Thinking of joining a study?

Register your interest

NCT00573651 | Completed | Arthritis


Safety and Efficacy of Gardasil in Females With Juvenile Idiopathic Arthritis (JIA)/Seronegative Arthritis
Sponsor:

University Hospitals Cleveland Medical Center

Information provided by (Responsible Party):

Nora G. Singer

Brief Summary:

The purpose of this research study is to see if patients with juvenile idiopathic arthritis or seronegative arthritis (and related conditions) mount protective immune responses to the human papillomavirus (HPV) vaccine called Gardasil. The researchers also want to monitor for any increase in disease activity following receipt of the vaccine.

Condition or disease

Arthritis

Intervention/treatment

Blood Draws for Serum Titers

Phase

Phase 4

Detailed Description:

Each individual subject's participation is scheduled to last approximately two years. Patients will be given Gardasil injections at months 0, 2, and 6. Patients will have geometric mean titers (GMT) measured at 7, 12, and 24 months. Questionnaires about health and function will also be completed at each visit.

Study Type : Interventional
Estimated Enrollment : 43 participants
Masking: Single
Masking Description: The geometric mean titers are analyzed in a de-identified manner at Merck Contract laboratories.
Primary Purpose: Other
Official Title: Pilot Study of the Safety and Efficacy of Quadrivalent Human Papillomavirus Vaccine (Gardasil®) in Female Subjects With Juvenile Idiopathic Arthritis (JIA)/ Seronegative Arthritis
Actual Study Start Date : November 2007
Estimated Primary Completion Date : December 11, 2020
Estimated Study Completion Date : December 11, 2020
Arm Intervention/treatment

Other: Group A pauciarticular JIA

Females age 9-26 with pauciarticular JIA. All study subjects are receiving the Gardasil vaccine as part of their clinical care. The study observes outcomes related to this clinical care. Study intervention consists of some Blood Draws for serum titres taken to measure antibody and RNA titers.

Other: Blood Draws for Serum Titers

Other: Group B polyarticular JIA

Females age 9-26 with polyarticular JIA. All study subjects are receiving the Gardasil vaccine as part of their clinical care. The study observes outcomes related to this clinical care. Study intervention consists of some Blood Draws for Serum Titers taken to measure antibody and RNA titers.

Other: Blood Draws for Serum Titers

Other: Group C seronegative arthritis

Females age 9-26 with seronegative arthritis (including ankylosing spondylitis and psoriatic arthritis). All study subjects are receiving the Gardasil vaccine as part of their clinical care. The study observes outcomes related to this clinical care. Study intervention consists of some blood samples taken to measure antibody and RNA titers.

Other: Blood Draws for Serum Titers

Ages Eligible for Study: 9 Years to 26 Years
Sexes Eligible for Study: Female
Accepts Healthy Volunteers: No
Criteria
Inclusion Criteria
  • Female patients, age 9-26 years, with polyarticular JIA, pauciarticular JIA, and sero-negative arthritis.
Exclusion Criteria
  • Pregnancy
  • Known allergy/sensitivity or any hypersensitivity to yeast or components of study drug or their formulation
  • Systemic onset JIA with active systemic symptoms (systemic onset JIA with polyarticular features but no fever or rash may be included).
  • Prior vaccination against HPV
  • Known HPV infection
  • Current or history of cervical cancer or cervical intraepithelial neoplasia (CIN).
  • Males are excluded from this study because Gardasil® is currently approved only for females.

Safety and Efficacy of Gardasil in Females With Juvenile Idiopathic Arthritis (JIA)/Seronegative Arthritis

Location Details


Please Choose a site



Safety and Efficacy of Gardasil in Females With Juvenile Idiopathic Arthritis (JIA)/Seronegative Arthritis

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations


Not yet recruiting

United States, Illinois

University of Chicago

Chicago, Illinois, United States, 60637

Not yet recruiting

United States, Ohio

University Hospitals Case Medical Center

Cleveland, Ohio, United States, 44106

Not yet recruiting

United States, Ohio

MetroHealth

Cleveland, Ohio, United States, 44109

Not yet recruiting

United States, Ohio

Cleveland Clinic

Cleveland, Ohio, United States, 44195

Loading...