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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

583 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-04-04

Study Completion Date

2018-03-19

Brief Summary

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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.

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Detailed Description

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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

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Rheumatoid Arthritis Ankylosing Spondylitis Psoriatic Arthritis

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Autoimmune Arthritis

Patients with autoimmune arthritis, including rheumatoid arthritis, ankylosing spondylitis, and psoriatic arthritis, receiving biosimilar etanercept in real-world settings

Etanercept

Intervention Type DRUG

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

Interventions

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Etanercept

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

Intervention Type DRUG

Other Intervention Names

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Biosimilar etanercept Altebrel

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No