAR response ：moderate response

Description

Percentage of subjects who meet the EULAR response criteria of moderate response at week 48

Time Frame

48 week

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Li xiao feng

Phone

086-0351-3074231

lixiaofeng_sxey@163.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

li xiao feng

Organizational Affiliation

Second Hospital of Shanxi Medical University

Official's Role

Principal Investigator

Facility Information:

Facility Name

rheumatism department,Second hospital of Shanxi medical university

City

TaiYuan

State/Province

Shanxi

ZIP/Postal Code

030001

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

li xiao feng

Phone

086-0351-3074231

lixiaofeng_sxey@163.com

12. IPD Sharing Statement

Learn more about this trial

Disease-Modifying Antirheumatic Drugs Cycle Combination Therapy Research

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