Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Study to Evaluate the Use of Apremilast in Patients With Psoriatic Arthritis, Naïve to Biological Treatment (PREVAIL)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03828045
Recruitment Status : Not yet recruiting
First Posted : February 4, 2019
Last Update Posted : February 4, 2019
Sponsor:
Information provided by (Responsible Party):
Celgene

Tracking Information
First Submitted Date October 24, 2018
First Posted Date February 4, 2019
Last Update Posted Date February 4, 2019
Estimated Study Start Date February 15, 2019
Estimated Primary Completion Date October 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 31, 2019)
Treatment persistence at 6 months after initiating apremilast treatment [ Time Frame: Up to approximately 6 months ]
Percentage of patients still being treated with apremilast after 6 months of initiating treatment
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: January 31, 2019)
  • Demographic characteristics [ Time Frame: Up to approximately 6 months ]
    Description of the demographic at time of initiating treatment with apremilast
  • To describe the characteristics of apremilast treatment (i.e., dosage and regimen) in patients with PsA who start treatment according to the routine clinical practice. [ Time Frame: Up to approximately 12 months ]
    To capture the changes in dose and regimen of apremilast.
  • To assess the persistence of apremilast treatment after 12 months of treatment start [ Time Frame: Up to approximately 12 months ]
    Percentage of patients still being treated with apremilast after 12 months of initiating treatment
  • To assess the disease activity at 6 and 12 months of treatment with apremilast. [ Time Frame: At 6 and 12 months ]
    The disease activity will be assessed by the DAPSA scale when the information available in the patient's medical record allows the estimation of the DAPSA score. Otherwise, the individual items of the DAPSA scale will be described separately.
  • Changes on clinical enthesitis and dactilitis [ Time Frame: UP to approximately 12 months ]
    Assessment of the changes on clinical enthesitis and dactilitis count after 6 and 12 months of treatment with apremilast.
  • Tender joints count [ Time Frame: Up to approximately 12 months ]
    Change from baseline in the joints deemed tender as per joint count assessment by physical exam.
  • Swollen joints count [ Time Frame: UP to approximately 12 months ]
    Change from baseline in the joints deemed tender as per joint count assessment by physical exam.
  • Changes in the plasma concentration of C-reactive protein. [ Time Frame: Up to approximately 12 months ]
    Assessment of the change in the plasma concentration of C-reactive protein after 6 and 12 months of apremilast treatment.
  • Physician Global Assessment of Disease Activity (PGA). [ Time Frame: Up to approximately 12 months ]
    Assessment of the Physician Global Assessment of Disease Activity (PGA) after 6 and 12 months of apremilast treatment.
  • To assess the presence of erosive changes after 6 and 12 months of treatment with apremilast. [ Time Frame: UP to approximately 12 months ]
    Joint erosion will be assessed radiologically, as regularly assessed in the routine practice of each center.
  • The VITACORA-19 questionnaires [ Time Frame: UP to approximately 12 months ]
    are used to assess the health-related quality of life of patients with PsA in the setting of clinical trials
  • The Psoriatic Arthritis Impact of Disease (PsAID)-9 questionnaires [ Time Frame: UP to approximately 12 months ]
    was developed under a 13-country EULAR initiative to evaluate the impact of psoriatic arthritis in clinical practice . The version used in this study (PsAID-9) consists of 9 items addressing pain, fatigue, skin problems, work and/or leisure activities, functional capacity, discomfort, sleeping disturbances, coping, and anxiety
  • Assessment of changes on affected joints [ Time Frame: Up to approximately 12 months ]
    Assessment of the changes on affected joints count after 6 and 12 months of treatment with apremilast.
  • Assessment of DAPSA/cDAPSA scores [ Time Frame: Up to approximately 12 months ]
    Assessment of the changes of the DAPSA/cDAPSA score at 6/12 month after treatment.
  • To assess the relationship between the count of affected joints DAPSA/cDAPSA score after 6 and 12 months of treatment with apremilast. [ Time Frame: Up to approximately 12 months ]
    Assessment of the relationship between the count of affected joints at treatment start and the DAPSA/cDAPSA score after 6 and 12 months of treatment with apremilast. The Pearson or Spearman correlation will be performed to evaluate the relationship between these variables
  • Adverse events (AEs) [ Time Frame: Up to approximately 12 months ]
    Number participants with adverse events.
  • To assess the changes in patient's assessment of disease activity after 6 and 12 months of apremilast treatment. [ Time Frame: UP to approximately 12 months ]
    To assess the changes in patient's assessment of disease activity after 6 and 12 months of apremilast treatment. Assessment of the relationship between the count of affected joints at treatment start and the DAPSA/cDAPSA score after 6 and 12 months of treatment with apremilast.
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 A Study to Evaluate the Use of Apremilast in Patients With Psoriatic Arthritis, Naïve to Biological Treatment
Official Title Routine Clinical Practice in Spain: Evaluation of the Use of Apremilast in Patients With Psoriatic Arthritis, Naïve to Biological Treatment (PREVAIL Study)
Brief Summary

Observational, prospective and multicenter study in approximately 25 sites nationwide. The investigators participating in this study will be rheumatologists specializing in this pathology.

The study will include patients diagnosed with PsA (according to the CASPAR diagnosis criteria), naïve to biological treatments, who have - following the routine practice in their centers - initiated treatment with apremilast 6 months (±1 months) before their inclusion in the study, irrespective of treatment duration.

Recruitment will be consecutive and the reason for not including a potential candidate patient will be registered. The decision to prescribe apremilast treatment should be clearly dissociated from the inclusion of the patient in the study, which will not occur earlier than 6 months (± 4 weeks after treatment start). Therefore, the choice of the therapeutic strategy will be made independently by the physician.

Before entering the study, all patients shall sign an informed consent to participate in the study, including permission to retrieve data from their medical records and to complete questionnaires regarding their quality of life.

To avoid recruitment biases and obtain a homogeneous cohort regarding treatment duration, all consecutive patients who attend to a routine follow-up visit and have been prescribed apremilast 6 months (+/- 4 weeks) before the baseline visit, will be offered to enter the study. All consecutive patients who can be contacted 6 months (+/- 4 weeks) following initiation of treatment with apremilast will be approached for entry to minimize bias in patient selection

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 Probability Sample
Study Population

Observational, prospective and multicenter study in approximately 25 sites nationwide. The investigators participating in this study will be rheumatologists specializing in this pathology.

The study will include patients diagnosed with PsA (according to the CASPAR diagnosis criteria), naïve to biological treatments, who have - following the routine practice in their centers - initiated treatment with apremilast 6 months (±1 months) before their inclusion in the study, irrespective of treatment duration.

Condition Arthritis, Psoriatic
Intervention Drug: Apremilast
Apremilast
Study Groups/Cohorts Psoriatic Arthritis patients on Apremilast
Patients diagnosed with PsA (according to the CASPAR diagnosis criteria), naïve to biological treatments, who have - following the routine practice in their centers - initiated treatment with apremilast 6 months (±1 months) before their inclusion in the study, irrespective of treatment duration.
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 Not yet recruiting
Estimated Enrollment
 (submitted: January 31, 2019)
120
Original Estimated Enrollment Same as current
Estimated Study Completion Date February 28, 2020
Estimated Primary Completion Date October 31, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Men and women older than 18 years.
  • Patients diagnosed with psoriatic arthritis according to the CASPAR criteria*.
  • Patients who, following the routine clinical practice, initiated treatment with apremilast 6 months (±4 weeks) before their inclusion in the study.
  • Patients naive to biologic treatments.

Exclusion Criteria:

  • Patients who reject to sign the informed consent.
  • Patients enrolled in a clinical trial within the 4 weeks preceding the baseline visit or for the duration of apremilast treatment.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Associate Director Clinical Trial Disclosure 1-888-260-1599 clinicaltrialdisclosure@celgene.com
Listed Location Countries Spain
Removed Location Countries  
 
Administrative Information
NCT Number NCT03828045
Other Study ID Numbers CC-10004-PSA-015
U1111-1221-8638 ( Registry Identifier: WHO )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement Not Provided
Responsible Party Celgene
Study Sponsor Celgene
Collaborators Not Provided
Investigators
Study Director: Eva Pascual, MD Celgene
PRS Account Celgene
Verification Date January 2019