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

N/ACompletedNCT04582084

AryoGen Pharmed Co.583 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

583

Conditions

Rheumatoid Arthritis Ankylosing Spondylitis Psoriatic Arthritis

Interventions

EtanerceptDRUG

Patients received biosimilar etanercept 25 mg twice weekly or 50 mg once weekly.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (10)

Connective Diseases Research Center, Tabriz University of Medical Sciences

Tabriz, East Azerbaijan Province, Iran

Hafez Hospital

Shiraz, Fars, Iran

Razi Hospital

Rasht, Gilan Province, Iran

Ghaem Hospital

Mashhad, Khorasan, Iran

Outcomes

Primary Outcomes

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).

Time frame: Throughout the study period (up to 12 months for each patient)

Secondary Outcomes

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.

Time frame: Baseline, 3, 6, 9, and 12 months

Pain score

Pain assessment is performed on a scale of 0 to 10, with higher scores indicating greater pain.

Time frame: Baseline, 3, 6, 9, and 12 months

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.

Time frame: 3, 6, 9, and 12 months

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.

Time frame: 3, 6, 9, and 12 months

Data from ClinicalTrials.gov

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