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Preventing Extension of Oligoarticular Juvenile Idiopathic Arthritis JIA (Limit-JIA) (Limit-JIA)

Primary Purpose

Juvenile Idiopathic Arthritis

Status
Recruiting
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Abatacept Injection
Usual Care
Sponsored by
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Juvenile Idiopathic Arthritis focused on measuring Polyarthritis, abatacept, uveitis, prevention

Eligibility Criteria

2 Years - 16 Years (Child)All SexesDoes not accept healthy volunteers

To be eligible for this trial, participants must meet all of the following criteria in order to be include in the study:

  1. Age ≥ 2 years old and ≤16.5 years old
  2. Clinical diagnosis of JIA by a pediatric rheumatologist within the past 6 months
  3. Arthritis affecting ≤4 joints between disease onset and enrollment
  4. Enrollment in the CARRA Registry
  5. Participants of childbearing potential must agree to remain abstinent or agree to use an effective and medically acceptable form of birth control from the time of written or verbal assent to at least 66 days after taking the last dose of study drug.
  6. Weight ≥50 kg (Canadian Sites only) ¹ Enrollment is defined as having signed consent to participate in the Limit-JIA study.

The presence of any of the following will exclude a study participant from inclusion in the study:

  1. 1. Systemic JIA as defined by 2004 ILAR criteria1
  2. Sacroiliitis (clinical or radiographic)
  3. Inflammatory bowel disease (IBD)
  4. History of psoriasis or currently active psoriasis
  5. History of uveitis or currently active uveitis
  6. Prior treatment with systemic medication(s) for JIA (e.g. one or more of the following: DMARD or biologic medication)
  7. Current or previous (within 30 days of enrollment) treatment with systemic glucocorticoids (A short course of oral prednisone [≤ 14 days] is allowed)
  8. History of active or chronic liver disease
  9. Chronic or acute renal disorder
  10. AST (SGOT), ALT (SGPT) or BUN >2 x ULN (upper limit of normal) or creatinine >1.5 mg/dL or any other laboratory abnormality considered by the examining physician to be clinically significant within 2 months of the enrollment visit
  11. Presence of any medical or psychological condition or laboratory result which would make the participant, in the opinion of the investigator, unsuitable for the study
  12. Participation in another concurrent clinical interventional study within 30 days of enrollment
  13. Known positive human immunodeficiency virus (HIV)
  14. Received a live virus vaccine within 1 month of the baseline visit
  15. Current or prior positive Purified Protein Derivative (PPD) test or Quantiferon Gold TB
  16. Pregnant, breast feeding, or planned breast feeding during the study duration
  17. Planned transfer to non-participating pediatric rheumatology center or adult rheumatologist in the next 12 months
  18. Active malignancy of any type or history of malignancy
  19. Chronic or active infection or any major episode of infection requiring hospitalization or treatment with intravenous (IV) antibiotics within 30 days or oral antibiotics within 14 days prior to screening
  20. Primary language other than English or Spanish
  21. Positive for Hepatitis B surface antigen or core antibody
  22. <10 Kg in weight
  23. If a potential subject has symptoms consistent with COVID-19 and/or known COVID-19 exposure at screening, it is recommended that the site follow CDC guidance regarding testing and quarantine requirements. The subject can be re-screened when there is no longer concern for active infection. A subject with a positive COVID -19 test may be re-screened.

Sites / Locations

  • University of Alabama at Birmingham
  • University of California at San Francisco Medical CenterRecruiting
  • The Children's Hospital ColoradoRecruiting
  • Shands at the University of FloridaRecruiting
  • Childrens Memorial Hospital/ Ann and Robert Lurie Children's Hospital
  • University of Chicago
  • Riley Hospital for Children at Indiana University HealthRecruiting
  • University of Iowa Hospitals of ClinicsRecruiting
  • University of Louisville School of Medicine/ Norton Charities Pediatric Clinical Research UnitRecruiting
  • Boston Children's HospitalRecruiting
  • University of Minnesota; Children's Hospital and Clinics of MinnesotaRecruiting
  • Mayo Clinic
  • Hackensack University Medical CenterRecruiting
  • The Pediatric Specialty Center at Saint Barnabas/RWJ Barnabas Health
  • Children's Hospital at Montefiore/ Albert Einstein University HospitalRecruiting
  • Hospital of Special Surgery
  • University of North CarolinaRecruiting
  • Levine Children's Hospital/ Carolina Medical Center
  • Duke Children's Hospital and Health Center
  • Cincinnati Children's Hospital Medical CenterRecruiting
  • MetroHealth SystemRecruiting
  • Nationwide Children's HospitalRecruiting
  • Children's Hospital of PhiladelphiaRecruiting
  • Monroe Carell Jr Children's Hospital at VanderbiltRecruiting
  • University of UtahRecruiting
  • Seattle Children's HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Experimental

Arm Label

Abatacept and Usual Care (Part I)

Active Comparator: Usual Care (Part I)

Abatacept and Usual Care (Part II)

Arm Description

Weekly abatacept injection at standard dosing for weight plus usual care with steroid joint injection and non-steroidal anti-inflammatory drugs per the discretion of the treating provider

Usual care includes steroid joint injections and treatment with non-steroidal anti-inflammatory drugs at the discretion of the treating provider

Weekly abatacept injection at standard dosing for weight plus usual care with steroid joint injection and non-steroidal anti-inflammatory drugs per the discretion of the treating provider

Outcomes

Primary Outcome Measures

Change in Joint Count by Physician Exam (Part I)
The number of affected joints involved at protocol specified visits by physician exam.
Change in Joint Count by Physician Exam (Part II)
The number of affected joints involved at protocol specified visits by physician exam.
Change in Number of participants with active anterior uveitis (Part I)
The presence of active anterior uveitis, defined according to the Standardization of Uveitis Nomenclature for Reporting Clinical Data (SUN criteria) as the presence of one or more cells in each 1mm x 1mm slit beam field,84 will be assessed at standard of care ophthalmology visits
Change in Number of participants with active anterior uveitis (Part II)
The presence of active anterior uveitis, defined according to the Standardization of Uveitis Nomenclature for Reporting Clinical Data (SUN criteria) as the presence of one or more cells in each 1mm x 1mm slit beam field,84 will be assessed at standard of care ophthalmology visits

Secondary Outcome Measures

Change in pain score as measured by PROMIS (patient reported outcome measurement system) (Part I)
We will use The Patient Reported Outcomes Measurement Information System (PROMIS), to compare patient and caregiver reported outcomes between the groups. PROMIS® (Patient-Reported Outcomes Measurement Information System) is a set of person-centeredmeasures that evaluates and monitors physical, mental, and social health in adults and children.
Change in pain score as measured by PROMIS (patient reported outcome measurement system) (Part II)
We will use The Patient Reported Outcomes Measurement Information System (PROMIS), to compare patient and caregiver reported outcomes between the groups. PROMIS® (Patient-Reported Outcomes Measurement Information System) is a set of person-centeredmeasures that evaluates and monitors physical, mental, and social health in adults and children.
Change in fatigue level as measured by PROMIS (Part I)
We will use The Patient Reported Outcomes Measurement Information System (PROMIS), to compare patient and caregiver reported outcomes between the groups. PROMIS® (Patient-Reported Outcomes Measurement Information System) is a set of person-centeredmeasures that evaluates and monitors physical, mental, and social health in adults and children.
Change in fatigue level as measured by PROMIS (Part II)
We will use The Patient Reported Outcomes Measurement Information System (PROMIS), to compare patient and caregiver reported outcomes between the groups. PROMIS® (Patient-Reported Outcomes Measurement Information System) is a set of person-centeredmeasures that evaluates and monitors physical, mental, and social health in adults and children.
Change in functional ability by PROMIS (Part I)
We will use The Patient Reported Outcomes Measurement Information System (PROMIS), to compare patient and caregiver reported outcomes between the groups. PROMIS® (Patient-Reported Outcomes Measurement Information System) is a set of person-centeredmeasures that evaluates and monitors physical, mental, and social health in adults and children.
Change in functional ability by PROMIS (Part II)
We will use The Patient Reported Outcomes Measurement Information System (PROMIS), to compare patient and caregiver reported outcomes between the groups. PROMIS® (Patient-Reported Outcomes Measurement Information System) is a set of person-centeredmeasures that evaluates and monitors physical, mental, and social health in adults and children.
Change in anxiety by PROMIS (Part I)
We will use The Patient Reported Outcomes Measurement Information System (PROMIS), to compare patient and caregiver reported outcomes between the groups. PROMIS® (Patient-Reported Outcomes Measurement Information System) is a set of person-centeredmeasures that evaluates and monitors physical, mental, and social health in adults and children.
Change in anxiety by PROMIS (Part II)
We will use The Patient Reported Outcomes Measurement Information System (PROMIS), to compare patient and caregiver reported outcomes between the groups. PROMIS® (Patient-Reported Outcomes Measurement Information System) is a set of person-centeredmeasures that evaluates and monitors physical, mental, and social health in adults and children.
Change in depression by PROMIS (Part I)
We will use The Patient Reported Outcomes Measurement Information System (PROMIS), to compare patient and caregiver reported outcomes between the groups. PROMIS® (Patient-Reported Outcomes Measurement Information System) is a set of person-centeredmeasures that evaluates and monitors physical, mental, and social health in adults and children.
Change in depression by PROMIS (Part II)
We will use The Patient Reported Outcomes Measurement Information System (PROMIS), to compare patient and caregiver reported outcomes between the groups. PROMIS® (Patient-Reported Outcomes Measurement Information System) is a set of person-centeredmeasures that evaluates and monitors physical, mental, and social health in adults and children.
Change in global health by PROMIS (Part I)
Global health is defined as overall well being; We will use The Patient Reported Outcomes Measurement Information System (PROMIS), to compare patient and caregiver reported outcomes between the groups. PROMIS® (Patient-Reported Outcomes Measurement Information System) is a set of person-centeredmeasures that evaluates and monitors physical, mental, and social health in adults and children.
Change in global health by PROMIS (Part II)
Global health is defined as overall well being; We will use The Patient Reported Outcomes Measurement Information System (PROMIS), to compare patient and caregiver reported outcomes between the groups. PROMIS® (Patient-Reported Outcomes Measurement Information System) is a set of person-centeredmeasures that evaluates and monitors physical, mental, and social health in adults and children.
Change in family impact by PedsQL (Part I)
The PedsQL (Pediatric Quality of Life InventoryTM) Measurement Model is a modular approach to measuring health-related quality of life (HRQOL) in healthy children and adolescents and those with acute and chronic health conditions.
Change in family impact by PedsQL (Part II)
The PedsQL (Pediatric Quality of Life InventoryTM) Measurement Model is a modular approach to measuring health-related quality of life (HRQOL) in healthy children and adolescents and those with acute and chronic health conditions.
Change in medications side effects by JAMAR (Part 1)
Change in medications side effects by JAMAR (Part II)

Full Information

First Posted
January 30, 2019
Last Updated
August 1, 2023
Sponsor
Duke University
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1. Study Identification

Unique Protocol Identification Number
NCT03841357
Brief Title
Preventing Extension of Oligoarticular Juvenile Idiopathic Arthritis JIA (Limit-JIA)
Acronym
Limit-JIA
Official Title
An Open Label, Multi-Center, Phase 3 Efficacy Study of Sub-Q Abatacept in Preventing Extension of Oligoarticular Juvenile Idiopathic Arthritis JIA (Limit-JIA)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 29, 2019 (Actual)
Primary Completion Date
December 30, 2023 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This is a research study to test whether a once-weekly injection of abatacept will prevent the progression of Juvenile Idiopathic Arthritis (JIA) to a more severe form. To evaluate the effectiveness of a 24-week course of treatment with abatacept plus usual care versus usual care to prevent polyarthritis (≥5 joints), uveitis, or treatment with other systemic medication within 18 months of randomization in children with recent-onset limited JIA.
Detailed Description
Part I enrolled participants into a randomized open-label multicenter trial with a planned sample size of 306 JIA participants recruited from CARRA Registry sites. Participants were randomly allocated (1:1) to receive 24 weeks of abatacept plus usual care or usual care alone. Upon completion of 24 weeks of randomized treatment, each participant was to receive usual care and undergo follow-up for assessment of outcomes for an additional 12 months. Planned duration of the study for each participant was 18 months. Due to slow accrual and apparent loss of equipoise, enrollment into Part I has been discontinued 17February2022 As of October 29, 2021, 39 participants have been randomized in Part I. Part I participants will continue follow-up as planned. Part II is a non-randomized continuation of LIMIT-JIA with planned enrollment of 89 to reach 80 evaluable participants receiving to the abatacept arm. Participants will now receive 24 doses of abatacept plus usual care. Upon completion of 24 doses of treatment, each participant will receive usual care and undergo follow-up for assessment of outcomes for an additional 6 months. Planned duration of the study for each participant is 12 months. Part II will assess the efficacy of abatacept in prevention of disease extension by comparison of outcomes between participants enrolled in the abatacept arm and 428 CARRA Registry patients who would have met major eligibility criteria for LIMIT-JIA.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Juvenile Idiopathic Arthritis
Keywords
Polyarthritis, abatacept, uveitis, prevention

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
130 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Abatacept and Usual Care (Part I)
Arm Type
Experimental
Arm Description
Weekly abatacept injection at standard dosing for weight plus usual care with steroid joint injection and non-steroidal anti-inflammatory drugs per the discretion of the treating provider
Arm Title
Active Comparator: Usual Care (Part I)
Arm Type
Active Comparator
Arm Description
Usual care includes steroid joint injections and treatment with non-steroidal anti-inflammatory drugs at the discretion of the treating provider
Arm Title
Abatacept and Usual Care (Part II)
Arm Type
Experimental
Arm Description
Weekly abatacept injection at standard dosing for weight plus usual care with steroid joint injection and non-steroidal anti-inflammatory drugs per the discretion of the treating provider
Intervention Type
Drug
Intervention Name(s)
Abatacept Injection
Other Intervention Name(s)
Orencia
Intervention Description
Supplied as a weekly injection via a pre-filled syringe
Intervention Type
Other
Intervention Name(s)
Usual Care
Intervention Description
Usual care will be defined by the clinical management team but includes steroid joint injections and non- steroidal anti-inflammatory drugs
Primary Outcome Measure Information:
Title
Change in Joint Count by Physician Exam (Part I)
Description
The number of affected joints involved at protocol specified visits by physician exam.
Time Frame
Baseline, up to 18 months
Title
Change in Joint Count by Physician Exam (Part II)
Description
The number of affected joints involved at protocol specified visits by physician exam.
Time Frame
Baseline, up to 12 months
Title
Change in Number of participants with active anterior uveitis (Part I)
Description
The presence of active anterior uveitis, defined according to the Standardization of Uveitis Nomenclature for Reporting Clinical Data (SUN criteria) as the presence of one or more cells in each 1mm x 1mm slit beam field,84 will be assessed at standard of care ophthalmology visits
Time Frame
Baseline, up to 18 months
Title
Change in Number of participants with active anterior uveitis (Part II)
Description
The presence of active anterior uveitis, defined according to the Standardization of Uveitis Nomenclature for Reporting Clinical Data (SUN criteria) as the presence of one or more cells in each 1mm x 1mm slit beam field,84 will be assessed at standard of care ophthalmology visits
Time Frame
Baseline, up to 12 months
Secondary Outcome Measure Information:
Title
Change in pain score as measured by PROMIS (patient reported outcome measurement system) (Part I)
Description
We will use The Patient Reported Outcomes Measurement Information System (PROMIS), to compare patient and caregiver reported outcomes between the groups. PROMIS® (Patient-Reported Outcomes Measurement Information System) is a set of person-centeredmeasures that evaluates and monitors physical, mental, and social health in adults and children.
Time Frame
Baseline, up to 18 months
Title
Change in pain score as measured by PROMIS (patient reported outcome measurement system) (Part II)
Description
We will use The Patient Reported Outcomes Measurement Information System (PROMIS), to compare patient and caregiver reported outcomes between the groups. PROMIS® (Patient-Reported Outcomes Measurement Information System) is a set of person-centeredmeasures that evaluates and monitors physical, mental, and social health in adults and children.
Time Frame
Baseline, up to 12 months
Title
Change in fatigue level as measured by PROMIS (Part I)
Description
We will use The Patient Reported Outcomes Measurement Information System (PROMIS), to compare patient and caregiver reported outcomes between the groups. PROMIS® (Patient-Reported Outcomes Measurement Information System) is a set of person-centeredmeasures that evaluates and monitors physical, mental, and social health in adults and children.
Time Frame
Baseline, up to 18 months
Title
Change in fatigue level as measured by PROMIS (Part II)
Description
We will use The Patient Reported Outcomes Measurement Information System (PROMIS), to compare patient and caregiver reported outcomes between the groups. PROMIS® (Patient-Reported Outcomes Measurement Information System) is a set of person-centeredmeasures that evaluates and monitors physical, mental, and social health in adults and children.
Time Frame
Baseline, up to 12 months
Title
Change in functional ability by PROMIS (Part I)
Description
We will use The Patient Reported Outcomes Measurement Information System (PROMIS), to compare patient and caregiver reported outcomes between the groups. PROMIS® (Patient-Reported Outcomes Measurement Information System) is a set of person-centeredmeasures that evaluates and monitors physical, mental, and social health in adults and children.
Time Frame
Baseline, up to 18 months
Title
Change in functional ability by PROMIS (Part II)
Description
We will use The Patient Reported Outcomes Measurement Information System (PROMIS), to compare patient and caregiver reported outcomes between the groups. PROMIS® (Patient-Reported Outcomes Measurement Information System) is a set of person-centeredmeasures that evaluates and monitors physical, mental, and social health in adults and children.
Time Frame
Baseline, up to 12 months
Title
Change in anxiety by PROMIS (Part I)
Description
We will use The Patient Reported Outcomes Measurement Information System (PROMIS), to compare patient and caregiver reported outcomes between the groups. PROMIS® (Patient-Reported Outcomes Measurement Information System) is a set of person-centeredmeasures that evaluates and monitors physical, mental, and social health in adults and children.
Time Frame
Baseline, up to 18 months
Title
Change in anxiety by PROMIS (Part II)
Description
We will use The Patient Reported Outcomes Measurement Information System (PROMIS), to compare patient and caregiver reported outcomes between the groups. PROMIS® (Patient-Reported Outcomes Measurement Information System) is a set of person-centeredmeasures that evaluates and monitors physical, mental, and social health in adults and children.
Time Frame
Baseline, up to 12 months
Title
Change in depression by PROMIS (Part I)
Description
We will use The Patient Reported Outcomes Measurement Information System (PROMIS), to compare patient and caregiver reported outcomes between the groups. PROMIS® (Patient-Reported Outcomes Measurement Information System) is a set of person-centeredmeasures that evaluates and monitors physical, mental, and social health in adults and children.
Time Frame
Baseline, up to 18 months
Title
Change in depression by PROMIS (Part II)
Description
We will use The Patient Reported Outcomes Measurement Information System (PROMIS), to compare patient and caregiver reported outcomes between the groups. PROMIS® (Patient-Reported Outcomes Measurement Information System) is a set of person-centeredmeasures that evaluates and monitors physical, mental, and social health in adults and children.
Time Frame
Baseline, up to 12 months
Title
Change in global health by PROMIS (Part I)
Description
Global health is defined as overall well being; We will use The Patient Reported Outcomes Measurement Information System (PROMIS), to compare patient and caregiver reported outcomes between the groups. PROMIS® (Patient-Reported Outcomes Measurement Information System) is a set of person-centeredmeasures that evaluates and monitors physical, mental, and social health in adults and children.
Time Frame
Baseline, up to 18 months
Title
Change in global health by PROMIS (Part II)
Description
Global health is defined as overall well being; We will use The Patient Reported Outcomes Measurement Information System (PROMIS), to compare patient and caregiver reported outcomes between the groups. PROMIS® (Patient-Reported Outcomes Measurement Information System) is a set of person-centeredmeasures that evaluates and monitors physical, mental, and social health in adults and children.
Time Frame
Baseline, up to 12 months
Title
Change in family impact by PedsQL (Part I)
Description
The PedsQL (Pediatric Quality of Life InventoryTM) Measurement Model is a modular approach to measuring health-related quality of life (HRQOL) in healthy children and adolescents and those with acute and chronic health conditions.
Time Frame
Baseline, up to 18 months
Title
Change in family impact by PedsQL (Part II)
Description
The PedsQL (Pediatric Quality of Life InventoryTM) Measurement Model is a modular approach to measuring health-related quality of life (HRQOL) in healthy children and adolescents and those with acute and chronic health conditions.
Time Frame
Baseline, up to 12 months
Title
Change in medications side effects by JAMAR (Part 1)
Time Frame
Baseline, up to 18 months
Title
Change in medications side effects by JAMAR (Part II)
Time Frame
Baseline, up to 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
To be eligible for this trial, participants must meet all of the following criteria in order to be include in the study: Age ≥ 2 years old and ≤16.5 years old Clinical diagnosis of JIA by a pediatric rheumatologist within the past 6 months Arthritis affecting ≤4 joints between disease onset and enrollment Enrollment in the CARRA Registry Participants of childbearing potential must agree to remain abstinent or agree to use an effective and medically acceptable form of birth control from the time of written or verbal assent to at least 66 days after taking the last dose of study drug. Weight ≥50 kg (Canadian Sites only) ¹ Enrollment is defined as having signed consent to participate in the Limit-JIA study. The presence of any of the following will exclude a study participant from inclusion in the study: 1. Systemic JIA as defined by 2004 ILAR criteria1 Sacroiliitis (clinical or radiographic) Inflammatory bowel disease (IBD) History of psoriasis or currently active psoriasis History of uveitis or currently active uveitis Prior treatment with systemic medication(s) for JIA (e.g. one or more of the following: DMARD or biologic medication) Current or previous (within 30 days of enrollment) treatment with systemic glucocorticoids (A short course of oral prednisone [≤ 14 days] is allowed) History of active or chronic liver disease Chronic or acute renal disorder AST (SGOT), ALT (SGPT) or BUN >2 x ULN (upper limit of normal) or creatinine >1.5 mg/dL or any other laboratory abnormality considered by the examining physician to be clinically significant within 2 months of the enrollment visit Presence of any medical or psychological condition or laboratory result which would make the participant, in the opinion of the investigator, unsuitable for the study Participation in another concurrent clinical interventional study within 30 days of enrollment Known positive human immunodeficiency virus (HIV) Received a live virus vaccine within 1 month of the baseline visit Current or prior positive Purified Protein Derivative (PPD) test or Quantiferon Gold TB Pregnant, breast feeding, or planned breast feeding during the study duration Planned transfer to non-participating pediatric rheumatology center or adult rheumatologist in the next 12 months Active malignancy of any type or history of malignancy Chronic or active infection or any major episode of infection requiring hospitalization or treatment with intravenous (IV) antibiotics within 30 days or oral antibiotics within 14 days prior to screening Primary language other than English or Spanish Positive for Hepatitis B surface antigen or core antibody <10 Kg in weight If a potential subject has symptoms consistent with COVID-19 and/or known COVID-19 exposure at screening, it is recommended that the site follow CDC guidance regarding testing and quarantine requirements. The subject can be re-screened when there is no longer concern for active infection. A subject with a positive COVID -19 test may be re-screened.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Valarie Morrow
Phone
9197248931
Email
valarie.morrow@duke.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laura Schanberg, MD
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Eveline Wu, MD
Organizational Affiliation
University of North Carolina, Chapel Hill
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Individual Site Status
Withdrawn
Facility Name
University of California at San Francisco Medical Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emily von Scheven, MD
Email
evonsche@peds.ucsf.edu
Facility Name
The Children's Hospital Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Katharine Moore, MD
Email
katharine.moore@childrenscolorado.org
Facility Name
Shands at the University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Melissa Elder, MD
Email
elderme@peds.ufl.edu
Facility Name
Childrens Memorial Hospital/ Ann and Robert Lurie Children's Hospital
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Individual Site Status
Withdrawn
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Individual Site Status
Withdrawn
Facility Name
Riley Hospital for Children at Indiana University Health
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stacey Tarvin, MD
Email
starvin@iupui.edu
Facility Name
University of Iowa Hospitals of Clinics
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sandy Hong, MD
Email
sandy-hong@uiowa.edu
Facility Name
University of Louisville School of Medicine/ Norton Charities Pediatric Clinical Research Unit
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kenneth Schikler, MD
Email
kenneth.schikler@louisville.edu
Facility Name
Boston Children's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mary Beth Son, MD
Email
marybeth.son@childrens.harvard.edu
Facility Name
University of Minnesota; Children's Hospital and Clinics of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55454
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Colleen Correll, MD
Email
corr0250@umn.edu
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Matthew Basiaga, MD
Email
basiaga.matthew@mayo.edu
Facility Name
Hackensack University Medical Center
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sivia Lapidus, MD
Email
sivia.lapidus@hmhn.org
Facility Name
The Pediatric Specialty Center at Saint Barnabas/RWJ Barnabas Health
City
West Orange
State/Province
New Jersey
ZIP/Postal Code
07052
Country
United States
Individual Site Status
Withdrawn
Facility Name
Children's Hospital at Montefiore/ Albert Einstein University Hospital
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dawn Wahezi, MD
Email
dwahezi@montefiore.org
Facility Name
Hospital of Special Surgery
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Individual Site Status
Withdrawn
Facility Name
University of North Carolina
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27514
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eveline Wu, MD
Email
eveline.wu@unc.edu
Facility Name
Levine Children's Hospital/ Carolina Medical Center
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28203
Country
United States
Individual Site Status
Withdrawn
Facility Name
Duke Children's Hospital and Health Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
Individual Site Status
Withdrawn
Facility Name
Cincinnati Children's Hospital Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sheila Angeles-Han, MD
Email
sheila.angeles-han@cchmc.org
Facility Name
MetroHealth System
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44109
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hulya Bukulmez, MD
Email
hbukulmez@metrohealth.org
Facility Name
Nationwide Children's Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43205
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stacy Ardoin
Email
stacy.ardoin@nationwidechildrens.org
Facility Name
Children's Hospital of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jay Mehta, MD
Email
mehtaj@email.chop.edu
Facility Name
Monroe Carell Jr Children's Hospital at Vanderbilt
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brent Graham, MD
Email
brent.graham@vumc.org
Facility Name
University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84158
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christi Inman, MD
Email
cj.inman@hsc.utah.edu
Facility Name
Seattle Children's Hospital
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kabita Nanda, MD
Email
kabita.nanda@seattlechildrens.org

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Preventing Extension of Oligoarticular Juvenile Idiopathic Arthritis JIA (Limit-JIA)

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