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

Arthritis Clinical Trial

— CHASE  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00573651
• Other study ID #: Gardasil in JIA
• Status: Completed
• Phase: Phase 4
• Start date: November 2007
• Est. completion date: December 11, 2020

Study information

• Verified date: December 2020
• Source: University Hospitals Cleveland Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: December 11, 2020
• Est. primary completion date: December 11, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 9 Years to 26 Years

Eligibility

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.

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Juvenile

Intervention

Other:
• Blood Draws for Serum Titers
All 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.

Locations

Country	Name	City	State
United States	University of Chicago	Chicago	Illinois
United States	Cleveland Clinic	Cleveland	Ohio
United States	MetroHealth	Cleveland	Ohio
United States	University Hospitals Case Medical Center	Cleveland	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
University Hospitals Cleveland Medical Center	Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum GMTs at 7 months	dichotomized as negative or positive	7 months
Secondary	Disease flare	increased arthritis requiring addition of steroids, intensification of NSAIDs or new DMARD or biological DMARD	2 years
Secondary	Peds QL	worsening of >30% from the prior visit	2 years
Secondary	Measure serum GMT	dichotomized as negative or positive	12 months
Secondary	Measure serum GMT		24 months