An Outcomes Study to Determine the Reasons Patients on Bi... | NCT03964168

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

NCT03964168

Sponsor

Psoriasis Treatment Center of Central New Jersey

Status

Completed

Last Update Posted

Mar 11, 2020Actual

Enrollment

3Actual

Phase

Not provided

Conditions

Psoriasis

Interventions

Biologic Agent

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 31, 2019Actual

Primary Completion Date

Mar 3, 2020Actual

Completion Date

Mar 3, 2020Actual

First Submitted Date

May 14, 2019

First Submission Date that Met QC Criteria

May 24, 2019

First Posted Date

May 28, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 10, 2020

Last Update Posted Date

Mar 11, 2020Actual

Name	Class
Janssen Scientific Affairs, LLC	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

3Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Biologic Therapy		Patient's who received and discontinued a biologic therapy	Drug: Biologic Agent

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Biologic Agent	Drug	Patients who discontinued a bioloic agent	Biologic Therapy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Determine the most common reason for discontinuation	Tally number of patients who discontinued due to adverse events, insurance issues or category other.	5 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Male or female adults ≥ 18 years of age.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Psoriasis Treatment Center of Central New Jersey		East Windsor	New Jersey	08520	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D011565	Psoriasis

Ancestor Terms

ID	Term
D017444	Skin Diseases, Papulosquamous
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D001685	Biological Factors

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided