Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT03470688
Registration number
NCT03470688
Ethics application status
Date submitted
6/03/2018
Date registered
20/03/2018
Date last updated
21/03/2018
Titles & IDs
Public title
Investigating the Utilisation and Effectiveness of Originator and Biosimilar Anti-TNF Agents
Query!
Scientific title
An Observational Study Designed to Investigate the Utilisation and Effectiveness of Originator and Biosimilar Anti-TNF Agents in Australian Rheumatology
Query!
Secondary ID [1]
0
0
MSD biosimilars
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Rheumatoid Arthritis
0
0
Query!
Psoriatic Arthritis
0
0
Query!
Ankylosing Spondylitis
0
0
Query!
Condition category
Condition code
Inflammatory and Immune System
0
0
0
0
Query!
Other inflammatory or immune system disorders
Query!
Musculoskeletal
0
0
0
0
Query!
Other muscular and skeletal disorders
Query!
Musculoskeletal
0
0
0
0
Query!
Osteoarthritis
Query!
Inflammatory and Immune System
0
0
0
0
Query!
Rheumatoid arthritis
Query!
Intervention/exposure
Study type
Observational [Patient Registry]
Query!
Patient registry
Query!
Target follow-up duration
Query!
Target follow-up type
Query!
Description of intervention(s) / exposure
Other interventions - Originator
Other interventions - Biosimilar
Originator - Originator anti-TNF agents. Dosage as per physician's decision based on approved indication.
Biosimilar - Biosimilar anti-TNF agents. Dosage as per physician's decision based on approved indication.
Other interventions: Originator
Originator anti-TNF agents
Other interventions: Biosimilar
Biosimilar anti-TNF agents
Query!
Intervention code [1]
0
0
Other interventions
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Disease activity score based on a 28 joint count (DAS28)
Query!
Assessment method [1]
0
0
Comparative assessment of disease activity as measured by DAS28 in patients receiving originators vs biosimilars. Higher DAS28 scores indicate more severe disease activity.
Query!
Timepoint [1]
0
0
3 years
Query!
Primary outcome [2]
0
0
Health Assessment Questionnaire Disability Index (HAQ-DI)
Query!
Assessment method [2]
0
0
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.
Query!
Timepoint [2]
0
0
3 years
Query!
Secondary outcome [1]
0
0
36-item Short Form Health Survey (SF-36)
Query!
Assessment method [1]
0
0
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.
Query!
Timepoint [1]
0
0
3 years
Query!
Secondary outcome [2]
0
0
Patient Health Questionnaire-2 (PHQ-2)
Query!
Assessment method [2]
0
0
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.
Query!
Timepoint [2]
0
0
3 years
Query!
Secondary outcome [3]
0
0
Fatigue assessed by the Functional Assessment of Chronic Illness Therapy (FACIT) questionnaire
Query!
Assessment method [3]
0
0
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.
Query!
Timepoint [3]
0
0
3 years
Query!
Secondary outcome [4]
0
0
Number of patients discontinuing the drug for safety reasons
Query!
Assessment method [4]
0
0
Comparison between number of patients using originator vs biosimilar who discontinue therapy for safety reasons.
Query!
Timepoint [4]
0
0
3 years
Query!
Eligibility
Key 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.
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
-
Query!
Study design
Purpose
Query!
Duration
Query!
Selection
Query!
Timing
Prospective
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Unknown status
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
1/03/2018
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
31/12/2021
Query!
Actual
Query!
Sample size
Target
5000
Query!
Accrual to date
Query!
Final
Query!
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,TAS,VIC,WA
Query!
Recruitment hospital [1]
0
0
Canberra Rheumatology - Canberra
Query!
Recruitment hospital [2]
0
0
Rheumatology ACT - Canberra
Query!
Recruitment hospital [3]
0
0
Susan Street Specialists Centre - Camperdown
Query!
Recruitment hospital [4]
0
0
Hills Rheumatology - Castle Hill
Query!
Recruitment hospital [5]
0
0
Orthopaedic and Arthritis Centre - Chatswood
Query!
Recruitment hospital [6]
0
0
Georgetown Arthritis - Georgetown
Query!
Recruitment hospital [7]
0
0
Combined Rheumatology Practice - Kogarah
Query!
Recruitment hospital [8]
0
0
Rheumatology United - Penrith
Query!
Recruitment hospital [9]
0
0
Coast Joint Care - Maroochydore
Query!
Recruitment hospital [10]
0
0
Gold Coast Rheumatology - Southport
Query!
Recruitment hospital [11]
0
0
Townsville Hospital - Rheumatology - Townsville
Query!
Recruitment hospital [12]
0
0
Hobart Specialists Group - Hobart
Query!
Recruitment hospital [13]
0
0
Rheumatology Tasmania - Hobart
Query!
Recruitment hospital [14]
0
0
Southern Rheumatology - Brighton
Query!
Recruitment hospital [15]
0
0
Northern Rheumatology and Specialists - Brunswick
Query!
Recruitment hospital [16]
0
0
Monash Rheumatology - Clayton
Query!
Recruitment hospital [17]
0
0
Coburg Rheumatology - Coburg
Query!
Recruitment hospital [18]
0
0
Melbourne Arthritis Associates - Fitzroy
Query!
Recruitment hospital [19]
0
0
Footscray Specialist Rooms - Footscray
Query!
Recruitment hospital [20]
0
0
Barwon Rheumatology Service - Geelong
Query!
Recruitment hospital [21]
0
0
Peninsula Rheumatology - Langwarrin
Query!
Recruitment hospital [22]
0
0
Subiaco Rheumatology - Subiaco
Query!
Recruitment postcode(s) [1]
0
0
2601 - Canberra
Query!
Recruitment postcode(s) [2]
0
0
2606 - Canberra
Query!
Recruitment postcode(s) [3]
0
0
2042 - Camperdown
Query!
Recruitment postcode(s) [4]
0
0
2154 - Castle Hill
Query!
Recruitment postcode(s) [5]
0
0
2067 - Chatswood
Query!
Recruitment postcode(s) [6]
0
0
2298 - Georgetown
Query!
Recruitment postcode(s) [7]
0
0
2217 - Kogarah
Query!
Recruitment postcode(s) [8]
0
0
2750 - Penrith
Query!
Recruitment postcode(s) [9]
0
0
4558 - Maroochydore
Query!
Recruitment postcode(s) [10]
0
0
4215 - Southport
Query!
Recruitment postcode(s) [11]
0
0
4814 - Townsville
Query!
Recruitment postcode(s) [12]
0
0
7000 - Hobart
Query!
Recruitment postcode(s) [13]
0
0
3186 - Brighton
Query!
Recruitment postcode(s) [14]
0
0
3055 - Brunswick
Query!
Recruitment postcode(s) [15]
0
0
3168 - Clayton
Query!
Recruitment postcode(s) [16]
0
0
3058 - Coburg
Query!
Recruitment postcode(s) [17]
0
0
3065 - Fitzroy
Query!
Recruitment postcode(s) [18]
0
0
3011 - Footscray
Query!
Recruitment postcode(s) [19]
0
0
3220 - Geelong
Query!
Recruitment postcode(s) [20]
0
0
3220 - Langwarrin
Query!
Recruitment postcode(s) [21]
0
0
6009 - Subiaco
Query!
Funding & Sponsors
Primary sponsor type
Other
Query!
Name
Opal Rheumatology Ltd.
Query!
Address
Query!
Country
Query!
Other collaborator category [1]
0
0
Commercial sector/Industry
Query!
Name [1]
0
0
Merck Sharp & Dohme LLC
Query!
Address [1]
0
0
Query!
Country [1]
0
0
Query!
Ethics approval
Ethics application status
Query!
Summary
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.
Query!
Trial website
https://clinicaltrials.gov/ct2/show/NCT03470688
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Paul Bird
Query!
Address
0
0
Optimus Research
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Tegan Smith
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
+61280706805
Query!
Fax
0
0
Query!
Email
0
0
[email protected]
Query!
Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03470688
Download to PDF