Clinical trial NCT04582084: Assessment of Treatment Safety and Quality of Life in Patients Receiving Etanercept Biosimilar for Autoimmune Arthritis
Official title: Assessment of Treatment Safety and Quality of Life in Patients Receiving Etanercept Biosimilar for Autoimmune Arthritis (ASQA): a Multicenter Post-marketing Surveillance Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Ankylosing Spondylitis
Psoriatic Arthritis
Keywords: Etanercept
Biosimilar
Safety
Quality of life
Rheumatoid Arthritis
Ankylosing Spondylitis
Psoriatic Arthritis
Lead sponsor: AryoGen Pharmed Co.
Sponsor class: INDUSTRY
First posted: 2020-10-09
Enrollment: 583
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients with rheumatoid arthritis, ankylosing spondylitis, or psoriatic arthritis receiving biosimilar etanercept (either 25 mg or 50 mg) for their medical condition were eligible for this study.

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.

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.

Primary outcomes:
measure: Safety: incidence of adverse events
timeFrame: Throughout the study period (up to 12 months for each patient)
Secondary outcomes:
measure: Health assessment questionnaire (HAQ)-score
timeFrame: Baseline, 3, 6, 9, and 12 months
measure: Pain score
timeFrame: Baseline, 3, 6, 9, and 12 months
measure: Patient global assessments of disease activity (PGA)
timeFrame: 3, 6, 9, and 12 months
measure: Physician global assessment of disease activity (PhGA)
timeFrame: 3, 6, 9, and 12 months
Other outcomes:
Locations:
city: Tabriz
country: Iran, Islamic Republic of
facility: Connective Diseases Research Center, Tabriz University of Medical Sciences
state: East Azerbaijan
city: Shiraz
country: Iran, Islamic Republic of
facility: Hafez Hospital
state: Fars
city: Rasht
country: Iran, Islamic Republic of
facility: Razi Hospital
state: Guilan
city: Mashhad
country: Iran, Islamic Republic of
facility: Ghaem Hospital
state: Khorasan
city: Ahvaz
country: Iran, Islamic Republic of
facility: Golestan Hospital
state: Khouzestan
city: Isfahan
country: Iran, Islamic Republic of
facility: Alzahra Hospital
city: Isfahan
country: Iran, Islamic Republic of
facility: Personal Office
city: Kerman
country: Iran, Islamic Republic of
facility: Kerman University of Medical Sciences
city: Shiraz
country: Iran, Islamic Republic of
facility: Personal Office
city: Tehran
country: Iran, Islamic Republic of
facility: Rheumatology Research Center, Tehran University of Medical Sciences
Study officials:
affiliation: Rheumatology Research Center, Tehran University of Medical Sciences
name: Ahmadreza Jamshidi
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gharibdoost F, Salari AH, Salesi M, Ebrahimi Chaharom F, Mottaghi P, Hosseini M, Sahebari M, Nazarinia M, Mirfeizi Z, Shakibi M, Moussavi H, Karimifar M, Mowla K, Karimzadeh H, Anjidani N, Jamshidi A. Assessment of Treatment Safety and Quality of Life in Patients Receiving Etanercept Biosimilar for Autoimmune Arthritis (ASQA): A Multicenter Post-marketing Surveillance Study. Adv Ther. 2021 Feb;38(2):1290-1300. doi: 10.1007/s12325-020-01611-8. Epub 2021 Jan 11.