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

• Conditions: Psoriatic Arthritis; Rheumatoid Arthritis; Ankylosing Spondylitis
• Interventions: Biological: Originator; Biological: Biosimilar

• Registration Number: NCT03470688
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2018-03
• Study Start: 2018-03-01
• Study First Submitted: 2018-03-06
• Study First Submitted QC: 2018-03-19
• Last Update Submitted: 2018-03-19
• Study First Posted: 2018-03-20
• Last Update Posted: 2018-03-21
• Primary Completion: 2021-06-01
• Study Completion: 2021-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 5000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Originator	Originator	Originator anti-TNF agents. Dosage as per physician's decision based on approved indication.
Biosimilar	Biosimilar	Biosimilar anti-TNF agents. Dosage as per physician's decision based on approved indication.

Primary Outcome Measures

Name	Time	Method
Disease activity score based on a 28 joint count (DAS28)	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)	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

Name	Time	Method
Number of patients discontinuing the drug for safety reasons	3 years	Comparison between number of patients using originator vs biosimilar who discontinue therapy for safety reasons.
36-item Short Form Health Survey (SF-36)	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.
Patient Health Questionnaire-2 (PHQ-2)	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.
Fatigue assessed by the Functional Assessment of Chronic Illness Therapy (FACIT) questionnaire	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.

Trial Locations

Locations (22)

Susan Street Specialists Centre; 🇦🇺 Camperdown, New South Wales, Australia

Hills Rheumatology; 🇦🇺 Castle Hill, New South Wales, Australia

Orthopaedic and Arthritis Centre; 🇦🇺 Chatswood, New South Wales, Australia

Georgetown Arthritis; 🇦🇺 Georgetown, New South Wales, Australia

Coast Joint Care; 🇦🇺 Maroochydore, Queensland, Australia

Townsville Hospital - Rheumatology; 🇦🇺 Townsville, Queensland, Australia

Rheumatology United; 🇦🇺 Penrith, New South Wales, Australia

Combined Rheumatology Practice; 🇦🇺 Kogarah, New South Wales, Australia

Gold Coast Rheumatology; 🇦🇺 Southport, Queensland, Australia

Southern Rheumatology; 🇦🇺 Brighton, Victoria, Australia

Monash Rheumatology; 🇦🇺 Clayton, Victoria, Australia

Footscray Specialist Rooms; 🇦🇺 Footscray, Victoria, Australia

Melbourne Arthritis Associates; 🇦🇺 Fitzroy, Victoria, Australia

Northern Rheumatology and Specialists; 🇦🇺 Brunswick, Victoria, Australia

Coburg Rheumatology; 🇦🇺 Coburg, Victoria, Australia

Barwon Rheumatology Service; 🇦🇺 Geelong, Victoria, Australia

Peninsula Rheumatology; 🇦🇺 Langwarrin, Victoria, Australia

Canberra Rheumatology; 🇦🇺 Canberra, Australian Capital Territory, Australia

Rheumatology ACT; 🇦🇺 Canberra, Australian Capital Territory, Australia

Hobart Specialists Group; 🇦🇺 Hobart, Tasmania, Australia

Rheumatology Tasmania; 🇦🇺 Hobart, Tasmania, Australia

Subiaco Rheumatology; 🇦🇺 Subiaco, Western Australia, Australia