A Phase 3 Study of NI-071 in Patients With Rheumatoid Arthritis
NCT ID: NCT01927263
Last Updated: 2016-04-08
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
PHASE3
242 participants
INTERVENTIONAL
2013-07-31
2016-03-31
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
NI-071
100mg/vial
Infliximab
Infliximab
100mg/vial
Interventions
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NI-071
100mg/vial
Infliximab
100mg/vial
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Patients who received MTX treatment (6- 16mg/week) for 2 weeks for at least 12 weeks prior to the screening visit
Exclusion Criteria
* Other Connective tissue disorders which may interfere the efficacy assessment
* Chronic or recurrent infectious disease
* Demyelinating disease
* Congestive heart failure
* lymphoproliferative disorder or myelodysplastic syndrome
* 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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NichiIko Investigational Site
Sendai, , Japan
Countries
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Other Identifiers
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NI071F1(EFC13464)
Identifier Type: -
Identifier Source: org_study_id
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