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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Opal Rheumatology Ltd.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Merck Sharp & Dohme LLC

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2018

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2021

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 6, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 19, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 20, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 21, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 19, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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