Rheumatoid Arthritis
Conditions
Keywords
RA, Leflunomide, Methotrexate
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.
Interventions
DRUGleflunomide
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.
DRUGmethotrexate
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
Sponsors
Shanxi Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ACR20 | 48 weeks | Percentage of subjects who meet the response rate of ACR20 at each post-dose visit |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ACR50 | 48 weeks | Percentage of subjects who meet the response rate of ACR 50 at week 48 |
| ACR70 | 48week | Percentage of subjects who meet the response rate of ACR 70 at week 48 |
| EULAR response：good response | 48 week | Percentage of subjects who meet the EULAR response criteria of good response at week 48 |
| EULAR response ：moderate response | 48 week | Percentage of subjects who meet the EULAR response criteria of moderate response at week 48 |
Countries
China
Contacts
Primary ContactLi xiao feng
Outcome results
None listed