A Study to Assess Immune Response Following Zoster Vaccination to Subjects With Rheumatoid Arthritis Receiving Tofacitinib or Placebo With Background Methotrexate
NCT ID: NCT02147587
Last Updated: 2018-04-11
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
112 participants
INTERVENTIONAL
2014-06-30
2015-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Tofacitinib 5 mg BID (oral) (70 subjects)
Zoster vaccine will be administered to subjects on background methotrexate; treatment with 5 mg tofacitinib twice daily will begin 2 to 3 weeks following vaccination and continue for 12 weeks.
Tofacitinib
5 mg twice daily of tofacitinib with background methotrexate for 12 weeks
Placebo tofacitinib BID (oral) (70 subjects)
Zoster vaccine will be administered to subjects on background methotrexate; treatment with placebo twice daily will begin 2 to 3 weeks following vaccination and continue for 12 weeks.
Placebo
Placebo tablets twice daily with background methotrexate for 12 weeks
Interventions
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Tofacitinib
5 mg twice daily of tofacitinib with background methotrexate for 12 weeks
Placebo
Placebo tablets twice daily with background methotrexate for 12 weeks
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
50 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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NEA Baptist Clinic
Jonesboro, Arkansas, United States
Drug Shipping Address (IRB# 14-000826) Ronald Regan
Los Angeles, California, United States
UCLA David Geffen School of Medicine
Los Angeles, California, United States
Pacific Arthritis Center Medical Group
Santa Maria, California, United States
Inland Rheumatology Clinical Trials, Inc.
Upland, California, United States
Jacksonville Center for Clinical Research
Jacksonville, Florida, United States
Center for Arthritis and Rheumatic Diseases
Miami, Florida, United States
Suncoast Clinical Research, Inc.
New Port Richey, Florida, United States
DMI Research, Inc.
Pinellas Park, Florida, United States
Florida Arthritis and Osteoporosis Center
Port Richey, Florida, United States
Gulf Coast Medical Center
Port Richey, Florida, United States
Sarasota Arthritis Research Center
Sarasota, Florida, United States
Suncoast Medical Clinic
St. Petersburg, Florida, United States
Sun Coast Medical Clinic
St. Petersburg, Florida, United States
Health Point Medical Group, Inc.
Tampa, Florida, United States
Deerbrook Medical Associates
Vernon Hills, Illinois, United States
Diagnostic Rheumatology And Research, PC
Indianapolis, Indiana, United States
Arthritis Treatment Center
Frederick, Maryland, United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States
The Center for Rheumatology, LLP
Albany, New York, United States
Buffalo Rheumatology and Medicine, PLLC
Orchard Park, New York, United States
Piedmont Rheumatology, P.A
Hickory, North Carolina, United States
PMG Research of Hickory, LLC
Hickory, North Carolina, United States
PMG Research of Salisbury, LLC
Salisbury, North Carolina, United States
Novant Health Imaging Julian Road
Salisbury, North Carolina, United States
East Penn Rheumatology Associates, PC
Bethlehem, Pennsylvania, United States
Altoona Center for Clinical Research
Duncansville, Pennsylvania, United States
Clinical Research Center of Reading LLP
Wyomissing, Pennsylvania, United States
Palmetto Clinical Trial Services, LLC
Greenville, South Carolina, United States
Arthritis Clinic
Jackson, Tennessee, United States
West Tennessee Research Institute
Jackson, Tennessee, United States
Rheumatology Consultants, PLLC
Knoxville, Tennessee, United States
Office of John P. Lavery, MD, PA
Allen, Texas, United States
Baylor Research Institute Arthritis Care and Research Center
Dallas, Texas, United States
The Vancouver Clinic (Drug Shipment Only)
Vancouver, Washington, United States
The Vancouver Clinic, Inc, PS
Vancouver, Washington, United States
Countries
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References
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Hetland ML, Strangfeld A, Bonfanti G, Soudis D, Deuring JJ, Edwards RA. Machine learning prediction and explanatory models of serious infections in patients with rheumatoid arthritis treated with tofacitinib. Arthritis Res Ther. 2024 Aug 27;26(1):153. doi: 10.1186/s13075-024-03376-9.
Kristensen LE, Danese S, Yndestad A, Wang C, Nagy E, Modesto I, Rivas J, Benda B. Identification of two tofacitinib subpopulations with different relative risk versus TNF inhibitors: an analysis of the open label, randomised controlled study ORAL Surveillance. Ann Rheum Dis. 2023 Jul;82(7):901-910. doi: 10.1136/ard-2022-223715. Epub 2023 Mar 17.
Hansen KE, Mortezavi M, Nagy E, Wang C, Connell CA, Radi Z, Litman HJ, Adami G, Rossini M. Fracture in clinical studies of tofacitinib in rheumatoid arthritis. Ther Adv Musculoskelet Dis. 2022 Dec 27;14:1759720X221142346. doi: 10.1177/1759720X221142346. eCollection 2022.
Curtis JR, Yamaoka K, Chen YH, Bhatt DL, Gunay LM, Sugiyama N, Connell CA, Wang C, Wu J, Menon S, Vranic I, Gomez-Reino JJ. Malignancy risk with tofacitinib versus TNF inhibitors in rheumatoid arthritis: results from the open-label, randomised controlled ORAL Surveillance trial. Ann Rheum Dis. 2023 Mar;82(3):331-343. doi: 10.1136/ard-2022-222543. Epub 2022 Dec 5.
Winthrop KL, Yndestad A, Henrohn D, Danese S, Marsal S, Galindo M, Woolcott JC, Jo H, Kwok K, Shapiro AB, Jones TV, Diehl A, Su C, Panes J, Cohen SB. Influenza Adverse Events in Patients with Rheumatoid Arthritis, Ulcerative Colitis, or Psoriatic Arthritis in the Tofacitinib Clinical Development Programs. Rheumatol Ther. 2023 Apr;10(2):357-373. doi: 10.1007/s40744-022-00507-z. Epub 2022 Dec 17.
Winthrop KL, Curtis JR, Yamaoka K, Lee EB, Hirose T, Rivas JL, Kwok K, Burmester GR. Clinical Management of Herpes Zoster in Patients With Rheumatoid Arthritis or Psoriatic Arthritis Receiving Tofacitinib Treatment. Rheumatol Ther. 2022 Feb;9(1):243-263. doi: 10.1007/s40744-021-00390-0. Epub 2021 Dec 6.
Cohen SB, Tanaka Y, Mariette X, Curtis JR, Lee EB, Nash P, Winthrop KL, Charles-Schoeman C, Wang L, Chen C, Kwok K, Biswas P, Shapiro A, Madsen A, Wollenhaupt J. Long-term safety of tofacitinib up to 9.5 years: a comprehensive integrated analysis of the rheumatoid arthritis clinical development programme. RMD Open. 2020 Oct;6(3):e001395. doi: 10.1136/rmdopen-2020-001395.
Panaccione R, Isaacs JD, Chen LA, Wang W, Marren A, Kwok K, Wang L, Chan G, Su C. Characterization of Creatine Kinase Levels in Tofacitinib-Treated Patients with Ulcerative Colitis: Results from Clinical Trials. Dig Dis Sci. 2021 Aug;66(8):2732-2743. doi: 10.1007/s10620-020-06560-4. Epub 2020 Aug 20.
Winthrop KL, Wouters AG, Choy EH, Soma K, Hodge JA, Nduaka CI, Biswas P, Needle E, Passador S, Mojcik CF, Rigby WF. The Safety and Immunogenicity of Live Zoster Vaccination in Patients With Rheumatoid Arthritis Before Starting Tofacitinib: A Randomized Phase II Trial. Arthritis Rheumatol. 2017 Oct;69(10):1969-1977. doi: 10.1002/art.40187. Epub 2017 Sep 6.
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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2014-000706-34
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
A3921237
Identifier Type: -
Identifier Source: org_study_id
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