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Trial record 1 of 1 for:    NCT04428424
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Study To Evaluate The Response To Enbrel And The Impact Of Rheumatoid Factor(RF) And Anti-Cyclic Citrullinated Peptide(Anti-CCP) In Rheumatoid Arthritis(RA) Patients

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ClinicalTrials.gov Identifier: NCT04428424
Recruitment Status : Completed
First Posted : June 11, 2020
Last Update Posted : September 25, 2020
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date June 10, 2020
First Posted Date June 11, 2020
Last Update Posted Date September 25, 2020
Actual Study Start Date July 5, 2020
Actual Primary Completion Date August 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 10, 2020)
  • Mean Change from base line in the Disease Activity Score 28 (DAS28) for patients with moderate to severe RA with positive RF and ACCP treated with etanercept [ Time Frame: May 2012 until August 2019 ]
    The assessment of efficacy of etanercept in patients with moderate to severe RA with positive RF and ACCP by the change of DAS28 from baseline to the end of the study.
  • Mean Change from base line in the Clinical Disease Activity Index (CDAI) for patients with moderate to severe RA with positive RF and ACCP treated with etanercept [ Time Frame: May 2012 until August 2019 ]
    The assessment of efficacy of etanercept in patients with moderate to severe RA with positive RF and ACCP by the change of CDAI from baseline to the end of the study.
  • Mean Change from base line in the Disease Activity Score 28 (DAS28) for patients with moderate to severe RA with negative RF and ACCP treated with etanercept [ Time Frame: May 2012 until August 2019 ]
    The assessment of efficacy of etanercept in patients with moderate to severe RA with negative RF and ACCP by the change of DAS28 from baseline to the end of the study.
  • Mean Change from base line in the Clinical Disease Activity Index (CDAI) for patients with moderate to severe RA with negative RF and ACCP treated with etanercept [ Time Frame: May 2012 until August 2019 ]
    The assessment of efficacy of etanercept in patients with moderate to severe RA with negative RF and ACCP by the change of CDAI from baseline to the end of the study.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Study To Evaluate The Response To Enbrel And The Impact Of Rheumatoid Factor(RF) And Anti-Cyclic Citrullinated Peptide(Anti-CCP) In Rheumatoid Arthritis(RA) Patients
Official Title The Impact of RF, and Anti-CCP on RA Patients in Response to Etanercept
Brief Summary This study is to evaluate available local data in Iraqi patients with rheumatoid arthritis on Enbrel treatment with regards to the impact of Rheumatoid factor and Anti-cyclic citrullinated peptide 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 the local registry at the Baghdad Teaching Hospital registry.
Condition Arthritis, Rheumatoid
Intervention Drug: Enbrel
As provided in real world practice
Study Groups/Cohorts Patients with rheumatoid arthritis
Iraqi patients with rheumatoid arthritis 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 Completed
Actual Enrollment
 (submitted: June 10, 2020)
1
Original Estimated Enrollment Same as current
Actual Study Completion Date August 30, 2020
Actual Primary Completion Date August 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Diagnosed RA patients.

    -≥18 years of age

  • Did not receive previous another biological treatment

Exclusion Criteria:

  • Had previous biological treatment
  • Use of etanercept for less than 1 year
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 NCT04428424
Other Study ID Numbers B1801417
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/data_requests.
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date September 2020