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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02683564
Recruitment Status : Unknown
Verified February 2016 by Epirus Biopharmaceuticals (Switzerland) GmbH.
Recruitment status was:  Not yet recruiting
First Posted : February 17, 2016
Last Update Posted : February 17, 2016
Sponsor:
Information provided by (Responsible Party):
Epirus Biopharmaceuticals (Switzerland) GmbH

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
Rheumatoid Arthritis Drug: BOW015 Drug: Remicade Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : February 2016
Estimated Primary Completion Date : July 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Infliximab

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 Name: 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 Name: infliximab




Primary Outcome Measures :
  1. American College of Rheumatology (ACR) 20 clinical response [ Time Frame: 16 weeks ]

Secondary Outcome Measures :
  1. ACR20 [ Time Frame: 54 weeks ]
  2. Diseases Activity Score (DAS)28 calculated with C-reactive protein (CRP) [ Time Frame: 54 weeks ]
  3. Health Assessment Questionnaire-Disability Index (HAQ-DI) [ Time Frame: 54 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02683564


Contacts
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Contact: EPIRUS Clinical Development info@epirusbiopharma.com

Sponsors and Collaborators
Epirus Biopharmaceuticals (Switzerland) GmbH
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Responsible Party: Epirus Biopharmaceuticals (Switzerland) GmbH
ClinicalTrials.gov Identifier: NCT02683564    
Other Study ID Numbers: EPI-BOW015-003
First Posted: February 17, 2016    Key Record Dates
Last Update Posted: February 17, 2016
Last Verified: February 2016
Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Infliximab
Dermatologic Agents
Gastrointestinal Agents
Antirheumatic Agents