Study To Evaluate The Impact Of Early Initiation Of Biological Treatment With Ankylosing Spondylitis

NCT04507763

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.
Ankylosing Spondylitis
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 AS patients.

- 18 years old

- Did not receive previous biological treatment for any reason

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


- Patients previously or currently treated with other biological therapies.


- Use of etanercept for less than 1 year duration.

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Advanced Information
Descriptive Information
Brief Title Study To Evaluate The Impact Of Early Initiation Of Biological Treatment With Ankylosing Spondylitis
Official Title Clinical Outcomes of Early Versus Delayed Management of Iraqi Patients With Ankylosing Spondylitis (AS) With Etanercept
Brief Summary This study is to evaluate available data in Iraqi patients with ankylosing spondylitis on Enbrel treatment with regards to the impact of early treatment using data from the 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 local registry at the Baghdad Teaching Hospital
Condition Ankylosing Spondylitis
Intervention Drug: Etanercept
Patients with ankylosing spondylitis as provided in real world practice
Other Name: Enbrel
Study Groups/Cohorts Patients with ankylosing spondylitis
Iraqi patients diagnosed with ankylosing spondylitis that received Etanercept as treatment for disease
Intervention: Drug: Etanercept
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: August 10, 2020)
1
Original Estimated Enrollment Same as current
Estimated Study Completion Date October 1, 2020
Estimated Primary Completion Date October 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Diagnosed AS patients.

    • 18 years old
  • Did not receive previous biological treatment for any reason

Exclusion Criteria:

  • Patients previously or currently treated with other biological therapies.
  • Use of etanercept 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 information is only displayed when the study is recruiting subjects
Listed Location Countries Iraq
Removed Location Countries  
 
Administrative Information
NCT Number NCT04507763
Other Study ID Numbers B1801415
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 September 2020