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A Study of Real-World Experience of Psoriasis Patients Treated With Apremilast in Clinical Dermatology Practice (APPRECIATE)

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ClinicalTrials.gov Identifier: NCT02740218
Recruitment Status : Recruiting
First Posted : April 15, 2016
Last Update Posted : April 23, 2018
Sponsor:
Information provided by (Responsible Party):
Celgene

Brief Summary:
This is a retrospective, multi-center observational cohort study. This study will be implemented first in Germany (approximately 50 sites), the United Kingdom (approximately 20 sites) and Sweden (approximately 25 sites), followed by a selected number of countries in Europe, depending on apremilast local availability. The design of this apremilast retrospective study aims to provide clinical information regarding the treatment initiation and outcomes in psoriasis patients when prescribed apremilast in real world settings. In addition, this study is aiming at capturing physicians' and patients' treatment goals when initiating apremilast and whether these goals are achieved following apremilast use. This study is primarily descriptive in nature, and no a priori hypotheses are specified. Patients must voluntarily sign an informed consent form, be 18 or over, have been diagnosed with plaque psoriasis and have been treated with apremilast during the previous 5-7 months to participate in this study. They must not be involved in any other clinical study involving apremilast.

Condition or disease Intervention/treatment
Psoriasis Other: Patient questionnaire

Study Type : Observational
Estimated Enrollment : 515 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: APPRECIATE (Apremilast Clinical Treatment Experience in Psoriasis): A Multi-center, Retrospective Observational Study of Real-World Experience of Psoriasis Patients Treated With Apremilast in Clinical Dermatology Practice
Actual Study Start Date : June 24, 2016
Estimated Primary Completion Date : June 30, 2018
Estimated Study Completion Date : June 30, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis
Drug Information available for: Apremilast

Group/Cohort Intervention/treatment
Psoriasis patients
Single cohort of psoriasis patients treated with OTEZLA (apremilast)
Other: Patient questionnaire
Patients will be asked to complete a questionnaire regarding their expectations, experience and satisfaction in taking OTEZLA (apremilast) treatment




Primary Outcome Measures :
  1. The Patient Benefit Index (PBI) outcome score [ Time Frame: Up to approximately 7 months ]
    Is a questionnaire regarding patient expectations and benefit of psoriasis treatment with apremilast, eg, effect on specific symptoms.


Secondary Outcome Measures :
  1. Treatment Satisfaction Questionnaire for Medication (TSQM) outcome score [ Time Frame: Up to approximately 7 months ]
    The TSQM-9 is a self-administrated instrument to understand a subject's satisfaction on the current therapy

  2. Percentage of patients achieving PASI75 [ Time Frame: Up to approximately 7 months ]
    PASI-75 response is the percentage of participants who achieved at least a 75% reduction (improvement) from baseline in PASI score at Week 16. The improvement in PASI score was used as a measure of efficacy. The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). The PASI score was set to missing if any severity score or degree of involvement is missing.

  3. Percentages of patients achieving PASI50 [ Time Frame: Up to approximately 7 months ]
    PASI score is based on an assessment of erythema (reddening), induration (plaque thickness), desquamation (scaling), and the percent area affected as observed on the day of examination.

  4. Mean change in Dermatology Life Quality Index (DLQI) [ Time Frame: Up to approximately 7 months ]
    DLQI is a simple, compact, and practical questionnaire for use in a dermatology clinical setting to assess limitations related to the impact of skin disease. The instrument contains ten items dealing with the participant's skin. With the exception of Item Number 7, the participant responds on a four-point scale, ranging from "Very Much" (score 3) to "Not at All" or "Not relevant" (score 0). Item Number 7 is a multi-part item, the first part of which ascertains whether the participant's skin prevented them from working or studying (Yes or No, scores 3 or 0 respectively), and if "No," then the participant is asked how much of a problem the skin has been at work or study over the past week, with response alternatives being "A lot," "A little," or "Not at all" (scores 2, 1, or 0 respectively). The DLQI total score is derived by summing all item scores, which has a possible range of 0 to 30, with 30 corresponding to the worst quality of life, and 0 corresponding to the best.

  5. Percentages of patients achieving ≥5 point improvement in DLQI [ Time Frame: Up to approximately 7 months ]
    DLQI is a simple, compact, and practical questionnaire for use in a dermatology clinical setting to assess limitations related to the impact of skin disease. The instrument contains ten items dealing with the participant's skin. With the exception of Item Number 7, the participant responds on a four-point scale, ranging from "Very Much" (score 3) to "Not at All" or "Not relevant" (score 0). Item Number 7 is a multi-part item, the first part of which ascertains whether the participant's skin prevented them from working or studying (Yes or No, scores 3 or 0 respectively), and if "No," then the participant is asked how much of a problem the skin has been at work or study over the past week, with response alternatives being "A lot," "A little," or "Not at all" (scores 2, 1, or 0 respectively). The DLQI total score is derived by summing all item scores, which has a possible range of 0 to 30, with 30 corresponding to the worst quality of life, and 0 corresponding to the best.

  6. Percentages of patients achieving PASI50 plus ≥5 point improvement in DLQI [ Time Frame: Up to approximately 7 months ]

    PASI score is based on an assessment of erythema (reddening), induration (plaque thickness), desquamation (scaling), and the percent area affected as observed on the day of examination.

    DLQI is a simple, compact, and practical questionnaire for use in a dermatology clinical setting to assess limitations related to the impact of skin disease


  7. Mean change in Body Surface Area (BSA) [ Time Frame: Up to approximately 7 months ]
    BSA was a measurement of involved skin. The overall BSA affected by psoriasis was estimated based on the palm area of the participant's hand (entire palmar surface or "handprint" including the fingers), which equates to approximately 1% of total body surface area.

  8. Mean change in PGA [ Time Frame: Up to approximately 7 months ]
    The PGA is a 5-point scale ranging from 0 (clear) to 4 (severe), incorporating an assessment of the severity of the 3 primary signs of the disease: erythema, scaling and plaque elevation. When making the assessment of overall severity, the assessor factors in areas that have already cleared (ie, have scores of 0) and not just remaining lesions for severity, ie, the severity of each sign was to be averaged across all areas of involvement, including cleared lesions

  9. Percentage of patients achieving PGA 0/1 (clear/almost clear) [ Time Frame: Up to approximately 7 months ]
    The PGA is a 5-point scale ranging from 0 (clear) to 4 (severe), incorporating an assessment of the severity of the 3 primary signs of the disease: erythema, scaling and plaque elevation. When making the assessment of overall severity, the assessor factors in areas that have already cleared (ie, have scores of 0) and not just remaining lesions for severity, ie, the severity of each sign was to be averaged across all areas of involvement, including cleared lesions

  10. Adverse Events (AEs) [ Time Frame: Up to approximately 7 months ]
    Number of patients with adverse events



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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
Patient charts will be selected for data abstraction by participating dermatologists and will be determined eligible for study enrollment based on the inclusion criteria. All consecutive adult psoriasis patients who can be contacted 6 months (+/- 1 month) following initiation of treatment with apremilast will be approached for entry to minimize bias in patient selection. All eligible patients will be included in consecutive order regarding the date of the signed Informed Consent.
Criteria

Inclusion Criteria:

  1. Must have understood and voluntarily signed the Informed Consent Form (ICF).
  2. Age ≥ 18 years at the time of signing the ICF.
  3. Diagnosed with plaque psoriasis.
  4. Initiated treatment with apremilast 6 months (+/- 1 month) previously (patients may or may not have completed 6 months of apremilast treatment)

Exclusion Criteria:

  1. Refusal to participate in this study or current participation in the treatment phase of an interventional clinical trial.
  2. Started apremilast as part of a clinical trial.

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): NCT02740218


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

  Show 116 Study Locations
Sponsors and Collaborators
Celgene
Investigators
Study Director: Volker Koscielny, MD Executive Director Medical Affairs I&I EMEA

Responsible Party: Celgene
ClinicalTrials.gov Identifier: NCT02740218     History of Changes
Other Study ID Numbers: CC-10004-PSOR-013
First Posted: April 15, 2016    Key Record Dates
Last Update Posted: April 23, 2018
Last Verified: April 2018

Keywords provided by Celgene:
Psoriasis
Apremilast
APPRECIATE
Dermatology
Retrospective
Observational

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