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Completed

NCT Number: NCT03608657

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

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®

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The Waterside Clinic, Barrie, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Apremilast

Drug

Apremilast

Other names: Otezla

Primary outcomes

  1. The rate of achieving Low Disease Activity (LDA)

    Time frame: Up to approximately 1 year

    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).

Secondary outcomes

  1. The rate of achieving Low Disease Activity (LDA)

    Time frame: Up to approximately 8 months

    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).

  2. Tender Joint Count (TJC)

    Time frame: Up to Approximately 1 year

    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

  3. Swollen Joint Count (SJC)

    Time frame: Up to Approximately 1 year

    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

  4. Assessment of Enthesitis (Leeds Enthesitis Index (LEI)

    Time frame: Up to Approximately 1 year

    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

  5. Assessment of Dactylitis (Leeds Dactylitis Index)

    Time frame: Up to approximately 1 year

    Resolution versus improvement versus no change versus worsening of dactylitis since the last available assessment

  6. Assessment of Body Surface Area (BSA)

    Time frame: Up to approximately 1 year

    height (cm) x weight (kg)/3600)½

  7. Health Assessment Questionnaire Disability Index (HAQ-DI)

    Time frame: Up to approximately 1 year

    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.

  8. Physician global assessment of disease activity (MDGA)

    Time frame: Up to approximately 1 year

    This is a 100-mm visual analog scale (VAS) with 0 indicating lowest disease and 100 highest disease activities

  9. Patient global assessment of disease activity (PtGA)

    Time frame: Up to approximately 1 year

    This is a 100-mm VAS with 0 indicating lowest disease and 100 highest disease activity

  10. Treatment Satisfaction Questionnaire for Medication (TSQM)

    Time frame: Up to approximately 1 year

    This is a 14-item questionnaire evaluating patient satisfaction in terms of the following: effectiveness, side effects, convenience, and global satisfaction

  11. Patient subjective assessment of Pain using a 100mm VAS

    Time frame: Up to approximately 1 year

    Patient subjective assessment of Pain using a 100mm VAS

  12. Psoriatic Arthritis (WPAI:PsA)

    Time frame: Up to approximately 1 year

    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

  13. Medical Outcomes Study Short- Form 36 (SF-36)

    Time frame: Up to approximately 1 year

    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

  14. Patient-reported adherence with PsA treatment from the last visit.

    Time frame: Up to approximately 1 year

    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.

  15. Proportion of patients in Patient Acceptable Symptom State (PASS)

    Time frame: Up to approximately 1 year

    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

  16. Adverse Events (AEs)

    Time frame: From enrollment until at least 28 days after completion of study treatment

    Number of subjects with adverse events

Sponsors and collaborators

Lead sponsor

Amgen

Industry

Registry information

Official study 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)

Acronym: APPRAISE

Important dates

Study start
2018
Primary completion
2021
Study completion
2022
First posted
Aug 1, 2018
Registry last updated
Jun 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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