Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 12:35 PM
Ignite Modification Date:
2025-12-24 @ 12:35 PM
NCT ID:
NCT01506661
Eligibility Criteria:
Inclusion Criteria:
* Age ≥ 50 years
* Willing and able to provide written informed consent
* History of primary varicella vaccination or positive VZV IgG antibodies
* Diagnosis of RA according to ACR criteria for \> 1 year, or healthy control subject
* Stable, mild disease activity as defined by a DAS28 score of 4.0
* Current medical treatment for RA has been stable for 4 weeks prior to screening
* Acceptable immunosuppressive medications are limited to Prednisone ≤ 10 mg daily Methotrexate ≤ 20 mg weekly Hydroxychloroquine ≤ 6.5 mg/kg daily Any TNF inhibitor
* Female subjects of childbearing potential and non-sterile males must agree to use acceptable form of contraception for the duration of the study
Exclusion Criteria:
* History of receiving any VZV-containing vaccine
* History of herpes zoster reactivation (shingles) within 5 years of enrollment
* Received any vaccine within 6 weeks
* Known Hepatitis B, C or HIV virus infection
* History of drug or alcohol abuse within 1 year
* Rituximab therapy within 2 years of screening
* Cyclophosphamide within 6 months of screening
* Biologic therapy: TNF inhibitors with longer half-lives (infliximab, golimumab, etc), or other non-TNF biologic therapies (IL-1 or IL-6 inhibition, or CTLA-4Ig)
* Use of mycophenolate mofetil within 3 months of screening
* History of receiving immunoglobulin or other blood product within 3 months of screening
* Allergic reaction, intolerance or other contraindication to use of famciclovir.
* Has received an experimental/investigational agent (vaccine, drug, biologic, device, blood product, or medication) within 3 months of screening; or expects to receive another experimental/investigational agent within 6 months post immunization.
* Pregnant or lactating women
* Unwilling to use acceptable method of contraception for the duration of the study
* WBC \<3.0; ANC \<1500; CD4+ \<200
* Proteinuria \>1.5 mg/day
* Impaired renal function defined by serum Cr \>1.5
* Transaminases \> 2x upper limit of normal
* DAS28 \> 4
* Anticipation of need to increase level of immunosuppression or add biologic therapy for 6 months following dosing.
* History of neoplastic disease within 5 years of screening, except for completely excised non-melanoma cancer of the skin or in-situ carcinoma of the uterine cervix.
* History of any hematological malignancy, current bleeding disorder or taking anticoagulant medication (heparin or warfarin).
* Any condition that would, in the opinion of the site investigator, place the subject at an unacceptable risk of injury or render the subject unable to meet the requirements of the protocol.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
50 Years
Maximum Age:
80 Years
Study:
NCT01506661
Study Brief:
Protocol Section:
NCT01506661