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

Not Applicable

Completed

• Conditions: Arthritis
• Interventions: Other: Blood Draws for Serum Titers

• Registration Number: NCT00573651
• Lead Sponsor: University Hospitals Cleveland Medical Center

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.

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 Timeline

• Study Start: 2007-11
• Study First Submitted: 2007-12-13
• Study First Submitted QC: 2007-12-13
• Study First Posted: 2007-12-14
• Primary Completion: 2014-10-20
• Study Completion: 2014-10-20
• Results First Submitted: 2023-01-03
• Status Verified: 2024-01
• Results First Submitted QC: 2024-01-25
• Last Update Submitted: 2024-01-25
• Results First Posted: 2024-07-05
• Last Update Posted: 2024-07-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 43

Inclusion Criteria

• Female patients, age 9-26 years, with polyarticular JIA, pauciarticular JIA, and sero-negative arthritis.

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
JIA except SJIA with active systemic symptoms	Blood Draws for Serum Titers	Females age 9-26 with JIA of all types that have had arthritis and do not have active systemic symptoms. 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.

Primary Outcome Measures

Name	Time	Method
Positive Serum GMTs at 7 Months (HPV06)	7 months	dichotomized as negative or positive
Positive Serum GMTs at 7 Months (HPV18)	7 months	dichotomized as negative or positive
Positive Serum GMTs at 7 Months (HPV16)	7 months	dichotomized as negative or positive
Positive Serum GMTs at 7 Months (HPV11)	7 months	dichotomized as negative or positive

Secondary Outcome Measures

Name	Time	Method
Peds QL	2 years	worsening of \>30% from the prior visit
Positive Serum GMT (HVP11)	12 months	dichotomized as negative or positive
Positive Serum GMT (HVP16)	12 months	dichotomized as negative or positive
Positive Serum GMT (HPV18)	24 months
Disease Flare	2 years	increased arthritis requiring addition of steroids, intensification of NSAIDs or new DMARD or biological DMARD
Positive Serum GMT (HVP06)	12 months	dichotomized as negative or positive
Positive Serum GMT (HVP18)	12 months	dichotomized as negative or positive
Positive Serum GMT (HPV06)	24 months
Positive Serum GMT (HPV11)	24 months
Positive Serum GMT (HPV16)	24 months

Trial Locations

Locations (4)

University Hospitals Medical Center; 🇺🇸 Cleveland, Ohio, United States

Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States

University of Chicago; 🇺🇸 Chicago, Illinois, United States

MetroHealth Medical Center; 🇺🇸 Cleveland, Ohio, United States