Study of NI-071 in Comparison With Remicade in Patients With Rheumatoid Arthritis
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
1 other identifier
interventional
14
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1 rheumatoid-arthritis
Started Feb 2012
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2012
CompletedFirst Submitted
Initial submission to the registry
March 23, 2012
CompletedFirst Posted
Study publicly available on registry
March 30, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2013
CompletedJune 19, 2013
June 1, 2013
10 months
March 23, 2012
June 18, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
Safety : Incidence of Adverse Events
14 weeks
Secondary Outcomes (2)
PK : Area under the serum concentration versus time curve(AUC)
14 weeks
Efficacy : ACR core-set
14 weeks
Study Arms (2)
NI-071
EXPERIMENTALRemicade
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
392001001
Sendai, Miyagi, 982-0032, Japan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 23, 2012
First Posted
March 30, 2012
Study Start
February 1, 2012
Primary Completion
December 1, 2012
Study Completion
April 1, 2013
Last Updated
June 19, 2013
Record last verified: 2013-06