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

Arthritis research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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.

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Arthritis

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Other:Blood Draws for Serum TitersAll study subjects are receiving the Gardasil vaccine as part of their clinical care. The Gardasil vaccine is not given because of study participation. The study observes outcomes related to this clinical care. Study intervention consists of some blood samples taken to measure antibody and RNA titers. Other study specific procedures performed include Questionnaires and observational data.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Group A pauciarticular JIAFemales 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.

Group B polyarticular JIAFemales 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.

Group C seronegative arthritisFemales 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.

Study Status

Active, not recruiting

Start Date: November 2007

Completed Date: September 30, 2018

Phase: Phase 4

Type: Interventional

Design:

Primary Outcome: Serum GMTs at 7 months

Secondary Outcome: Disease flare

Study sponsors, principal investigator, and references

Principal Investigator: Nora G Singer, MD

Lead Sponsor: University Hospitals Cleveland Medical Center

Collaborator:

More information:https://clinicaltrials.gov/show/NCT00573651

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