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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
500
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.
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
rheumatism department,Second hospital of Shanxi medical university
Taiyuan, Shanxi, China
RECRUITINGACR20
Percentage of subjects who meet the response rate of ACR20 at each post-dose visit
Time frame: 48 weeks
ACR50
Percentage of subjects who meet the response rate of ACR 50 at week 48
Time frame: 48 weeks
ACR70
Percentage of subjects who meet the response rate of ACR 70 at week 48
Time frame: 48week
EULAR response:good response
Percentage of subjects who meet the EULAR response criteria of good response at week 48
Time frame: 48 week
EULAR response :moderate response
Percentage of subjects who meet the EULAR response criteria of moderate response at week 48
Time frame: 48 week
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