BOW015 (Infliximab-EPIRUS) and Infliximab in Patients With Active Rheumatoid Arthritis: The UNIFORM Study

Study Overview
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Brief Summary
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This is a prospective, randomized, double-blind, parallel group, multicentre global phase 3 clinical study to evaluate the efficacy, safety and immunogenicity of BOW015 (infliximab-EPIRUS) compared to Remicade in subjects with active Rheumatoid Arthritis (RA) despite Methotrexate (MTX) therapy.

Official Title
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A Study of BOW015 (Infliximab-EPIRUS) and Infliximab in Patients With Active Rheumatoid Arthritis on Stable Methotrexate: The UNIFORM Study

Conditions
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Rheumatoid Arthritis

Intervention / Treatment
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* Drug: BOW015
* Drug: Remicade


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: Male and female, aged 18 to 80 Diagnosis of Rheumatoid Arthritis (RA) according to the revised ACR/ EULAR 2010 classification criteria for RA Patients must have ACR/EULAR 2010 classification criteria score ≥ 6 Patients must have active disease Patients must have been on treatment with methotrexate Key Exclusion Criteria: Prior use of infliximab, adalimumab, certolizumab, golimumab, tocilizumab, rituximab, or etanercept or any other biological treatment Patients with any prior or current use of anakinra and abatacept Patients with suspected or confirmed current active tuberculosis (TB) Patients with latent tuberculosis must start treatment for latent tuberculosis Patients who have a current or past history of chronic infection with Hepatitis B, Hepatitis C, or infection with Human Immunodeficiency Virus-1 or-2 History of completely excised and cured squamous carcinoma of the uterine cervix, cutaneous basal cell carcinoma or cutaneous squamous cell carcinoma History of lymphoproliferative disease History or presence of any other form of malignancy Current signs or symptoms of severe, progressive or uncontrolled renal, hepatic, hematologic, gastrointestinal, endocrine, pulmonary, cardiac, neurologic or cerebral disease History of congestive heart failure or unstable angina History of any autoimmune disease other than RA Major surgery within 12 weeks and planned major surgery History of serious infection Pre-existing central nervous system demyelinating disorders Administration of live or live-attenuated vaccine within 4 weeks of screening Clinically significant adverse reaction to murine or chimeric proteins History or presence of any medical or psychiatric condition or disease, or clinically significant laboratory abnormality Participation in any clinical study of an investigational product within the previous 3 months prior to screening

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BOW015<br>Infliximab-EPIRUS, 3mg/kg body weight as intra venous infusion at weeks 0, 2, 6 then every 8 weeks thereafter up to Week 46. | Drug: BOW015<br>* monoclonal antibody against TNF-alpha<br>* Other names: infliximab-EPIRUS;|
| Active Comparator: Remicade<br>Remicade (infliximab) , 3mg/kg body weight as intra venous infusion at weeks 0, 2, 6 then every 8 weeks thereafter up to Week 46. | Drug: Remicade<br>* monoclonal antibody against TNF-alpha<br>* Other names: infliximab;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| American College of Rheumatology (ACR) 20 clinical response |  | 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ACR20 |  | 54 weeks | 
| Diseases Activity Score (DAS)28 calculated with C-reactive protein (CRP) |  | 54 weeks | 
| Health Assessment Questionnaire-Disability Index (HAQ-DI) |  | 54 weeks |