An observational study in Arthritis, Psoriatic, sponsored by Amgen. Completed at 19 sites in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-06-05.
Sponsored by Amgen · Observational
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®
3,554 studies on the registry are indexed under Arthritis; 317 are open to participants now.
This study's enrollment of 102 is below the median of 155 across 1,057 observational studies indexed under Arthritis.
Browse Arthritis studies →Amgen is the lead sponsor of 1,015 studies on the registry; 49 are open to participants now.
Of its 245 completed or terminated interventional studies of FDA-regulated products, 159 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
Adult patients with active PsA and access to commercial Otezla® who are under the care of a Canadian rheumatologist.
Exclusion Criteria:
Active PsA as per the CASPAR criteria, based on the investigator's clinical judgement with access to commercially available Otezla
Drug: Apremilast
Apremilast
Also known as: Otezla
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).
Time frame: Up to approximately 1 year
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).
Time frame: Up to approximately 8 months
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Up to approximately 1 year
Assessment of Body Surface Area (BSA)
height (cm) x weight (kg)/3600)½
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Up to approximately 1 year
Patient subjective assessment of Pain using a 100mm VAS
Patient subjective assessment of Pain using a 100mm VAS
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: Up to approximately 1 year
Adverse Events (AEs)
Number of subjects with adverse events
Time frame: From enrollment until at least 28 days after completion of study treatment
This study is completed, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.
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