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

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


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

Layout table for study information
Study Type : Observational
Estimated Enrollment : 120 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Routine Clinical Practice in Spain: Evaluation of the Use of Apremilast in Patients With Psoriatic Arthritis, Naïve to Biological Treatment (PREVAIL Study)
Estimated Study Start Date : February 15, 2019
Estimated Primary Completion Date : October 31, 2019
Estimated Study Completion Date : February 28, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Apremilast

Group/Cohort Intervention/treatment
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.
Drug: Apremilast
Apremilast




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Demographic characteristics [ Time Frame: Up to approximately 6 months ]
    Description of the demographic at time of initiating treatment with apremilast

  2. 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.

  3. 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

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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

  12. 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

  13. 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.

  14. 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.

  15. 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

  16. Adverse events (AEs) [ Time Frame: Up to approximately 12 months ]
    Number participants with adverse events.

  17. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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.

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): NCT03828045


Contacts
Layout table for location contacts
Contact: Associate Director Clinical Trial Disclosure 1-888-260-1599 clinicaltrialdisclosure@celgene.com

Locations
Layout table for location information
Spain
Hospital Monte Naranco Not yet recruiting
Oviedo, Asturias, Spain, 33012
Hospital Can Misses. Not yet recruiting
Ibiza, Baleares, Spain, 07800
Hospital Universitario de Canarias Not yet recruiting
Tenerife, Canarias, Spain, 38320
Hospital Virgen de la Luz Not yet recruiting
Toledo, Castilla La Mancha, Spain, 45004
Hospital Del Mar Not yet recruiting
Barcelona, Catalunya, Spain, 08003
Hospital de Bellvitge Not yet recruiting
Barcelona, Catalunya, Spain, 08097
Hospital Parc Taulí Not yet recruiting
Sabadell, Catalunya, Spain, 08208
Hospital Esperit Sant Not yet recruiting
Santa Coloma, Catalunya, Spain, 08923
Hospital de Donosti Not yet recruiting
Hospital De Donosti, Euskadi, Spain, 20014
Infanta Cristina Badajoz Not yet recruiting
Badajoz, Extremadura, Spain, 06080
Complexo Hosp Univ de Vigo Not yet recruiting
Vigo, Galicia, Spain, 36312
Complejo Hosp de Navarra Not yet recruiting
Pamplona, Navarra, Spain, 31008
Hospital de Arritxaca Not yet recruiting
Murcia, Spain, 30120
Sponsors and Collaborators
Celgene
Investigators
Layout table for investigator information
Study Director: Eva Pascual, MD Celgene

Layout table for additonal information
Responsible Party: Celgene
ClinicalTrials.gov Identifier: NCT03828045     History of Changes
Other Study ID Numbers: CC-10004-PSA-015
U1111-1221-8638 ( Registry Identifier: WHO )
First Posted: February 4, 2019    Key Record Dates
Last Update Posted: February 4, 2019
Last Verified: January 2019

Layout table for additional information
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

Keywords provided by Celgene:
Psoriatic Arthritis
Apremilast
CC-10004
Biologic Treatments

Additional relevant MeSH terms:
Layout table for 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