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

Last updated on April 19, 2018

FOR MORE INFORMATION
Study Location
University of Alabama at Birmingham (UAB)
Birmingham, Alabama, 35294-7201 United States
Contact
1-800-718-1021
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

NCT02092467
Pfizer
Recruiting
Safety Study Of Tofacitinib Versus Tumor Necrosis Factor (TNF) Inhibitor In Subjects With Rheumatoid Arthritis

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Safety Study Of Tofacitinib Versus Tumor Necrosis Factor (TNF) Inhibitor In Subjects With Rheumatoid Arthritis
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
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.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Arthritis, Rheumatoid
  • 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
  • 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
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
4400
August 8, 2019
August 8, 2019   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
50 Years and older   (Adult, Senior)
No

Contact: Pfizer CT.gov Call Center 1-800-718-1021 [email protected]
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
Austria,   Czech Republic,   Sweden
 
NCT02092467
A3921133
2013-003177-99 ( EudraCT Number )
Yes
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
November 2017

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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