Disease-Modifying Antirheumatic Drugs Cycle Combination Therapy Research (DCCT)
The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2012 by Shanxi Medical University.
Recruitment status was: Recruiting
Information provided by (Responsible Party):
Li Xiaofeng, Shanxi Medical University
First received: May 28, 2012
Last updated: June 12, 2012
Last verified: June 2012
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.
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
||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
Primary Outcome Measures:
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:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||December 2013 (Final data collection date for primary outcome measure)
Leflunomide 10-20 mg/d
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
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
|Ages Eligible for Study:
||18 Years to 75 Years (Adult, Senior)
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- 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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01617590
|rheumatism department,Second hospital of Shanxi medical university
|TaiYuan, Shanxi, China, 030001 |
Shanxi Medical University
||li xiao feng
||Second Hospital of Shanxi Medical University
||Li Xiaofeng, dean, Shanxi Medical University
History of Changes
|Other Study ID Numbers:
|Study First Received:
||May 28, 2012
||June 12, 2012
||China: Ethics Committee
Keywords provided by Shanxi Medical University:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on January 17, 2017
Connective Tissue Diseases
Immune System Diseases
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Physiological Effects of Drugs
Molecular Mechanisms of Pharmacological Action
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