Adalimumab Biosimilar in Clinical Practice

NCT04808739 | Completed DMC

• 1 other identifier: IIBSP-ADA-2020-32
• Study Type: observational
• Target: 604
• Locations: 1 country
• Sites: 1

Brief Summary

This is an observational, retrospective, multicenter, and descriptive study of patients treated with adalimumab biosimilar for psoriasis, according to clinical practice. 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.

Conditions

Psoriasis

Outcome Measures

Primary Outcomes (1)

• Median time of survival (months) of adalimumab biosimilar in clinical practice

  Median time of survival (months) of patients under treatment with adalimumab biosimilar in clinical practice

  1 year

Interventions

Adalimumab BIOLOGICAL

Analysis of survival of adalimumab biosimilar in clinical practice

Eligibility Criteria

• Age: 2 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with moderate-severe psoriasis vulgaris who are candidates for systemic treatment undergoing adalimumab treatment.

You may qualify if:

• Patients of both sexes who have received treatment with adalimumab and who have signed an informed consent.

You may not qualify if:

• Refusal to participate.

Sponsors & Collaborators

• Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau: lead

Study Sites (1)

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Barcelona, 08041, Spain

Location

Related Publications (3)

• 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.

  PMID: 32087993 BACKGROUND

• 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.

  PMID: 32048187 BACKGROUND

• 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.

  PMID: 31206593 BACKGROUND

MeSH Terms

Conditions

Psoriasis

Interventions

Adalimumab

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Lluís Puig, MD, PhD

  Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2021
• First Posted: March 22, 2021
• Study Start: June 1, 2020
• Primary Completion: February 28, 2021
• Study Completion: February 28, 2021
• Last Updated: March 22, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)