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

February 11, 2016 updated by: Epirus Biopharmaceuticals (Switzerland) GmbH

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

548

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
American College of Rheumatology (ACR) 20 clinical response
Time Frame: 16 weeks
16 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
ACR20
Time Frame: 54 weeks
54 weeks
Diseases Activity Score (DAS)28 calculated with C-reactive protein (CRP)
Time Frame: 54 weeks
54 weeks
Health Assessment Questionnaire-Disability Index (HAQ-DI)
Time Frame: 54 weeks
54 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Epirus Biopharmaceuticals (Switzerland) GmbH

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2016

Primary Completion (Anticipated)

July 1, 2017

Study Registration Dates

First Submitted

February 9, 2016

First Submitted That Met QC Criteria

February 11, 2016

First Posted (Estimate)

February 17, 2016

Study Record Updates

Last Update Posted (Estimate)

February 17, 2016

Last Update Submitted That Met QC Criteria

February 11, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EPI-BOW015-003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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