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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02147587 |
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Date of registration:
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22/05/2014 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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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
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Scientific title:
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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 |
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Date of first enrolment:
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June 2014 |
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Target sample size:
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112 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02147587 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
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Phase:
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Phase 2
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Countries of recruitment
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United Kingdom
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United States
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Contacts
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Name:
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Pfizer CT.gov Call Center |
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Address:
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Telephone:
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Email:
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Affiliation:
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Pfizer |
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Key inclusion & exclusion criteria
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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.
Age minimum:
50 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Rheumatoid Arthritis
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Intervention(s)
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Drug: Placebo
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Drug: Tofacitinib
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Primary Outcome(s)
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Fold Change From Baseline in Varicella Zoster Virus (VZV)-Specific Immunoglobulin G (IgG) Levels at Week 4
[Time Frame: Baseline (pre-vaccination; Day -14), Week 4 (6 weeks post-vaccination)]
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Secondary Outcome(s)
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Fold Change From Baseline in VZV-Specific IgG Levels at Day 1 and Week 12
[Time Frame: Baseline (pre-vaccination; Day -14), Day 1 (2 weeks post-vaccination), Week 12 (14 weeks post-vaccination)]
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Absolute Values in VZV-Specific IgG Levels at Day 1, Week 4 and Week 12
[Time Frame: Day 1 (2 weeks post-vaccination), Week 4 (6 weeks post-vaccination), Week 12 (14 weeks post-vaccination)]
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Percentage of Participants With >=1.5 Fold Change in VZV-Specific IgG Levels Day 1, Week 4 and Week 12
[Time Frame: Day 1 (2 weeks post-vaccination), Week 4 (6 weeks post-vaccination), Week 12 (14 weeks post-vaccination)]
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Secondary ID(s)
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2014-000706-34
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A3921237
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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