A Study of Apremilast Use and Effectiveness in Patients With Psoriatic Arthritis in The Netherlands (REWARD)
|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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02875184|
Recruitment Status : Recruiting
First Posted : August 23, 2016
Last Update Posted : November 21, 2018
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 Summary of Product Characteristics (SPC) of apremilast (Otezla®). Each patient will be followed up for a maximum of 24 months.
|Condition or disease|
|Study Type :||Observational|
|Estimated Enrollment :||200 participants|
|Official Title:||Observational Study of Apremilast Use and Effectiveness in Patients With Psoriatic Arthritis in The Netherlands|
|Actual Study Start Date :||March 6, 2017|
|Estimated Primary Completion Date :||March 1, 2020|
|Estimated Study Completion Date :||March 1, 2020|
Psoriatic arthritis patients treated with apremilast
Psoriatic arthritis patients who are treated with apremilast according to daily practice
- 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 [ Time Frame: Up to 24 months ]The HAQ is a general questionnaire to assess physical functioning.
- Change from Baseline in Psoriatic Arthritis Impact of Disease (PsAID) at various time point [ Time Frame: Up to 24 months ]PsAID is a general questionnaire that measures the health impact of psoriatic arthritis.
- Change from Baseline in Treatment Satisfaction Questionnaire for Medication (TSQM) at various time points [ Time Frame: Up to 24 months ]The TSQM questionnaire is a general measure of treatment satisfaction across medication types and patient conditions.
- Change from Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at month 6 [ Time Frame: Up to 6 months ]The BASDAI is used for measuring and evaluating disease activity in Ankylosing Spondylitis.
- Change from Baseline in Dermatology Life Quality Index (DLQI) at month 6 [ Time Frame: Up to 6 months ]The DLQI is a dermatology specific Quality of Life instrument.
- Change from Baseline in Short Form 36 (SF36) at 12 months [ Time Frame: Up to 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.
- Change from Baseline in EuroQol-5 dimensions (EQ5D) at 12 months [ Time Frame: Up to 12 months ]EQ-5D is a standard instrument to measure of health status.
- Change from Baseline in visual analogue scales (VAS) at various time point [ Time Frame: Up to 24 months ]VAS is a simple assessment of the global health, itch and pain severity using a visual analogue scale
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): NCT02875184
|Contact: Associate Director Clinical Trial Disclosurefirstname.lastname@example.org|
|Viecuri Medisch Centrum||Recruiting|
|Venlo, Limburg, Netherlands, 5912 BL|
|Roosendaal, Noord-Brabant, Netherlands, 4707 CH|
|Breda, North-Brabant, Netherlands, 4819 EV|
|Helmond, North-Brabant, Netherlands, 5707 HA|
|Rotterdam, South-Holland, Netherlands, 3015 CE|
|Rotterdam, South-Holland, Netherlands, 3079 DZ|
|Study Director:||Jan Pander, PhD||Celgene B.V|