BOW015 (Infliximab-EPIRUS) and Infliximab in Patients With Active Rheumatoid Arthritis: The UNIFORM Study
Study Details
Study Description
Brief Summary
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.
Condition or Disease | Intervention/Treatment | Phase |
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Phase 3 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: BOW015 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
monoclonal antibody against TNF-alpha
Other Names:
|
Active Comparator: Remicade 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
monoclonal antibody against TNF-alpha
Other Names:
|
Outcome Measures
Primary Outcome Measures
- American College of Rheumatology (ACR) 20 clinical response [16 weeks]
Secondary Outcome Measures
- 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]
Eligibility Criteria
Criteria
Key Inclusion Criteria:
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Male and female, aged 18 to 80
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Diagnosis of Rheumatoid Arthritis (RA) according to the revised ACR/ EULAR 2010 classification criteria for RA
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Patients must have ACR/EULAR 2010 classification criteria score ≥ 6
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Patients must have active disease
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Patients must have been on treatment with methotrexate
Key Exclusion Criteria:
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Prior use of infliximab, adalimumab, certolizumab, golimumab, tocilizumab, rituximab, or etanercept or any other biological treatment
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Patients with any prior or current use of anakinra and abatacept
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Patients with suspected or confirmed current active tuberculosis (TB)
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Patients with latent tuberculosis must start treatment for latent tuberculosis
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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
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History of completely excised and cured squamous carcinoma of the uterine cervix, cutaneous basal cell carcinoma or cutaneous squamous cell carcinoma
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History of lymphoproliferative disease
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History or presence of any other form of malignancy
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Current signs or symptoms of severe, progressive or uncontrolled renal, hepatic, hematologic, gastrointestinal, endocrine, pulmonary, cardiac, neurologic or cerebral disease
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History of congestive heart failure or unstable angina
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History of any autoimmune disease other than RA
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Major surgery within 12 weeks and planned major surgery
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History of serious infection
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Pre-existing central nervous system demyelinating disorders
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Administration of live or live-attenuated vaccine within 4 weeks of screening
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Clinically significant adverse reaction to murine or chimeric proteins
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History or presence of any medical or psychiatric condition or disease, or clinically significant laboratory abnormality
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Participation in any clinical study of an investigational product within the previous 3 months prior to screening
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Epirus Biopharmaceuticals (Switzerland) GmbH
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- EPI-BOW015-003