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

Sponsor:	University Hospitals of Cleveland
Collaborator:	Merck
Information provided by (Responsible Party):	Nora G. Singer, University Hospitals of Cleveland
ClinicalTrials.gov Identifier:	NCT00573651

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 IV

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:

Genetics Home Reference related topics: juvenile idiopathic arthritis psoriatic arthritis

MedlinePlus related topics: Juvenile Rheumatoid Arthritis

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, 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

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:	October 23, 2011
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 February 09, 2012