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NCT Number: NCT00573651

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

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.

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Key information

Conditions

Arthritis Arthritis, Psoriatic Bone Diseases Joint Diseases Musculoskeletal Diseases Psoriasis Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases Spinal Diseases Spondylarthritis Spondylarthropathies Spondylitis

Age range

9 year–26 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Chicago, Chicago, Illinois, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Blood Draws for Serum Titers

Other

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 outcomes

  1. Positive Serum GMTs at 7 Months (HPV06)

    Time frame: 7 months

    dichotomized as negative or positive

  2. Positive Serum GMTs at 7 Months (HPV11)

    Time frame: 7 months

    dichotomized as negative or positive

  3. Positive Serum GMTs at 7 Months (HPV16)

    Time frame: 7 months

    dichotomized as negative or positive

  4. Positive Serum GMTs at 7 Months (HPV18)

    Time frame: 7 months

    dichotomized as negative or positive

Secondary outcomes

  1. Disease Flare

    Time frame: 2 years

    increased arthritis requiring addition of steroids, intensification of NSAIDs or new DMARD or biological DMARD

  2. Peds QL

    Time frame: 2 years

    worsening of >30% from the prior visit

  3. Positive Serum GMT (HVP06)

    Time frame: 12 months

    dichotomized as negative or positive

  4. Positive Serum GMT (HVP11)

    Time frame: 12 months

    dichotomized as negative or positive

  5. Positive Serum GMT (HVP16)

    Time frame: 12 months

    dichotomized as negative or positive

  6. Positive Serum GMT (HVP18)

    Time frame: 12 months

    dichotomized as negative or positive

  7. Positive Serum GMT (HPV06)

    Time frame: 24 months

  8. Positive Serum GMT (HPV11)

    Time frame: 24 months

  9. Positive Serum GMT (HPV16)

    Time frame: 24 months

  10. Positive Serum GMT (HPV18)

    Time frame: 24 months

Sponsors and collaborators

Lead sponsor

University Hospitals Cleveland Medical Center

Other

Collaborators

  • Merck Sharp & Dohme LLC
  • MetroHealth System, Ohio
  • The Cleveland Clinic
  • University of Chicago

Registry information

Official study title

Pilot Study of the Safety and Efficacy of Quadrivalent Human Papillomavirus Vaccine (Gardasil®) in Female Subjects With Juvenile Idiopathic Arthritis (JIA)/ Seronegative Arthritis

Acronym: CHASE

Important dates

Study start
2007
Primary completion
2014
Study completion
2014
First posted
Dec 14, 2007
Registry last updated
Jul 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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