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

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ClinicalTrials.gov Identifier: NCT03841357
Recruitment Status : Recruiting
First Posted : February 15, 2019
Last Update Posted : May 24, 2021
Sponsor:
Information provided by (Responsible Party):
Duke University

Study Description
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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
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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, 2023
Estimated Study Completion Date : December 15, 2023

Resource links provided by the National Library of Medicine

Drug Information available for: Abatacept

Arms and Interventions
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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
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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
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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. 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 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
  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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03841357


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

Locations
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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
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Principal Investigator: Laura Schanberg, MD Duke University
Principal Investigator: Stephen Balevic, MD Duke University
More Information
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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT03841357    
Other Study ID Numbers: Pro00100523
First Posted: February 15, 2019    Key Record Dates
Last Update Posted: May 24, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Arthritis
Arthritis, Juvenile
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
 Abatacept
Immune Checkpoint Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents