AzTrials
AzTrials

Arthritis, PsoriaticAPPRAISENCT03608657

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

An observational study of Arthritis, Psoriatic, run by Amgen at 19 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Arthritis, Psoriatic
What is being tested?
Apremilast
How many people
102 participants
Where
19 sitesCanada
Study dates
31 Jul 2018to 30 Mar 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Adult patients with active PsA and access to commercial Otezla® who are under the care of a Canadian rheumatologist.

Who may be able to join

  • 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®

Who cannot join

  • 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 locations and contacts

19 sites in 1 country.

19 sites in 1 country

Canada19 sites

  • The Waterside Clinic

    Barrie, L4M 6L2

  • The Arthritis and Osteoporosis Centre

    Burlington, L7L 0B7

  • Adachi Medicine Professional Corporation

    Hamilton, L8N 1Y2

  • Credit Valley Rheumatology

    Mississauga, L5M 2V8

  • Institut de Recherche en Rhumatologie de Montréal

    Montreal, H2L 1S6

  • Applied Medical Informatics Research Inc. (A.M.I.R.)

    Montreal, H4A 3T2

  • Brent Appleton Clinic New Westminster

    New Westminster, V6Z 2C7

  • Dr. A. M. Jaroszynska Rheumatology and Osteoporosis Clinic

    Oakville, L6M 4J2

  • Drs M&W Teo

    Penticton, V2A 4Z1

  • Groupe de recherche en maladies osseuses Inc.

    Québec, G1V 3M7

  • Centre de Rhumatologie de l'Est du Quebec

    Rimouski, G5L 8W1

  • Polmed Research Inc.

    Saskatoon, S7N 4A4

  • Clinique Jacques Cartier

    Sherbrooke, J1J 2E3

  • St. Clare's Mercy Hospital

    St. John's, A1A 5B8

  • Dr. Juris Lazovskis Incorporated

    Sydney, B1S 3N1

  • Toronto Western Hospital, University Health Network

    Toronto, M5T 2S8

  • Arthur Karasik Medicine Professional Inc.

    Toronto, M9C 5N2

  • Dr. Jonathan D. Chan Inc.

    Vancouver, V5Z 1J9

  • Dr. Sabeen Anwar Medicine Professional Corporation

    Windsor, N8X 5A6

Other trials in Canada

About this study

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)

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®

Being tested
Apremilast
Keywords
Psoriatic Arthritis, Canada, CC-10004, Apremilast, APPRAISE, Safety, Non-interventional, Observation, DMARDs
Medical subject headings
Arthritis, Psoriatic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ApremilastDrug

    Also called Otezla

    Apremilast

Study groups in NCT03608657
Study groupRoleWhat they receive
Psoriatic Arthritis patients treated with ApremilastActive PsA as per the CASPAR criteria, based on the investigator's clinical judgement with access to commercially available Otezla
Receives: Drug: Apremilast

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: Up to approximately 1 year

Secondary outcomes (16)

  1. 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).

    Measured: Up to approximately 8 months

  2. 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

    Measured: Up to Approximately 1 year

  3. 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

    Measured: Up to Approximately 1 year

  4. 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

    Measured: Up to Approximately 1 year

  5. Assessment of Dactylitis (Leeds Dactylitis Index)

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

    Measured: Up to approximately 1 year

  6. Assessment of Body Surface Area (BSA)

    height (cm) x weight (kg)/3600)½

    Measured: Up to approximately 1 year

  7. 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.

    Measured: Up to approximately 1 year

  8. 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

    Measured: Up to approximately 1 year

  9. Patient global assessment of disease activity (PtGA)

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

    Measured: Up to approximately 1 year

  10. 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

    Measured: Up to approximately 1 year

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

    Patient subjective assessment of Pain using a 100mm VAS

    Measured: Up to approximately 1 year

  12. 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

    Measured: Up to approximately 1 year

  13. 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

    Measured: Up to approximately 1 year

  14. 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.

    Measured: Up to approximately 1 year

  15. 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

    Measured: Up to approximately 1 year

  16. Adverse Events (AEs)

    Number of subjects with adverse events

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Aug 2018
  2. Study start31 Jul 2018
  3. Primary completion12 Apr 2021
  4. Study completion30 Mar 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
102 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03608657
Sponsor's protocol ID
CC-10004-PSA-011
Other IDs
U1111-1214-0693
Acronym
APPRAISE
Status last verified
Jun 2024
First submitted
30 May 2018
Last updated
5 Jun 2024
Results posted
No
Data monitoring committee
No

Publications

  • Chandran V, Bessette L, Thorne C, Sheriff M, Rahman P, Gladman DD, Anwar S, Jelley J, Gaudreau AJ, Chohan M, Sampalis JS. Use of Apremilast to Achieve Psoriatic Arthritis Treatment Goals and Satisfaction at 1 Year in the Canadian Real-World APPRAISE Study. Rheumatol Ther. 2024 Apr;11(2):443-455. doi: 10.1007/s40744-024-00641-w. Epub 2024 Feb 28.

    PubMed 38416391

Questions about this trial

What is this clinical trial studying?

An observational study of Arthritis, Psoriatic, run by Amgen at 19 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The rate of achieving Low Disease Activity (LDA) (time frame: Up to approximately 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03608657, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in