Investigating the Utilisation and Effectiveness of Originator and Biosimilar Anti-TNF Agents

NCT ID: NCT03470688

Last Updated: 2018-03-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

5000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-03-01

Study Completion Date

2021-12-31

Brief Summary

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An observational study investigating the utilisation and effectiveness of originator and biosimilar anti-TNF agents in patients with rheumatoid arthritis, psoriatic arthritis, or ankylosing spondylitis.

Detailed Description

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Conditions

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Rheumatoid Arthritis Psoriatic Arthritis Ankylosing Spondylitis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Originator

Originator anti-TNF agents. Dosage as per physician's decision based on approved indication.

Originator

Intervention Type BIOLOGICAL

Originator anti-TNF agents

Biosimilar

Biosimilar anti-TNF agents. Dosage as per physician's decision based on approved indication.

Biosimilar

Intervention Type BIOLOGICAL

Biosimilar anti-TNF agents

Interventions

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Originator

Originator anti-TNF agents

Intervention Type BIOLOGICAL

Biosimilar

Biosimilar anti-TNF agents

Intervention Type BIOLOGICAL

Other Intervention Names

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Enbrel All other originator anti-TNF agents Brenzys All other anti-TNF biosimilars as they come to market

Eligibility Criteria

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Inclusion Criteria

* Patients with a confirmed diagnosis of rheumatoid arthritis (RA), psoriatic arthritis (PsA) or ankylosing spondylitis (AS) who are being treated at a participating OPAL clinic.

Exclusion Criteria

\-
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role collaborator

Opal Rheumatology Ltd.

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Paul Bird

Role: PRINCIPAL_INVESTIGATOR

Optimus Research

Locations

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Canberra Rheumatology

Canberra, Australian Capital Territory, Australia

Site Status RECRUITING

Rheumatology ACT

Canberra, Australian Capital Territory, Australia

Site Status RECRUITING

Susan Street Specialists Centre

Camperdown, New South Wales, Australia

Site Status RECRUITING

Hills Rheumatology

Castle Hill, New South Wales, Australia

Site Status RECRUITING

Orthopaedic and Arthritis Centre

Chatswood, New South Wales, Australia

Site Status RECRUITING

Georgetown Arthritis

Georgetown, New South Wales, Australia

Site Status RECRUITING

Combined Rheumatology Practice

Kogarah, New South Wales, Australia

Site Status RECRUITING

Rheumatology United

Penrith, New South Wales, Australia

Site Status RECRUITING

Coast Joint Care

Maroochydore, Queensland, Australia

Site Status RECRUITING

Gold Coast Rheumatology

Southport, Queensland, Australia

Site Status RECRUITING

Townsville Hospital - Rheumatology

Townsville, Queensland, Australia

Site Status RECRUITING

Hobart Specialists Group

Hobart, Tasmania, Australia

Site Status RECRUITING

Rheumatology Tasmania

Hobart, Tasmania, Australia

Site Status RECRUITING

Southern Rheumatology

Brighton, Victoria, Australia

Site Status RECRUITING

Northern Rheumatology and Specialists

Brunswick, Victoria, Australia

Site Status RECRUITING

Monash Rheumatology

Clayton, Victoria, Australia

Site Status RECRUITING

Coburg Rheumatology

Coburg, Victoria, Australia

Site Status RECRUITING

Melbourne Arthritis Associates

Fitzroy, Victoria, Australia

Site Status RECRUITING

Footscray Specialist Rooms

Footscray, Victoria, Australia

Site Status RECRUITING

Barwon Rheumatology Service

Geelong, Victoria, Australia

Site Status RECRUITING

Peninsula Rheumatology

Langwarrin, Victoria, Australia

Site Status RECRUITING

Subiaco Rheumatology

Subiaco, Western Australia, Australia

Site Status RECRUITING

Countries

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Australia

Central Contacts

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Tegan Smith

Role: CONTACT

+61280706805

Other Identifiers

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MSD biosimilars

Identifier Type: -

Identifier Source: org_study_id

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