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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Last refreshed on: 18 April 2016
Main ID:  NCT01927263
Date of registration: 09/08/2013
Prospective Registration: Yes
Primary sponsor: Nichi-Iko Pharmaceutical Co.,Ltd.
Public title: A Phase 3 Study of NI-071 in Patients With Rheumatoid Arthritis
Scientific 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?
Date of first enrolment: July 2013
Target sample size: 242
Recruitment status: Completed
Study type:  Interventional
Study design:  Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment  
Phase:  Phase 3
Countries of recruitment
Key inclusion & exclusion criteria

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

Age minimum: 20 Years
Age maximum: 75 Years
Gender: Both
Health Condition(s) or Problem(s) studied
Rheumatoid Arthritis
Biological: Infliximab
Biological: NI-071
Primary Outcome(s)
Efficacy : Changes in DAS28-ESR [Time Frame: week 0 to week 14]
Secondary Outcome(s)
Efficacy : Changes in ACR core-set [Time Frame: week 0 to week 54]
Efficacy : Changes in ACR20, 50, 70 [Time Frame: week 0 to week 54]
Efficacy : Changes in DAS28 [Time Frame: week 0 to week 54]
Safety : Long term safety (Adverse Events, Immunogenicity, etc.) [Time Frame: to 54 weeks]
Secondary ID(s)
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results available:
Date Posted:
Date Completed:
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