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

Last updated on August 9, 2018

FOR MORE INFORMATION
Study Location
NEA Baptist Clinic
Jonesboro, Arkansas, 72401 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

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

- 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.

NCT02147587
Pfizer
Completed
A Study to Assess Immune Response Following Zoster Vaccination to Subjects With Rheumatoid Arthritis Receiving Tofacitinib or Placebo With Background Methotrexate

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A Study to Assess Immune Response Following Zoster Vaccination to Subjects With Rheumatoid Arthritis Receiving Tofacitinib or Placebo With Background Methotrexate
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Rheumatoid Arthritis
  • Drug: Tofacitinib
    5 mg twice daily of tofacitinib with background methotrexate for 12 weeks
  • Drug: Placebo
    Placebo tablets twice daily with background methotrexate for 12 weeks
  • Experimental: 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.
    Intervention: Drug: Tofacitinib
  • Placebo Comparator: 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.
    Intervention: Drug: Placebo
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
112
July 2015
June 2015   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
50 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
United Kingdom
 
NCT02147587
A3921237
2014-000706-34 ( EudraCT Number )
Yes
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
July 2015

ICMJE     Data element required by the

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

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Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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