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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02652494
Recruitment Status : Active, not recruiting
First Posted : January 12, 2016
Last Update Posted : April 27, 2020
Sponsor:
Information provided by (Responsible Party):
Amgen

Tracking Information
First Submitted Date January 8, 2016
First Posted Date January 12, 2016
Last Update Posted Date April 27, 2020
Actual Study Start Date February 22, 2016
Actual Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 8, 2016)
  • 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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: January 8, 2016)
  • 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
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Observational Study of Apremilast in Patients With Psoriasis in The Netherlands
Official Title Observational Study of Apremilast Use and Effectiveness Over a One Year Treatment Period in Patients With Psoriasis in The Netherlands
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.

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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Psoriasis
Intervention Not Provided
Study Groups/Cohorts Patients receiving Apremilast per daily clinical practice
Dutch patients receiving Apremilast according to daily clinical practice
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Actual Enrollment
 (submitted: March 2, 2020)
154
Original Estimated Enrollment
 (submitted: January 8, 2016)
200
Estimated Study Completion Date June 30, 2020
Actual Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number NCT02652494
Other Study ID Numbers CC-10004-PSOR-014
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Amgen
Study Sponsor Amgen
Collaborators Not Provided
Investigators
Study Director: MD Amgen
PRS Account Amgen
Verification Date April 2020