Study of NI-071 in Comparison With Remicade in Patients With Rheumatoid Arthritis

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01567358
• Date of registration: 23/03/2012
• Prospective Registration: No
• 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
• URL: http://clinicaltrials.gov/show/NCT01567358
• 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

Japan

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
etc.)

- 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

Intervention(s)

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)

NI071C1(ACT12719)

Source(s) of Monetary Support

Please refer to primary and secondary sponsors