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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

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

Brief Summary:

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.


Detailed Summary: 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).
Sponsor: Celgene

Current Primary Outcome: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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


Original Secondary Outcome:

  • 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 psoriactic 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


Information By: Celgene

Dates:
Date Received: August 18, 2016
Date Started: September 2016
Date Completion: March 2020
Last Updated: February 22, 2017
Last Verified: February 2017