Study To Evaluate The Impact Of Difficult To Treat Sites On Biological Response In Moderate-To-Severe Plaque Psoriasis(PsO).

NCT04428411

Last updated date
Study Location
Pfizer
Baghdad, , , Iraq
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Plaque Psoriasis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Moderate-to-severe plaque psoriasis patients whom have been receiving etanercept for at least 1 year duration.

- Have difficult to treat sites at presentation.

- Age ≥18 years.

- No history of using other biological treatments, other than etanercept for the treatment of moderate-to-severe PsO.

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Etanercept use for treatment of moderate-to-severe PsO less than 1 year duration.


- Previous use of another biological treatment for treatment of moderate-to-severe PsO.

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Advanced Information
Descriptive Information
Brief Title Study To Evaluate The Impact Of Difficult To Treat Sites On Biological Response In Moderate-To-Severe Plaque Psoriasis(PsO).
Official Title The Impact of Difficult to Treat Sites on Biological Treatment Response in Patients With Moderate-to-Severe Plaque Psoriasis
Brief Summary This study is to evaluate available local data in Iraq patients with moderate-to-severe plaque psoriasis on Enbrel treatment with regards to efficacy, treatment for PsO who have difficult to treat sites at presentation.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients data from the local Dermatology Center of the Baghdad Teaching Hospital
Condition Plaque Psoriasis
Intervention Drug: Enbrel
As provided in real world practice
Study Groups/Cohorts Patients with moderate to severe plaque psoriasis
Iraqi patients diagnosed with moderate to severe plaque psoriasis that received Enbrel as treatment for disease
Intervention: Drug: Enbrel
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 Active, not recruiting
Actual Enrollment
 (submitted: June 10, 2020)
1
Original Estimated Enrollment Same as current
Estimated Study Completion Date August 1, 2020
Estimated Primary Completion Date August 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Moderate-to-severe plaque psoriasis patients whom have been receiving etanercept for at least 1 year duration.
  • Have difficult to treat sites at presentation.
  • Age ?18 years.
  • No history of using other biological treatments, other than etanercept for the treatment of moderate-to-severe PsO.

Exclusion Criteria:

  • Etanercept use for treatment of moderate-to-severe PsO less than 1 year duration.
  • Previous use of another biological treatment for treatment of moderate-to-severe PsO.
Sex/Gender
Sexes Eligible for Study:All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Iraq
Removed Location Countries  
 
Administrative Information
NCT Number NCT04428411
Other Study ID Numbers B1801416
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD:No
Plan Description:Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d….
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date July 2020