Rheumatoid Arthritis Clinical Trial
Official title:
A Phase 3 Clinical Study of NI-071 in Patients With Rheumatoid Arthritis ―A Double-blind, Active Drug-controlled Study and Long-term Study―
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.
Status | Completed |
Enrollment | 242 |
Est. completion date | March 2016 |
Est. primary completion date | March 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 20 Years to 75 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Japan | NichiIko Investigational Site | Sendai-Shi |
Lead Sponsor | Collaborator |
---|---|
Nichi-Iko Pharmaceutical Co.,Ltd. |
Japan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Efficacy : Changes in DAS28-ESR | week 0 to week 14 | No | |
Secondary | Efficacy : Changes in DAS28 | week 0 to week 54 | No | |
Secondary | Efficacy : Changes in ACR20, 50, 70 | week 0 to week 54 | No | |
Secondary | Efficacy : Changes in ACR core-set | week 0 to week 54 | No | |
Secondary | Safety : Long term safety (Adverse Events, Immunogenicity, etc.) | to 54 weeks | Yes |
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