Observational Study of Apremilast in Patients With Psoriasis in The Netherlands (APRIL)
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| ClinicalTrials.gov Identifier: NCT02652494 |
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Recruitment Status
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Recruiting
First Posted
: January 12, 2016
Last Update Posted
: February 28, 2018
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This is a multicenter, prospective, non-interventional, observational single arm study.
Two-hundred patients will be recruited in the Netherlands over a one year period. In all cases, the decision to treat the patient with apremilast will be made prior to the decision to enter the subject into this study. Treatment will be according to routine clinical practice and based on recommendations as per the SPC of apremilast (Otezla®). Recruitment will continue until 200 patients have entered the study. Each patient will be followed for 12 months.
| Condition or disease |
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| Psoriasis |
Baseline Demographics, disease characteristics and medication history prior to start of treatment with apremilast will be collected. Patients will be asked to complete baseline DLQI, SF36, EQ5D, TSQM,WPAI and PBI questionnaires. Photographs of the finger nails will be taken.
Follow-up visits Follow-up assessments will take place at the regularly scheduled outpatient visits at 6 and 12 months (+/- 1 month) after initiation of apremilast.
- Skin-specific disease measures (Psoriasis Activity and Severity Index (PASI), (static) Physician Global Assessment (sPGA), Body Surface Area (BSA))
- Patients will be asked to complete the following questionnaires:
- DLQI
- TSQM
- EQ5D
- SF36- Itch Visual Analog Scale (VAS)
- WPAI Work Productivity and Activity Index
- Patient Benefit Index PBI
End of treatment Upon discontinuation of treatment with apremilast, the date, the dose and reason for discontinuation will be documented.
AE monitoring All patients will be monitored for adverse events throughout the study.
From the time of the patient signing informed consent until treatment with apremilast is permanently abrogated, all non-serious adverse events that are considered related to apremilast and all Serious Adverse Events (SAEs) regardless of causality will be reported.
| Study Type : | Observational |
| Estimated Enrollment : | 200 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | Observational Study of Apremilast Use and Effectiveness Over a One Year Treatment Period in Patients With Psoriasis in The Netherlands |
| Actual Study Start Date : | February 22, 2016 |
| Estimated Primary Completion Date : | December 31, 2018 |
| Estimated Study Completion Date : | December 31, 2018 |
| Group/Cohort |
|---|
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Patients receiving Apremilast per daily clinical practice
Dutch patients receiving Apremilast according to daily clinical practice
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- Percentage of patients with Dermatology Life Quality Index (DLQI) ≤ 5 points [ Time Frame: Up to approximately 12 months ]The Dermatology Life Quality Index or DLQI is a dermatology-specific Quality of Life instrument. It is a simple 10-question validated questionnaire that has been used in over 40 different skin conditions.
- Percentage of patients with Dermatology Life Quality Index (DLQI) improvement in DLQI ≥ 5 points [ Time Frame: Up to approximately 12 months ]The Dermatology Life Quality Index or DLQI is a dermatology-specific Quality of Life instrument. It is a simple 10-question validated questionnaire that has been used in over 40 different skin conditions.
- Changes in treatment satisfaction questionnaire for medication (TSQM) at 6 and 12 months treatment [ Time Frame: Up to approximately 12 months ]The TSQM questionnaire is a general measure of treatment satisfaction across medication types and patient conditions.
- Changes in generic quality of life at 6 and 12 months treatment Short Form 36 (SF-36v2) health survey [ Time Frame: Up to approximately 12 months ]The SF-36v2® Health Survey measures functional health and well-being from the patient's point of view. It can be used across age (18 and older), disease, and treatment group.
- Changes in generic quality of life at 6 and 12 months treatment using EuroQol-5 dimensions (EQ-5D) [ Time Frame: Up to approximately 12 months ]EQ-5D is a standardized instrument for use as a measure of health outcome in a wide range of health conditions and treatment
- Change in itch at 6 and 12 months treatment using the itch Visual Analog Scale (VAS) [ Time Frame: Up to approximately 12 months ]Itch VAS is a simple assessment of the itch severity using a visual analogue scale
- Changes in psoriasis area and severity index (PASI) at 6 and 12 months treatment [ Time Frame: Up to approximately 2 months ]PASI score is a tool used to measure the severity and extent of psoriasis (Psoriasis Area and Severity Index).
- Changes in body surface area (BSA)at 6 and 12 months treatment [ Time Frame: Up to approximately 12 months ]BSA (Body Surface Area): severity is defined by how much of the body surface area is affected.
- Changes in static physician global assessment (sPGA) at 6 and 12 months treatment [ Time Frame: Up to approximately 12 months ]sPGA: assessment by physician to classify disease activity in a consistent manner
- Baseline characteristics of patients initiating apremilast treatment [ Time Frame: Up to approximately 1 month ]Characteristics at baseline of patient initiating apremilast treatment
- Reasons for discontinuation of apremilast [ Time Frame: Up to approximately 12 months ]Rate and reasons for discontinuation of apremilast within 12 months of start
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- Patients ≥ 18 years of age who understand and voluntarily sign an informed consent form.
- Patients starting treatment for psoriasis with apremilast in clinical practice.
Exclusion Criteria:
- Refusal to participate in the study.
- Women who are pregnant or breast-feeding.
- Hypersensitivity to the active substance or to any of the excipients.
- Prior exposure to apremilast
- Psoriatic arthritis treated by a rheumatologist in the previous year
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02652494
| Contact: Associate Director Clinical Trial Disclosure | 1-888-260-1599 | clinicaltrialdisclosure@celgene.com |
| Netherlands | |
| Antonius Ziekenhuis Sneek | Recruiting |
| Sneek, Friesland, Netherlands, 8601 DZ | |
| Zorggroep Twente | Recruiting |
| Hengelo, Gelderland, Netherlands, 7555 DL | |
| Radboud UMC | Recruiting |
| Nijmegen, Gelderland, Netherlands, 6525 GL | |
| Zuyderland MC | Recruiting |
| Sittard, Limburg, Netherlands, 6162 BG | |
| TweeSteden Ziekenhuis | Recruiting |
| Tilburg, North Brabant, Netherlands, 5042 AD | |
| Bravis Ziekenhuis | Not yet recruiting |
| Bergen op Zoom, North-Brabant, Netherlands, 4624 VT | |
| Amphia | Recruiting |
| Breda, North-Brabant, Netherlands, 4818 CK | |
| Maxima MC | Recruiting |
| Veldhoven, North-Brabant, Netherlands, 5504 DB | |
| Centrum Oosterwal | Recruiting |
| Alkmaar, North-Holland, Netherlands, 1817 MS | |
| Spaarne Gasthuis | Not yet recruiting |
| Hoofddorp, North-Holland, Netherlands, 2134 TM | |
| Maasstad Ziekenhuis | Recruiting |
| Rotterdam, South Holland, Netherlands, 3079 DZ | |
| Meander MC | Not yet recruiting |
| Amsersfoort, Utrecht, Netherlands, 3813 TZ | |
| Study Director: | Jan Pander, PHD | Celgene |
| Responsible Party: | Celgene |
| ClinicalTrials.gov Identifier: | NCT02652494 History of Changes |
| Other Study ID Numbers: |
CC-10004-PSOR-014 |
| First Posted: | January 12, 2016 Key Record Dates |
| Last Update Posted: | February 28, 2018 |
| Last Verified: | February 2018 |
Keywords provided by Celgene:
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Psoriasis Observational Apremilast |
APRIL Non-Interventional The Netherlands |
Additional relevant MeSH terms:
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Psoriasis Skin Diseases, Papulosquamous Skin Diseases Apremilast Thalidomide Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Inflammatory Agents |
Antirheumatic Agents Immunosuppressive Agents Immunologic Factors Leprostatic Agents Anti-Bacterial Agents Anti-Infective Agents Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Growth Inhibitors Antineoplastic Agents |