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

Rheumatoid Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02683564
• Other study ID #: EPI-BOW015-003
• Status: Not yet recruiting
• Phase: Phase 3
• First received: February 9, 2016
• Last updated: February 11, 2016
• Start date: February 2016

Study information

• Verified date: February 2016
• Source: Epirus Biopharmaceuticals (Switzerland) GmbH
• Contact: EPIRUS Clinical Development
• Email: info[@]epirusbiopharma.com
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationEuropean Union: European Medicines AgencyGeorgia: Ministry of HealthIsrael: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 548
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• BOW015
monoclonal antibody against TNF-alpha
• Remicade
monoclonal antibody against TNF-alpha

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Epirus Biopharmaceuticals (Switzerland) GmbH

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	American College of Rheumatology (ACR) 20 clinical response		16 weeks	No
Secondary	ACR20		54 weeks	No
Secondary	Diseases Activity Score (DAS)28 calculated with C-reactive protein (CRP)		54 weeks	No
Secondary	Health Assessment Questionnaire-Disability Index (HAQ-DI)		54 weeks	No