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

Phase 1

Completed

• Conditions: Rheumatoid Arthritis
• Interventions: Biological: Infliximab

• Registration Number: NCT01567358
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-02
• Study First Submitted: 2012-03-23
• Study First Submitted QC: 2012-03-28
• Study First Posted: 2012-03-30
• Primary Completion: 2012-12
• Study Completion: 2013-04
• Status Verified: 2013-06
• Last Update Submitted: 2013-06-18
• Last Update Posted: 2013-06-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NI-071	Infliximab	-
Remicade	Infliximab	-

Primary Outcome Measures

Name	Time	Method
Safety : Incidence of Adverse Events	14 weeks

Secondary Outcome Measures

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

Trial Locations

Locations (1)

392001001; 🇯🇵 Sendai, Miyagi, Japan