Assessment of Treatment Safety and Quality of Life in Patients Receiving Etanercept Biosimilar for Autoimmune Arthritis (ASQA): a Multicenter Post-marketing Surveillance Study
Overview
- Phase
- Not Applicable
- Intervention
- Etanercept
- Conditions
- Rheumatoid Arthritis
- Sponsor
- AryoGen Pharmed Co.
- Enrollment
- 583
- Locations
- 9
- Primary Endpoint
- Safety: incidence of adverse events
- Status
- Completed
- Last Updated
- 5 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •No strict exclusion criteria were applied.
Arms & Interventions
Autoimmune Arthritis
Patients with autoimmune arthritis, including rheumatoid arthritis, ankylosing spondylitis, and psoriatic arthritis, receiving biosimilar etanercept in real-world settings
Intervention: Etanercept
Outcomes
Primary Outcomes
Safety: incidence of adverse events
Time Frame: 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 Outcomes
- Pain score(Baseline, 3, 6, 9, and 12 months)
- Health assessment questionnaire (HAQ)-score(Baseline, 3, 6, 9, and 12 months)
- Patient global assessments of disease activity (PGA)(3, 6, 9, and 12 months)
- Physician global assessment of disease activity (PhGA)(3, 6, 9, and 12 months)