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

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ClinicalTrials.gov Identifier: NCT03608657
Recruitment Status : Recruiting
First Posted : August 1, 2018
Last Update Posted : November 21, 2018
Sponsor:
Information provided by (Responsible Party):
Celgene

Brief 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®


Condition or disease Intervention/treatment
Arthritis, Psoriatic Drug: Apremilast

Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
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)
Actual Study Start Date : June 15, 2018
Estimated Primary Completion Date : June 30, 2019
Estimated Study Completion Date : June 1, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Apremilast

Group/Cohort Intervention/treatment
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
Drug: Apremilast
Apremilast
Other Name: Otezla




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult patients with active PsA and access to commercial Otezla® who are under the care of a Canadian rheumatologist.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03608657


Contacts
Contact: Associate Director Clinical Trial Disclosure 1-888-260-1599 clinicaltrialdisclosure@celgene.com

Locations
Canada
The Waterside Clinic Recruiting
Barrie, Canada, L4M 6L2
The Arthritis and Osteoporosis Centre Not yet recruiting
Burlington, Canada, L7L 0B7
Adachi Medicine Professional Corporation Not yet recruiting
Hamilton, Canada, L8N 1Y2
Credit Valley Rheumatology Recruiting
Mississauga, Canada, L5M 2V8
Institut de Recherche en Rhumatologie de Montréal Not yet recruiting
Montreal, Canada, H2L 1S6
Applied Medical Informatics Research Inc. (A.M.I.R.) Not yet recruiting
Montreal, Canada, H4A 3T2
Dr. A. M. Jaroszynska Rheumatology and Osteoporosis Clinic Not yet recruiting
Oakville, Canada, L6M 4J2
Drs M&W Teo Recruiting
Penticton, Canada, V2A 4Z1
Groupe de recherche en maladies osseuses Inc. Recruiting
Quebec, Canada, G1V 3M7
Centre de Rhumatologie de l'Est du Quebec Recruiting
Rimouski, Canada, G5L 8W1
Polmed Research Inc. Not yet recruiting
Saskatoon, Canada, S7N 4A4
Clinique Jacques Cartier Not yet recruiting
Sherbrooke, Canada, J1J 2E3
St. Clare's Mercy Hospital Not yet recruiting
St John's, Canada, A1A 5B8
Dr. Juris Lazovskis Incorporated Not yet recruiting
Sydney, Canada, B1S 3N1
Toronto Western Hospital, University Health Network Not yet recruiting
Toronto, Canada, M5T 2S8
Arthur Karasik Medicine Professional Inc. Not yet recruiting
Toronto, Canada, M9C 5N2
Dr. Jonathan D. Chan Inc. Not yet recruiting
Vancouver, Canada, V5Z 1J9
Dr. Sabeen Anwar Medicine Professional Corporation Not yet recruiting
Windsor, Canada, N8X 5A6
Sponsors and Collaborators
Celgene
Investigators
Study Director: Simona Greco, MD Celgene Corporation

Additional Information:
Responsible Party: Celgene
ClinicalTrials.gov Identifier: NCT03608657     History of Changes
Other Study ID Numbers: CC-10004-PSA-011
U1111-1214-0693 ( Other Identifier: UTN )
First Posted: August 1, 2018    Key Record Dates
Last Update Posted: November 21, 2018
Last Verified: November 2018

Keywords provided by Celgene:
Psoriatic Arthritis
Canada
CC-10004
Apremilast
APPRAISE
Safety
Non-interventional
Observation
DMARDs

Additional relevant MeSH terms:
Arthritis
Arthritis, Psoriatic
Joint Diseases
Musculoskeletal Diseases
Spondylarthropathies
Spondylarthritis
Spondylitis
Spinal Diseases
Bone Diseases
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Apremilast
Thalidomide
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Immunosuppressive Agents
Immunologic Factors
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances