PsoriasisOTELONCT03097003
A Study of the Real-life Management of Psoriasis Patients Treated With Otezla® (Apremilast) in Belgium
An observational study of Psoriasis, run by Amgen at 22 sites in Belgium.
Trial summary
OTELO is a national (Belgium), multicentre, prospective, non-interventional, post-marketing study. The study will include a representative sample of approximately 250 patients with moderate-to-severe plaque psoriasis for whom the treating dermatologist has decided to begin apremilast treatment in accordance with the… 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
- 124 participants
- Where
- 22 sitesBelgium
- Study dates
- 6 Apr 2017to 20 Dec 2018
- 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: Adult patients with moderate-to-severe plaque psoriasis visiting dermatology practices in Belgium and eligible for treatment with apremilast according to the local label and reimbursement criteria. Patients may be enrolled into the study up to 4 weeks after commencing the treatment with apremilast. The decision to treat the patient with apremilast will be made prior to the decision to enter the patient into the study.
Who may be able to join
- Patients who meet ALL the following criteria can be enrolled:
- Male or female aged at least 18 years.
- With a diagnosis of moderate-to-severe chronic plaque psoriasis. As per Belgian National Institute for Health and Disability Insurance (NIHDI), moderate-to-severe plaque psoriasis in adult patients is defined by a Body Surface Area (BSA) > 10% or aPsoriasis Area and Severity Index (PASI) > 10.
- For whom the treating dermatologist has made the decision to commence apremilast treatment in accordance with the local label and reimbursement criteria
- Able to follow the instructions of the study.
- Having signed an Informed Consent Form (ICF)
Who cannot join
- Patients who meet AT LEAST one of the following exclusion criteria will be excluded:
- Patients who have received apremilast > 4 weeks prior to the enrolment visit.
- Women who are pregnant, breastfeeding or planning on becoming pregnant.
- Non-menopausal women who are not using an adequate contraception method.
- Patients with hypersensitivity to apremilast or to one of its excipients.
Trial locations and contacts
22 sites in 1 country.
22 sites in 1 country
Belgium22 sites
AZ Sint Jan
Bruges, 8000
CHU St Pierre
Brussels, 1000
CHU Brugmann (Victor Horta)
Brussels, 1020
Clin Univ de Bxl Hôpital Erasme
Brussels, 1070
UZ Brussel
Brussels, 1090
Cliniques Universitaires St-Luc
Brussels, 1200
UZ Antwerpen
Edegem, 2650
Private Practice Geel
Geel, 2440
Private Practice Genk
Genk, 3600
AZ Sint Lucas
Ghent, 9000
UZ Gent
Ghent, 9000
CHU UCL Mont-Godinne
Godinne, 5530
Clinique André Renard d'Herstal
Herstal, 4040
Private Practice Lede
Lede, 9340
UZ Leuven Sint Rafael
Leuven, 3000
CHU Sart-Tilman
Liège, 4000
GHdC - site IMTR
Loverval, 6280
Dermatologie Maldegem
Malgegem, 9990
Private Practice Mons
Mons, 7000
Private Practice Namur
Namur, 5000
Ste Elisabeth - Namur
Namur, 5000
CH Bois Abbaye-Hesbaye
Seraing, 4100
About this study
Official title: An Observational Study of the Real-life Management of Psoriasis Patients Treated With Otezla® (Apremilast) in Belgium
OTELO is a national (Belgium), multicentre, prospective, non-interventional, post-marketing study. The study will include a representative sample of approximately 250 patients with moderate-to-severe plaque psoriasis for whom the treating dermatologist has decided to begin apremilast treatment in accordance with the local label and reimbursement criteria. Patients may be enrolled into the study up to 4 weeks after commencing the study treatment.
As this study is non-interventional, drug dosing and treatment duration will be at the sole discretion of the treating dermatologist, in accordance with the local label and daily clinical practice.
Read the detailed description
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 dermatologists every 3 months. In this study, patients will be followed-up for a least 6 months and at most 18 months after apremilast treatment initiation. Patient data will be collected until 31st December 2018. Assuming a recruitment phase of 18-month duration starting as of December 2016, individual patient follow-up times will range from 6 to 18 months, depending on the inclusion date. During the first months of the study, the recruitment rate has been slower than expected. Therefore, it has been decided in October 2017 to increase the period of recruitment to 18 months in order to have enough evaluable patients to keep the accuracy required for the statistical analysis.
During the study, it is expected to collect data at inclusion and at 6 months after apremilast initiation in all patients. As per NIHDI recommendations, patients should consult their treating dermatologists 6 months after apremilast initiation in order to evaluate treatment response and decide on treatment continuation for an additional period of 12 months. For patients recruited early in the study, data will be collected during the next follow-up visits up to 18 months after apremilast initiation. Only data pertaining to visits occurring at 9 (± 1), 12 (± 1), 15 (±1), and 18 (± 1) months after treatment initiation will be collected. If a study visit occurs approximately 3 (± 1) months after treatment initiation, the data will also be recorded.
All clinical data collected during this non-interventional study will be routinely documented in the patient's medical records, which are the main source of information. The study data will be collecting via an eCRF. Data from source documents including PRO-questionnaires will be entered in the eCRF by the investigator or other authorised appropriately designed and trained study site personnel. Data entered into the eCRF will be reviewed for consistency by the Data Manager using both automated logical checks (issuing in automatic queries generated by the system) and manual review (issuing in manual checks set by the Data Manager or the Monitor into the eCRF). All data collected within the eCRF will be approved and electronically signed and dated by the Investigator or designee. At the conclusion of the study, before the final statistical analysis, the eCRF and other study data will be locked to further additions or corrections.
During the study, the Clinical Research Associate (CRA) will contact each study site on a regular basis in order to check the progress and conduct of the study. If issues regarding study conduct arise, additional on-site visits may be performed. In particular, a quality analysis will also be performed and based on data quality, it will be decided whether on-site monitoring is necessary, for which site and on which percentage of patients. During monitoring visits, eCRFs, patient's source documents, and all other study documentation will be reviewed by the CRA. Accuracy will be checked by performing source data verification that is a direct comparison of the entries made onto the eCRF against the appropriate source documentation.
Adverse events AEs will be coded using the Medical Dictionary for Regulatory Activities (MedDRA) terminology. The detailed methodology of the statistical analyses will be documented in a statistical analysis plan (SAP). The SAP will be written by the Clinical Research Organisation (CRO) in charge of the study and will be validated by sponsor prior to performing the analysis and obligatory before the database lock. A scientific committee has been selected for this study. This committee will provide advice on the SAP.
- Conditions
- Psoriasis
- Being tested
- Apremilast
- Keywords
- Proriasis, Real-life management, Observational, Otezla, CC-10004, Apremilast, Belgium, OTELO
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ApremilastDrug
Psoriasis patients treated with Otezla® (Apremilast) in Belgium
| Study group | Role | What they receive |
|---|---|---|
| Use of Apremilast in patient with plaque psoriasis | Psoriasis patients treated with Otezla® (Apremilast) in Belgium 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 for skin diseases (standard version) (PBI-S) ≥ 1 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
Secondary outcomes (15)
Characteristics of the patients treated with apremilast
The patients treated with Apremilast will be described according to the following characteristics: demographics (age, gender, weight, height, and ethnicity), professional status, lifestyle habits, medical history (including psoriasis treatment history), and comorbidities
Measured: Baseline
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
PBI-S outcome score 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 18 months
Proportion of patients having clear/no psoriasis based on Patient Global Assessment (PtGA) at 6 months after apremilast initiation
PtGA is defined as single-item 5-point categorised scale reflecting the patient's overall impression of psoriasis severity. This scale ranges from 0 (clear/no psoriasis) to 4 (severe psoriasis)
Measured: up to 6 months
Change from baseline in the PtGA after apremilast initiation
PtGA is defined as single-item 5-point categorised scale reflecting the patient's overall impression of psoriasis severity. This scale ranges from 0 (clear/no psoriasis) to 4 (severe psoriasis)
Measured: up to 18 months
Proportion of patients with Dermatology Life Quality Index (DLQI) ≤ 5 at 6 months after apremilast initiation.
DLQI is 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. 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 6 Months
Change from baseline in the DLQI score after apremilast initiation
DLQI is 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. 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 18 months
Change from baseline in the psoriasis symptomatology
Psoriasis symptomatology - pruritus, scalp psoriasis, nail psoriasis, skin discomfort/pain, joint pain, fatigue, overall wellbeing. Each symptom will be graded using a 7-grade discrete rating scale
Measured: up to 18 months
Change from baseline in the patient-reported treatment satisfaction (TSQM-9)
TSQM-9 is 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 18 months
Proportion of patients achieving Psoriasis Area and Severity Index (PASI) 50 or PASI 75 at 6 months after apremilast initiation
PASI is 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. PASI 50 and PASI 75 responses were defined as >=50% and >= 75% improvement in overall PASI score when compared to baseline
Measured: Up to 6 Months
Change from baseline in the disease activity scores in terms of Body Surface Area (BSA)
BSA is measurement of the body area involved in relation to the whole body surface.
Measured: up to 18 months
Change from baseline in the disease activity scores in terms of PASI
PASI is 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. PASI 50 and PASI 75 responses were defined as >=50% and >= 75% improvement in overall PASI score when compared to baseline
Measured: up to 18 months
Mean duration of apremilast treatment in biologic-naïve patients and in patients having received a previous biological treatment
Time to the stop of the treatment by Apremilast will be calculated as the time interval from the date of apremilast initiation to the date of the apremilast stop
Measured: Up to 18 Months
Rate of discontinuation of apremilast treatment within 6 months after initiation
Descriptive statistics will be provided for the rate and reasons for discontinuation of treatment within 6 months. This analysis will be performed on safety population and restricted to patients who stop the treatment before the time point to analyse or for which the follow-up is at least so long as the time point to analyse.
Measured: Up to 6 months
Adverse Events (AEs)
Number of participants with adverse event
Measured: Up to 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2017
- Study start6 Apr 2017
- Primary completion20 Dec 2018
- Study completion20 Dec 2018
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
- Prospective
- Enrolment
- 124 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
- NCT03097003
- Sponsor's protocol ID
- CC-10004-PSOR-016
- Other IDs
- U1111-1194-1580
- Acronym
- OTELO
- Status last verified
- Apr 2020
- First submitted
- 24 Mar 2017
- Last updated
- 27 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Ghislain PD, Lambert J, Lam Hoai XL, Hillary T, Roquet-Gravy PP, de la Brassinne M, Segaert S. Real-Life Effectiveness of Apremilast for the Treatment of Psoriasis in Belgium: Results From the Observational OTELO Study. Adv Ther. 2022 Feb;39(2):1068-1080. doi: 10.1007/s12325-021-01981-7. Epub 2022 Jan 3.
PubMed 34977985
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Study of the Real-life Management of Psoriasis Patients Treated With Otezla® (Apremilast) in Belgium
- ClinicalTrials.gov ID
- NCT03097003
- Acronym / sponsor ID
- OTELO / CC-10004-PSOR-016
- Conditions
- Psoriasis
- Keywords
- Proriasis, Real-life management, Observational, Otezla, CC-10004, Apremilast, Belgium, OTELO
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- 6 Apr 2017 (actual)
- Primary completion
- 20 Dec 2018 (actual)
- Study completion
- 20 Dec 2018 (actual)
- First posted
- 31 Mar 2017 (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.
OTELO is a national (Belgium), multicentre, prospective, non-interventional, post-marketing study. The study will include a representative sample of approximately 250 patients with moderate-to-severe plaque psoriasis for whom the treating dermatologist has decided to begin apremilast treatment in accordance with the local label and reimbursement criteria. Patients may be enrolled into the study up to 4 weeks after commencing the study treatment.
As this study is non-interventional, drug dosing and treatment duration will be at the sole discretion of the treating dermatologist, in accordance with the local label and daily clinical practice.
Detailed description
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 dermatologists every 3 months. In this study, patients will be followed-up for a least 6 months and at most 18 months after apremilast treatment initiation. Patient data will be collected until 31st December 2018. Assuming a recruitment phase of 18-month duration starting as of December 2016, individual patient follow-up times will range from 6 to 18 months, depending on the inclusion date. During the first months of the study, the recruitment rate has been slower than expected. Therefore, it has been decided in October 2017 to increase the period of recruitment to 18 months in order to have enough evaluable patients to keep the accuracy required for the statistical analysis.
During the study, it is expected to collect data at inclusion and at 6 months after apremilast initiation in all patients. As per NIHDI recommendations, patients should consult their treating dermatologists 6 months after apremilast initiation in order to evaluate treatment response and decide on treatment continuation for an additional period of 12 months. For patients recruited early in the study, data will be collected during the next follow-up visits up to 18 months after apremilast initiation. Only data pertaining to visits occurring at 9 (± 1), 12 (± 1), 15 (±1), and 18 (± 1) months after treatment initiation will be collected. If a study visit occurs approximately 3 (± 1) months after treatment initiation, the data will also be recorded.
All clinical data collected during this non-interventional study will be routinely documented in the patient's medical records, which are the main source of information. The study data will be collecting via an eCRF. Data from source documents including PRO-questionnaires will be entered in the eCRF by the investigator or other authorised appropriately designed and trained study site personnel. Data entered into the eCRF will be reviewed for consistency by the Data Manager using both automated logical checks (issuing in automatic queries generated by the system) and manual review (issuing in manual checks set by the Data Manager or the Monitor into the eCRF). All data collected within the eCRF will be approved and electronically signed and dated by the Investigator or designee. At the conclusion of the study, before the final statistical analysis, the eCRF and other study data will be locked to further additions or corrections.
During the study, the Clinical Research Associate (CRA) will contact each study site on a regular basis in order to check the progress and conduct of the study. If issues regarding study conduct arise, additional on-site visits may be performed. In particular, a quality analysis will also be performed and based on data quality, it will be decided whether on-site monitoring is necessary, for which site and on which percentage of patients. During monitoring visits, eCRFs, patient's source documents, and all other study documentation will be reviewed by the CRA. Accuracy will be checked by performing source data verification that is a direct comparison of the entries made onto the eCRF against the appropriate source documentation.
Adverse events AEs will be coded using the Medical Dictionary for Regulatory Activities (MedDRA) terminology. The detailed methodology of the statistical analyses will be documented in a statistical analysis plan (SAP). The SAP will be written by the Clinical Research Organisation (CRO) in charge of the study and will be validated by sponsor prior to performing the analysis and obligatory before the database lock. A scientific committee has been selected for this study. This committee will provide advice on the SAP.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Use of Apremilast in patient with plaque psoriasis | – | Drug: ApremilastPsoriasis patients treated with Otezla® (Apremilast) in Belgium |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with moderate-to-severe plaque psoriasis visiting dermatology practices in Belgium and eligible for treatment with apremilast according to the local label and reimbursement criteria. Patients may be enrolled into the study up to 4 weeks after commencing the treatment with apremilast. The decision to treat the patient with apremilast will be made prior to the decision to enter the patient into the study.
Key inclusion criteria (6 listed)
- Patients who meet ALL the following criteria can be enrolled:
- Male or female aged at least 18 years.
- With a diagnosis of moderate-to-severe chronic plaque psoriasis. As per Belgian National Institute for Health and Disability Insurance (NIHDI), moderate-to-severe plaque psoriasis in adult patients is defined by a Body Surface Area (BSA) > 10% or aPsoriasis Area and Severity Index (PASI) > 10.
- For whom the treating dermatologist has made the decision to commence apremilast treatment in accordance with the local label and reimbursement criteria
- Able to follow the instructions of the study.
Key exclusion criteria (5 listed)
- Patients who have received apremilast > 4 weeks prior to the enrolment visit.
- Women who are pregnant, breastfeeding or planning on becoming pregnant.
- Non-menopausal women who are not using an adequate contraception method.
- Patients with hypersensitivity to apremilast or to one of its excipients.
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 |
|---|---|---|
| ApremilastPsoriasis patients treated with Otezla® (Apremilast) in Belgium | Drug | Use of Apremilast in patient with plaque psoriasis |
Primary outcome
Proportion of patients with Patient Benefit Index for skin diseases (standard version) (PBI-S) ≥ 1 at 6 months after apremilast initiation.
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.
15 secondary outcomes
Characteristics of the patients treated with apremilast
Time frame: Baseline
Proportion of patients with PBI-S = 4 at 6 months after apremilast initiation
Time frame: Up to 6 Months
PBI-S outcome score after apremilast initiation
Time frame: up to 18 months
Proportion of patients having clear/no psoriasis based on Patient Global Assessment (PtGA) at 6 months after apremilast initiation
Time frame: up to 6 months
Change from baseline in the PtGA after apremilast initiation
Time frame: up to 18 months
Proportion of patients with Dermatology Life Quality Index (DLQI) ≤ 5 at 6 months after apremilast initiation.
Time frame: Up to 6 Months
Change from baseline in the DLQI score after apremilast initiation
Time frame: up to 18 months
Change from baseline in the psoriasis symptomatology
Time frame: up to 18 months
Change from baseline in the patient-reported treatment satisfaction (TSQM-9)
Time frame: up to 18 months
Proportion of patients achieving Psoriasis Area and Severity Index (PASI) 50 or PASI 75 at 6 months after apremilast initiation
Time frame: Up to 6 Months
Change from baseline in the disease activity scores in terms of Body Surface Area (BSA)
Time frame: up to 18 months
Change from baseline in the disease activity scores in terms of PASI
Time frame: up to 18 months
Mean duration of apremilast treatment in biologic-naïve patients and in patients having received a previous biological treatment
Time frame: Up to 18 Months
Rate of discontinuation of apremilast treatment within 6 months after initiation
Time frame: Up to 6 months
Adverse Events (AEs)
Time frame: Up to 18 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 27 Apr 2020.
- Derived from this study: PubMed 34977985Ghislain PD, Lambert J, Lam Hoai XL, Hillary T, Roquet-Gravy PP, de la Brassinne M, Segaert S. Real-Life Effectiveness of Apremilast for the Treatment of Psoriasis in Belgium: Results From the Observational OTELO Study. Adv Ther. 2022 Feb;39(2):1068-1080. doi: 10.1007/s12325-021-01981-7. Epub 2022 Jan 3.
- 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
22 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 22 sites in Belgium.
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 5 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 27 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in Belgium. 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 for skin diseases (standard version) (PBI-S) ≥ 1 at 6 months after apremilast initiation. (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 NCT03097003, 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 27 Apr 2020.