A Study to Assess Immune Response Following Zoster Vaccination to Subjects With Rheumatoid Arthritis Receiving Tofacitinib or Placebo With Background Methotrexate



Status:Completed
Conditions:Arthritis, Rheumatoid Arthritis
Therapuetic Areas:Rheumatology
Healthy:No
Age Range:50 - Any
Updated:4/17/2018
Start Date:June 2014
End Date:July 2015

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A Randomized, Double-blind, Placebo-controlled, Phase 2 Study To Assess The Immune Response Following Administration Of Zoster Vaccine To Subjects With Rheumatoid Arthritis Receiving Tofacitinib (Cp-690,550) Or Placebo With Background Methotrexate Treatment

This study will evaluate immune response following administration of zoster vaccine in
subjects with rheumatoid arthritis who are receiving background methotrexate and initiate 5
mg twice daily of tofacitinib or placebo for tofacitinib 2 to 3 weeks following vaccination.


Inclusion Criteria:

- Subjects must have moderate to severe rheumatoid arthritis inadequately controlled by
methotrexate as defined by the American College of Rheumatology (ACR) classification
criteria for Rheumatoid arthritis, painful and swollen joint counts and C-reactive
protein (CRP).

- Screening CRP >3 mg/L or CDAI score > 10 at screening or at baseline before
vaccination.

- Subjects must have active disease at screening and baseline.

- Must be at least 50 years of age or older.

Exclusion Criteria:

- History of receiving any varicella-zoster virus vaccine

- Receipt of any vaccines within 6 weeks of first dose of study treatment.

- Subjects with current infections or history of infections.

- History of recurrent (more than one episode) of herpes zoster or disseminated (a
single episode) of herpes zoster or disseminated (a single episode) of herpes simplex.
We found this trial at
36
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Orchard Park, New York 14127
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4085 University Blvd S # 1
Jacksonville, Florida 32216
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Albany, New York 12206
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Allen, TX
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Bethlehem, Pennsylvania 18015
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Dallas, TX
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Duncansville, Pennsylvania 16635
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Frederick, Maryland 21702
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Frederick, MD
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Greenville, South Carolina 29607
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Hickory, North Carolina 28602
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Hickory, NC
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Hickory, North Carolina 28602
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Indianapolis, Indiana 46227
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Jackson, Tennessee 38305
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Jackson, TN
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Jackson, Tennessee 38305
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Jackson, TN
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Jonesboro, Arkansas 72401
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Knoxville, Tennessee 37909
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Knoxville, TN
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1 Medical Center Dr
Lebanon, New Hampshire 03756
 (603) 650-5000
Dartmouth Hitchcock Medical Center Dartmouth-Hitchcock is a national leader in patient-centered health care and building...
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Los Angeles, CA
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Los Angeles, California 90095
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Miami, FL
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New Port Richey, Florida 34652
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Pinellas Park, Florida 33782
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Port Richey, Florida 34668
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Port Richey, Florida 34668
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12450 Roosevelt Boulevard North
Saint Petersburg, Florida 33782
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Saint Petersburg, Florida 33710
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Salisbury, North Carolina 28147
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Salisbury, North Carolina 28144
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Santa Maria, California 93454
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Sarasota, Florida 34239
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Tampa, Florida 33607
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Upland, CA
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Vancouver, Washington 98664
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Vancouver, WA
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Vancouver, Washington 98664
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Vernon Hills, Illinois 60061
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Wyomissing, Pennsylvania 19610
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