Safety Study Of Tofacitinib Versus Tumor Necrosis Factor (TNF) Inhibitor In Subjects With Rheumatoid Arthritis

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NCT02092467

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Study Location
Pfizer BioBank - Biomedical Systems
Groton, Connecticut, 06340, United States
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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.
Rheumatoid Arthritis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
50 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Moderate to severe rheumatoid arthritis

- Taking methotrexate without adequate control of symptoms

- Have at least one cardiovascular risk factor (eg, current smoker, high blood pressure, high cholesterol levels, diabetes mellitus, history of heart attack, family history of coronary heart disease, extra-articular RA disease)

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


- Current or recent infection


- Clinically significant laboratory abnormalities


- Pregnancy

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Advanced Information
Descriptive Information
Brief Title  ICMJE Safety Study Of Tofacitinib Versus Tumor Necrosis Factor (TNF) Inhibitor In Subjects With Rheumatoid Arthritis
Official Title  ICMJE PHASE 3B/4 RANDOMIZED SAFETY ENDPOINT STUDY OF 2 DOSES OF TOFACITINIB IN COMPARISON TO A TUMOR NECROSIS FACTOR (TNF) INHIBITOR IN SUBJECTS WITH RHEUMATOID ARTHRITIS
Brief Summary This post-marketing study is designed to compare the safety of tofacitinib versus TNF inhibitor with respect to major cardiovascular adverse events and malignancies, excluding non-melanoma skin cancers when given to subjects with rheumatoid arthritis. Other safety events, including non-melanoma skin cancers, hepatic events, infections, and efficacy parameters will be collected and evaluated in the study.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Arthritis, Rheumatoid
Intervention  ICMJE
  • Drug: tofacitinib
    Oral tablet, 5 mg BID
  • Drug: tofacitinib
    Oral tablet, 10 mg BID
  • Biological: adalimumab
    Pre-filled syringe, 40 mg subcutaneous injection, every other week
    Other Name: Humira
  • Biological: etanercept
    Pre-filled syringe, 50 mg subcutaneous injection, every week
    Other Name: Enbrel
Study Arms  ICMJE
  • Experimental: Treatment Arm 1
    Intervention: Drug: tofacitinib
  • Experimental: Treatment Arm 2
    Intervention: Drug: tofacitinib
  • Active Comparator: Treatment Arm 3
    TNF inhibitor Arm - adalimumab will be used in US, Canada and Puerto Rico; etanercept will be used in all other countries.
    Interventions:
    • Biological: adalimumab
    • Biological: 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  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: June 1, 2020)		4412
Original Estimated Enrollment  ICMJE
 (submitted: March 18, 2014)		4000
Estimated Study Completion Date  ICMJE July 3, 2020
Estimated Primary Completion Date July 3, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Moderate to severe rheumatoid arthritis
  • Taking methotrexate without adequate control of symptoms
  • Have at least one cardiovascular risk factor (eg, current smoker, high blood pressure, high cholesterol levels, diabetes mellitus, history of heart attack, family history of coronary heart disease, extra-articular RA disease)

Exclusion Criteria:

  • Current or recent infection
  • Clinically significant laboratory abnormalities
  • Pregnancy
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Australia,   Brazil,   Bulgaria,   Canada,   Chile,   China,   Colombia,   Czechia,   Finland,   Hong Kong,   Israel,   Jordan,   Lebanon,   Malaysia,   Mexico,   Netherlands,   New Zealand,   Peru,   Poland,   Puerto Rico,   Russian Federation,   Slovakia,   South Africa,   Spain,   Taiwan,   Thailand,   Turkey,   United Kingdom,   United States
Removed Location Countries Austria,   Czech Republic,   Sweden
 
Administrative Information
NCT Number  ICMJE NCT02092467
Other Study ID Numbers  ICMJE A3921133
2013-003177-99 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD:Yes
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….
URL:https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d…
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP