NCT01567358CompletedPhase 1
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
Nichi-Iko Pharmaceutical Co., Ltd.1 site in 1 country14 target enrollmentStarted: February 1, 2012Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Enrollment
- 14
- Locations
- 1
- Primary Endpoint
- Safety : Incidence of Adverse Events
Study Overview
Brief Summary
The purpose of this study is to compare the safety of NI-071 with Remicade® (infliximab) in patients with Rheumatoid Arthritis inadequately treated with Methotrexate.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 20 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
- •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
- •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
- •Patients with active or latent tuberculosis or history of tuberculosis
Arms & Interventions
Remicade
Active Comparator
Intervention: Infliximab (Biological)
NI-071
Experimental
Intervention: Infliximab (Biological)
Outcomes
Primary Outcomes
Safety : Incidence of Adverse Events
Time Frame: 14 weeks
Secondary Outcomes
- PK : Area under the serum concentration versus time curve(AUC)(14 weeks)
- Efficacy : ACR core-set(14 weeks)
Investigators
Study Sites (1)
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