Assessment of Treatment Safety and Quality of Life in Patients Receiving Etanercept Biosimilar for Autoimmune Arthritis
- Conditions
- Psoriatic ArthritisAnkylosing SpondylitisRheumatoid Arthritis
- Interventions
- Registration Number
- NCT04582084
- Lead Sponsor
- AryoGen Pharmed Co.
- Brief Summary
In this open-label, multi-center, observational, post-marketing surveillance study, patients with ankylosing spondylitis, psoriatic arthritis, or rheumatoid arthritis received biosimilar etanercept 25 mg twice weekly or 50 mg once weekly in real-world settings. Safety and effectiveness of biosimilar etanercept were evaluated in study participants for a duration of up to 12 months.
- Detailed Description
In this open-label, multi-center, observational, post-marketing surveillance study, patients with ankylosing spondylitis, psoriatic arthritis, or rheumatoid arthritis received biosimilar etanercept 25 mg twice weekly or 50 mg once weekly in real-world settings. Safety and effectiveness of biosimilar etanercept were evaluated in study participants for a duration of up to 12 months. Patient information was recorded in four notebooks, and each notebook had three sections, one section for each month. The first section of notebook I contained demographic information, pregnancy and lactation status in female patients, cigarette smoking and alcohol consumption, and past medical history. All safety and effectiveness outcomes were recorded at the appropriate sections of the notebooks.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 583
- Adults with the diagnosis of rheumatoid arthritis, ankylosing spondylitis, or psoriatic arthritis receiving biosimilar etanercept (either 25 mg or 50 mg) for their medical condition.
- No strict exclusion criteria were applied.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Autoimmune Arthritis Etanercept Patients with autoimmune arthritis, including rheumatoid arthritis, ankylosing spondylitis, and psoriatic arthritis, receiving biosimilar etanercept in real-world settings
- Primary Outcome Measures
Name Time Method Safety: incidence of adverse events Throughout the study period (up to 12 months for each patient) All adverse events, including serious adverse events, are reported using system organ classes and preferred terms of the medical dictionary for regulatory activities (MedDRA Desktop Browser 4.0 Beta).
- Secondary Outcome Measures
Name Time Method Pain score Baseline, 3, 6, 9, and 12 months Pain assessment is performed on a scale of 0 to 10, with higher scores indicating greater pain.
Health assessment questionnaire (HAQ)-score Baseline, 3, 6, 9, and 12 months Health assessment questionnaire (HAQ) is a functional test used in patients with a wide variety of rheumatic diseases, including rheumatoid arthritis, ankylosing spondylitis, and psoriatic arthritis. HAQ score ranges from 0 to 3, with higher scores indicating more severe functional disability.
Patient global assessments of disease activity (PGA) 3, 6, 9, and 12 months Patient global assessment of disease activity (PGA) is a very common patient reported outcome measure used in rheumatic disorders. PGA assessment is performed on a scale of 0 to 10, with higher scores indicating higher disease activity.
Physician global assessment of disease activity (PhGA) 3, 6, 9, and 12 months Physician global assessment of disease activity (PhGA) is used to assess disease severity by physicians. PhGA assessment is performed on a scale of 0 to 10, with higher scores indicating higher disease activity.
Trial Locations
- Locations (9)
Alzahra Hospital
🇮🇷Isfahan, Iran, Islamic Republic of
Connective Diseases Research Center, Tabriz University of Medical Sciences
🇮🇷Tabriz, East Azerbaijan, Iran, Islamic Republic of
Hafez Hospital
🇮🇷Shiraz, Fars, Iran, Islamic Republic of
Golestan Hospital
🇮🇷Ahvaz, Khouzestan, Iran, Islamic Republic of
Razi Hospital
🇮🇷Rasht, Guilan, Iran, Islamic Republic of
Personal Office
🇮🇷Shiraz, Iran, Islamic Republic of
Rheumatology Research Center, Tehran University of Medical Sciences
🇮🇷Tehran, Iran, Islamic Republic of
Ghaem Hospital
🇮🇷Mashhad, Khorasan, Iran, Islamic Republic of
Kerman University of Medical Sciences
🇮🇷Kerman, Iran, Islamic Republic of