Study Results
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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COMPLETED
604 participants
OBSERVATIONAL
2020-06-01
2021-02-28
Brief Summary
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Existing data will be collected from the Dermatology Services database of the hospitals participating in the study, from the medical histories of all treated patients who meet the inclusion criteria and sign informed consent.
The aim of the study is to determine the effectiveness of the different adalimumab biosimilars in clinical practice.
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Detailed Description
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The reduction in the cost of production of biosimilar drugs with respect to reference products has led to their replacement by biosimilar drugs in patients initiating biological therapy, but some centers are also switching to adalimumab biosimilar in patients who are controlled with original adalimumab (Humira).
There are no actual clinical efficacy / safety data in our setting on the use of adalimumab biosimilars.
There is also no evidence of maintenance response in patients who are switched from adalimumab (Humira) to biosimilar adalimumab in clinical practice.
This retrospective study will collect demographic and disease data of the psoriasis patient treated with the different biosimilars of adalimumab, as well as their comorbidities, response to treatment, and safety. In this way, data will be available in usual clinical practice to improve the management of the patient with psoriasis treated with biosimilar drugs.
Conditions
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Study Design
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COHORT
RETROSPECTIVE
Interventions
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Adalimumab
Analysis of survival of adalimumab biosimilar in clinical practice
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Any other cause of exclusion based on clinical criteria and the technical data sheet of the drug.
2 Years
90 Years
ALL
Yes
Sponsors
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Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
OTHER
Responsible Party
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Principal Investigators
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Lluís Puig, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Locations
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Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Barcelona, , Spain
Countries
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References
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Khandpur S, Sondhi P, Taneja N, Sharma P, Das D, Sharma A, Sreenivas V. Evaluation of adalimumab biosimilar in treatment of psoriatic arthritis with concomitant moderate to severe chronic plaque psoriasis: An open-labeled, prospective, pilot case series. J Am Acad Dermatol. 2020 Jul;83(1):248-251. doi: 10.1016/j.jaad.2019.12.071. Epub 2020 Feb 19. No abstract available.
Reynolds KA, Pithadia DJ, Lee EB, Liao W, Wu JJ. Safety and Effectiveness of Anti-Tumor Necrosis Factor-Alpha Biosimilar Agents in the Treatment of Psoriasis. Am J Clin Dermatol. 2020 Aug;21(4):483-491. doi: 10.1007/s40257-020-00507-1.
Hercogova J, Papp KA, Chyrok V, Ullmann M, Vlachos P, Edwards CJ. AURIEL-PsO: a randomized, double-blind phase III equivalence trial to demonstrate the clinical similarity of the proposed biosimilar MSB11022 to reference adalimumab in patients with moderate-to-severe chronic plaque-type psoriasis. Br J Dermatol. 2020 Feb;182(2):316-326. doi: 10.1111/bjd.18220. Epub 2019 Sep 26.
Other Identifiers
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IIBSP-ADA-2020-32
Identifier Type: -
Identifier Source: org_study_id
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