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

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. Identifier: NCT01567358
Recruitment Status : Completed
First Posted : March 30, 2012
Last Update Posted : June 19, 2013
Information provided by (Responsible Party):
Nichi-Iko Pharmaceutical Co., Ltd.

Brief Summary:
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 or disease Intervention/treatment Phase
Rheumatoid Arthritis Biological: Infliximab Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
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
Study Start Date : February 2012
Actual Primary Completion Date : December 2012
Actual Study Completion Date : April 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Infliximab
U.S. FDA Resources

Arm Intervention/treatment
Experimental: NI-071 Biological: Infliximab
Active Comparator: Remicade Biological: Infliximab

Primary Outcome Measures :
  1. Safety : Incidence of Adverse Events [ Time Frame: 14 weeks ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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 identifier (NCT number): NCT01567358

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

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

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