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Observational Study of Apremilast in Patients With Psoriasis in The Netherlands (APRIL)

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ClinicalTrials.gov Identifier: NCT02652494
Recruitment Status : Recruiting
First Posted : January 12, 2016
Last Update Posted : November 21, 2018
Sponsor:
Information provided by (Responsible Party):
Celgene

Study Description
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Brief Summary:

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
Psoriasis

Detailed Description:

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 Design
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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis
Drug Information available for: Apremilast

Groups and Cohorts
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Group/Cohort
Patients receiving Apremilast per daily clinical practice
Dutch patients receiving Apremilast according to daily clinical practice


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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

  4. 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

  5. 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).

  6. 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.

  7. 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

  8. Baseline characteristics of patients initiating apremilast treatment [ Time Frame: Up to approximately 1 month ]
    Characteristics at baseline of patient initiating apremilast treatment

  9. Reasons for discontinuation of apremilast [ Time Frame: Up to approximately 12 months ]
    Rate and reasons for discontinuation of apremilast within 12 months of start


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Two hundred adult patients treated with apremilast for psoriasis in clinical practice. In all cases, the decision to treat the patient with apremilast will be made prior to the decision to enter the subject into the study.
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
Contact: Associate Director Clinical Trial Disclosure 1-888-260-1599 clinicaltrialdisclosure@celgene.com

Locations
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
Sponsors and Collaborators
Celgene
Investigators
Study Director: Jan Pander, PHD Celgene
More Information
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Additional Information:
Expanded Access for CC-10004  This link exits the ClinicalTrials.gov site

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: November 21, 2018
Last Verified: November 2018

Keywords provided by Celgene:
Psoriasis
Observational
Apremilast
 APRIL
Non-Interventional
The Netherlands

Additional relevant MeSH terms:
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