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

Arthritis, Psoriatic Clinical Trial

— APPRAISE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03608657
• Other study ID #: CC-10004-PSA-011
• Secondary ID: U1111-1214-0693
• Status: Completed
• Start date: July 31, 2018
• Est. completion date: March 30, 2022

Study information

• Verified date: June 2024
• Source: Amgen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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®

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: March 30, 2022
• Est. primary completion date: April 12, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Psoriatic

Intervention

Drug:
• Apremilast
Apremilast

Locations

Country	Name	City	State
Canada	The Waterside Clinic	Barrie
Canada	The Arthritis and Osteoporosis Centre	Burlington
Canada	Adachi Medicine Professional Corporation	Hamilton
Canada	Credit Valley Rheumatology	Mississauga
Canada	Applied Medical Informatics Research Inc. (A.M.I.R.)	Montreal
Canada	Institut de Recherche en Rhumatologie de Montréal	Montreal
Canada	Brent Appleton Clinic New Westminster	New Westminster
Canada	Dr. A. M. Jaroszynska Rheumatology and Osteoporosis Clinic	Oakville
Canada	Drs M&W Teo	Penticton
Canada	Groupe de recherche en maladies osseuses Inc.	Quebec
Canada	Centre de Rhumatologie de l'Est du Quebec	Rimouski
Canada	Polmed Research Inc.	Saskatoon
Canada	Clinique Jacques Cartier	Sherbrooke
Canada	St. Clare's Mercy Hospital	St John's
Canada	Dr. Juris Lazovskis Incorporated	Sydney
Canada	Arthur Karasik Medicine Professional Inc.	Toronto
Canada	Toronto Western Hospital, University Health Network	Toronto
Canada	Dr. Jonathan D. Chan Inc.	Vancouver
Canada	Dr. Sabeen Anwar Medicine Professional Corporation	Windsor

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The rate of achieving Low Disease Activity (LDA)	Is defined as Clinical Disease Activity Index for Psoriatic Arthritis (cDAPSA) < 14. cDAPSA is calculated as the sum of TJC - 68, SJC - 66, PtGA (10-cm VAS) and Pain (10-cm VAS).	Up to approximately 1 year
Secondary	The rate of achieving Low Disease Activity (LDA)	Is defined as Clinical Disease Activity Index for Psoriatic Arthritis (cDAPSA) < 14. cDAPSA is calculated as the sum of TJC - 68, SJC - 66, PtGA (10-cm VAS) and Pain (10-cm VAS).	Up to approximately 8 months
Secondary	Tender Joint Count (TJC)	Based on 68/66 joints to determine joint pain/tenderness and joint swelling, as conducted during the physical examination and per the practices of the treating physician	Up to Approximately 1 year
Secondary	Swollen Joint Count (SJC)	Based on 68/66 joints to determine joint pain/tenderness and joint swelling, as conducted during the physical examination and per the practices of the treating physician	Up to Approximately 1 year
Secondary	Assessment of Enthesitis (Leeds Enthesitis Index (LEI)	This is completed by the treating physician and assesses tenderness at six (6) sites, specifically two (2) lateral at the following: epicondyles of the humerus, medial condyles of the femur and the insertion of the Achilles tendon. The LEI is scored between 0 and 6. Resolution versus improvement versus no change versus worsening of enthesitis since the last available assessment	Up to Approximately 1 year
Secondary	Assessment of Dactylitis (Leeds Dactylitis Index)	Resolution versus improvement versus no change versus worsening of dactylitis since the last available assessment	Up to approximately 1 year
Secondary	Assessment of Body Surface Area (BSA)	height (cm) x weight (kg)/3600)½	Up to approximately 1 year
Secondary	Health Assessment Questionnaire Disability Index (HAQ-DI)	This is a self-administered questionnaire measuring the patient's functional ability during the last week. It consists of 20 items converging to 8 scales measuring dressing and grooming, arising, eating, walking, hygiene, reach, grip and common daily activities. The patients rate each activity as 0 = without any difficulty, 1 = some difficulty, 2 = much difficulty and 4 = unable. The final score ranges from 0 to 3 with higher scores indicating more disability.	Up to approximately 1 year
Secondary	Physician global assessment of disease activity (MDGA)	This is a 100-mm visual analog scale (VAS) with 0 indicating lowest disease and 100 highest disease activities	Up to approximately 1 year
Secondary	Patient global assessment of disease activity (PtGA)	This is a 100-mm VAS with 0 indicating lowest disease and 100 highest disease activity	Up to approximately 1 year
Secondary	Treatment Satisfaction Questionnaire for Medication (TSQM)	This is a 14-item questionnaire evaluating patient satisfaction in terms of the following: effectiveness, side effects, convenience, and global satisfaction	Up to approximately 1 year
Secondary	Patient subjective assessment of Pain using a 100mm VAS	Patient subjective assessment of Pain using a 100mm VAS	Up to approximately 1 year
Secondary	Psoriatic Arthritis (WPAI:PsA)	A 6-item questionnaire assessing the effect of PsA on the patient's ability to work and perform daily activities. It assesses presenteeism, absenteeism, productivity and activity impairment	Up to approximately 1 year
Secondary	Medical Outcomes Study Short- Form 36 (SF-36)	A generic quality of life index that is comprised of 36 items converging to eight (8) domains: Vitality, Physical Functioning, Bodily Pain, General Health Perception, Physical Role Functioning, Emotional Role Functioning, Social Role Functioning, and Mental Health	Up to approximately 1 year
Secondary	Patient-reported adherence with PsA treatment from the last visit.	An optional weekly take-home diary will be offered to patients; this diary will aid in documenting how many doses (if any) of PsA treatment were missed, and the reason(s) why.	Up to approximately 1 year
Secondary	Proportion of patients in Patient Acceptable Symptom State (PASS)	A single question phrased as "If you were to remain for the next few months as you were during the last week, would this be acceptable or unacceptable to you?" with a binary (Yes or No) response	Up to approximately 1 year
Secondary	Adverse Events (AEs)	Number of subjects with adverse events	From enrollment until at least 28 days after completion of study treatment

External Links

•   AmgenTrials clinical trials website
•   Expanded Access for CC-10004