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

March 19, 2018 updated by: Opal Rheumatology Ltd.

An Observational Study Designed to Investigate the Utilisation and Effectiveness of Originator and Biosimilar Anti-TNF Agents in Australian Rheumatology

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

5000

Contacts and Locations

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

Study Locations

  • Australia
    • Australian Capital Territory
      • Canberra, Australian Capital Territory, Australia, 2601
        • Recruiting
        • Canberra Rheumatology
      • Canberra, Australian Capital Territory, Australia, 2606
        • Recruiting
        • Rheumatology ACT
    • New South Wales
      • Camperdown, New South Wales, Australia, 2042
        • Recruiting
        • Susan Street Specialists Centre
      • Castle Hill, New South Wales, Australia, 2154
        • Recruiting
        • Hills Rheumatology
      • Chatswood, New South Wales, Australia, 2067
        • Recruiting
        • Orthopaedic and Arthritis Centre
      • Georgetown, New South Wales, Australia, 2298
        • Recruiting
        • Georgetown Arthritis
      • Kogarah, New South Wales, Australia, 2217
        • Recruiting
        • Combined Rheumatology Practice
      • Penrith, New South Wales, Australia, 2750
        • Recruiting
        • Rheumatology United
    • Queensland
      • Maroochydore, Queensland, Australia, 4558
        • Recruiting
        • Coast Joint Care
      • Southport, Queensland, Australia, 4215
        • Recruiting
        • Gold Coast Rheumatology
      • Townsville, Queensland, Australia, 4814
        • Recruiting
        • Townsville Hospital - Rheumatology
    • Tasmania
      • Hobart, Tasmania, Australia, 7000
        • Recruiting
        • Hobart Specialists Group
      • Hobart, Tasmania, Australia, 7000
        • Recruiting
        • Rheumatology Tasmania
    • Victoria
      • Brighton, Victoria, Australia, 3186
        • Recruiting
        • Southern Rheumatology
      • Brunswick, Victoria, Australia, 3055
        • Recruiting
        • Northern Rheumatology and Specialists
      • Clayton, Victoria, Australia, 3168
        • Recruiting
        • Monash Rheumatology
      • Coburg, Victoria, Australia, 3058
        • Recruiting
        • Coburg Rheumatology
      • Fitzroy, Victoria, Australia, 3065
        • Recruiting
        • Melbourne Arthritis Associates
      • Footscray, Victoria, Australia, 3011
        • Recruiting
        • Footscray Specialist Rooms
      • Geelong, Victoria, Australia, 3220
        • Recruiting
        • Barwon Rheumatology Service
      • Langwarrin, Victoria, Australia, 3220
        • Recruiting
        • Peninsula Rheumatology
    • Western Australia
      • Subiaco, Western Australia, Australia, 6009
        • Recruiting
        • Subiaco Rheumatology

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Male and female adults (>= 18 years) with a confirmed diagnosis of RA, PsA, or AS

Description

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:

-

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Originator
Originator anti-TNF agents. Dosage as per physician's decision based on approved indication.
Biological: Originator
Originator anti-TNF agents
Other Names:
  • Enbrel
  • All other originator anti-TNF agents
Biosimilar
Biosimilar anti-TNF agents. Dosage as per physician's decision based on approved indication.
Biological: Biosimilar
Biosimilar anti-TNF agents
Other Names:
  • Brenzys
  • All other anti-TNF biosimilars as they come to market

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease activity score based on a 28 joint count (DAS28)
Time Frame: 3 years
Comparative assessment of disease activity as measured by DAS28 in patients receiving originators vs biosimilars. Higher DAS28 scores indicate more severe disease activity.
3 years
Health Assessment Questionnaire Disability Index (HAQ-DI)
Time Frame: 3 years
Comparative assessment of disease impact on quality of life and daily physical functions in patients receiving originators vs biosimilars. HAQ-DI is designed to measure impact on everyday life. Higher scores indicate more severe disability.
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
36-item Short Form Health Survey (SF-36)
Time Frame: 3 years

Comparative assessment of disease impact on quality of life in patients receiving originators vs biosimilars.

The SF-36 uses 8 sub scales to assess patient vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning and mental health. Each sub scale is scored between 0-100, where lower scores indicate a greater impact on function.
3 years
Patient Health Questionnaire-2 (PHQ-2)
Time Frame: 3 years

Comparative assessment of disease impact on the emotional health in patients receiving originators vs biosimilars, as measured by the PHQ-2.

The PHQ-2 is a two-question survey to screen for depression, and higher scores indicate that the patient experienced depressed mood or anhedonia more frequently over the past two weeks.
3 years
Fatigue assessed by the Functional Assessment of Chronic Illness Therapy (FACIT) questionnaire
Time Frame: 3 years

Comparative assessment of fatigue in patients receiving originators vs biosimilars, assessed using the FACIT-fatigue scale.

FACIT-fatigue is a questionnaire used to measure fatigue levels in patients with rheumatoid arthritis. A higher score is associated with a greater level of fatigue.
3 years
Number of patients discontinuing the drug for safety reasons
Time Frame: 3 years
Comparison between number of patients using originator vs biosimilar who discontinue therapy for safety reasons.
3 years

Collaborators and Investigators

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

Sponsor

Opal Rheumatology Ltd.

Collaborators

Merck Sharp & Dohme LLC

Investigators

  • Principal Investigator: Paul Bird, Optimus Research

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 (Actual)

March 1, 2018

Primary Completion (Anticipated)

June 1, 2021

Study Completion (Anticipated)

December 31, 2021

Study Registration Dates

First Submitted

March 6, 2018

First Submitted That Met QC Criteria

March 19, 2018

First Posted (Actual)

March 20, 2018

Study Record Updates

Last Update Posted (Actual)

March 21, 2018

Last Update Submitted That Met QC Criteria

March 19, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MSD biosimilars

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

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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