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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
Scientific title
An Observational Study Designed to Investigate the Utilisation and Effectiveness of Originator and Biosimilar Anti-TNF Agents in Australian Rheumatology
Secondary ID [1] 0 0
MSD biosimilars
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Rheumatoid Arthritis 0 0
Psoriatic Arthritis 0 0
Ankylosing Spondylitis 0 0
Condition category
Condition code
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders
Musculoskeletal 0 0 0 0
Osteoarthritis
Inflammatory and Immune System 0 0 0 0
Rheumatoid arthritis

Intervention/exposure
Study type
Observational [Patient Registry]
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Other - Originator
Treatment: Other - 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.


Treatment: Other: Originator
Originator anti-TNF agents

Treatment: Other: Biosimilar
Biosimilar anti-TNF agents
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Disease activity score based on a 28 joint count (DAS28)
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.
Timepoint [1] 0 0
3 years
Primary outcome [2] 0 0
Health Assessment Questionnaire Disability Index (HAQ-DI)
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.
Timepoint [2] 0 0
3 years
Secondary outcome [1] 0 0
36-item Short Form Health Survey (SF-36)
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.
Timepoint [1] 0 0
3 years
Secondary outcome [2] 0 0
Patient Health Questionnaire-2 (PHQ-2)
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.
Timepoint [2] 0 0
3 years
Secondary outcome [3] 0 0
Fatigue assessed by the Functional Assessment of Chronic Illness Therapy (FACIT) questionnaire
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.
Timepoint [3] 0 0
3 years
Secondary outcome [4] 0 0
Number of patients discontinuing the drug for safety reasons
Assessment method [4] 0 0
Comparison between number of patients using originator vs biosimilar who discontinue therapy for safety reasons.
Timepoint [4] 0 0
3 years

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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
-

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
UNKNOWN
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/03/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/12/2021
Actual
Sample size
Target
5000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,TAS,VIC,WA
Recruitment hospital [1] 0 0
Canberra Rheumatology - Canberra
Recruitment hospital [2] 0 0
Rheumatology ACT - Canberra
Recruitment hospital [3] 0 0
Susan Street Specialists Centre - Camperdown
Recruitment hospital [4] 0 0
Hills Rheumatology - Castle Hill
Recruitment hospital [5] 0 0
Orthopaedic and Arthritis Centre - Chatswood
Recruitment hospital [6] 0 0
Georgetown Arthritis - Georgetown
Recruitment hospital [7] 0 0
Combined Rheumatology Practice - Kogarah
Recruitment hospital [8] 0 0
Rheumatology United - Penrith
Recruitment hospital [9] 0 0
Coast Joint Care - Maroochydore
Recruitment hospital [10] 0 0
Gold Coast Rheumatology - Southport
Recruitment hospital [11] 0 0
Townsville Hospital - Rheumatology - Townsville
Recruitment hospital [12] 0 0
Hobart Specialists Group - Hobart
Recruitment hospital [13] 0 0
Rheumatology Tasmania - Hobart
Recruitment hospital [14] 0 0
Southern Rheumatology - Brighton
Recruitment hospital [15] 0 0
Northern Rheumatology and Specialists - Brunswick
Recruitment hospital [16] 0 0
Monash Rheumatology - Clayton
Recruitment hospital [17] 0 0
Coburg Rheumatology - Coburg
Recruitment hospital [18] 0 0
Melbourne Arthritis Associates - Fitzroy
Recruitment hospital [19] 0 0
Footscray Specialist Rooms - Footscray
Recruitment hospital [20] 0 0
Barwon Rheumatology Service - Geelong
Recruitment hospital [21] 0 0
Peninsula Rheumatology - Langwarrin
Recruitment hospital [22] 0 0
Subiaco Rheumatology - Subiaco
Recruitment postcode(s) [1] 0 0
2601 - Canberra
Recruitment postcode(s) [2] 0 0
2606 - Canberra
Recruitment postcode(s) [3] 0 0
2042 - Camperdown
Recruitment postcode(s) [4] 0 0
2154 - Castle Hill
Recruitment postcode(s) [5] 0 0
2067 - Chatswood
Recruitment postcode(s) [6] 0 0
2298 - Georgetown
Recruitment postcode(s) [7] 0 0
2217 - Kogarah
Recruitment postcode(s) [8] 0 0
2750 - Penrith
Recruitment postcode(s) [9] 0 0
4558 - Maroochydore
Recruitment postcode(s) [10] 0 0
4215 - Southport
Recruitment postcode(s) [11] 0 0
4814 - Townsville
Recruitment postcode(s) [12] 0 0
7000 - Hobart
Recruitment postcode(s) [13] 0 0
3186 - Brighton
Recruitment postcode(s) [14] 0 0
3055 - Brunswick
Recruitment postcode(s) [15] 0 0
3168 - Clayton
Recruitment postcode(s) [16] 0 0
3058 - Coburg
Recruitment postcode(s) [17] 0 0
3065 - Fitzroy
Recruitment postcode(s) [18] 0 0
3011 - Footscray
Recruitment postcode(s) [19] 0 0
3220 - Geelong
Recruitment postcode(s) [20] 0 0
3220 - Langwarrin
Recruitment postcode(s) [21] 0 0
6009 - Subiaco

Funding & Sponsors
Primary sponsor type
Other
Name
Opal Rheumatology Ltd.
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Merck Sharp & Dohme LLC
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Public notes

Contacts
Principal investigator
Name 0 0
Paul Bird
Address 0 0
Optimus Research
Country 0 0
Phone 0 0
Email 0 0
Contact person for public queries
Name 0 0
Tegan Smith
Address 0 0
Country 0 0
Phone 0 0
+61280706805
Email 0 0
info@opalrheumatology.com.au
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT03470688