Trial | NCT02683564  Report issue

Title

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

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Unknown status

  • Intervention/Treatment

    infliximab ...

  • Study Participants

    548
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 Started
Feb 29
2016
Primary Completion
Jul 31
2017
Anticipated
Last Update
Feb 17
2016
Estimate

Drug BOW015

monoclonal antibody against TNF-alpha

  • Other names: infliximab-EPIRUS

Drug Remicade

monoclonal antibody against TNF-alpha

  • Other names: infliximab

BOW015 Experimental

Infliximab-EPIRUS, 3mg/kg body weight as intra venous infusion at weeks 0, 2, 6 then every 8 weeks thereafter up to Week 46.

Remicade Active Comparator

Remicade (infliximab) , 3mg/kg body weight as intra venous infusion at weeks 0, 2, 6 then every 8 weeks thereafter up to Week 46.

Criteria 

Key Inclusion Criteria:

Male and female, aged 18 to 80
Diagnosis of Rheumatoid Arthritis (RA) according to the revised ACR/ EULAR 2010 classification criteria for RA
Patients must have ACR/EULAR 2010 classification criteria score ≥ 6
Patients must have active disease
Patients must have been on treatment with methotrexate

Key Exclusion Criteria:

Prior use of infliximab, adalimumab, certolizumab, golimumab, tocilizumab, rituximab, or etanercept or any other biological treatment
Patients with any prior or current use of anakinra and abatacept
Patients with suspected or confirmed current active tuberculosis (TB)
Patients with latent tuberculosis must start treatment for latent tuberculosis
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
History of completely excised and cured squamous carcinoma of the uterine cervix, cutaneous basal cell carcinoma or cutaneous squamous cell carcinoma
History of lymphoproliferative disease
History or presence of any other form of malignancy
Current signs or symptoms of severe, progressive or uncontrolled renal, hepatic, hematologic, gastrointestinal, endocrine, pulmonary, cardiac, neurologic or cerebral disease
History of congestive heart failure or unstable angina
History of any autoimmune disease other than RA
Major surgery within 12 weeks and planned major surgery
History of serious infection
Pre-existing central nervous system demyelinating disorders
Administration of live or live-attenuated vaccine within 4 weeks of screening
Clinically significant adverse reaction to murine or chimeric proteins
History or presence of any medical or psychiatric condition or disease, or clinically significant laboratory abnormality
Participation in any clinical study of an investigational product within the previous 3 months prior to screening
No Results Posted