Assessment of Treatment Safety and Quality of Life in Patients Receiving Etanercept Biosimilar for Autoimmune Arthritis

Rheumatoid Arthritis Clinical Trial

— ASQA  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04582084
• Other study ID #: ETA.ARY.AJ.93
• Status: Completed
• Start date: April 4, 2014
• Est. completion date: March 19, 2018

Study information

• Verified date: October 2020
• Source: AryoGen Pharmed Co.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 583
• Est. completion date: March 19, 2018
• Est. primary completion date: March 19, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Ankylosing Spondylitis
• Arthritis
• Arthritis, Psoriatic
• Arthritis, Rheumatoid
• Psoriatic Arthritis
• Rheumatoid Arthritis
• Spondylitis
• Spondylitis, Ankylosing

Intervention

Drug:
• Etanercept
Patients received biosimilar etanercept 25 mg twice weekly or 50 mg once weekly.

Locations

Country	Name	City	State
Iran, Islamic Republic of	Golestan Hospital	Ahvaz	Khouzestan
Iran, Islamic Republic of	Alzahra Hospital	Isfahan
Iran, Islamic Republic of	Personal Office	Isfahan
Iran, Islamic Republic of	Kerman University of Medical Sciences	Kerman
Iran, Islamic Republic of	Ghaem Hospital	Mashhad	Khorasan
Iran, Islamic Republic of	Razi Hospital	Rasht	Guilan
Iran, Islamic Republic of	Hafez Hospital	Shiraz	Fars
Iran, Islamic Republic of	Personal Office	Shiraz
Iran, Islamic Republic of	Connective Diseases Research Center, Tabriz University of Medical Sciences	Tabriz	East Azerbaijan
Iran, Islamic Republic of	Rheumatology Research Center, Tehran University of Medical Sciences	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
AryoGen Pharmed Co.

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety: incidence of adverse events	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).	Throughout the study period (up to 12 months for each patient)
Secondary	Health assessment questionnaire (HAQ)-score	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.	Baseline, 3, 6, 9, and 12 months
Secondary	Pain score	Pain assessment is performed on a scale of 0 to 10, with higher scores indicating greater pain.	Baseline, 3, 6, 9, and 12 months
Secondary	Patient global assessments of disease activity (PGA)	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.	3, 6, 9, and 12 months
Secondary	Physician global assessment of disease activity (PhGA)	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.	3, 6, 9, and 12 months