This is the trial to see how our product is similar to remicade by comparing the results of blood samples when co-administered with methotrexate between 12.5 to 25 mg/week, oral or parenteral dose and folic acid in rheumatoid arthritis patients who are not receiving adequate response to methotrexate alone up to week 30.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
617
Infliximab 3mg/kg is going to be administered for both arm as a 2-hour infusion per dose.
Hanyang University Medical Center
Seoul, South Korea
PK equivalence to remicade
Time frame: PK sampling at week 30
efficacy endpoint
-ACR criteria comparison with Baseline at Weeks 14,30,54
Time frame: up to week 54.
efficacy endpoint
\- Time to onset of ACR20 response
Time frame: Up to week 54.
efficacy endpoint
\- Mean decrease in disease activity measured by DAS28 comparison with Baseline at week 30
Time frame: Up to week 54.
efficacy endpoint
\- Proportion of patients with a good response, defined according to the EULAR response criteria
Time frame: Up to week 54.
efficacy endpoint
\- ACR20 at weeks 14 and 54
Time frame: Up to week 54.
efficacy endpoint
\- ACR50 and ACR70 at weeks 14, 30, and 54
Time frame: Up to week 54.
efficacy endpoint
\- Hybrid ACR response at weeks 14, 30, and 54
Time frame: Up to week 54.
efficacy endpoint
\- SDAI and CDAI at weeks 14, 30, and 54
Time frame: Up to week 54.
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efficacy endpoint
\- Joint damage progression at week 54
Time frame: Up to week 54.
efficacy endpoint
\- SF-36 at weeks 14, 30, and 54
Time frame: Up to week 54.
efficacy endpoint
\- Fatigue
Time frame: Up to week 54.
efficacy endpoint
\- Number of patients requiring salvage retreatment at weeks 30 and 54
Time frame: Up to week 54.