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

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

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.

Study Overview

• Status: Completed
• Conditions: Rheumatoid Arthritis
• Intervention / Treatment: Biological: Infliximab

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Phase 1

Contacts and Locations

Study Locations

• Japan
  • Miyagi
    • Sendai, Miyagi, Japan, 982-0032
      • 392001001

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: NI-071	Biological: Infliximab; 100mg/vial
Active Comparator: Remicade	Biological: Infliximab; 100mg/vial

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Safety : Incidence of Adverse Events	14 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
PK : Area under the serum concentration versus time curve(AUC)	14 weeks
Efficacy : ACR core-set	14 weeks

Collaborators and Investigators

• Sponsor: Nichi-Iko Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start: February 1, 2012
• Primary Completion (Actual): December 1, 2012
• Study Completion (Actual): April 1, 2013

Study Registration Dates

• First Submitted: March 23, 2012
• First Submitted That Met QC Criteria: March 28, 2012
• First Posted (Estimate): March 30, 2012

Study Record Updates

• Last Update Posted (Estimate): June 19, 2013
• Last Update Submitted That Met QC Criteria: June 18, 2013
• Last Verified: June 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Arthritis, Rheumatoid; Antirheumatic Agents; Gastrointestinal Agents; Dermatologic Agents; Infliximab
• Other Study ID Numbers: NI071C1(ACT12719)