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A Study of Otezla® in Patients With Plaque Psoriasis Under Routine Conditions

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ClinicalTrials.gov Identifier: NCT02626793
Recruitment Status : Active, not recruiting
First Posted : December 10, 2015
Last Update Posted : June 13, 2018
Sponsor:
Information provided by (Responsible Party):
Celgene

Brief Summary:
The objective of this Non-interventional study (NIS) is the collection of data on the utilization of Apremilast under routine conditions in Germany. Patients' quality-of-life and treatment satisfaction on treatment with Apremilast in daily practice will be documented. Moreover, physician's and patient's assessments of the effectiveness and safety of Apremilast will be recorded.

Condition or disease
Psoriasis

Detailed Description:

The objective of this NIS (according to section 67(6) of the German Medicinal Products Act) is the documentation of data on the effectiveness and tolerability of an Apremilast treatment under routine clinical conditions in German patients with plaque psoriasis.

This NIS is intended to reflect the apremilast treatment of patients with plaque psoriasis who have received at least one prior conventional, systemic therapy or, if a contraindication is present, did not receive a systemic therapy so far, and who were diagnosed by their treating physicians to be eligible for an apremilast treatment. The treatment of Apremilast will be documented for a period of approximately 52 weeks.


Study Type : Observational
Actual Enrollment : 401 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Long-term Documentation of the Utilization of Otezla® in Patients With Plaque Psoriasis Under Routine Conditions (LAPIS-Pso)
Actual Study Start Date : August 3, 2015
Estimated Primary Completion Date : June 14, 2018
Estimated Study Completion Date : July 15, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis
Drug Information available for: Apremilast

Group/Cohort
Patients with ≤ 1 conventional, systemic pre-treatment
After failure (inadequate response/intolerance) to or contraindication for ≤ 1 conventional, systemic pre-treatment
Patients with > 1 conventional, systemic pre-treatment
After failure (inadequate response/intolerance) to or contraindication for > 1 conventional, systemic pre-treatment



Primary Outcome Measures :
  1. Change from baseline in the Dermatology Life Quality Index (DLQI) ≤ 5 or improvement in DLQI by ≥ 5 points at Visit 2 from baseline [ Time Frame: Approximately 4 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.


Secondary Outcome Measures :
  1. Change from Baseline in the Dermatology Life Quality Index (DLQI) ≤ 5 or improvement in DLQI by ≥ 5 points at all other visits from baseline. [ Time Frame: Up to approximately 52 weeks ]
    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.

  2. Change in the Physician Global Assessment (PGA) Score [ Time Frame: Up to approximately 52 weeks ]
    The PGA is a 5-point scale ranging from 0 (clear), 1 (almost clear), 2 (mild), 3 (moderate), to 4 (severe), incorporating an assessment of the severity of the Plaque-Psoriasis.

  3. Percent Change in Percent of Affected Body Surface Area (BSA) [ Time Frame: Up to approximately 52 weeks ]
    BSA is a measurement of involved skin. The overall BSA affected by psoriasis is estimated based on the palm area of the participant's hand (entire palmer surface or "handprint" excluding DIPs), which equates to approximately 1% of total body surface area.

  4. Percent Change in the Psoriasis Area Severity Index (PASI) Score [ Time Frame: Up to approximately 52 weeks ]
    Psoriasis Area Severity Index (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 total qualitative score (sum of erythema, thickness, and scaling scores) is multiplied by the degree of involvement for each anatomic region and then multiplied by a constant. These values for each anatomic region are summed to yield the PASI score.

  5. Change in the Patient's Global Assessment (PaGA) [ Time Frame: Up to approximately 52 weeks ]
    The PaGA is a 5-point scale ranging from 0 (clear), 1 (almost clear), 2 (mild), 3 (moderate), to 4 (severe), incorporating an assessment of the severity of the Plaque-Psoriasis by the patient.

  6. Patient Preference Questionnaire (PPQ) [ Time Frame: Approximately 4 months ]
    PPQ is a questionnaire consisting of 5 questions. PPQ asks the patient for his preference of the actual therapy versus the previous systemic therapy.

  7. Patient Satisfaction (Systemic Therapy Adherence Questionnaire, STAQ) [ Time Frame: Approximately 13 months ]
    STAQ; patient questionnaire on patient benefit, communication physician/patient, patient knowledge, and treatment satisfaction with the current systemic treatment (38 questions).

  8. Change in Pain (Visual Analogue Scale; VAS) [ Time Frame: Up to approximately 52 weeks ]
    The Pain Visual Analog Scores (VAS) is used to measure the amount of pain a participant experiences. Participants are asked: How much pain do you actually experience? All VAS values range from 0 to 100. Higher scores correspond to more severe symptom or disease.

  9. Adverse Events (AEs) [ Time Frame: Up to approximately 52 weeks ]
    All Serious Adverse Events (SAEs), irrespective of relationship to Apremilast, and all non-serious AEs considered at least possibly related to Apremilast administration [non-serious adverse drug reactions (NS ADRs)], must be recorded within 24 hours of the physician's knowledge to the Sponsors` Drug Safety Department. AEs will be reported by the sponsor as required to Regulatory Authorities and Ethics Committees as applicable, in accordance with the national requirements for marketing authorization holders.

  10. Change in Itch (Pruritus) (Visual Analogue Scale; VAS) [ Time Frame: Up to approximately 52 weeks ]
    The Itch Visual Analog Scores (VAS) is used to measure the amount of itch a participant experiences. Participants are asked: How much itch do you actually experience? All VAS values range from 0 to 100. Higher scores correspond to more severe symptom or disease.

  11. Change in Scalp Involvement -Physician's Global Assessment (PGA) [ Time Frame: Up to approximately 52 weeks ]
    PGA: 5-point scale for the physician's global assessment of the severity of scalp psoriasis.

  12. Change in Scalp Involvement - Patient's Global Assessment (PaGA) [ Time Frame: Up to approximately 52 weeks ]
    PaGA: 5-point scale for the patient's global assessment of the severity of scalp psoriasis.

  13. Change in Nail Involvement - Target Nail Psoriasis Severity Index (NAPSI) [ Time Frame: Up to approximately 52 weeks ]
    NAPSI: Assessment of target fingernail for nail bed and nail matrix involvement, each can be scored 0-4. Total score ranges from 0-8.

  14. Change in Nail Involvement Fingernail - Patient's Global Assessment (PaGA) [ Time Frame: Up to approximately 52 weeks ]
    Fingernail Patient Global Assessment ; 5-point scale on the patient's global assessment of the fingernail involvement, substituted with a 0-100 Visual analog scale (VAS) for the assessment of the impairment caused by this nail involvement.

  15. Change in Palmoplantar involvement - Palmoplantar physician's global assessment (PGA) [ Time Frame: Up to approximately 52 weeks ]
    PGA: 5-point scale for the physician's global assessment of the severity of palmoplantar involvement.

  16. Change in Palmoplantar involvement - Palmoplantar patient's global assessment (PaGA) [ Time Frame: Up to approximately 52 weeks ]
    PaGA: 5-point scale for the patient's global assessment of the severity of palmoplantar involvement.



Information from the National Library of Medicine

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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
A total of 500 patients with moderate to severe plaque psoriasis are planned to be enrolled in this NIS. In- and exclusion criteria are derived from the Summary of product characteristics (SmPC) of Apremilast.
Criteria

Inclusion Criteria:

  • The decision for a therapy with Apremilast was made before enrolment and independent of this study.
  • Patient ≥ 18 years of age
  • Diagnosis of moderate to severe plaque psoriasis
  • Inadequate response or intolerance to a previous systemic treatment, or contraindication for systemic therapies.
  • Written informed consent by the patient for data recording, statistical analysis, filing and forwarding of the data

Exclusion Criteria:

  • Pregnancy
  • Hypersensitivity to apremilast or any of the excipients of the film-coated tablet
  • Other criteria according to the Summary of product characteristics (SmPC).

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): NCT02626793


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Sponsors and Collaborators
Celgene
Investigators
Study Director: Volker Koscielny, MD Celgene Sarl

Responsible Party: Celgene
ClinicalTrials.gov Identifier: NCT02626793     History of Changes
Other Study ID Numbers: CC-10004-PPSO-002
First Posted: December 10, 2015    Key Record Dates
Last Update Posted: June 13, 2018
Last Verified: June 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Celgene:
Plaque psoriasis
Apremilast
Otezla®
LAPIS-Pso
Observational
CC-10004
non-interventional
Germany

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Apremilast
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