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

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ClinicalTrials.gov Identifier: NCT00573651
Recruitment Status : Active, not recruiting
First Posted : December 14, 2007
Last Update Posted : March 6, 2018
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Nora G. Singer, 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.

Condition or disease Intervention/treatment Phase
Arthritis Other: Blood Draws for Serum Titers 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  (Clinical Trial)
Actual Enrollment : 43 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Intervention Model Description: Open label vaccination study.
Masking: Single (Outcomes Assessor)
Masking Description: The geometric mean titers are analyzed in a de-identified manner at Merck Contract laboratories.
Primary Purpose: Treatment
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 Start Date : November 2007
Estimated Primary Completion Date : June 30, 2018
Estimated Study Completion Date : September 30, 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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
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.
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
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.
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
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 Measures :
  1. Serum GMTs at 7 months [ Time Frame: 7 months ]

Secondary Outcome Measures :
  1. Disease flare [ Time Frame: 2 years ]
  2. Peds QL [ Time Frame: 2 years ]
  3. Measure serum GMT [ Time Frame: 12 months ]
  4. Measure serum GMT [ Time Frame: 24 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   9 Years to 26 Years   (Child, Adult)
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00573651


Locations
United States, Illinois
University of Chicago
Chicago, Illinois, United States, 60637
United States, Ohio
University Hospitals Case Medical Center
Cleveland, Ohio, United States, 44106
MetroHealth
Cleveland, Ohio, United States, 44109
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
University Hospitals Cleveland Medical Center
Merck Sharp & Dohme Corp.
Investigators
Principal Investigator: Nora G Singer, MD UHospitals Cleveland

Responsible Party: Nora G. Singer, M.D., University Hospitals Cleveland Medical Center
ClinicalTrials.gov Identifier: NCT00573651     History of Changes
Other Study ID Numbers: Gardasil in JIA
First Posted: December 14, 2007    Key Record Dates
Last Update Posted: March 6, 2018
Last Verified: March 2018

Keywords provided by Nora G. Singer, University Hospitals Cleveland Medical Center:
JIA
SEA syndrome
AS
psoriatic arthritis
HPV vaccine

Additional relevant MeSH terms:
Arthritis
Arthritis, Juvenile
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Vaccines
Antibodies
Immunologic Factors
Physiological Effects of Drugs