NCT02683564

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.

Trial Health

50
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
548

participants targeted

Target at P50-P75 for phase_3 rheumatoid-arthritis

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2016

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

February 9, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 17, 2016

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
Last Updated

February 17, 2016

Status Verified

February 1, 2016

Enrollment Period

1.4 years

First QC Date

February 9, 2016

Last Update Submit

February 11, 2016

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

  • American College of Rheumatology (ACR) 20 clinical response

    16 weeks

Secondary Outcomes (3)

  • ACR20

    54 weeks

  • Diseases Activity Score (DAS)28 calculated with C-reactive protein (CRP)

    54 weeks

  • Health Assessment Questionnaire-Disability Index (HAQ-DI)

    54 weeks

Study Arms (2)

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.

Drug: BOW015

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.

Drug: Remicade

Interventions

BOW015DRUG

monoclonal antibody against TNF-alpha

Also known as: infliximab-EPIRUS
BOW015
RemicadeDRUG

monoclonal antibody against TNF-alpha

Also known as: infliximab
Remicade

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Infliximab

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Central Study Contacts

EPIRUS Clinical Development

CONTACT

info@epirusbiopharma.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 9, 2016

First Posted

February 17, 2016

Study Start

February 1, 2016

Primary Completion

July 1, 2017

Last Updated

February 17, 2016

Record last verified: 2016-02