PsoriasisNCT04808739
Adalimumab Biosimilar in Clinical Practice
An observational study of Psoriasis, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 2 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Psoriasis
- What is being tested?
- Adalimumab
- How many people
- 604 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jun 2020to 28 Feb 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 90 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Patients with moderate-severe psoriasis vulgaris who are candidates for systemic treatment undergoing adalimumab treatment.
Who may be able to join
- Patients of both sexes who have received treatment with adalimumab and who have signed an informed consent.
Who cannot join
- Refusal to participate.
- Any other cause of exclusion based on clinical criteria and the technical data sheet of the drug.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Barcelona, 08041
About this study
Official title: Retrospective Observational Study to Analyze the Effectiveness of Adalimumab
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.
Read the 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.
- Conditions
- Psoriasis
- Being tested
- Adalimumab
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AdalimumabBiological
Analysis of survival of adalimumab biosimilar in clinical practice
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2021
- Study start1 Jun 2020
- Primary completion28 Feb 2021
- Study completion28 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 604 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lluís Puig, MD, PhD, Principal investigator, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04808739
- Sponsor's protocol ID
- IIBSP-ADA-2020-32
- Status last verified
- Mar 2021
- First submitted
- 17 Mar 2021
- Last updated
- 22 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will be collected and data analysed in Institut de Recerca Hospital de la Santa Creu i Sant Pau
Publications
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.
PubMed 32087993Reynolds 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.
PubMed 32048187Hercogova 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.
PubMed 31206593
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Observational Study to Analyze the Effectiveness of Adalimumab
- ClinicalTrials.gov ID
- NCT04808739
- Acronym / sponsor ID
- IIBSP-ADA-2020-32
- Conditions
- Psoriasis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 604 participants (actual)
- Lead sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauUniversity, hospital or other
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 28 Feb 2021 (actual)
- Study completion
- 28 Feb 2021 (actual)
- First posted
- 22 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 2 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with moderate-severe psoriasis vulgaris who are candidates for systemic treatment undergoing adalimumab treatment.
Key inclusion criteria (1 listed)
- Patients of both sexes who have received treatment with adalimumab and who have signed an informed consent.
Key exclusion criteria (2 listed)
- Refusal to participate.
- Any other cause of exclusion based on clinical criteria and the technical data sheet of the drug.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AdalimumabAnalysis of survival of adalimumab biosimilar in clinical practice | Biological | – |
Primary outcome
Median time of survival (months) of adalimumab biosimilar in clinical practice
Time frame: 1 year
Median time of survival (months) of patients under treatment with adalimumab biosimilar in clinical practice
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2021.
- Background: PubMed 32087993Khandpur 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.
- Background: PubMed 32048187Reynolds 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.
- Background: PubMed 31206593Hercogova 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.
- Individual participant dataSharing planned: No. IPD will be collected and data analysed in Institut de Recerca Hospital de la Santa Creu i Sant Pau
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lluís Puig, MD, PhD principal investigator
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Psoriasis, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Median time of survival (months) of adalimumab biosimilar in clinical practice (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04808739, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2021.