PsoriasisPSOBIOTEQNCT01617018
Assessing the Long Term Effectiveness and Safety of Biotherapies in the Treatment of Cutaneous Psoriasis
An observational study of Psoriasis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
PSOBIOTEQ is a national multicentric prospective cohort of cutaneous psoriasis patients receiving systemic treatment (biotherapy or DMARDs) for moderate to severe cutaneous psoriasis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psoriasis
- How many people
- 4,613 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2012to 5 Sep 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient consulting or being hospitalized for cutaneous psoriasis (clinical diagnosis), justifying the prescription of a major systemic therapy (methotrexate or cyclosporine, or biotherapy) and for whom cutaneous psoriasis is the main reason for systemic treatment
Who may be able to join
- Patients aged 18 years
- Having been informed of the objectives and conduct of the research and having signed a written informed consent to participate
- Consulting or being hospitalized for cutaneous psoriasis (clinical diagnosis) justifying the prescription of a major systemic therapy and for whom cutaneous psoriasis is the main reason for systemic treatment and belonging to one of the two following groups:
- Patients exposed to a major conventional systemic therapy (methotrexate or cyclosporine, excluding biotherapies) since at least 3 months and for which there are no plans to institute treatment with biotherapy in the next 6 months : non-exposed group.
- Patients exposed to a biological therapy (infliximab, adalimumab, etanercept, ustekinumab and other biotherapy entering the market) : exposed group.
Who cannot join
- Patients for whom cutaneous psoriasis is not the main reason for systemic treatment: treatment justified by psoriatic arthritis, concomitant Crohn's disease ...;
- Patients unable to comply with the planned cohort monitoring or whose follow-up is expected to be difficult.
- Patient for whom the treatment given at baseline cannot be identified (Patient participating to a double-blind trialinvolving biotherapies for example).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Systemic Treatment for Psoriasis Patients: A Prospective Multicentric Observational Cohort Study
PSOBIOTEQ is a national multicentric prospective cohort of cutaneous psoriasis patients receiving systemic treatment (biotherapy or DMARDs) for moderate to severe cutaneous psoriasis. It is resulting from the merging of two studies that share the same study population but address different objectives: PSOBIO, developed by academic dermatologists and epidemiologists and supported by the National Drug Agency (AGENCE NATIONALE DE SECURITE DU MEDICAMENT ET DES PRODUITS DE SANTE,ANSM) and the ministry of health (PHRC 2009) focusing on safety issues, and Pso-TEQ, developed by industrials at the request of the French Transparency Commission (HAUTE AUTORITE DE SANTE) focusing on utilisation issues.
The overall general objective of PSOBIO is to assess "in real life" the safety and efficacy of biotherapies in the treatment of cutaneous psoriasis in comparison with major conventional systemic therapy while Pso-TEQ has a descriptive objective concerning the modalities of use of biological therapies "in real life" and long-term benefit.
Read the detailed description
PSOBIOTEQ is a national multicentric prospective cohort, including patients receiving systemic treatment (biotherapy or DMARDs) for moderate to severe cutaneous psoriasis.
The exposure of interest is the exposure to a biological therapy: infliximab, adalimumab, etanercept, ustekinumab and other biotherapy entering the market.
The nature of the systemic treatment as well as its administration modalities are defined by the investigator according to usual practice.
All dermatology departments located in the French metropolitan area and using biotherapies as treatment of cutaneous psoriasis will be solicited for participation to the cohort.
The inclusion will last at least 3 years with a follow-up of at least 5 years for each patient (8 years maximum), with a 6 month periodicity for the data collection (complying with good clinical practice for these patients). Follow-up duration may be extended in the case of the identification of safety signals in the early years.
Each study within the cohort has its specific endpoints according to its specific objectives but the whole data required will be collected at the same time for both studies then registered in a single database (eCRF). The statistical analyses will be performed by the clinical investigation and epidemiology center (INSERM CIE 801) of BICHAT hospital's department of epidemiology and clinical research
2 636 patients will be included with the following distribution:.
- Non-exposed group: 1200 patients
- Exposed group: 1436 patients (naive or not) with at least 1200 patients naive for biotherapy.
- Conditions
- Psoriasis
- Keywords
- Psoriasis; Biological therapy; Methotrexate; Cyclosporine
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Exposed group | Biotherapy | |
| Non-exposed group | Major conventional systemic therapy (methotrexate or cyclosporine) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of skin cancer
Occurrence of skin cancer (spinocellular carcinomas [including carcinoma in situ (Bowen) and keratoacanthomas], basocellular carcinomas and melanomas).
Measured: Each patient will be followed for at least 5 years(8 years maximum), data being collected at each visit (approximately every 6 month)
Secondary outcomes (1)
Event-free survival; incidence of serious adverse events;effectiveness;therapeutic strategy,long-term safety(serious and non-serious adverse events,quality of life, rebounds after treatment discontinuation;maintenance of a therapeutic response over time
Composite measure
Measured: Each patient will be followed for at least 5 years(8 years maximum), data being collected at each visit (approximately every 6 month)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2012 (estimated)
- Study startJul 2012
- Primary completion5 Sep 2021
- Study completion5 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 4,613 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- French Health Products Safety Agency, Société de Dermatologie Française, Janssen, LP, Pfizer, AbbVie, Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
- Investigators
- Olivier Chosidow, Md, Phd, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01617018
- Sponsor's protocol ID
- AOM09195
- Other IDs
- N° IRB00006477
- Acronym
- PSOBIOTEQ
- Status last verified
- Sep 2021
- First submitted
- 8 Jun 2012
- Last updated
- 10 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Systemic Treatment for Psoriasis Patients: A Prospective Multicentric Observational Cohort Study
- ClinicalTrials.gov ID
- NCT01617018
- Acronym / sponsor ID
- PSOBIOTEQ / AOM09195
- Conditions
- Psoriasis
- Keywords
- Psoriasis; Biological therapy; Methotrexate; Cyclosporine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,613 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- French Health Products Safety Agency, Société de Dermatologie Française, Janssen, LP, Pfizer, AbbVie, Merck Sharp & Dohme LLC
- Study start
- Jul 2012 (actual)
- Primary completion
- 5 Sep 2021 (actual)
- Study completion
- 5 Sep 2021 (actual)
- First posted
- 12 Jun 2012 (estimated)
- 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.
PSOBIOTEQ is a national multicentric prospective cohort of cutaneous psoriasis patients receiving systemic treatment (biotherapy or DMARDs) for moderate to severe cutaneous psoriasis. It is resulting from the merging of two studies that share the same study population but address different objectives: PSOBIO, developed by academic dermatologists and epidemiologists and supported by the National Drug Agency (AGENCE NATIONALE DE SECURITE DU MEDICAMENT ET DES PRODUITS DE SANTE,ANSM) and the ministry of health (PHRC 2009) focusing on safety issues, and Pso-TEQ, developed by industrials at the request of the French Transparency Commission (HAUTE AUTORITE DE SANTE) focusing on utilisation issues.
The overall general objective of PSOBIO is to assess "in real life" the safety and efficacy of biotherapies in the treatment of cutaneous psoriasis in comparison with major conventional systemic therapy while Pso-TEQ has a descriptive objective concerning the modalities of use of biological therapies "in real life" and long-term benefit.
Detailed description
PSOBIOTEQ is a national multicentric prospective cohort, including patients receiving systemic treatment (biotherapy or DMARDs) for moderate to severe cutaneous psoriasis.
The exposure of interest is the exposure to a biological therapy: infliximab, adalimumab, etanercept, ustekinumab and other biotherapy entering the market.
The nature of the systemic treatment as well as its administration modalities are defined by the investigator according to usual practice.
All dermatology departments located in the French metropolitan area and using biotherapies as treatment of cutaneous psoriasis will be solicited for participation to the cohort.
The inclusion will last at least 3 years with a follow-up of at least 5 years for each patient (8 years maximum), with a 6 month periodicity for the data collection (complying with good clinical practice for these patients). Follow-up duration may be extended in the case of the identification of safety signals in the early years.
Each study within the cohort has its specific endpoints according to its specific objectives but the whole data required will be collected at the same time for both studies then registered in a single database (eCRF). The statistical analyses will be performed by the clinical investigation and epidemiology center (INSERM CIE 801) of BICHAT hospital's department of epidemiology and clinical research
2 636 patients will be included with the following distribution:.
- Non-exposed group: 1200 patients
- Exposed group: 1436 patients (naive or not) with at least 1200 patients naive for biotherapy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exposed group | – | –Biotherapy |
| Non-exposed group | – | –Major conventional systemic therapy (methotrexate or cyclosporine) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient consulting or being hospitalized for cutaneous psoriasis (clinical diagnosis), justifying the prescription of a major systemic therapy (methotrexate or cyclosporine, or biotherapy) and for whom cutaneous psoriasis is the main reason for systemic treatment
Key inclusion criteria (5 listed)
- Patients aged 18 years
- Having been informed of the objectives and conduct of the research and having signed a written informed consent to participate
- Consulting or being hospitalized for cutaneous psoriasis (clinical diagnosis) justifying the prescription of a major systemic therapy and for whom cutaneous psoriasis is the main reason for systemic treatment and belonging to one of the two following groups:
Key exclusion criteria (3 listed)
- Patients for whom cutaneous psoriasis is not the main reason for systemic treatment: treatment justified by psoriatic arthritis, concomitant Crohn's disease ...;
- Patients unable to comply with the planned cohort monitoring or whose follow-up is expected to be difficult.
- Patient for whom the treatment given at baseline cannot be identified (Patient participating to a double-blind trialinvolving biotherapies for example).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Occurrence of skin cancer
Time frame: Each patient will be followed for at least 5 years(8 years maximum), data being collected at each visit (approximately every 6 month)
Occurrence of skin cancer (spinocellular carcinomas [including carcinoma in situ (Bowen) and keratoacanthomas], basocellular carcinomas and melanomas).
1 secondary outcome
Event-free survival; incidence of serious adverse events;effectiveness;therapeutic strategy,long-term safety(serious and non-serious adverse events,quality of life, rebounds after treatment discontinuation;maintenance of a therapeutic response over time
Time frame: Each patient will be followed for at least 5 years(8 years maximum), data being collected at each visit (approximately every 6 month)
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 10 Sep 2021.
Related trials for Psoriasis
Not yet recruitingPhase 2
Extension Study of Safety and Tolerability of DDY391 in Participants With Moderate to Severe Psoriatic Arthritis (CDDY391A12201-extension)
Moderate to Severe Psoriatic Arthritis
Recruiting
Efficacy of a Self-Management Smartphone App to Improve Safety Skills in Patients With Inflammatory Arthritis
Rhumatoid Arthisis, Spondyloarthritis (SA)
Active, not recruitingPhase 2
Dose Ranging Study of ORKA-001 in Patients With Moderate-to-Severe Plaque Psoriasis
Plaque Psoriasis
RecruitingPhase 1
A Study of HB0017 Injection in Healthy Volunteers to Evaluate Safety and Tolerability of a Single Subcutaneous Injection in Low-Body-Weight Subjects; and Pharmacokinetics at Different Subcutaneous Injection Sites at the Same Dose
Psoriasis, Ankylosing Spondylitis
RecruitingPhase 1
A Study to Learn if Bimekizumab Given in Different Ways is Safe and Moves Similarly Throughout the Body Over Time in Adults
Psoriatic Arthritis, Axial Spondyloarthritis
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.
Olivier Chosidow, Md, Phd principal investigator
Assistance Publique - Hôpitaux de Paris
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 Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 5 inclusion and 3 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 10 Sep 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 France. 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?
Occurrence of skin cancer (time frame: Each patient will be followed for at least 5 years(8 years maximum), data being collected at each visit (approximately every 6 month)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Sep 2021.