Rheumatoid Arthritis
Conditions
Brief summary
The purpose of this study is to investigate similarity between NI-071 and infliximab(the comparator) in terms of efficacy in patients with Rheumatoid Arthritis not adequately responding to Methotrexate.
Interventions
BIOLOGICALNI-071
100mg/vial
BIOLOGICALInfliximab
100mg/vial
Sponsors
Nichi-Iko Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Patients with a diagnosis of RA as defined by the American College Rheumatology (ACR) and European League Against Rheumatism (EULAR) criteria (ACR/EULAR 2010) 2. Patients who received MTX treatment (6- 16mg/week) for 2 weeks for at least 12 weeks prior to the screening visit
Exclusion criteria
1. Patients with a following past History or concomitant diseases * Other Connective tissue disorders which may interfere the efficacy assessment * Chronic or recurrent infectious disease * Demyelinating disease * Congestive heart failure * lymphoproliferative disorder or myelodysplastic syndrome * Malignancy * Interstitial lung disease 2. Patients with active or latent tuberculosis or history of tuberculosis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy : Changes in DAS28-ESR | week 0 to week 14 |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy : Changes in DAS28 | week 0 to week 54 |
| Efficacy : Changes in ACR20, 50, 70 | week 0 to week 54 |
| Efficacy : Changes in ACR core-set | week 0 to week 54 |
| Safety : Long term safety (Adverse Events, Immunogenicity, etc.) | to 54 weeks |
Countries
Japan
Outcome results
None listed