ArthritisCHASENCT00573651

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

A study testing Blood Draws for Serum Titers in people with Arthritis, run by University Hospitals Cleveland Medical Center at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 9 to 26 years, women only
Conditions the study is for: Arthritis
What is being tested?: Blood Draws for Serum Titers
Type of treatment: Vaccines
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 43 participants
Where: 4 sitesUnited States
Study dates: Nov 2007to 20 Oct 2014
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 9 to 26 years
Women only
No healthy volunteers
Child, Adult

Who may be able to join

Female patients, age 9-26 years, with polyarticular JIA, pauciarticular JIA, and sero-negative arthritis.

Who cannot join

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.

Trial locations and contacts

4 sites in 1 country.

United States4 sites

University of Chicago
Chicago, Illinois, 60637
University Hospitals Medical Center
Cleveland, Ohio, 44106
MetroHealth Medical Center
Cleveland, Ohio, 44109
Cleveland Clinic
Cleveland, Ohio, 44189

Other trials in United States

About this study

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

Read the 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.

Conditions: Arthritis
Being tested: Blood Draws for Serum Titers
Keywords: JIA, SEA syndrome, AS, psoriatic arthritis, HPV vaccine
Medical subject headings: Arthritis, Arthritis, Psoriatic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Blood Draws for Serum TitersOther
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.

Study groups in NCT00573651
Study group	Role	What they receive
JIA except SJIA with active systemic symptoms	Other	Females age 9-26 with JIA of all types that have had arthritis and do not have active systemic symptoms. 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. Receives: Other: Blood Draws for Serum Titers

What is being measured

The primary outcome is the main question the study is designed to answer.

Positive Serum GMTs at 7 Months (HPV06)
dichotomized as negative or positive
Measured: 7 months
Positive Serum GMTs at 7 Months (HPV11)
dichotomized as negative or positive
Measured: 7 months
Positive Serum GMTs at 7 Months (HPV16)
dichotomized as negative or positive
Measured: 7 months
Positive Serum GMTs at 7 Months (HPV18)
dichotomized as negative or positive
Measured: 7 months

Secondary outcomes (10)

Disease Flare
increased arthritis requiring addition of steroids, intensification of NSAIDs or new DMARD or biological DMARD
Measured: 2 years
Peds QL
worsening of >30% from the prior visit
Measured: 2 years
Positive Serum GMT (HVP06)
dichotomized as negative or positive
Measured: 12 months
Positive Serum GMT (HVP11)
dichotomized as negative or positive
Measured: 12 months
Positive Serum GMT (HVP16)
dichotomized as negative or positive
Measured: 12 months
Positive Serum GMT (HVP18)
dichotomized as negative or positive
Measured: 12 months
Positive Serum GMT (HPV06)
Measured: 24 months
Positive Serum GMT (HPV11)
Measured: 24 months
Positive Serum GMT (HPV16)
Measured: 24 months
Positive Serum GMT (HPV18)
Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 200720 Oct 2014

First posted14 Dec 2007 (estimated)
Study startNov 2007
Primary completion20 Oct 2014
Study completion20 Oct 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for ArthritisStudies of the same condition, open and under way.
More trials run by University Hospitals Cleveland Medical CenterThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Model description: Open label vaccination study Gardasil vaccine (4 component).
Masking: None (open label)
Enrolment: 43 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00573651
Sponsor's protocol ID: Gardasil in JIA
Other IDs: CHASE
Acronym: CHASE
Status last verified: Jan 2024
First submitted: 13 Dec 2007
Last updated: 5 Jul 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 2
Extension Study of Safety and Tolerability of DDY391 in Participants With Moderate to Severe Psoriatic Arthritis (CDDY391A12201-extension)
Moderate to Severe Psoriatic Arthritis
RecruitingPhase 2
Study of PTC844 in Participants With Active Rheumatoid Arthritis
Rheumatoid Arthritis
Not yet recruitingPhase 1
An Ascending Dose Study of DKB903 in Participants With Rheumatoid Arthritis (RA) and Participants With Systemic Lupus Erythematosus (SLE)
Rheumatoid Arthritis and Systemic Lupus Erythematosus
Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Active, not recruiting
Effects of Resistance Exercise on Enthesitis in Patients With Spondyloarthritis
Spondyloarthritis (SpA), Axial Spondylarthritis (axSpA)

All Arthritis trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT00573651
Acronym / sponsor ID: CHASE / Gardasil in JIA
Conditions: Arthritis
Keywords: JIA, SEA syndrome, AS, psoriatic arthritis, HPV vaccine
Study type: Interventional
Recruitment status: Completed
Enrolment: 43 participants (actual)
Lead sponsor: University Hospitals Cleveland Medical CenterUniversity, hospital or other
Collaborators: Merck Sharp & Dohme LLC, MetroHealth System, Ohio, The Cleveland Clinic, University of Chicago
Study start: Nov 2007
Primary completion: 20 Oct 2014 (actual)
Study completion: 20 Oct 2014 (actual)
First posted: 14 Dec 2007 (estimated)
Results: Posted 5 Jul 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: Open label vaccination study Gardasil vaccine (4 component).

Arm	Type	Receives
JIA except SJIA with active systemic symptoms	Other	Other: Blood Draws for Serum TitersFemales age 9-26 with JIA of all types that have had arthritis and do not have active systemic symptoms. 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.

Who may qualify

Ages: 9 to 26 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Child, Adult

Key inclusion criteria (1 listed)

Female patients, age 9-26 years, with polyarticular JIA, pauciarticular JIA, and sero-negative arthritis.

Key exclusion criteria (7 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Blood Draws for Serum TitersAll 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.	Other	JIA except SJIA with active systemic symptoms

Primary outcome

Positive Serum GMTs at 7 Months (HPV06)
Time frame: 7 months
dichotomized as negative or positive
Positive Serum GMTs at 7 Months (HPV11)
Time frame: 7 months
dichotomized as negative or positive
Positive Serum GMTs at 7 Months (HPV16)
Time frame: 7 months
dichotomized as negative or positive
Positive Serum GMTs at 7 Months (HPV18)
Time frame: 7 months
dichotomized as negative or positive

10 secondary outcomes

Disease Flare
Time frame: 2 years
Peds QL
Time frame: 2 years
Positive Serum GMT (HVP06)
Time frame: 12 months
Positive Serum GMT (HVP11)
Time frame: 12 months
Positive Serum GMT (HVP16)
Time frame: 12 months
Positive Serum GMT (HVP18)
Time frame: 12 months
Positive Serum GMT (HPV06)
Time frame: 24 months
Positive Serum GMT (HPV11)
Time frame: 24 months
Positive Serum GMT (HPV16)
Time frame: 24 months
Positive Serum GMT (HPV18)
Time frame: 24 months

Results and safety

Results posted to the registry on 5 Jul 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
JIA Except SJIA Active Systemic Symptoms	43	39

Primary outcome: Positive Serum GMTs at 7 Months (HPV06)

Time frame: 7 months. Number. Unit: participants

Measure	JIA Except SJIA With Active Systemic Symptoms n = 35
Value	34

Population analysed: 3 samples were lost in transport to lab

Primary outcome: Positive Serum GMTs at 7 Months (HPV11)

Time frame: 7 months. Number. Unit: participants

Measure	JIA Except SJIA With Active Systemic Symptoms n = 35
Value	35

Population analysed: 3 samples were lost in transport to lab

Primary outcome: Positive Serum GMTs at 7 Months (HPV16)

Time frame: 7 months. Number. Unit: participants

Measure	JIA Except SJIA With Active Systemic Symptoms n = 35
Value	35

Population analysed: 3 samples were lost in transport to lab

Primary outcome: Positive Serum GMTs at 7 Months (HPV18)

Time frame: 7 months. Number. Unit: participants

Measure	JIA Except SJIA With Active Systemic Symptoms n = 35
Value	35

Population analysed: 3 samples were lost in transport to lab

10 secondary outcomes are reported in the full results.

Adverse events

Time frame: Data was collected for up to completion of the 24 month visit for patients that completed the study or the last known study visit.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Aggregate of All Three Arms.	1 of 43 (2.3%)	21 of 43 (48.8%)	0 of 43

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Arthritis

Not yet recruitingPhase 2
Extension Study of Safety and Tolerability of DDY391 in Participants With Moderate to Severe Psoriatic Arthritis (CDDY391A12201-extension)
Moderate to Severe Psoriatic Arthritis
RecruitingPhase 2
Study of PTC844 in Participants With Active Rheumatoid Arthritis
Rheumatoid Arthritis
Not yet recruitingPhase 1
An Ascending Dose Study of DKB903 in Participants With Rheumatoid Arthritis (RA) and Participants With Systemic Lupus Erythematosus (SLE)
Rheumatoid Arthritis and Systemic Lupus Erythematosus
Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Active, not recruiting
Effects of Resistance Exercise on Enthesitis in Patients With Spondyloarthritis
Spondyloarthritis (SpA), Axial Spondylarthritis (axSpA)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Nora G Singer, MD study director

UHospitals Cleveland

4 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Blood Draws for Serum Titers in people with Arthritis, run by University Hospitals Cleveland Medical Center at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Jul 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Positive Serum GMTs at 7 Months (HPV06) (time frame: 7 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00573651.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2024.