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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 by University Hospital Case Medical Center
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Nora G. Singer, University Hospitals of Cleveland
ClinicalTrials.gov Identifier:
NCT00573651
First received: December 13, 2007
Last updated: June 17, 2013
Last verified: June 2013
  Purpose

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 Intervention Phase
Arthritis
Other: Blood Draws for Serum Titers
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
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

Resource links provided by NLM:


Further study details as provided by University Hospital Case Medical Center:

Primary Outcome Measures:
  • Serum GMTs at 7 months [ Time Frame: 7 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Disease flare [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Peds QL [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Measure serum GMT [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Measure serum GMT [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 72
Study Start Date: November 2007
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   9 Years to 26 Years
Genders 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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00573651

Contacts
Contact: Nora Singer, M.D. 216-778-5154 nora.singer@uhhospitals.org
Contact: Angela Robinson, M.D. 216-844-3645 angela.robinson@uhhospitals.org

Locations
United States, Illinois
University of Chicago Recruiting
Chicago, Illinois, United States, 60637
Contact: Rebecca Puplava    773-702-2879    rpuplava@peds.bsd.uchicago.edu   
Principal Investigator: Linda Wagner-Weiner, MD         
United States, Ohio
Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44195
Contact: Carolyn Mawhorter    216-445-1099    MAWHORC@ccf.org   
Principal Investigator: Steven Spalding         
MetroHealth Recruiting
Cleveland, Ohio, United States, 44109
Contact: Dianne Morus, RRT    216-778-3309    dmorus@metrohealth.org   
Principal Investigator: Nora Singer, MD         
University Hospitals Case Medical Center Recruiting
Cleveland, Ohio, United States, 44106
Contact: Kirk Krogstad    216-844-1000    kirk.krogstad@uhhospitals.org   
Contact: Sonya Mihalus, RN    216-844-1000    sonya.mihalus@uhhospitals.org   
Sub-Investigator: Elizabeth Brooks, MD,PHD         
Sub-Investigator: Angela Robinson, MD         
Sub-Investigator: Nellie Coughlin, PNP         
Sponsors and Collaborators
University Hospital Case Medical Center
Merck Sharp & Dohme Corp.
Investigators
Principal Investigator: Nora G Singer, MD UHospitals Cleveland
  More Information

No publications provided

Responsible Party: Nora G. Singer, M.D., University Hospitals of Cleveland
ClinicalTrials.gov Identifier: NCT00573651     History of Changes
Other Study ID Numbers: Gardasil in JIA
Study First Received: December 13, 2007
Last Updated: June 17, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University Hospital Case Medical Center:
JIA
SEA syndrome
AS
psoriatic arthritis
HPV vaccine

Additional relevant MeSH terms:
Arthritis
Arthritis, Juvenile
Autoimmune Diseases
Connective Tissue Diseases
Immune System Diseases
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on November 20, 2014