An observational study in Psoriasis, sponsored by Amgen. Completed at 96 sites in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-02-08.
Sponsored by Amgen · Observational
The objective of this 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. FPI was 3rd August 2015, LPO was 14th of June 2018. A total of 391 patients have been enrolled.
The objective of this NIS (according to section 4(23) 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.
1,899 studies on the registry are indexed under Psoriasis; 233 are open to participants now.
This study's enrollment of 391 is above the median of 200 across 396 observational studies indexed under Psoriasis.
Browse Psoriasis studies →Amgen is the lead sponsor of 1,016 studies on the registry; 50 are open to participants now.
Of its 245 completed or terminated interventional studies of FDA-regulated products, 159 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
After failure (inadequate response/intolerance) to or contraindication for ≤ 1 conventional, systemic pre-treatment
After failure (inadequate response/intolerance) to or contraindication for \> 1 conventional, systemic pre-treatment
Change from baseline in the Dermatology Life Quality Index (DLQI) ≤ 5 or improvement in DLQI by ≥ 5 points at Visit 2 from baseline
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.
Time frame: Approximately 4 months
Change from Baseline in the Dermatology Life Quality Index (DLQI) ≤ 5 or improvement in DLQI by ≥ 5 points at all other visits from baseline.
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.
Time frame: Up to approximately 52 weeks
Change in the Physician Global Assessment (PGA) Score
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.
Time frame: Up to approximately 52 weeks
Percent Change in Percent of Affected Body Surface Area (BSA)
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.
Time frame: Up to approximately 52 weeks
Percent Change in the Psoriasis Area Severity Index (PASI) Score
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.
Time frame: Up to approximately 52 weeks
Change in the Patient's Global Assessment (PaGA)
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.
Time frame: Up to approximately 52 weeks
Patient Preference Questionnaire (PPQ)
PPQ is a questionnaire consisting of 5 questions. PPQ asks the patient for his preference of the actual therapy versus the previous systemic therapy.
Time frame: Approximately 4 months
Patient Satisfaction (Systemic Therapy Adherence Questionnaire, STAQ)
STAQ; patient questionnaire on patient benefit, communication physician/patient, patient knowledge, and treatment satisfaction with the current systemic treatment (38 questions).
Time frame: Approximately 13 months
Change in Pain (Visual Analogue Scale; VAS)
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.
Time frame: Up to approximately 52 weeks
Adverse Events (AEs)
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.
Time frame: Up to approximately 52 weeks
Change in Itch (Pruritus) (Visual Analogue Scale; VAS)
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.
Time frame: Up to approximately 52 weeks
Change in Scalp Involvement -Physician's Global Assessment (PGA)
PGA: 5-point scale for the physician's global assessment of the severity of scalp psoriasis.
Time frame: Up to approximately 52 weeks
Change in Scalp Involvement - Patient's Global Assessment (PaGA)
PaGA: 5-point scale for the patient's global assessment of the severity of scalp psoriasis.
Time frame: Up to approximately 52 weeks
Change in Nail Involvement - Target Nail Psoriasis Severity Index (NAPSI)
NAPSI: Assessment of target fingernail for nail bed and nail matrix involvement, each can be scored 0-4. Total score ranges from 0-8.
Time frame: Up to approximately 52 weeks
Change in Nail Involvement Fingernail - Patient's Global Assessment (PaGA)
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.
Time frame: Up to approximately 52 weeks
Change in Palmoplantar involvement - Palmoplantar physician's global assessment (PGA)
PGA: 5-point scale for the physician's global assessment of the severity of palmoplantar involvement.
Time frame: Up to approximately 52 weeks
Change in Palmoplantar involvement - Palmoplantar patient's global assessment (PaGA)
PaGA: 5-point scale for the patient's global assessment of the severity of palmoplantar involvement.
Time frame: Up to approximately 52 weeks
This study is completed, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Amgen