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

Sponsor
Epirus Biopharmaceuticals (Switzerland) GmbH (Industry)
Overall Status
Unknown status
CT.gov ID
NCT02683564
Collaborator
(none)
548
2

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
Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
548 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Study of BOW015 (Infliximab-EPIRUS) and Infliximab in Patients With Active Rheumatoid Arthritis on Stable Methotrexate: The UNIFORM Study
Study Start Date :
Feb 1, 2016
Anticipated Primary Completion Date :
Jul 1, 2017

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:
  • infliximab-EPIRUS
  • 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:
  • infliximab
  • Outcome Measures

    Primary Outcome Measures

    1. American College of Rheumatology (ACR) 20 clinical response [16 weeks]

    Secondary Outcome Measures

    1. ACR20 [54 weeks]

    2. Diseases Activity Score (DAS)28 calculated with C-reactive protein (CRP) [54 weeks]

    3. Health Assessment Questionnaire-Disability Index (HAQ-DI) [54 weeks]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    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.
    Responsible Party:
    Epirus Biopharmaceuticals (Switzerland) GmbH
    ClinicalTrials.gov Identifier:
    NCT02683564
    Other Study ID Numbers:
    • EPI-BOW015-003
    First Posted:
    Feb 17, 2016
    Last Update Posted:
    Feb 17, 2016
    Last Verified:
    Feb 1, 2016
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Feb 17, 2016