Adalimumab Biosimilar in Clinical Practice | NCT04808739

Studies
Adalimumab Biosimilar in Clinical Practice

NCT04808739

Sponsor

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

Status

Completed

Last Update Posted

Mar 22, 2021Actual

Enrollment

604Actual

Phase

Not provided

Conditions

Psoriasis

Interventions

Adalimumab

Countries

Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 1, 2020Actual

Primary Completion Date

Feb 28, 2021Actual

Completion Date

Feb 28, 2021Actual

First Submitted Date

Mar 17, 2021

First Submission Date that Met QC Criteria

Mar 18, 2021

First Posted Date

Mar 22, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 18, 2021

Last Update Posted Date

Mar 22, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Adalimumab is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic treatment. There are currently several biosimilar drugs (Amgevita, Imraldi, Hyrimoz, Idacio, Hulio,…) in addition to the reference product (Humira).

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

604Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Adalimumab	Biological	Analysis of survival of adalimumab biosimilar in clinical practice

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Refusal to participate.
Any other cause of exclusion based on clinical criteria and the technical data sheet of the drug.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

2 Years

Maximum Age

90 Years

Standard Ages

ChildAdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Lluís Puig, MD, PhD	Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau		Barcelona		08041	Spain

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
32087993	Background	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.
32048187

ID	Term
D017444	Skin Diseases, Papulosquamous
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases

ID	Term
D061067	Antibodies, Monoclonal, Humanized
D000911	Antibodies, Monoclonal
D000906	Antibodies
D007136	Immunoglobulins