Rheumatoid Arthritis
Conditions
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.
Interventions
DRUGBOW015
monoclonal antibody against TNF-alpha
DRUGRemicade
monoclonal antibody against TNF-alpha
Sponsors
Epirus Biopharmaceuticals (Switzerland) GmbH
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: 1. Male and female, aged 18 to 80 2. Diagnosis of Rheumatoid Arthritis (RA) according to the revised ACR/ EULAR 2010 classification criteria for RA 3. Patients must have ACR/EULAR 2010 classification criteria score ≥ 6 4. Patients must have active disease 5. Patients must have been on treatment with methotrexate Key
Exclusion criteria
1. Prior use of infliximab, adalimumab, certolizumab, golimumab, tocilizumab, rituximab, or etanercept or any other biological treatment 2. Patients with any prior or current use of anakinra and abatacept 3. Patients with suspected or confirmed current active tuberculosis (TB) 4. Patients with latent tuberculosis must start treatment for latent tuberculosis 5. 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 6. History of completely excised and cured squamous carcinoma of the uterine cervix, cutaneous basal cell carcinoma or cutaneous squamous cell carcinoma 7. History of lymphoproliferative disease 8. History or presence of any other form of malignancy 9. Current signs or symptoms of severe, progressive or uncontrolled renal, hepatic, hematologic, gastrointestinal, endocrine, pulmonary, cardiac, neurologic or cerebral disease 10. History of congestive heart failure or unstable angina 11. History of any autoimmune disease other than RA 12. Major surgery within 12 weeks and planned major surgery 13. History of serious infection 14. Pre-existing central nervous system demyelinating disorders 15. Administration of live or live-attenuated vaccine within 4 weeks of screening 16. Clinically significant adverse reaction to murine or chimeric proteins 17. History or presence of any medical or psychiatric condition or disease, or clinically significant laboratory abnormality 18. Participation in any clinical study of an investigational product within the previous 3 months prior to screening
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| American College of Rheumatology (ACR) 20 clinical response | 16 weeks |
Secondary
| Measure | 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 |
Contacts
Primary ContactEPIRUS Clinical Development
Outcome results
None listed