Study of NI-071 in Comparison With Remicade in Patients With Rheumatoid Arthritis
NCT ID: NCT01567358
Last Updated: 2013-06-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
14 participants
INTERVENTIONAL
2012-02-29
2013-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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NI-071
Infliximab
100mg/vial
Remicade
Infliximab
100mg/vial
Interventions
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Infliximab
100mg/vial
Infliximab
100mg/vial
Eligibility Criteria
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Inclusion Criteria
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
* 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
20 Years
75 Years
ALL
No
Sponsors
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Nichi-Iko Pharmaceutical Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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392001001
Sendai, Miyagi, Japan
Countries
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Other Identifiers
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NI071C1(ACT12719)
Identifier Type: -
Identifier Source: org_study_id
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