PsoriasisAPPROPIATENCT03539419
Study to Evaluate the Benefits for the Patient Associated With the Treatment of Plaque Psoriasis With Apremilast After Other Systemic Treatment in Conditions of Clinical Practice in Spain
An observational study of Psoriasis, run by Amgen at 58 sites in Spain.
Trial summary
Observational, prospective and multicenter study in approximately 30 sites nationwide. The investigators participating in this study will be dermatologists specializing in this pathology. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psoriasis
- How many people
- 153 participants
- Where
- 58 sitesSpain
- Study dates
- 12 Jun 2018to 31 Oct 2020
- 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: The study will include adult patients with moderate to severe plaque who have started apremilast treatment for first time 3 months (+/- 4 weeks) before their inclusion in the study, according to the specifications of the drug's prescribing information and under usual clinical practice. Recruitment will be consecutive and the reason for not including a potential candidate patient will be registered. The decision to prescribe apremilast treatment should be clearly dissociated from the inclusion of the patient in the study. Therefore, the choice of the therapeutic strategy will be made independently by the physician.
Who may be able to join
- Adult male and female (≥ 18 years).
- Patients diagnosed with moderate to severe plaque psoriasis and for which treatment with apremilast is indicated according to the doctor's criteria (established before the patient enters the study) and according to the specifications of the medication's data sheet
- Patients with available data regarding the PASI and DLQI assessments at the moment of initiating treatment with apremilast.
- Patients for whom, according to the physician's criteria (established prior to patient's entry into the study) and according to the specifications of the drug's prescribing information, apremilast treatment is indicated.
- All patients who, according to the routine clinical practice, initiated apremilast treatment for the first time 3 months (+/- 4 weeks) before their inclusion in the study (patients may or may not have completed 3 months of apremilast treatment).
- Patients who have previously received at least one systemic treatment for moderate to severe plaque psoriasis.
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- Patients who have not previously been treated with a biological agent for moderate to severe plaque psoriasis.
- Patients who agree to participate in the study by signing the informed consent.
- Patients who are able to understand and complete the questionnaires specified in the study protocol.
Who cannot join
- Patients participating in another study at the time of entering the study.
Trial locations and contacts
58 sites in 1 country.
58 sites in 1 country
Spain58 sites
Hospital General de Alicante
Alicante, Valencia, 03010
Research Site
Alicante, 03010
Hospital Nuestra Señora de Sonsoles
Ávila, Castille and León, 05004
Research Site
Ávila, 05004
Hospital Infanta Cristina Badajoz
Badajoz, Extremadura, 06080
Research Site
Badajoz, 06010
Hospital Germans Tries i Pujol
Badalona, Catalonia, 08026
Research Site
Badalona, Catalonia, 08916
Hospital del Mar
Barcelona, Catalonia, 08003
Research Site
Barcelona, Catalonia, 08003
Research Site
Barcelona, Catalonia, 08025
Hospital Sant Pau
Barcelona, Catalonia, 08026
Hospital Valle Hebrón
Barcelona, Catalonia, 08035
Hospital de Bellvitge
Barcelona, Catalonia, 08907
Research Site
Barcelona, 08907
Hospital Santa Lucía
Cartagena, Murcia, Murcia, 30202
Research Site
Cuesta, 38320
Hospital Juan Ramón Jiménez
Huelva, Andalusia, 50009
Research Site
Huelva, 21003
Complejo Hospitalario de Jaén
Jaén, Andalusia, 23007
Research Site
Jaén, 23007
Hospital Dr Negrin
Las Palmas de Gran Canaria, Canary Islands, 35010
Research Site
Las Palmas de Gran Canaria, Canary Islands, 35010
Hospital La Princesa
Madrid, 28006
Research Site
Madrid, 28006
Hospital Infanta Leonor
Madrid, 28031
Research Site
Madrid, 28031
Hospital de 12 Octubre
Madrid, 28041
Research Site
Madrid, 28041
Hospital Universitario Puerta del Hierro
Madrid, 28222
Hospital de Móstoles
Madrid, 28933
Research Site
Majadahonda, 28022
Hospital Carlos Haya
Málaga, Andalusia, 29010
Research Site
Málaga, 29009
Research Site
Móstoles, Madrid, 28935
Research Site
Murica, 30203
Hospital Universitario de Ourense
Ourense, Galicia, 32005
Research Site
Ourense, 32003
Hospital Universitario de Pontevedra
Pontevedra, Galicia, 36164
Research Site
Pontevedra, 36001
Hospital Universitario de Canarias
Santa Cruz de Tenerife, Canary Islands, 38320
Hospital Universitario Marqués de Valdecilla
Santander, Cantabria, 39008
Research Site
Santander, Cantabria, 39008
Hospital Mutua de Terrassa
Terrassa, Catalonia, 08221
Research Site
Terrassa, 08221
Hospital Clínico Valencia
Valencia, Valencia, 46010
Hospital General Valencia
Valencia, Valencia, 46014
Hospital La Fe Valencia
Valencia, Valencia, 46026
Research Site
Valencia, 46010
Research Site
Valencia, 46014
Research Site
Valencia, 46026
Hospital Universitario Río hortega de Valladolid
Valladolid, Castille and León, 47012
Research Site
Valladolid, Castille and León, 47012
Research Site
Zaragoza, Aragon, 50014
Hospital Royo Vilanova
Zaragoza, Aragon, 50015
Research Site
Zaragoza, 50009
Hospital Clínico de Zaragoza
Zaragoza, Áragon, 50009
Hospital Miguel Servet
Zaragoza, Áragon, 50009
About this study
Official title: Prospective Observational Study to Evaluate the Benefits for the Patient Associated With the Treatment of Plaque Psoriasis With Apremilast After Other Systemic Treatment in Conditions of Clinical Practice in Spain (APPROPRIATE Study)
Observational, prospective and multicenter study in approximately 30 sites nationwide. The investigators participating in this study will be dermatologists specializing in this pathology.
The present study will include adult patients with moderate to severe plaque who have started apremilast treatment for first time 3 months (+/- 4 weeks) before their inclusion in the study, according to the specifications of the drug's prescribing information and under usual clinical practice. Recruitment will be consecutive and the reason for not including a potential candidate patient will be registered. The decision to prescribe apremilast treatment should be clearly dissociated from the inclusion of the patient in the study. Therefore, the choice of the therapeutic strategy will be made independently by the physician.
- Conditions
- Psoriasis
- Keywords
- Psoriasis, Plaque Psoriasis, Apremilast, 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.
| Study group | Role | What they receive |
|---|---|---|
| Patients with plaque psoriasis on apremilast | Adult patients with moderate to severe plaque who have started apremilast treatment for first time 3 months (+/- 4 weeks) before their inclusion in the study, according to the specifications of the drug's prescribing information and under usual clinical practice. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of subjects achieving PBI ≥ 1
Patient Benefit Index (PBI) is a measure of the benefit associated with a patient-reported treatment consisting of the administration of two questionnaires: the Patient needs questionnaire (PNQ), administered at baseline, and the patient benefit questionnaire (PBQ), administered during treatment
Measured: Approximately 7 months
Secondary outcomes (10)
Describe the persistence of apremilast treatment
Is defined as the duration of time from initiation to discontinuation of therapy.
Measured: Approximately 7 months
Describe changes in the perception of pruritus intensity during apremilast treatment in patients with moderate to severe plaque psoriasis
Pruritus intensity measures: Usually used scales are based on patient perception: Visual analogue scale (VAS). Horizontal line of 100 mm, with descriptive signs at the ends indicating "no itching" and "the worst imaginable itch". The score is obtained by measuring the distance in millimeters from the beginning of the line to a vertical mark placed by the patient to indicate the intensity of the pain
Measured: Approximately 13 months
Describe the changes in the quality of life associated with treatment with apremilast
The information on the variables studied will be obtained from the clinical record and the tests and evaluations carried out routinely during the patient follow-up who initiate a first treatment with apremilast, as well as the questionnaires for the evaluation of the dermatological quality of life (DLQI self-administered questionnaire), the evaluation of treatment satisfaction reported by the patient (PBI) and the intensity of pruritus (self-reported measures, VAS).
Measured: Approximately 13 months
Describe the percentage of patients with moderate to severe plaque psoriasis who achieve a relevant minimum clinical benefit, defined as PBI ≥ 1
Patient Benefit Index (PBI) is a measure of the benefit associated with a patient-reported treatment consisting of the administration of two questionnaires: the Patient needs questionnaire (PNQ), administered at baseline, and the patient benefit questionnaire (PBQ), administered during treatment.
Measured: Approximately 13 months
Describe changes in concomitant medication associated with management of moderate to severe plaque psoriasis during apremilast treatment
Describe changes of concomitant medication specific for psoriasis associated to apremilast treatment indicating the date of beginning and end of the concomitant treatments that the patient receives during the treatment with apremilast.
Measured: Approximately 13 months
Describe changes in cutaneous involvement of patients with psoriasis in severe intensity plaques that change to moderate intensity
A patient with moderate-intensity psoriasis will be considered if he/she has PASI 7-15 and DLQI scores ≤ 15, or PASI scores <7 and DLQI ≥ 5 at the time of starting apremilast treatment. (Patients with PASI 7-15 and DLQI> 15 scores and presenting cutaneous lesions in locations that are difficult to access for treatment or that have a significant psychosocial impact may be classified as moderate or severe psoriasis cases according to the investigators' criteria.) In this subgroup of patients will estimate the proportion of patients with moderate-intensity psoriasis who change to mild intensity.
Measured: Approximately 13 months
Adverse Events (AEs)
Number of subjects with adverse event. Safety and tolerability to treatment will be assessed by the collection of adverse events (AE) occurring during follow-up.
Measured: Approximately 13 months
Clinical and demographic characteristics of plaque psoriasis patients: Body surface affected (BSA).
Psoriasis is characterized as mild, moderate, or severe according to the amount of body surface area (BSA) affected and the severity of redness, thickness, and scaling of the skin. According to the centers usual clinical practice, the clinical assessment of psoriatic disease is based on the BSA. Percentage of body surface affected by psoriasis (scale 0-100).
Measured: Approximately 7 months
Clinical and demographic characteristics of plaque psoriasis patients: Physician Global Assessment (PGA).
The Psoriasis Global Assessment (PGA) of improvement (or Physician's global assessment of improvement) measure the global assessment of the patient's overall severity of the disease on a 6-point scale, scored from "severe" to "clear".
Measured: Approximately 7 months
Clinical and demographic characteristics of plaque psoriasis patients: PGA x BSA
Commonly used instruments for measuring psoriasis, such as Psoriasis Area and Severity Index (PASI), have limitations, including high complexity. PGAxBSA is a simple and sensitive instrument for measuring psoriasis severity. PGA×BSA is practical alternative to PASI for measuring severity and treatment response
Measured: Approximately 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2018
- Study start12 Jun 2018
- Primary completion2 Nov 2019
- Study completion31 Oct 2020
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 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
- Prospective
- Enrolment
- 153 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
- NCT03539419
- Sponsor's protocol ID
- CC-10004-PSOR-017
- Other IDs
- U1111-1212-0643
- Acronym
- APPROPIATE
- Status last verified
- Jun 2024
- First submitted
- 20 Apr 2018
- Last updated
- 5 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Observational Study to Evaluate the Benefits for the Patient Associated With the Treatment of Plaque Psoriasis With Apremilast After Other Systemic Treatment in Conditions of Clinical Practice in Spain (APPROPRIATE Study)
- ClinicalTrials.gov ID
- NCT03539419
- Acronym / sponsor ID
- APPROPIATE / CC-10004-PSOR-017
- Conditions
- Psoriasis
- Keywords
- Psoriasis, Plaque Psoriasis, Apremilast, CC-10004
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 153 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- 12 Jun 2018 (actual)
- Primary completion
- 2 Nov 2019 (actual)
- Study completion
- 31 Oct 2020 (actual)
- First posted
- 29 May 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.
Observational, prospective and multicenter study in approximately 30 sites nationwide. The investigators participating in this study will be dermatologists specializing in this pathology.
The present study will include adult patients with moderate to severe plaque who have started apremilast treatment for first time 3 months (+/- 4 weeks) before their inclusion in the study, according to the specifications of the drug's prescribing information and under usual clinical practice. Recruitment will be consecutive and the reason for not including a potential candidate patient will be registered. The decision to prescribe apremilast treatment should be clearly dissociated from the inclusion of the patient in the study. Therefore, the choice of the therapeutic strategy will be made independently by the physician.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with plaque psoriasis on apremilast | – | –Adult patients with moderate to severe plaque who have started apremilast treatment for first time 3 months (+/- 4 weeks) before their inclusion in the study, according to the specifications of the drug's prescribing information and under usual clinical practice. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study will include adult patients with moderate to severe plaque who have started apremilast treatment for first time 3 months (+/- 4 weeks) before their inclusion in the study, according to the specifications of the drug's prescribing information and under usual clinical practice. Recruitment will be consecutive and the reason for not including a potential candidate patient will be registered. The decision to prescribe apremilast treatment should be clearly dissociated from the inclusion of the patient in the study. Therefore, the choice of the therapeutic strategy will be made independently by the physician.
Key inclusion criteria (9 listed)
- Adult male and female (≥ 18 years).
- Patients diagnosed with moderate to severe plaque psoriasis and for which treatment with apremilast is indicated according to the doctor's criteria (established before the patient enters the study) and according to the specifications of the medication's data sheet
- Patients with available data regarding the PASI and DLQI assessments at the moment of initiating treatment with apremilast.
- Patients for whom, according to the physician's criteria (established prior to patient's entry into the study) and according to the specifications of the drug's prescribing information, apremilast treatment is indicated.
- All patients who, according to the routine clinical practice, initiated apremilast treatment for the first time 3 months (+/- 4 weeks) before their inclusion in the study (patients may or may not have completed 3 months of apremilast treatment).
Key exclusion criteria (1 listed)
- Patients participating in another study at the time of entering the study.
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
Percentage of subjects achieving PBI ≥ 1
Time frame: Approximately 7 months
Patient Benefit Index (PBI) is a measure of the benefit associated with a patient-reported treatment consisting of the administration of two questionnaires: the Patient needs questionnaire (PNQ), administered at baseline, and the patient benefit questionnaire (PBQ), administered during treatment
10 secondary outcomes
Describe the persistence of apremilast treatment
Time frame: Approximately 7 months
Describe changes in the perception of pruritus intensity during apremilast treatment in patients with moderate to severe plaque psoriasis
Time frame: Approximately 13 months
Describe the changes in the quality of life associated with treatment with apremilast
Time frame: Approximately 13 months
Describe the percentage of patients with moderate to severe plaque psoriasis who achieve a relevant minimum clinical benefit, defined as PBI ≥ 1
Time frame: Approximately 13 months
Describe changes in concomitant medication associated with management of moderate to severe plaque psoriasis during apremilast treatment
Time frame: Approximately 13 months
Describe changes in cutaneous involvement of patients with psoriasis in severe intensity plaques that change to moderate intensity
Time frame: Approximately 13 months
Adverse Events (AEs)
Time frame: Approximately 13 months
Clinical and demographic characteristics of plaque psoriasis patients: Body surface affected (BSA).
Time frame: Approximately 7 months
Clinical and demographic characteristics of plaque psoriasis patients: Physician Global Assessment (PGA).
Time frame: Approximately 7 months
Clinical and demographic characteristics of plaque psoriasis patients: PGA x BSA
Time frame: Approximately 7 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 5 Jun 2024.
- AmgenTrials clinical trials websiteLink provided by the sponsor.
- Expanded Access for CC-10004Link 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
58 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 58 sites 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 9 inclusion and 1 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 5 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 58 sites 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?
Percentage of subjects achieving PBI ≥ 1 (time frame: Approximately 7 months). 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 5 Jun 2024.