Trial | NCT01567358  Report issue

Title

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

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    infliximab ...

  • Study Participants

    14
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 Started
Feb 29
2012
Primary Completion
Dec 31
2012
Study Completion
Apr 30
2013
Last Update
Jun 19
2013
Estimate

Biological Infliximab

100mg/vial

Biological Infliximab

100mg/vial

NI-071 Experimental

Remicade Active Comparator

Criteria 

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
No Results Posted