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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03608657
Recruitment Status : Active, not recruiting
First Posted : August 1, 2018
Last Update Posted : June 5, 2020
Sponsor:
Information provided by (Responsible Party):
Amgen

Tracking Information
First Submitted Date May 30, 2018
First Posted Date August 1, 2018
Last Update Posted Date June 5, 2020
Actual Study Start Date June 15, 2018
Estimated Primary Completion Date February 21, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 30, 2018)
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).
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: July 30, 2018)
  • 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).
  • 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
  • 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
  • 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
  • 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
  • Assessment of Body Surface Area (BSA) [ Time Frame: Up to approximately 1 year ]
    height (cm) x weight (kg)/3600)½
  • 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.
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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.
  • 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
  • Adverse Events (AEs) [ Time Frame: From enrollment until at least 28 days after completion of study treatment ]
    Number of subjects with adverse events
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Study to Evaluate the Real-World Effectiveness, Safety and Tolerability of Treatment With Apremilast in Psoriatic Arthritis Patients Followed in Canadian Routine Care (APPRAISE
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)
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®

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Arthritis, Psoriatic
Intervention Drug: Apremilast
Apremilast
Other Name: Otezla
Study Groups/Cohorts 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
Intervention: Drug: Apremilast
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Actual Enrollment
 (submitted: June 3, 2020)
101
Original Estimated Enrollment
 (submitted: July 30, 2018)
200
Estimated Study Completion Date February 21, 2021
Estimated Primary Completion Date February 21, 2021   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Canada
Removed Location Countries  
 
Administrative Information
NCT Number NCT03608657
Other Study ID Numbers CC-10004-PSA-011
U1111-1214-0693 ( Other Identifier: UTN )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Amgen
Study Sponsor Amgen
Collaborators Not Provided
Investigators
Study Director: MD Amgen
PRS Account Amgen
Verification Date June 2020