Study of NI-071 in Comparison With Remicade in Patients With Rheumatoid Arthritis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Nichi-Iko Pharmaceutical Co.,Ltd.
ClinicalTrials.gov Identifier:
NCT01567358
First received: March 23, 2012
Last updated: June 18, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention Phase
Rheumatoid Arthritis
Biological: Infliximab
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Nichi-Iko Pharmaceutical Co.,Ltd.:

Primary Outcome Measures:
  • Safety : Incidence of Adverse Events [ Time Frame: 14 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • PK : Area under the serum concentration versus time curve(AUC) [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]
  • Efficacy : ACR core-set [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]

Enrollment: 14
Study Start Date: February 2012
Study Completion Date: April 2013
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: NI-071 Biological: Infliximab
100mg/vial
Active Comparator: Remicade Biological: Infliximab
100mg/vial

  Eligibility

Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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
  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:

  1. 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
  2. Patients with active or latent tuberculosis or history of tuberculosis
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01567358

Locations
Japan
392001001
Sendai, Miyagi, Japan, 982-0032
Sponsors and Collaborators
Nichi-Iko Pharmaceutical Co.,Ltd.
  More Information

No publications provided

Responsible Party: Nichi-Iko Pharmaceutical Co.,Ltd.
ClinicalTrials.gov Identifier: NCT01567358     History of Changes
Other Study ID Numbers: NI071C1(ACT12719)
Study First Received: March 23, 2012
Last Updated: June 18, 2013
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Infliximab
Dermatologic Agents
Therapeutic Uses
Pharmacologic Actions
Gastrointestinal Agents
Antirheumatic Agents
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on April 23, 2014