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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.
Verified June 2012 by University Hospitals of Cleveland
Sponsor:
Collaborator:
Merck
Information provided by (Responsible Party):
Nora G. Singer, University Hospitals of Cleveland
ClinicalTrials.gov Identifier:
NCT00573651
First received: December 13, 2007
Last updated: June 13, 2012
Last verified: June 2012
History of Changes
  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
 Biological: Gardasil
 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:

U.S. FDA Resources

Further study details as provided by University Hospitals of Cleveland:

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
Experimental: Group A pauciarticular JIA
Females age 9-26 with pauciarticular JIA.
 Biological: Gardasil
0.5mL, IM, 3 doses. Immunization at time 0 months, 2 months and 6 months
Experimental: Group B polyarticular JIA
Females age 9-26 with polyarticular JIA.
 Biological: Gardasil
0.5mL, IM, 3 doses. Immunization at time 0 months, 2 months and 6 months
Experimental: Group C seronegative arthritis
Females age 9-26 with seronegative arthritis (including ankylosing spondylitis and psoriatic arthritis)
 Biological: Gardasil
0.5mL, IM, 3 doses. Immunization at time 0 months, 2 months and 6 months

Detailed Description:

The study will 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
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: Kabita Nanda, M.D. 216-844-3645 kabita.nanda@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
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    
Principal Investigator: Kabita Nanda, MD            
Sub-Investigator: Elizabeth Brooks, MD,PHD            
Sub-Investigator: Angela Robinson, MD            
Sub-Investigator: Nellie Coughlin, PNP            
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            
Sponsors and Collaborators
University Hospitals of Cleveland
Merck
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 13, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University Hospitals of Cleveland:
JIA
SEA syndrome
AS
psoriatic arthritis
HPV vaccine

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

ClinicalTrials.gov processed this record on May 19, 2013