A Study of Apremilast Use and Effectiveness in Patients With Psoriatic Arthritis in The Netherlands

Arthritis, Psoriatic Clinical Trial

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Official title:

Observational Study of Apremilast Use and Effectiveness in Patients With Psoriatic Arthritis in The Netherlands

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02875184
• Other study ID #: CC-10004-PSA-009
• Secondary ID: CC-10004-PSA-009
• Status: Completed
• Start date: March 6, 2017
• Est. completion date: June 30, 2022

Study information

• Verified date: October 2023
• Source: Amgen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This is a multicenter, prospective, non-interventional, observational single arm study. 100 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 Summary of Product Characteristics (SPC) of apremilast (Otezla®). Each patient will be followed up for a maximum of 24 months.

Description:

The objective of this non-interventional study is to describe patient reported outcomes, effectiveness and real-life use of apremilast treatment in patients with psoriatic arthritis (PsA).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: June 30, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criter

• Patients = 18 years of age who understand and voluntarily sign an informed consent form.
• Patients starting treatment with apremilast for psoriatic arthritis.

Exclusion Criteria:

• Refusal to participate in the study.
• Language barrier for completing the questionnaires.
• Women who are pregnant or breast-feeding.
• Hypersensitivity to the active substance or to any of the excipients.
• Prior exposure to apremilast
• Initiation of apremilast treatment by a dermatologist for psoriasis

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Psoriatic

Locations

Country	Name	City	State
Netherlands	Amphia	Breda	North-Brabant
Netherlands	Research Site	Breda
Netherlands	Reumazorg ZWN	Goes	Zeeland
Netherlands	Beatrix Ziekenhuis	Gorinchem	South-Holland
Netherlands	Research Site	Gorinchem
Netherlands	Groene Hart Ziekenhuis	Gouda	South-Holland
Netherlands	Research Site	Gouda
Netherlands	Research Site	Harderwijk
Netherlands	St. Jansdal	Harderwijk	Gelderland
Netherlands	Elkerliek ziekenhuis	Helmond	North-Brabant
Netherlands	MC Leeuwarden	Leeuwarden	Friesland
Netherlands	Research Site	Leeuwarden
Netherlands	Reumazorg ZWN	Lelystad/Emmeloord	Flevoland
Netherlands	Research Site	Roosendaal
Netherlands	Reumazorg ZWN	Roosendaal	Noord-Brabant
Netherlands	Erasmus MC	Rotterdam	South-Holland
Netherlands	Maasstad Ziekenhuis	Rotterdam	South-Holland
Netherlands	Research Site	Rotterdam
Netherlands	Research Site	Rotterdam
Netherlands	Research Site	Venlo
Netherlands	Viecuri Medisch Centrum	Venlo	Limburg

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of patients with a Health Assessment Questionnaire - Disability Index (HAQ-DI) score of = 0.5 or with a decrease of = 0.3 of the HAQ-DI score compared with baseline	The HAQ is a general questionnaire to assess physical functioning.	Up to 24 months
Secondary	Change from Baseline in Psoriatic Arthritis Impact of Disease (PsAID) at various time point	PsAID is a general questionnaire that measures the health impact of psoriatic arthritis.	Up to 24 months
Secondary	Change from Baseline in Treatment Satisfaction Questionnaire for Medication (TSQM) at various time points	The TSQM questionnaire is a general measure of treatment satisfaction across medication types and patient conditions.	Up to 24 months
Secondary	Change from Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at month 6	The BASDAI is used for measuring and evaluating disease activity in Ankylosing Spondylitis.	Up to 6 months
Secondary	Change from Baseline in Dermatology Life Quality Index (DLQI) at month 6	The DLQI is a dermatology specific Quality of Life instrument.	Up to 6 months
Secondary	Change from Baseline in Short Form 36 (SF36) at 12 months	The SF-36v2® Health Survey measures functional health and well-being from the patients point of view. It can be used across age (18 and older), disease and treatments.	Up to 12 months
Secondary	Change from Baseline in EuroQol-5 dimensions (EQ5D) at 12 months	EQ-5D is a standard instrument to measure of health status.	Up to 12 months
Secondary	Change from Baseline in visual analogue scales (VAS) at various time point	VAS is a simple assessment of the global health, itch and pain severity using a visual analogue scale	Up to 24 months

External Links

•   AmgenTrials clinical trials website
•   Expanded Access for CC-100004