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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04582084
Other study ID # ETA.ARY.AJ.93
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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.

Study Design


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
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