PsoriasisREALIZENCT03757013
A Study to Assess Benefits of Apremilast in Patients With Moderate to Severe Chronic Plaque Psoriasis Followed by Dermatologists Under Real Life Settings in France
An observational study of Psoriasis, run by Amgen at 93 sites in France.
Trial summary
REALIZE study will include a representative sample of 500 patients with moderate to severe plaque psoriasis for whom the treating dermatologist has decided to begin apremilast treatment in accordance with the local label reimbursement criteria. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psoriasis
- What is being tested?
- Apremilast
- How many people
- 453 participants
- Where
- 93 sitesFrance
- Study dates
- 25 Sep 2018to 10 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: Patients with moderate to severe plaque psoriasis for whom the treating dermatologist has decided to begin apremilast treatment in accordance with the local label reimbursement criteria. Patients may be enrolled into the study up to 4 weeks after starting the study treatment. All eligible patients will be included in the safety population in consecutive order based on the date of the non-opposition form. However, only patients who have completed 6 (± 1) months of treatment will be included in the reference analysis population
Who may be able to join
- Male or female aged at least 18 years
- Patient with a diagnosis of stable moderate to severe chronic plaque psoriasis
- For whom the treating dermatologist has made the decision to initiate apremilast treatment in accordance with the local label and reimbursement criteria i.e. a history of failure or contra-indication or intolerance to other systemic therapy including ciclosporin, methotrexate, or phototherapy UVA + psoralen (PUVA therapy)
- Patient having started apremilast up to 4 weeks before the enrolment visit for treatment of moderate to severe chronic plaque psoriasis even if apremilast has been stopped before inclusion in the study
- Patient literate and willing to fill in questionnaires
- Non-opposition form signed by the investigator indicating that the patient received information about the study, and orally agreed.
Who cannot join
- Patient who refuses to participate in the study or is unable to give his/her oral consent
- Patient having participated in an interventional study in the last 30 days
Trial locations and contacts
93 sites in 1 country.
93 sites in 1 country
France93 sites
Private Practice, Amiens
Amiens, 80000
Saint-Joseph Clinic, Angouleme
Angoulême, 16000
Private Practice, Antibes
Antibes, 06600
Private Practice 2, Antony
Antony, 92160
Private Practice 2, Arcachon
Arcachon, 33120
Private Practice, Argenteuil
Argenteuil, 95100
Private Practice, Aubière
Aubière, 63170
Private Practice, Auch
Auch, 32000
Auxerre Hospital
Auxerre, 89000
Henri Duffaut Hospital
Avignon, 84902
Private Practice, Bègles
Bègles, 33130
Private Practice, Besançon
Besançon, 25000
Reims-Bezannes Polyclinic 2
Bezannes, 51430
Reims-Bezannes Polyclinic 3
Bezannes, 51430
Reims-Bezannes Polyclinic
Bezannes, 51430
Private Practice, Biarritz
Biarritz, 64200
Private Practice, Bordeaux
Bordeaux, 33000
Docteur Duchenne Hospital 2
Boulogne-sur-Mer, 62321
Docteur Duchenne Hospital
Boulogne-sur-Mer, 62321
Private Practice 2, Caen
Caen, 14000
Private Practice 3, Caen
Caen, 14000
Private Practice, Caen
Caen, 14000
Private Practice, Cannes
Cannes, 06400
Private Practice 2, Chalons-en-Champagne
Châlons-en-Champagne, 51000
Private Practice, Chalons-en-Champagne
Châlons-en-Champagne, 51000
Chalons-en-Champagne Hospital
Châlons-en-Champagne, 51005
Private Practice, Chamalières
Chamalières, 63400
Métropole Savoie Hospital
Chambéry, 73000
Trousseau Hospital
Chambray-lès-Tours, 37171
Private Practice 2, Chartres
Chartres, 28000
Private Practice, Chartres
Chartres, 28000
New Sud Francilien Hospital
Corbeil-Essonnes, 91100
GH de Dax, Dax
Dax, 40107
Private Practice 2, Dijon
Dijon, 21000
Private Practice 3, Dijon
Dijon, 21000
Private Practice, Dijon
Dijon, 21000
Private Practice, Dole
Dole, 39100
Victor Jousselin Hospital
Dreux, 28102
Emile Durkheim Hospital - Saint Jean Health Center
Épinal, 88021
Private Practice, Essey-les-Nancy
Essey-lès-Nancy, 54270
Golfe de St-Tropez Clinic
Gassin, 83580
Private Practice 2, Joue les Tours
Joué-lès-Tours, 37300
Private Practice 3, Joue les Tours
Joué-lès-Tours, 37300
Private Practice, Joue les Tours
Joué-lès-Tours, 37300
Private Practice, L'Union
L'Union, 31240
Private Practice 2, La Teste-de-Buch
La Teste-de-Buch, 33260
Private Practice, La Teste-de-Buch
La Teste-de-Buch, 33260
Private Practice, La Valette du Var
La Valette-du-Var, 83160
Private Practice, La Varenne Saint Hilaire
La Varenne-Saint-Hilaire, 94210
Private Practice 2, Laval
Laval, 53000
Private Practice, Laval
Laval, 53000
Private Practice, Le-Bourget-du-Lac
Le Bourget-du-Lac, 73370
Private Practice, Le Mans
Le Mans, 72000
Mans Hospital 2
Le Mans, 72037
Mans Hospital
Le Mans, 72037
Private Practice, Lille
Lille, 59000
Private Practice 2, Luce
Lucé, 28110
Private Practice, Luce
Lucé, 28110
Private Practice, Lyon
Lyon, 69002
Edouard Herriot Hospital
Lyon, 69003
Private Practice 2, Lyon
Lyon, 69006
Private Practice 4, Lyon
Lyon, 69008
Private Practice, Martigues
Martigues, 13500
Annecy Genevois Hospital, Metz Tessy
Metz-Tessy, 74370
Private Practice, Meudon-la-Forêt
Meudon-la-Forêt, 92360
Private Practice, Muret
Muret, 31600
Hotel Dieu Hospital, Dermatologic Clinic
Nantes, 44093
Private Practice, Narbonne
Narbonne, 11100
Private Practice, Nevers
Nevers, 58000
Private Practice 2, Nice
Nice, 06000
Private Practice 3, Nice
Nice, 06000
Private Practice, Nogent-Le-Rotrou
Nogent-le-Rotrou, 28400
Private Practice, Orléans
Orléans, 45000
Private Practice, Paris
Paris, 75005
Private Practice 2, Paris
Paris, 75006
Private Practice 3, Paris
Paris, 75008
Private Practice 4, Paris
Paris, 75009
Private Practice 5, Paris
Paris, 75010
Private Practice, Pontarlier
Pontarlier, 25300
Private Practice, Pontoise
Pontoise, 95300
Private Practice, Quimper
Quimper, 29000
CHI de Cornouaille - Laennec
Quimper, 29107
Mathilde II Clinic
Rouen, 76100
Private Practice, Saint-Etienne
Saint-Etienne, 42000
Saint-Etienne Hospital
Saint-Priest-en-Jarez, 42277
Private Practice, Torcy
Torcy, 77200
BCRM Toulon - HIA Saint-Anne
Toulon, 83800
Private Practice, Toulouse
Toulouse, 31000
Nord Franche-Comté Hospital
Trévenans, 90400
Valence Hospital 2
Valence, 26953
Valence Hospital 3
Valence, 26953
Valence Hospital
Valence, 26953
Jacques Lacarin Hospital
Vichy, 03201
About this study
Official title: Real Life Data for Otezla Evidence: Assessing Benefits of Apremilast in Patients With Moderate to Severe Chronic Plaque Psoriasis Followed by Dermatologists Under Real Life Settings in France
REALIZE study will include a representative sample of 500 patients with moderate to severe plaque psoriasis for whom the treating dermatologist has decided to begin apremilast treatment in accordance with the local label reimbursement criteria. Patients may be enrolled into the study up to 4 weeks after starting the study treatment.
REALIZE is a longitudinal, multicenter, observational study under real life settings in patients with moderate to severe chronic plaque psoriasis after failure or contra-indication or intolerance to other systemic therapy including ciclosporin, methotrexate, or phototherapy UVA + psoralen (PUVA therapy).
Read the detailed description
Eligible patients will be identified and invited to enroll from approximately 100 dermatologists in France practicing in public hospitals (or private clinics) or private practice. Patients will be followed over 12 months after initiation of apremilast or until discontinuation of apremilast whatever the earlier. Given the observational nature of the study, apremilast dosing and duration will be at the sole discretion of the treating dermatologist, in accordance with the local label and daily clinical practice. Patient care will follow routine clinical practice, involving regular follow-up visits, without any mandatory visit. In daily practice, patients are usually seen by their treating dermatologist every 6 months. In this study, patients will be followed up at most 12 months after apremilast initiation.
During this study, it is expected to collect data at inclusion (enrolment visit) and around 6 months and 12 months after apremilast initiation, on electronic case report forms (eCRF) by the dermatologist after performing a visit around 6 and 12 months to evaluate the treatment response following the apremilast initiation.
Due to the observational nature of the study, the study protocol does not require any specific tests or additional examinations. All assessments will be recorded in the electronic case report form (eCRF) according to the normal practice of the treating dermatologist. Self-questionnaires will be filled by the patient when visiting his/her dermatologist.
Total duration of the study is 2 years and 6 months, which includes an enrollment period of 1 year and 6 months and a follow up period of up to 1 year.
- Conditions
- Psoriasis
- Being tested
- Apremilast
- Keywords
- Plaque Psoriasis, Apremilast, France, CC-10004
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ApremilastDrug
Apremilast
| Study group | Role | What they receive |
|---|---|---|
| Patients treated with Apremilast | Patients with moderate to severe chronic plaque psoriasis after failure or contra-indication or intolerance to other systemic therapy including ciclosporin, methotrexate, or phototherapy UVA + psoralen (PUVA therapy). Receives: Drug: Apremilast |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with Patient Benefit Index score (PBI-S) ≥1 at 6 months after initiation of apremilast.
The PBI-S questionnaire for skin diseases is a validated instrument to assess treatment needs and benefits in patients with skin diseases. It comprises 23 items on patient-relevant therapy needs and benefits.
Measured: Up to 6 months
Secondary outcomes (27)
Proportion of subjects with PBI-S (range 0-4) at 6 months after apremilast initiation
The PBI-S questionnaire for skin diseases is a validated instrument to assess treatment needs and benefits in patients with skin diseases. It comprises 23 items on patient-relevant therapy needs and benefits.
Measured: Up to 6 months
Proportion of patients with PBI-S=4 at 6 months after apremilast initiation
The PBI-S questionnaire for skin diseases is a validated instrument to assess treatment needs and benefits in patients with skin diseases. It comprises 23 items on patient-relevant therapy needs and benefits
Measured: Up to 6 months
Adherence Rate
The adherence rate will be defined as the percentage of patients pursuing the treatment with apremilast at 12 months after the initiation of apremilast.. The calculation will take into account the patients having started and discontinued apremilast within 4 weeks before the enrolment visit.
Measured: Up to 12 months
Percentage of patients substituting apremilast
The percentage of patients substituting apremilast by a biologic will be estimated by the Kaplan Meier method. The date of origin will be defined as the date apremilast has been started.
Measured: Up to 24 months
Dermatology Life Quality Index (DLQI)
DLQ is a 10-item validated questionnaire used in a wide range of dermatological conditions and across a wide range of disease severity as a quality of life instrument. It covers a variety of health dimensions, including symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. The recall period is 7 days. Each item is graded on a Likert scale of 0-3, which gives an overall score ranging from 0 to 30 where lower scores mean better quality of life.
Measured: Up to 24 months
Proportion of patients with DLQI ≤ 5
DLQ is a 10-item validated questionnaire used in a wide range of dermatological conditions and across a wide range of disease severity as a quality of life instrument. It covers a variety of health dimensions, including symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. The recall period is 7 days. Each item is graded on a Likert scale of 0-3, which gives an overall score ranging from 0 to 30 where lower scores mean better quality of life.
Measured: Up to 24 months
Proportion of patients achieving DLQI 0/1
DLQ is a 10-item validated questionnaire used in a wide range of dermatological conditions and across a wide range of disease severity as a quality of life instrument. It covers a variety of health dimensions, including symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. The recall period is 7 days. Each item is graded on a Likert scale of 0-3, which gives an overall score ranging from 0 to 30 where lower scores mean better quality of life.
Measured: Up to 24 months
Change in DLQI score from M0 to M6 and M12
DLQ is a 10-item validated questionnaire used in a wide range of dermatological conditions and across a wide range of disease severity as a quality of life instrument. It covers a variety of health dimensions, including symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. The recall period is 7 days. Each item is graded on a Likert scale of 0-3, which gives an overall score ranging from 0 to 30 where lower scores mean better quality of life.
Measured: Up to 12 months
Proportion of patients with improvement in DLQI ≥ 5 points between M0 and M6, M12
DLQ is a 10-item validated questionnaire used in a wide range of dermatological conditions and across a wide range of disease severity as a quality of life instrument. It covers a variety of health dimensions, including symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. The recall period is 7 days. Each item is graded on a Likert scale of 0-3, which gives an overall score ranging from 0 to 30 where lower scores mean better quality of life.
Measured: Up to 12 months
Treatment Satisfaction Questionnaire for Medication (TSQM9)
TSQM-9 is a 9-item validated self-administered questionnaire used to evaluate the patient's overall satisfaction with study treatment. The TSQM-9 consists of 8 items that make up 3 specific scales (effectiveness, side effects, convenience) and one global satisfaction scale. Scale scores are transformed into scores from 0 to 100 with higher scores representing higher satisfaction in that domain.
Measured: Up to 24 months
Proportion of patients with sPGA 0 or 1
sPGA static physician global assessment is defined as single-item-5-point categorized scale reflecting the physician's assessment of psoriasis severity. This scale ranges from 0 to 4.
Measured: Up to 24 months
Change in sPGA from baseline to M6 and M12
sPGA static physician global assessment is defined as single-item-5-point categorized scale reflecting the physician's assessment of psoriasis severity. This scale ranges from 0 to 4.
Measured: Up to 12 months
Percentage of BSA (%BSA) involved at M0, M6, M12
BSA is the measurement of the body area involved in relation to the whole body surface
Measured: Up to 12 months
Change in % BSA from M0 to M6, M12
BSA is the measurement of the body area involved in relation to the whole body surface
Measured: Up to 12 months
Psoriasis Area Severity Index (PASI) at M0, M6, M12
PASI is a common clinical tool used to measure the severity and extent of psoriasis. PASI score is a composite score grading the severity of psoriasis in four body regions according to erythema, scaling, and thickness, and the total area of skin affected. The final composite score ranges from 0 to 72, with a higher score indicating a greater severity of psoriasis
Measured: Up to 12 months
Change in PASI from M0 to M6, M12
PASI is a common clinical tool used to measure the severity and extent of psoriasis. PASI score is a composite score grading the severity of psoriasis in four body regions according to erythema, scaling, and thickness, and the total area of skin affected. The final composite score ranges from 0 to 72, with a higher score indicating a greater severity of psoriasis
Measured: Up to 12 months
Proportion of patients achieving PASI50 at M6, M12
PASI is a common clinical tool used to measure the severity and extent of psoriasis. PASI score is a composite score grading the severity of psoriasis in four body regions according to erythema, scaling, and thickness, and the total area of skin affected. The final composite score ranges from 0 to 72, with a higher score indicating a greater severity of psoriasis
Measured: Up to 12 months
Proportion of patients achieving PASI75 at M6, M12.
PASI is a common clinical tool used to measure the severity and extent of psoriasis. PASI score is a composite score grading the severity of psoriasis in four body regions according to erythema, scaling, and thickness, and the total area of skin affected. The final composite score ranges from 0 to 72, with a higher score indicating a greater severity of psoriasis
Measured: Up to 12 months
Adverse Events (AEs)
Number of participants with adverse events
Measured: Up to 24 months
Duration of disease
Duration of disease will be defined as the length of time the disease has been present, indication by months of years.
Measured: Baseline
Number of areas of plaque psoriasis
The number of area of plaque psoriasis will be defined by the number of area observed by the Investigator
Measured: Baseline
Type of chronic psoriasis involved
Types if chronic psoriasis, scalp, palmoplantar, genital
Measured: Baseline
The number of lines of previous systemic treatments
Number of lines of previous systemic treatments will be described by one line, two lines
Measured: Baseline
Type of systemic therapy previously administered
The type of systemic therapies includes corticosteroids, topical, other classification of medications
Measured: Baseline
Duration of previous chronic psoriasis treatment
The duration of previous treatment will be described in months, years.
Measured: Baseline
Number of motivations of the prescription of apremilast
Motivations will be described by the number of patients with lack of response or intolerance or patient's dissatisfaction regarding the previous treatment.
Measured: Up to 24 months
Percentage of motivations of the prescription of apremilast
Motivations will be described by the percentage of patients with lack of response or intolerance or patient's dissatisfaction regarding the previous treatment.
Measured: Up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2018
- Study start25 Sep 2018
- Primary completion21 Jul 2021
- Study completion10 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- More trials run by AmgenThe 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
- Retrospective
- Enrolment
- 453 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03757013
- Sponsor's protocol ID
- CC-10004-PSOR-021
- Other IDs
- U1111-1218-9791
- Acronym
- REALIZE
- Status last verified
- Dec 2021
- First submitted
- 25 Sep 2018
- Last updated
- 3 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Jullien D, Richard MA, Halioua B, Bessette C, Derancourt C, Bouloc A. The Needs of Patients with Psoriasis and Benefits of Apremilast in French Clinical Practice: Results from the Observational REALIZE Study. Dermatol Ther (Heidelb). 2023 Jun;13(6):1361-1376. doi: 10.1007/s13555-023-00933-z. Epub 2023 May 19.
PubMed 37204608
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real Life Data for Otezla Evidence: Assessing Benefits of Apremilast in Patients With Moderate to Severe Chronic Plaque Psoriasis Followed by Dermatologists Under Real Life Settings in France
- ClinicalTrials.gov ID
- NCT03757013
- Acronym / sponsor ID
- REALIZE / CC-10004-PSOR-021
- Conditions
- Psoriasis
- Keywords
- Plaque Psoriasis, Apremilast, France, CC-10004
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 453 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- 25 Sep 2018 (actual)
- Primary completion
- 21 Jul 2021 (actual)
- Study completion
- 10 Sep 2021 (actual)
- First posted
- 28 Nov 2018 (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.
REALIZE study will include a representative sample of 500 patients with moderate to severe plaque psoriasis for whom the treating dermatologist has decided to begin apremilast treatment in accordance with the local label reimbursement criteria. Patients may be enrolled into the study up to 4 weeks after starting the study treatment.
REALIZE is a longitudinal, multicenter, observational study under real life settings in patients with moderate to severe chronic plaque psoriasis after failure or contra-indication or intolerance to other systemic therapy including ciclosporin, methotrexate, or phototherapy UVA + psoralen (PUVA therapy).
Detailed description
Eligible patients will be identified and invited to enroll from approximately 100 dermatologists in France practicing in public hospitals (or private clinics) or private practice. Patients will be followed over 12 months after initiation of apremilast or until discontinuation of apremilast whatever the earlier. Given the observational nature of the study, apremilast dosing and duration will be at the sole discretion of the treating dermatologist, in accordance with the local label and daily clinical practice. Patient care will follow routine clinical practice, involving regular follow-up visits, without any mandatory visit. In daily practice, patients are usually seen by their treating dermatologist every 6 months. In this study, patients will be followed up at most 12 months after apremilast initiation.
During this study, it is expected to collect data at inclusion (enrolment visit) and around 6 months and 12 months after apremilast initiation, on electronic case report forms (eCRF) by the dermatologist after performing a visit around 6 and 12 months to evaluate the treatment response following the apremilast initiation.
Due to the observational nature of the study, the study protocol does not require any specific tests or additional examinations. All assessments will be recorded in the electronic case report form (eCRF) according to the normal practice of the treating dermatologist. Self-questionnaires will be filled by the patient when visiting his/her dermatologist.
Total duration of the study is 2 years and 6 months, which includes an enrollment period of 1 year and 6 months and a follow up period of up to 1 year.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients treated with Apremilast | – | Drug: ApremilastPatients with moderate to severe chronic plaque psoriasis after failure or contra-indication or intolerance to other systemic therapy including ciclosporin, methotrexate, or phototherapy UVA + psoralen (PUVA therapy). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with moderate to severe plaque psoriasis for whom the treating dermatologist has decided to begin apremilast treatment in accordance with the local label reimbursement criteria. Patients may be enrolled into the study up to 4 weeks after starting the study treatment. All eligible patients will be included in the safety population in consecutive order based on the date of the non-opposition form. However, only patients who have completed 6 (± 1) months of treatment will be included in the reference analysis population
Key inclusion criteria (6 listed)
- Male or female aged at least 18 years
- Patient with a diagnosis of stable moderate to severe chronic plaque psoriasis
- For whom the treating dermatologist has made the decision to initiate apremilast treatment in accordance with the local label and reimbursement criteria i.e. a history of failure or contra-indication or intolerance to other systemic therapy including ciclosporin, methotrexate, or phototherapy UVA + psoralen (PUVA therapy)
- Patient having started apremilast up to 4 weeks before the enrolment visit for treatment of moderate to severe chronic plaque psoriasis even if apremilast has been stopped before inclusion in the study
- Patient literate and willing to fill in questionnaires
Key exclusion criteria (2 listed)
- Patient who refuses to participate in the study or is unable to give his/her oral consent
- Patient having participated in an interventional study in the last 30 days
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 |
|---|---|---|
| ApremilastApremilast | Drug | Patients treated with Apremilast |
Primary outcome
Proportion of patients with Patient Benefit Index score (PBI-S) ≥1 at 6 months after initiation of apremilast.
Time frame: Up to 6 months
The PBI-S questionnaire for skin diseases is a validated instrument to assess treatment needs and benefits in patients with skin diseases. It comprises 23 items on patient-relevant therapy needs and benefits.
27 secondary outcomes
Proportion of subjects with PBI-S (range 0-4) at 6 months after apremilast initiation
Time frame: Up to 6 months
Proportion of patients with PBI-S=4 at 6 months after apremilast initiation
Time frame: Up to 6 months
Adherence Rate
Time frame: Up to 12 months
Percentage of patients substituting apremilast
Time frame: Up to 24 months
Dermatology Life Quality Index (DLQI)
Time frame: Up to 24 months
Proportion of patients with DLQI ≤ 5
Time frame: Up to 24 months
Proportion of patients achieving DLQI 0/1
Time frame: Up to 24 months
Change in DLQI score from M0 to M6 and M12
Time frame: Up to 12 months
Proportion of patients with improvement in DLQI ≥ 5 points between M0 and M6, M12
Time frame: Up to 12 months
Treatment Satisfaction Questionnaire for Medication (TSQM9)
Time frame: Up to 24 months
Proportion of patients with sPGA 0 or 1
Time frame: Up to 24 months
Change in sPGA from baseline to M6 and M12
Time frame: Up to 12 months
Percentage of BSA (%BSA) involved at M0, M6, M12
Time frame: Up to 12 months
Change in % BSA from M0 to M6, M12
Time frame: Up to 12 months
Psoriasis Area Severity Index (PASI) at M0, M6, M12
Time frame: Up to 12 months
Change in PASI from M0 to M6, M12
Time frame: Up to 12 months
Proportion of patients achieving PASI50 at M6, M12
Time frame: Up to 12 months
Proportion of patients achieving PASI75 at M6, M12.
Time frame: Up to 12 months
Adverse Events (AEs)
Time frame: Up to 24 months
Duration of disease
Time frame: Baseline
Number of areas of plaque psoriasis
Time frame: Baseline
Type of chronic psoriasis involved
Time frame: Baseline
The number of lines of previous systemic treatments
Time frame: Baseline
Type of systemic therapy previously administered
Time frame: Baseline
Duration of previous chronic psoriasis treatment
Time frame: Baseline
Number of motivations of the prescription of apremilast
Time frame: Up to 24 months
Percentage of motivations of the prescription of apremilast
Time frame: Up to 24 months
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 3 Dec 2021.
- Derived from this study: PubMed 37204608Jullien D, Richard MA, Halioua B, Bessette C, Derancourt C, Bouloc A. The Needs of Patients with Psoriasis and Benefits of Apremilast in French Clinical Practice: Results from the Observational REALIZE Study. Dermatol Ther (Heidelb). 2023 Jun;13(6):1361-1376. doi: 10.1007/s13555-023-00933-z. Epub 2023 May 19.
- AmgenTrials clinical trials websiteLink provided by the sponsor.
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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.
MD study director
Amgen
93 sites 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 Amgen at 93 sites 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 6 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 3 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 93 sites 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?
Proportion of patients with Patient Benefit Index score (PBI-S) ≥1 at 6 months after initiation of apremilast. (time frame: Up to 6 months). 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 NCT03757013, which also lists 1 linked publication.
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 3 Dec 2021.