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

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Epirus Biopharmaceuticals (Switzerland) GmbH
• Treatments: Infliximab

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