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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1214-0693 | Other Identifier | UTN |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Apremilast | Drug | Apremilast |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Tender Joint Count (TJC) |
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Inclusion Criteria:
Exclusion Criteria:
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Adult patients with active PsA and access to commercial Otezla® who are under the care of a Canadian rheumatologist.
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| Name | Affiliation | Role |
|---|---|---|
| MD | Amgen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Waterside Clinic | Barrie | L4M 6L2 | Canada | |||
| The Arthritis and Osteoporosis Centre |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38416391 | Derived | 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. |
| Label | URL |
|---|---|
| AmgenTrials clinical trials website | View source |
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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 |
| 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 |
| 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 |
| 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 |
| Assessment of Body Surface Area (BSA) | height (cm) x weight (kg)/3600)½ | Up to approximately 1 year |
| 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 |
| 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 |
| 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 |
| 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 |
| Patient subjective assessment of Pain using a 100mm VAS | Patient subjective assessment of Pain using a 100mm VAS | Up to approximately 1 year |
| 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 |
| 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 |
| 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 |
| 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 |
| Adverse Events (AEs) | Number of subjects with adverse events | From enrollment until at least 28 days after completion of study treatment |
| Burlington |
| L7L 0B7 |
| Canada |
| Adachi Medicine Professional Corporation | Hamilton | L8N 1Y2 | Canada |
| Credit Valley Rheumatology | Mississauga | L5M 2V8 | Canada |
| Institut de Recherche en Rhumatologie de Montréal | Montreal | H2L 1S6 | Canada |
| Applied Medical Informatics Research Inc. (A.M.I.R.) | Montreal | H4A 3T2 | Canada |
| Brent Appleton Clinic New Westminster | New Westminster | V6Z 2C7 | Canada |
| Dr. A. M. Jaroszynska Rheumatology and Osteoporosis Clinic | Oakville | L6M 4J2 | Canada |
| Drs M&W Teo | Penticton | V2A 4Z1 | Canada |
| Groupe de recherche en maladies osseuses Inc. | Québec | G1V 3M7 | Canada |
| Centre de Rhumatologie de l'Est du Quebec | Rimouski | G5L 8W1 | Canada |
| Polmed Research Inc. | Saskatoon | S7N 4A4 | Canada |
| Clinique Jacques Cartier | Sherbrooke | J1J 2E3 | Canada |
| St. Clare's Mercy Hospital | St. John's | A1A 5B8 | Canada |
| Dr. Juris Lazovskis Incorporated | Sydney | B1S 3N1 | Canada |
| Toronto Western Hospital, University Health Network | Toronto | M5T 2S8 | Canada |
| Arthur Karasik Medicine Professional Inc. | Toronto | M9C 5N2 | Canada |
| Dr. Jonathan D. Chan Inc. | Vancouver | V5Z 1J9 | Canada |
| Dr. Sabeen Anwar Medicine Professional Corporation | Windsor | N8X 5A6 | Canada |
| Expanded Access for CC-10004 | View source |
| ID | Term |
|---|---|
| D015535 | Arthritis, Psoriatic |
| ID | Term |
|---|---|
| D025242 | Spondylarthropathies |
| D025241 | Spondylarthritis |
| D013166 | Spondylitis |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D011565 | Psoriasis |
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| C505730 | apremilast |
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