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

Rheumatoid Arthritis Clinical Trial

Official title:

An Observational Study Designed to Investigate the Utilisation and Effectiveness of Originator and Biosimilar Anti-TNF Agents in Australian Rheumatology

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03470688
• Other study ID #: MSD biosimilars
• Status: Recruiting
• First received: March 6, 2018
• Last updated: March 19, 2018
• Start date: March 1, 2018
• Est. completion date: December 31, 2021

Study information

• Verified date: March 2018
• Source: Opal Rheumatology Ltd.
• Contact: Tegan Smith
• Phone: +61280706805
• Email: info[@]opalrheumatology.com.au
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5000
• Est. completion date: December 31, 2021
• Est. primary completion date: June 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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:

Related Conditions & MeSH terms

• Ankylosing Spondylitis
• Arthritis
• Arthritis, Psoriatic
• Arthritis, Rheumatoid
• Psoriatic Arthritis
• Rheumatoid Arthritis
• Spondylitis
• Spondylitis, Ankylosing

Intervention

Biological:
• Originator
Originator anti-TNF agents
• Biosimilar
Biosimilar anti-TNF agents

Locations

Country	Name	City	State
Australia	Southern Rheumatology	Brighton	Victoria
Australia	Northern Rheumatology and Specialists	Brunswick	Victoria
Australia	Susan Street Specialists Centre	Camperdown	New South Wales
Australia	Canberra Rheumatology	Canberra	Australian Capital Territory
Australia	Rheumatology ACT	Canberra	Australian Capital Territory
Australia	Hills Rheumatology	Castle Hill	New South Wales
Australia	Orthopaedic and Arthritis Centre	Chatswood	New South Wales
Australia	Monash Rheumatology	Clayton	Victoria
Australia	Coburg Rheumatology	Coburg	Victoria
Australia	Melbourne Arthritis Associates	Fitzroy	Victoria
Australia	Footscray Specialist Rooms	Footscray	Victoria
Australia	Barwon Rheumatology Service	Geelong	Victoria
Australia	Georgetown Arthritis	Georgetown	New South Wales
Australia	Hobart Specialists Group	Hobart	Tasmania
Australia	Rheumatology Tasmania	Hobart	Tasmania
Australia	Combined Rheumatology Practice	Kogarah	New South Wales
Australia	Peninsula Rheumatology	Langwarrin	Victoria
Australia	Coast Joint Care	Maroochydore	Queensland
Australia	Rheumatology United	Penrith	New South Wales
Australia	Gold Coast Rheumatology	Southport	Queensland
Australia	Subiaco Rheumatology	Subiaco	Western Australia
Australia	Townsville Hospital - Rheumatology	Townsville	Queensland

Sponsors (2)

Lead Sponsor	Collaborator
Opal Rheumatology Ltd.	Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	3 years
Primary	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.	3 years
Secondary	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.	3 years
Secondary	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.	3 years
Secondary	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.	3 years
Secondary	Number of patients discontinuing the drug for safety reasons	Comparison between number of patients using originator vs biosimilar who discontinue therapy for safety reasons.	3 years