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Trial record 4 of 10 for:    biosimilar for etanercept

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

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ClinicalTrials.gov Identifier: NCT03470688
Recruitment Status : Recruiting
First Posted : March 20, 2018
Last Update Posted : March 20, 2018
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Opal Rheumatology Ltd.

Brief Summary:
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.

Condition or disease Intervention/treatment
Rheumatoid Arthritis Psoriatic Arthritis Ankylosing Spondylitis Biological: Originator Biological: Biosimilar

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 5000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 3 Years
Official Title: An Observational Study Designed to Investigate the Utilisation and Effectiveness of Originator and Biosimilar Anti-TNF Agents in Australian Rheumatology
Actual Study Start Date : March 1, 2018
Estimated Primary Completion Date : June 1, 2021
Estimated Study Completion Date : December 31, 2021


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




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.


  2. 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. 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.


  4. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Male and female adults (>= 18 years) with a confirmed diagnosis of RA, PsA, or AS
Criteria

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:

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03470688


Contacts
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Contact: Tegan Smith +61280706805 info@opalrheumatology.com.au

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

Additional Information:

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Responsible Party: Opal Rheumatology Ltd.
ClinicalTrials.gov Identifier: NCT03470688     History of Changes
Other Study ID Numbers: MSD biosimilars
First Posted: March 20, 2018    Key Record Dates
Last Update Posted: March 20, 2018
Last Verified: March 2018

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Spondylitis
Arthritis
Arthritis, Psoriatic
Spondylitis, Ankylosing
Joint Diseases
Musculoskeletal Diseases
Bone Diseases, Infectious
Infection
Bone Diseases
Spinal Diseases
Spondylarthropathies
Spondylarthritis
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Ankylosis