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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 24, 2014