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

Primary Purpose

Arthritis

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Blood Draws for Serum Titers
Sponsored by
University Hospitals Cleveland Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Arthritis focused on measuring JIA, SEA syndrome, AS, psoriatic arthritis, HPV vaccine

Eligibility Criteria

9 Years - 26 Years (Child, Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Chicago
  • University Hospitals Case Medical Center
  • MetroHealth
  • Cleveland Clinic

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Other

Other

Arm Label

Group A pauciarticular JIA

Group B polyarticular JIA

Group C seronegative arthritis

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Serum GMTs at 7 months
dichotomized as negative or positive

Secondary Outcome Measures

Disease flare
increased arthritis requiring addition of steroids, intensification of NSAIDs or new DMARD or biological DMARD
Peds QL
worsening of >30% from the prior visit
Measure serum GMT
dichotomized as negative or positive
Measure serum GMT

Full Information

First Posted
December 13, 2007
Last Updated
December 13, 2020
Sponsor
University Hospitals Cleveland Medical Center
Collaborators
Merck Sharp & Dohme LLC
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1. Study Identification

Unique Protocol Identification Number
NCT00573651
Brief Title
Safety and Efficacy of Gardasil in Females With Juvenile Idiopathic Arthritis (JIA)/Seronegative Arthritis
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
November 2007 (undefined)
Primary Completion Date
December 11, 2020 (Actual)
Study Completion Date
December 11, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospitals Cleveland Medical Center
Collaborators
Merck Sharp & Dohme LLC

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arthritis
Keywords
JIA, SEA syndrome, AS, psoriatic arthritis, HPV vaccine

7. Study Design

Primary Purpose
Other
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Model Description
Open label vaccination study Gardasil vaccine (4 component).
Masking
Outcomes Assessor
Masking Description
The geometric mean titers are analyzed in a de-identified manner at Merck Contract laboratories.
Allocation
Non-Randomized
Enrollment
43 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A pauciarticular JIA
Arm Type
Other
Arm Description
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.
Arm Title
Group B polyarticular JIA
Arm Type
Other
Arm Description
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.
Arm Title
Group C seronegative arthritis
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Blood Draws for Serum Titers
Intervention Description
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.
Primary Outcome Measure Information:
Title
Serum GMTs at 7 months
Description
dichotomized as negative or positive
Time Frame
7 months
Secondary Outcome Measure Information:
Title
Disease flare
Description
increased arthritis requiring addition of steroids, intensification of NSAIDs or new DMARD or biological DMARD
Time Frame
2 years
Title
Peds QL
Description
worsening of >30% from the prior visit
Time Frame
2 years
Title
Measure serum GMT
Description
dichotomized as negative or positive
Time Frame
12 months
Title
Measure serum GMT
Time Frame
24 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
9 Years
Maximum Age & Unit of Time
26 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nora G Singer, MD
Organizational Affiliation
UHospitals Cleveland
Official's Role
Study Director
Facility Information:
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
University Hospitals Case Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
MetroHealth
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44109
Country
United States
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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