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

October 13, 2020 updated by: AryoGen Pharmed Co.

Assessment of Treatment Safety and Quality of Life in Patients Receiving Etanercept Biosimilar for Autoimmune Arthritis (ASQA): a Multicenter Post-marketing Surveillance Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

583

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Autoimmune Arthritis
Patients with autoimmune arthritis, including rheumatoid arthritis, ankylosing spondylitis, and psoriatic arthritis, receiving biosimilar etanercept in real-world settings
Drug: Etanercept
Patients received biosimilar etanercept 25 mg twice weekly or 50 mg once weekly.
Other Names:
  • Altebrel
  • Biosimilar etanercept

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety: incidence of adverse events
Time Frame: Throughout the study period (up to 12 months for each patient)
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Health assessment questionnaire (HAQ)-score
Time Frame: Baseline, 3, 6, 9, and 12 months
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
Pain score
Time Frame: Baseline, 3, 6, 9, and 12 months
Pain assessment is performed on a scale of 0 to 10, with higher scores indicating greater pain.
Baseline, 3, 6, 9, and 12 months
Patient global assessments of disease activity (PGA)
Time Frame: 3, 6, 9, and 12 months
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
Physician global assessment of disease activity (PhGA)
Time Frame: 3, 6, 9, and 12 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AryoGen Pharmed Co.

Investigators

  • Principal Investigator: Ahmadreza Jamshidi, Rheumatology Research Center, Tehran University of Medical Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 4, 2014

Primary Completion (Actual)

March 19, 2018

Study Completion (Actual)

March 19, 2018

Study Registration Dates

First Submitted

October 3, 2020

First Submitted That Met QC Criteria

October 3, 2020

First Posted (Actual)

October 9, 2020

Study Record Updates

Last Update Posted (Actual)

October 19, 2020

Last Update Submitted That Met QC Criteria

October 13, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ETA.ARY.AJ.93

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

All collected deidentified individual participant data (IPD) will be shared.

IPD Sharing Time Frame

Starting 6 months after publication.

IPD Sharing Access Criteria

Data would be shared upon reasonable request from the Study Principal Investigator, without any specific criteria:

Ahmadreza Jamshidi Rheumatology Research Center, Tehran University of Medical Sciences, Tehran, Iran Email: dr.ahmadreza.jamshidi@gmail.com Tel: +982188220065

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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