Study To Evaluate The Impact Of Anti-Cyclic Citrullinated Peptide(Anti-CCP) For Management With Enbrel In Patients With Psoriatic Arthritis(PsA)

NCT04428502

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

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1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Psoriatic Arthritis
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

- Diagnosed PsA patients.

- ≥18 years of age

- Have not received previous biological treatment

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


- Previous use of other biological treatments.


- Etanercept use for less than 1 year duration.

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Advanced Information
Descriptive Information
Brief Title Study To Evaluate The Impact Of Anti-Cyclic Citrullinated Peptide(Anti-CCP) For Management With Enbrel In Patients With Psoriatic Arthritis(PsA)
Official Title Correlation of Anti-CCP With Disease Activity and Its Impact on Biological Response in PsA in Iraqi Patients
Brief Summary This study is to evaluate the local data in Iraqi patients with psoriatic arthritis on Enbrel treatment with positive Anti-Cyclic Citrullinated Peptide using data from the Rheumatologist in Baghdad Teaching Hospital registry.
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 Rheumatology Center of Baghdad Teaching Hospital registry
Condition Psoriatic Arthritis
Intervention Drug: Enbrel
As provided in real world practice
Study Groups/Cohorts Patients with psoriatic arthritis
Iraqi patients diagnosed with psoriatic arthritis that receive 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 Not yet recruiting
Estimated 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:

  • Diagnosed PsA patients.
  • ?18 years of age
  • Have not received previous biological treatment

Exclusion Criteria:

  • Previous use of other biological treatments.
  • Etanercept use for less than 1 year duration.
Sex/Gender
Sexes Eligible for Study:All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Pfizer CT.gov Call Center1-800-718-1021[email protected]
Listed Location Countries Iraq
Removed Location Countries  
 
Administrative Information
NCT Number NCT04428502
Other Study ID Numbers B1801418
Has Data Monitoring Committee Not Provided
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 June 2020