Rheumatoid ArthritisNCT03470688
Investigating the Utilisation and Effectiveness of Originator and Biosimilar Anti-TNF Agents
An observational study of Rheumatoid Arthritis and Psoriatic Arthritis, run by Opal Rheumatology Ltd. at 22 sites in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis
- What is being tested?
- Originator and Biosimilar
- How many people
- 5,000 participants
- Where
- 22 sitesAustralia
- Study dates
- 1 Mar 2018to 31 Dec 2021
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Male and female adults (>= 18 years) with a confirmed diagnosis of RA, PsA, or AS
Who may be able to join
- 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.
Who cannot join
- -
Trial locations and contacts
22 sites in 1 country.
22 sites in 1 country
Australia22 sites, 22 recruiting
- Recruiting
Southern Rheumatology
Brighton, Victoria, 3186
- Recruiting
Northern Rheumatology and Specialists
Brunswick, Victoria, 3055
- Recruiting
Susan Street Specialists Centre
Camperdown, New South Wales, 2042
- Recruiting
Canberra Rheumatology
Canberra, Australian Capital Territory, 2601
- Recruiting
Rheumatology ACT
Canberra, Australian Capital Territory, 2606
- Recruiting
Hills Rheumatology
Castle Hill, New South Wales, 2154
- Recruiting
Orthopaedic and Arthritis Centre
Chatswood, New South Wales, 2067
- Recruiting
Monash Rheumatology
Clayton, Victoria, 3168
- Recruiting
Coburg Rheumatology
Coburg, Victoria, 3058
- Recruiting
Melbourne Arthritis Associates
Fitzroy, Victoria, 3065
- Recruiting
Footscray Specialist Rooms
Footscray, Victoria, 3011
- Recruiting
Barwon Rheumatology Service
Geelong, Victoria, 3220
- Recruiting
Georgetown Arthritis
Georgetown, New South Wales, 2298
- Recruiting
Hobart Specialists Group
Hobart, Tasmania, 7000
- Recruiting
Rheumatology Tasmania
Hobart, Tasmania, 7000
- Recruiting
Combined Rheumatology Practice
Kogarah, New South Wales, 2217
- Recruiting
Peninsula Rheumatology
Langwarrin, Victoria, 3220
- Recruiting
Coast Joint Care
Maroochydore, Queensland, 4558
- Recruiting
Rheumatology United
Penrith, New South Wales, 2750
- Recruiting
Gold Coast Rheumatology
Southport, Queensland, 4215
- Recruiting
Subiaco Rheumatology
Subiaco, Western Australia, 6009
- Recruiting
Townsville Hospital - Rheumatology
Townsville, Queensland, 4814
About this study
Official title: 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.
- Being tested
- Originator, Biosimilar
- Medical subject headings
- Arthritis, Rheumatoid, Arthritis, Psoriatic, Spondylitis, Ankylosing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OriginatorBiological
Also called Enbrel, All other originator anti-TNF agents
Originator anti-TNF agents
BiosimilarBiological
Also called Brenzys, All other anti-TNF biosimilars as they come to market
Biosimilar anti-TNF agents
| Study group | Role | What they receive |
|---|---|---|
| Originator | Originator anti-TNF agents. Dosage as per physician's decision based on approved indication. Receives: Biological: Originator | |
| Biosimilar | Biosimilar anti-TNF agents. Dosage as per physician's decision based on approved indication. Receives: Biological: Biosimilar |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease activity score based on a 28 joint count (DAS28)
Comparative assessment of disease activity as measured by DAS28 in patients receiving originators vs biosimilars. Higher DAS28 scores indicate more severe disease activity.
Measured: 3 years
Health Assessment Questionnaire Disability Index (HAQ-DI)
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.
Measured: 3 years
Secondary outcomes (4)
36-item Short Form Health Survey (SF-36)
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.
Measured: 3 years
Patient Health Questionnaire-2 (PHQ-2)
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.
Measured: 3 years
Fatigue assessed by the Functional Assessment of Chronic Illness Therapy (FACIT) questionnaire
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.
Measured: 3 years
Number of patients discontinuing the drug for safety reasons
Comparison between number of patients using originator vs biosimilar who discontinue therapy for safety reasons.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2018
- Study start1 Mar 2018
- Primary completion1 Jun 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5,000 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Opal Rheumatology Ltd.
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
- Investigators
- Paul Bird, Principal investigator, Optimus Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03470688
- Sponsor's protocol ID
- MSD biosimilars
- Status last verified
- Mar 2018
- First submitted
- 6 Mar 2018
- Last updated
- 21 Mar 2018
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Study Designed to Investigate the Utilisation and Effectiveness of Originator and Biosimilar Anti-TNF Agents in Australian Rheumatology
- ClinicalTrials.gov ID
- NCT03470688
- Acronym / sponsor ID
- MSD biosimilars
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Opal Rheumatology Ltd.University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 1 Jun 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 20 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Originator | – | Biological: OriginatorOriginator anti-TNF agents. Dosage as per physician's decision based on approved indication. |
| Biosimilar | – | Biological: BiosimilarBiosimilar anti-TNF agents. Dosage as per physician's decision based on approved indication. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Male and female adults (>= 18 years) with a confirmed diagnosis of RA, PsA, or AS
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OriginatorAlso: Enbrel, All other originator anti-TNF agentsOriginator anti-TNF agents | Biological | Originator |
| BiosimilarAlso: Brenzys, All other anti-TNF biosimilars as they come to marketBiosimilar anti-TNF agents | Biological | Biosimilar |
Primary outcome
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.
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.
4 secondary outcomes
36-item Short Form Health Survey (SF-36)
Time frame: 3 years
Patient Health Questionnaire-2 (PHQ-2)
Time frame: 3 years
Fatigue assessed by the Functional Assessment of Chronic Illness Therapy (FACIT) questionnaire
Time frame: 3 years
Number of patients discontinuing the drug for safety reasons
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul Bird principal investigator
Optimus Research
22 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rheumatoid Arthritis and Psoriatic Arthritis, run by Opal Rheumatology Ltd. at 22 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tegan Smith (+61280706805, info@opalrheumatology.com.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease activity score based on a 28 joint count (DAS28) (time frame: 3 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2018.