Trials / Completed
CompletedNCT04582084
Assessment of Treatment Safety and Quality of Life in Patients Receiving Etanercept Biosimilar for Autoimmune Arthritis
Assessment of Treatment Safety and Quality of Life in Patients Receiving Etanercept Biosimilar for Autoimmune Arthritis (ASQA): a Multicenter Post-marketing Surveillance Study
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 583 (actual)
- Sponsor
- AryoGen Pharmed Co. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Etanercept | Patients received biosimilar etanercept 25 mg twice weekly or 50 mg once weekly. |
Timeline
- Start date
- 2014-04-04
- Primary completion
- 2018-03-19
- Completion
- 2018-03-19
- First posted
- 2020-10-09
- Last updated
- 2020-10-19
Locations
10 sites across 1 country: Iran
Source: ClinicalTrials.gov record NCT04582084. Inclusion in this directory is not an endorsement.