An Outcomes Study to Determine the Reasons Patients on Biologic Therapy Discontinue Treatment and Fail to Follow-up With Their Providers
March 10, 2020 updated by: Psoriasis Treatment Center of Central New Jersey
Patient interviews to evaluate the reason patients discontinue biologic therapy and/or fail to follow up with provider.
Study Overview
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.
Study Type
Observational
Enrollment (Actual)
3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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New Jersey
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East Windsor, New Jersey, United States, 08520
- Psoriasis Treatment Center of Central New Jersey
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Male or female adults ≥ 18 years of age.
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Biologic Therapy
Patient's who received and discontinued a biologic therapy
|
Patients who discontinued a bioloic agent
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
5 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
July 31, 2019
Primary Completion (ACTUAL)
March 3, 2020
Study Completion (ACTUAL)
March 3, 2020
Study Registration Dates
First Submitted
May 14, 2019
First Submitted That Met QC Criteria
May 24, 2019
First Posted (ACTUAL)
May 28, 2019
Study Record Updates
Last Update Posted (ACTUAL)
March 11, 2020
Last Update Submitted That Met QC Criteria
March 10, 2020
Last Verified
March 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PTC05
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.