Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Autoimmune Arthritis | Patients with autoimmune arthritis, including rheumatoid arthritis, ankylosing spondylitis, and psoriatic arthritis, receiving biosimilar etanercept in real-world settings |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Etanercept | Drug | Patients received biosimilar etanercept 25 mg twice weekly or 50 mg once weekly. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
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.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Ahmadreza Jamshidi | Rheumatology Research Center, Tehran University of Medical Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Connective Diseases Research Center, Tabriz University of Medical Sciences | Tabriz | East Azerbaijan Province | Iran | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33432540 | Derived | 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. |
Not provided
Not provided
All collected deidentified individual participant data (IPD) will be shared.
Not provided
Starting 6 months after publication.
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
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
| 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 |
| 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 |
| Hafez Hospital |
| Shiraz |
| Fars |
| Iran |
| Razi Hospital | Rasht | Gilan Province | Iran |
| Ghaem Hospital | Mashhad | Khorasan | Iran |
| Golestan Hospital | Ahvāz | Khouzestan | Iran |
| Alzahra Hospital | Isfahan | Iran |
| Personal Office | Isfahan | Iran |
| Kerman University of Medical Sciences | Kerman | Iran |
| Personal Office | Shiraz | Iran |
| Rheumatology Research Center, Tehran University of Medical Sciences | Tehran | Iran |
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| D013167 | Spondylitis, Ankylosing |
| D015535 | Arthritis, Psoriatic |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D000089183 | Axial Spondyloarthritis |
| D025242 | Spondylarthropathies |
| D025241 | Spondylarthritis |
| D013166 | Spondylitis |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D000844 | Ankylosis |
| D011565 | Psoriasis |
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068800 | Etanercept |
| C000711255 | etanercept biosimilar SB4 |
| ID | Term |
|---|---|
| D007141 | Immunoglobulin Fc Fragments |
| D007128 | Immunoglobulin Fragments |
| D010446 | Peptide Fragments |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D007127 | Immunoglobulin Constant Regions |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D018124 | Receptors, Tumor Necrosis Factor |
| D018121 | Receptors, Cytokine |
| D011971 | Receptors, Immunologic |
| D011956 | Receptors, Cell Surface |
| D008565 | Membrane Proteins |
Not provided
Not provided