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

NCT04582084 | Completed

• 1 other identifier: ETA.ARY.AJ.93
• Study Type: observational
• Target: 583
• Locations: 1 country
• Sites: 10

Brief 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.

Conditions

Rheumatoid Arthritis; Ankylosing Spondylitis; Psoriatic Arthritis

Keywords

Etanercept; Biosimilar; Safety; Quality of life; Rheumatoid Arthritis; Ankylosing Spondylitis; Psoriatic Arthritis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Health assessment questionnaire (HAQ)-score

  Baseline, 3, 6, 9, and 12 months

• Pain score

  Baseline, 3, 6, 9, and 12 months

• Patient global assessments of disease activity (PGA)

  3, 6, 9, and 12 months

• Physician global assessment of disease activity (PhGA)

  3, 6, 9, and 12 months

Study Arms (1)

Autoimmune Arthritis

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

Drug: Etanercept

Interventions

Etanercept DRUG

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

Also known as: Biosimilar etanercept, Altebrel

Autoimmune Arthritis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

Sponsors & Collaborators

• AryoGen Pharmed Co.: lead

Study Sites (10)

Connective Diseases Research Center, Tabriz University of Medical Sciences

Tabriz, East Azerbaijan Province, Iran

Location

Hafez Hospital

Shiraz, Fars, Iran

Location

Razi Hospital

Rasht, Gilan Province, Iran

Location

Ghaem Hospital

Mashhad, Khorasan, Iran

Location

Golestan Hospital

Ahvāz, Khouzestan, Iran

Location

Alzahra Hospital

Isfahan, Iran

Location

Personal Office

Isfahan, Iran

Location

Kerman University of Medical Sciences

Kerman, Iran

Location

Personal Office

Shiraz, Iran

Location

Rheumatology Research Center, Tehran University of Medical Sciences

Tehran, Iran

Location

Related Publications (1)

• Gharibdoost F, Salari AH, Salesi M, Ebrahimi Chaharom F, Mottaghi P, Hosseini M, Sahebari M, Nazarinia M, Mirfeizi Z, Shakibi M, Moussavi H, Karimifar M, Mowla K, Karimzadeh H, Anjidani N, Jamshidi A. Assessment of Treatment Safety and Quality of Life in Patients Receiving Etanercept Biosimilar for Autoimmune Arthritis (ASQA): A Multicenter Post-marketing Surveillance Study. Adv Ther. 2021 Feb;38(2):1290-1300. doi: 10.1007/s12325-020-01611-8. Epub 2021 Jan 11.

  PMID: 33432540 DERIVED

MeSH Terms

Conditions

Arthritis, Rheumatoid; Spondylitis, Ankylosing; Arthritis, Psoriatic

Interventions

Etanercept; etanercept biosimilar SB4

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Axial Spondyloarthritis; Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Ankylosis; Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases

Intervention Hierarchy (Ancestors)

Immunoglobulin Fc Fragments; Immunoglobulin Fragments; Peptide Fragments; Peptides; Amino Acids, Peptides, and Proteins; Immunoglobulin Constant Regions; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins; Receptors, Tumor Necrosis Factor; Receptors, Cytokine; Receptors, Immunologic; Receptors, Cell Surface; Membrane Proteins

Study Officials

• Ahmadreza Jamshidi

  Rheumatology Research Center, Tehran University of Medical Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 3, 2020
• First Posted: October 9, 2020
• Study Start: April 4, 2014
• Primary Completion: March 19, 2018
• Study Completion: March 19, 2018
• Last Updated: October 19, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will share
• Time Frame: Starting 6 months after publication.
• 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

Locations

IR (10)