Study to Evaluate the Real-World Effectiveness, Safety and Tolerability of Treatment With Apremilast in Psoriatic Arthritis Patients Followed in Canadian Routine Care (APPRAISE)

Sponsor
Amgen
Study ID
NCT03608657
Status
Completed

Conditions

  • Arthritis, Psoriatic

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

This will be a Canadian observational study utilizing a prospective cohort design. Patients with active psoriatic arthritis (PsA) for whom the treating physician has decided, prior to and independently of enrollment in the study, to initiate treatment with Otezla® will be considered for participation in the study. Patients will be enrolled from the practices of predominantly community rheumatologists and will be followed for 12 months from the time of initiation of treatment with Otezla® In line with the observational nature of the study, there will be no protocol imposed tests or assessments. However, recommended follow up visits will be at 4, 8 and 12 months. In addition, patients may be asked to voluntarily complete self-administered questionnaires. The 24-month assessment will be aimed to determine whether or not treatment with Otezla® has been maintained, and if not, to ascertain the reason for discontinuation and what new treatment was initiated following discontinuation of Otezla®

Key Dates

First listed
Aug 1, 2018
Start date
Jul 31, 2018
Status verified
Jun 2024
Primary completion
Apr 12, 2021
Completion
Mar 30, 2022

Study Design

Enrollment
102 participants (actual)

Arms

  • Arm: Psoriatic Arthritis patients treated with Apremilast
    Active PsA as per the CASPAR criteria, based on the investigator's clinical judgement with access to commercially available Otezla

Primary Outcome Measure

The rate of achieving Low Disease Activity (LDA) [ Time Frame: Up to approximately 1 year ]

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