Back to resultsBOW015 (Infliximab-EPIRUS) and Infliximab in Patients With Active Rheumatoid Arthritis: The UNIFORM Study
Primary Purpose
Rheumatoid Arthritis
Status
Unknown status
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
BOW015
Remicade
Sponsored by
About this trial
This is an interventional treatment trial for Rheumatoid Arthritis
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
BOW015
Remicade
Arm Description
Infliximab-EPIRUS, 3mg/kg body weight as intra venous infusion at weeks 0, 2, 6 then every 8 weeks thereafter up to Week 46.
Remicade (infliximab) , 3mg/kg body weight as intra venous infusion at weeks 0, 2, 6 then every 8 weeks thereafter up to Week 46.
Outcomes
Primary Outcome Measures
American College of Rheumatology (ACR) 20 clinical response
Secondary Outcome Measures
ACR20
Diseases Activity Score (DAS)28 calculated with C-reactive protein (CRP)
Health Assessment Questionnaire-Disability Index (HAQ-DI)
Full Information
NCT ID
NCT02683564
First Posted
February 9, 2016
Last Updated
February 11, 2016
Sponsor
Epirus Biopharmaceuticals (Switzerland) GmbH
1. Study Identification
Unique Protocol Identification Number
NCT02683564
Brief Title
BOW015 (Infliximab-EPIRUS) and Infliximab in Patients With Active Rheumatoid Arthritis: The UNIFORM Study
Official Title
A Study of BOW015 (Infliximab-EPIRUS) and Infliximab in Patients With Active Rheumatoid Arthritis on Stable Methotrexate: The UNIFORM Study
Study Type
Interventional
2. Study Status
Record Verification Date
February 2016
Overall Recruitment Status
Unknown status
Study Start Date
February 2016 (undefined)
Primary Completion Date
July 2017 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Epirus Biopharmaceuticals (Switzerland) GmbH
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
548 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
BOW015
Arm Type
Experimental
Arm Description
Infliximab-EPIRUS, 3mg/kg body weight as intra venous infusion at weeks 0, 2, 6 then every 8 weeks thereafter up to Week 46.
Arm Title
Remicade
Arm Type
Active Comparator
Arm Description
Remicade (infliximab) , 3mg/kg body weight as intra venous infusion at weeks 0, 2, 6 then every 8 weeks thereafter up to Week 46.
Intervention Type
Drug
Intervention Name(s)
BOW015
Other Intervention Name(s)
infliximab-EPIRUS
Intervention Description
monoclonal antibody against TNF-alpha
Intervention Type
Drug
Intervention Name(s)
Remicade
Other Intervention Name(s)
infliximab
Intervention Description
monoclonal antibody against TNF-alpha
Primary Outcome Measure Information:
Title
American College of Rheumatology (ACR) 20 clinical response
Time Frame
16 weeks
Secondary Outcome Measure Information:
Title
ACR20
Time Frame
54 weeks
Title
Diseases Activity Score (DAS)28 calculated with C-reactive protein (CRP)
Time Frame
54 weeks
Title
Health Assessment Questionnaire-Disability Index (HAQ-DI)
Time Frame
54 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
EPIRUS Clinical Development
Email
info@epirusbiopharma.com
12. IPD Sharing Statement
Learn more about this trial
BOW015 (Infliximab-EPIRUS) and Infliximab in Patients With Active Rheumatoid Arthritis: The UNIFORM Study
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