This Study is to Investigate the Effect of Etanercept in Early Versus Delayed Referral for Management of Rheumatoid Arthritis Patients.

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NCT04267614

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Study Location
Pfizer
Baghdad, , , Iraq
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Contact
1-800-718-1021
[email protected]
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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Arthritis Rheumatoid
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
0 +
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Diagnosed RA patients. 18 years old and above. Did not receive pervious biological treatment.

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


- Had previous biological treatment Use etanercept for less than 1 year

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Advanced Information
Descriptive Information
Brief Title This Study is to Investigate the Effect of Etanercept in Early Versus Delayed Referral for Management of Rheumatoid Arthritis Patients.
Official Title Clinical Outcomes of Early Versus Delayed Management of Iraqi Patients With Rheumatoid Arthritis With Etanercept
Brief Summary This study is to investigate the effect of etanercept in early versus delayed referral for management of rheumatoid arthritis patients assessing real-world patient data entered in the Iraq National Center of Rheumatology database between May 2012 and May 2017.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Other
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Data will be collected from the Baghdad teaching hospital registry. The Rheumatology patient registry is a prospective longitudinal multicentre cohort initiated in 2012.
Condition Arthritis Rheumatoid
Intervention Drug: Etanercept
Patients who received etanercept for RA
Study Groups/Cohorts Patients with Rheumatoid Arthritis (RA)
Patients receiving etanercept from Baghdad teaching hospital registry(Rheumatology center) from 2012 till 2017. Patients were identified as receiving early versus delayed etanercept treatment.
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 Completed
Actual Enrollment
 (submitted: February 11, 2020)		1226
Original Actual Enrollment Same as current
Actual Study Completion Date December 1, 2018
Actual Primary Completion Date December 1, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Diagnosed RA patients. 18 years old and above. Did not receive pervious biological treatment.

Exclusion Criteria:

  • Had previous biological treatment Use etanercept for less than 1 year
Sex/Gender
Sexes Eligible for Study:All
Ages Child, 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 NCT04267614
Other Study ID Numbers B1801411
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 February 2020