Ankylosing Spondylitis, Psoriatic Arthritis, Rheumatoid Arthritis
Conditions
Keywords
Etanercept, Biosimilar, Safety, Quality of life, Rheumatoid Arthritis, Ankylosing Spondylitis, Psoriatic Arthritis
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.
Interventions
DRUGEtanercept
Patients received biosimilar etanercept 25 mg twice weekly or 50 mg once weekly.
Sponsors
AryoGen Pharmed Co.
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
Countries
Iran
Outcome results
None listed