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

Rheumatoid Arthritis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01567358
• Other study ID #: NI071C1(ACT12719)
• Status: Completed
• Phase: Phase 1
• First received: March 23, 2012
• Last updated: June 18, 2013
• Start date: February 2012
• Est. completion date: April 2013

Study information

• Verified date: June 2013
• Source: Nichi-Iko Pharmaceutical Co.,Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: April 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 75 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Biological:
• Infliximab
100mg/vial
• Infliximab
100mg/vial

Locations

Country	Name	City	State
Japan	392001001	Sendai	Miyagi

Sponsors (1)

Lead Sponsor	Collaborator
Nichi-Iko Pharmaceutical Co.,Ltd.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety : Incidence of Adverse Events		14 weeks	Yes
Secondary	PK : Area under the serum concentration versus time curve(AUC)		14 weeks	No
Secondary	Efficacy : ACR core-set		14 weeks	No