We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01567358
First Posted: March 30, 2012
Last Update Posted: June 19, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Nichi-Iko Pharmaceutical Co., Ltd.
  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
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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 ]

Secondary Outcome Measures:
  • PK : Area under the serum concentration versus time curve(AUC) [ Time Frame: 14 weeks ]
  • Efficacy : ACR core-set [ Time Frame: 14 weeks ]

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   20 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01567358


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

Responsible Party: Nichi-Iko Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT01567358     History of Changes
Other Study ID Numbers: NI071C1(ACT12719)
First Submitted: March 23, 2012
First Posted: March 30, 2012
Last Update Posted: June 19, 2013
Last Verified: June 2013

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Infliximab
Dermatologic Agents
Gastrointestinal Agents
Antirheumatic Agents