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

• ClinicalTrials.gov Identifier: NCT03841357
• Recruitment Status: Recruiting
• First Posted: February 15, 2019
• Last Update Posted: September 1, 2020
• Sponsor: Duke University
• Information provided by (Responsible Party): Duke University

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.

Condition or disease	Intervention/treatment	Phase
Juvenile Idiopathic Arthritis	Drug: Abatacept Injection; Other: Usual Care	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 306 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Randomized, Open Label, Multi-Center, Phase 3 Efficacy Study of Sub-Q Abatacept in Preventing Extension of Oligoarticular Juvenile Idiopathic Arthritis JIA (Limit-JIA)
• Actual Study Start Date: October 29, 2019
• Estimated Primary Completion Date: December 15, 2022
• Estimated Study Completion Date: December 15, 2022

Arms and Interventions

Arm	Intervention/treatment
Experimental: Abatacept and Usual Care; 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	Drug: Abatacept Injection; Supplied as a weekly injection via a pre-filled syringe; Other Name: Orencia; Other: Usual Care; Usual care will be defined by the clinical management team but includes steroid joint injections and non-steroidal anti-inflammatory drugs
Active Comparator: Usual Care; Usual care includes steroid joint injections and treatment with non-steroidal anti-inflammatory drugs at the discretion of the treating provider	Other: Usual Care; Usual care will be defined by the clinical management team but includes steroid joint injections and non-steroidal anti-inflammatory drugs

Outcome Measures

Primary Outcome Measures :

1. Change in Joint Count by Physician Exam [ Time Frame: Baseline, up to 18 months ]
   The number of affected joints involved at protocol specified visits by physician exam.
2. Change in Number of participants with active anterior uveitis [ Time Frame: Baseline, up to 18 months ]
   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 :

1. Change in pain score as measured by PROMIS (patient reported outcome measurement system) [ Time Frame: Baseline, up to 18 months ]
   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.
2. Change in fatigue level as measured by PROMIS [ Time Frame: Baseline, up to 18 months ]
   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.
3. Change in functional ability by PROMIS [ Time Frame: Baseline, up to 18 months ]
   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.
4. Change in anxiety by PROMIS [ Time Frame: Baseline, up to 18 months ]
   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.
5. Change in depression by PROMIS [ Time Frame: Baseline, up to 18 months ]
   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.
6. Change in global health by PROMIS [ Time Frame: Baseline, up to 18 months ]
   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.
7. Change in family impact by PedsQL [ Time Frame: Baseline, up to 18 months ]
   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.
8. Change in medications side effects by JAMAR [ Time Frame: Baseline, up to 18 months ]

Eligibility Criteria

• Ages Eligible for Study: 2 Years to 16 Years (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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 randomization
4. Clinically active arthritis of at least 1 joint at the time of enrollment ¹
5. Enrollment in the CARRA Registry

6. 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.

   • 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
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
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 randomization 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 randomization
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

Contacts and Locations

Contacts

Contact: Valarie Morrow; 9197248931; valarie.morrow@duke.edu

Locations

United States, California

University of California at San Francisco Medical Center; Recruiting

San Francisco, California, United States, 94143

Contact: Emily von Scheven, MD

United States, Illinois

Children's Memorial Hospital/ Ann & Robert H Lurie Children's Hospital; Recruiting

Chicago, Illinois, United States, 60611

Contact: Marisa Klein-Gitelman, MD

United States, Indiana

Riley Hospital for Children at Indiana University Health; Recruiting

Indianapolis, Indiana, United States, 46202

Contact: Stacey Tarvin, MD

United States, Minnesota

University of Minnesota; Children's Hospital and Clinics of Minnesota; Recruiting

Minneapolis, Minnesota, United States, 55454

Contact: Richard Vehe, MD

United States, New Jersey

Hackensack University Medical Center; Recruiting

Hackensack, New Jersey, United States, 07601

Contact: Sivia Lapidus, MD

The Pediatric Specialty Center at Saint Barnabas/RWJ Barnabas Health; Recruiting

West Orange, New Jersey, United States, 07052

Contact: Elizabeth Chalom, MD

United States, New York

Children's Hospital at Montefiore/ Albert Einstein University Hospital; Recruiting

Bronx, New York, United States, 10461

Contact: Dawn Wahezi, MD

United States, North Carolina

University of North Carolina; Recruiting

Chapel Hill, North Carolina, United States, 27514

Contact: Eveline Wu, MD

Levine Children's Hospital/ Carolina Medical Center; Recruiting

Charlotte, North Carolina, United States, 28203

Contact: Thomas Griffin, MD

Duke Children's Hospital and Health Center; Recruiting

Durham, North Carolina, United States, 27705

Contact: Laura Schanberg, MD 919-684-6601

Wake Forest Baptist Hospital; Recruiting

Winston-Salem, North Carolina, United States, 27157

Contact: Alysha Taxter, MD

United States, Ohio

Cincinnati Children's Hospital Medical Center; Recruiting

Cincinnati, Ohio, United States, 45229

Contact: Sheila Angeles-Han, MD

United States, Washington

Seattle Children's Hospital; Recruiting

Seattle, Washington, United States, 98105

Contact: Sarah Ringold, MD

Sponsors and Collaborators

Duke University

Investigators

• Principal Investigator: Laura Schanberg, MD; Duke University
• Principal Investigator: Stephen Balevic, MD; Duke University

More Information

• Responsible Party: Duke University
• ClinicalTrials.gov Identifier: NCT03841357
• Other Study ID Numbers: Pro00100523
• First Posted: February 15, 2019
• Last Update Posted: September 1, 2020
• Last Verified: May 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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

Keywords provided by Duke University:

Polyarthritis; abatacept; uveitis; prevention

Additional relevant MeSH terms:

Arthritis; Arthritis, Juvenile; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Abatacept; Immunosuppressive Agents; Immunologic Factors; Physiological Effects of Drugs; Antirheumatic Agents