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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04267614
Recruitment Status : Completed
First Posted : February 13, 2020
Last Update Posted : February 13, 2020
Sponsor:
Information provided by (Responsible Party):
Pfizer

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.

Condition or disease Intervention/treatment
Arthritis Rheumatoid Drug: Etanercept

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Study Type : Observational
Actual Enrollment : 1226 participants
Observational Model: Other
Time Perspective: Retrospective
Official Title: Clinical Outcomes of Early Versus Delayed Management of Iraqi Patients With Rheumatoid Arthritis With Etanercept
Actual Study Start Date : November 1, 2018
Actual Primary Completion Date : December 1, 2018
Actual Study Completion Date : December 1, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Etanercept

Group/Cohort Intervention/treatment
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.
Drug: Etanercept
Patients who received etanercept for RA




Primary Outcome Measures :
  1. Mean change from baseline in the 28-joint Disease Activity Score (DAS28) scores for patients with early versus delayed management with etanercept [ Time Frame: 01May2012 to 01May2017 ]

    The early referral define as: the patients referred for biological treatment in period of less than the mean of disease duration of RA patients (The mean for disease duration will calculated as follow: duration of disease for all RA patients in this study/no. of patients, the patients with disease duration below the mean will consider as early referral).

    Impact of early referral for management (etanercept) defined as: will compare the DAS28 and CDAI for early referral group (according to above definition of early) with DAS28 and CDAI of delayed of referral group.


  2. Mean change from baseline in the Clinical Disease Activity Index (DAS28) scores for patients with early versus delayed management with etanercept [ Time Frame: 01May2012 to 01May2017 ]

    The early referral define as: the patients referred for biological treatment in period of less than the mean of disease duration of RA patients (The mean for disease duration will calculated as follow: duration of disease for all RA patients in this study/no. of patients, the patients with disease duration below the mean will consider as early referral).

    Impact of early referral for management (etanercept) defined as: will compare the DAS28 and CDAI for early referral group (according to above definition of early) with DAS28 and CDAI of delayed of referral group.




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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04267614


Locations
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Iraq
Pfizer
Baghdad, Iraq
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer

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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT04267614    
Other Study ID Numbers: B1801411
First Posted: February 13, 2020    Key Record Dates
Last Update Posted: February 13, 2020
Last Verified: February 2020
Individual Participant Data (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.
Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Etanercept
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Gastrointestinal Agents
Immunosuppressive Agents
Immunologic Factors