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

Amgen

Status: Completed

Conditions: Arthritis, Psoriatic

Treatments: Drug: Apremilast

Study type: Observational

Funder types: Industry

Identifiers

NCT03608657

CC-10004-PSA-011

U1111-1214-0693 (Other Identifier)

Details and patient eligibility

About

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®

Enrollment: 102 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Active psoriatic arthritis (PsA) as per the Classification criteria for Psoriatic Arthritis (CASPAR) criteria, based on the investigator's clinical judgement.
• Adult patients (≥18 years of age) with PsA
• Prescribing physician has decided to initiate treatment with Otezla®, and this decision was prior to and independent of patient enrollment in the study.
• Access to commercially available Otezla®

Exclusion criteria

• Patients who are pregnant, breastfeeding, or who are planning on becoming pregnant during the course of the study
• Participation in Investigational Clinical Trial within the last 60 days.

Trial design

102 participants in 1 patient group

Psoriatic Arthritis patients treated with Apremilast

Description:

Active PsA as per the CASPAR criteria, based on the investigator's clinical judgement with access to commercially available Otezla

Treatment:

Drug: Apremilast