Comparative Effectiveness Of Tumor Necrosis Factor Inhibitors And Tofacitinib Use In Earlier Lines Of Therapy And Use As Monotherapy.

NCT ID: NCT04721821

Last Updated: 2024-04-12

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

7807 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-01-22

Study Completion Date

2021-11-29

Brief Summary

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This study is to investigate if there has been a shift in treatment with tofacitinib, assessing real world patient data and entered in the Corrona registry between 2016 and 2020.

Detailed Description

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Conditions

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Arthritis Rheumatoid

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Patients with Rheumatoid Arthritis (RA)

Tofacitinib

Intervention Type DRUG

Patients who received Tofacitinib for RA

Interventions

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Tofacitinib

Patients who received Tofacitinib for RA

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* RA patients in Corrona initiating tofacitinib or a TNF biologic (adalimumab, etanercept, infliximab, golimumab, certolizumab pegol) after 06 November 2012 (market approval of Tofacitinib) during follow-up in Corrona with no prior use of tofacitinib. Only the patient's first initiation after 06 November 2012 will be included in the analysis
* Have a 6 and / or 12-month follow-up visit (with +/- 2 month window)
* Have Clinical Disease Activity Index (CDAI) measures at baseline and at the follow-up visit

Exclusion Criteria

* Patients who have not failed methotrexate (MTX) or another csDMARD (ie 1st line initiators)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer

New York, New York, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

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https://pmiform.com/clinical-trial-info-request?StudyID=A3921389

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Other Identifiers

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A3921389

Identifier Type: -

Identifier Source: org_study_id

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