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An Outcomes Study to Determine the Reasons Patients on Biologic Therapy Discontinue Treatment and Fail to Follow-up With Their Providers

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ClinicalTrials.gov Identifier: NCT03964168
Recruitment Status : Recruiting
First Posted : May 27, 2019
Last Update Posted : May 27, 2019
Sponsor:
Collaborator:
Janssen Scientific Affairs, LLC
Information provided by (Responsible Party):
Psoriasis Treatment Center of Central New Jersey

Brief Summary:
Patient interviews to evaluate the reason patients discontinue biologic therapy and/or fail to follow up with provider.

Condition or disease Intervention/treatment
Psoriasis Drug: Biologic Agent

Detailed Description:
Retrospective chart review and patient interviews to evaluate the reason patients discontinue biologic therapy and/or fail to follow up with provider. This research intends to improve the continuity of care by determining why patients stop therapy and what can be done to improve their experience with the provider, pharmaceutical companies and specialty pharmacies.

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: An Outcomes Study to Determine the Reasons Patients on Biologic Therapy Discontinue Treatment and Fail to Follow-up With Their Providers
Estimated Study Start Date : May 14, 2019
Estimated Primary Completion Date : May 15, 2020
Estimated Study Completion Date : June 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Group/Cohort Intervention/treatment
Biologic Therapy
Patient's who received and discontinued a biologic therapy
Drug: Biologic Agent
Patients who discontinued a bioloic agent




Primary Outcome Measures :
  1. Determine the most common reason for discontinuation [ Time Frame: 5 years ]
    Tally number of patients who discontinued due to adverse events, insurance issues or category other.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Male or female adults ≥ 18 years of age.
Criteria

Inclusion Criteria:

  • Male or female adults ≥ 18 years of age.
  • Was receiving first or second biologic therapy
  • Has not had a follow up with treating physician in ≥ 9 months

Exclusion Criteria:

  • Actively receiving biologic therapy

    • Was not receiving first or second biologic therapy

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): NCT03964168


Contacts
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Contact: Jerry Bagel, MD 6094434500 enelson@windsordermatology.com
Contact: Elise Nelson 6094434500 enelson@windsordermatology.com

Locations
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United States, New Jersey
Psoriasis Treatment Center of Central New Jersey Recruiting
East Windsor, New Jersey, United States, 08520
Contact: Elise Nelson    609-443-4500 ext 1402    enelson@windsordermatology.com   
Principal Investigator: Jerry Bagel, MD         
Sub-Investigator: Brian Keegan, MD, PhD         
Sub-Investigator: David Nieves, MD         
Sub-Investigator: Alexa Hetzel, PA-C         
Sponsors and Collaborators
Psoriasis Treatment Center of Central New Jersey
Janssen Scientific Affairs, LLC

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Responsible Party: Psoriasis Treatment Center of Central New Jersey
ClinicalTrials.gov Identifier: NCT03964168     History of Changes
Other Study ID Numbers: PTC05
First Posted: May 27, 2019    Key Record Dates
Last Update Posted: May 27, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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

Additional relevant MeSH terms:
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Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases