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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: 19 February 2015
Main ID:  NCT01567358
Date of registration: 23/03/2012
Prospective Registration: Yes
Primary sponsor: Nichi-Iko Pharmaceutical Co.,Ltd.
Public title: Study of NI-071 in Comparison With Remicade in Patients With Rheumatoid Arthritis
Scientific title: A Randomized, Double-Blind, Repeated Dose, Active Control Drug, Parallel-group and Single-center Phase I Study of the Safety of Intravenous Administration of NI-071 in Comparison With Remicade® in Japanese Patients With Rheumatoid Arthritis Inadequately Treated With Methotrexate
Date of first enrolment: February 2012
Target sample size: 14
Recruitment status: Completed
Study type:  Interventional
Study design:  Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment  
Phase:  Phase 1
Countries of recruitment
Key inclusion & exclusion criteria

Inclusion Criteria:

1. Diagnosis of Rheumatoid Arthritis (RA) as defined by the 1987 revised American
College of Rheumatology (ACR) criteria with ACR Functional Classification class I-III
and disease duration of no less than 3 months

2. Patients must receive a minimum of 3 months treatment with methotrexate (MTX) (= 6
mg/week) prior to the Screening Visit. Patients must be on a stable dose of MTX (6
mg~16 mg mg/week) for a minimum of 4 weeks prior to the Screening Visit

Exclusion Criteria:

1. History of following diseases

- Other Connective tissue disorders with joint symptom which may interfere the
efficacy assessment

- Chlonic or recurrent infectious disease(bronchial ectasia, sinus inflammation

- Severe infectious disease(hepatitis, pneumonia?sepsis)

- History of demyelinating disease or multiple sclerosis

- Congestive heart failure

- lymphoproliferative disorder or myelodysplastic syndrome

- History of 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
Primary Outcome(s)
Safety : Incidence of Adverse Events [Time Frame: 14 weeks]
Secondary Outcome(s)
Efficacy : ACR core-set [Time Frame: 14 weeks]
PK : Area under the serum concentration versus time curve(AUC) [Time Frame: 14 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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