A Phase 3 Study of NI-071 in Patients With Rheumatoid Arthritis
Phase 3
Completed
- Conditions
- Rheumatoid Arthritis
- Interventions
- Biological: NI-071Biological: Infliximab
- Registration Number
- NCT01927263
- Lead Sponsor
- Nichi-Iko Pharmaceutical Co., Ltd.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 242
Inclusion Criteria
- Patients with a diagnosis of RA as defined by the American College Rheumatology (ACR) and European League Against Rheumatism (EULAR) criteria (ACR/EULAR 2010)
- Patients who received MTX treatment (6- 16mg/week) for 2 weeks for at least 12 weeks prior to the screening visit
Exclusion Criteria
-
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
-
Patients with active or latent tuberculosis or history of tuberculosis
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description NI-071 NI-071 - Infliximab Infliximab -
- Primary Outcome Measures
Name Time Method Efficacy : Changes in DAS28-ESR week 0 to week 14
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
NichiIko Investigational Site
🇯🇵Sendai-Shi, Japan