Preventing Extension of Oligoarticular Juvenile Idiopathic Arthritis JIA (Limit-JIA)
- Conditions
- Juvenile Idiopathic Arthritis
- Interventions
- Drug: Abatacept InjectionOther: Usual Care
- Registration Number
- NCT03841357
- Lead Sponsor
- Duke University
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 121
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Abatacept and Usual Care (Part II) Abatacept Injection 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 Abatacept and Usual Care (Part I) Abatacept Injection 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 Abatacept and Usual Care (Part I) 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 Active Comparator: Usual Care (Part I) Usual Care Usual care includes steroid joint injections and treatment with non-steroidal anti-inflammatory drugs at the discretion of the treating provider Abatacept and Usual Care (Part II) 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
- Primary Outcome Measures
Name Time Method Change in Number of participants with active anterior uveitis (Part I) 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
Change in Number of participants with active anterior uveitis (Part II) Baseline, up to 12 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
Change in Joint Count by Physician Exam (Part I) Baseline, up to 18 months The number of affected joints involved at protocol specified visits by physician exam.
Change in Joint Count by Physician Exam (Part II) Baseline, up to 12 months The number of affected joints involved at protocol specified visits by physician exam.
- Secondary Outcome Measures
Name Time Method Change in fatigue level as measured by PROMIS (Part I) 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.
Change in anxiety by PROMIS (Part II) Baseline, up to 12 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.
Change in global health by PROMIS (Part I) 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.
Change in family impact by PedsQL (Part II) Baseline, up to 12 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.
Change in family impact by PedsQL (Part I) 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.
Change in pain score as measured by PROMIS (patient reported outcome measurement system) (Part II) Baseline, up to 12 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.
Change in fatigue level as measured by PROMIS (Part II) Baseline, up to 12 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.
Change in functional ability by PROMIS (Part I) 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.
Change in depression by PROMIS (Part I) 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.
Change in pain score as measured by PROMIS (patient reported outcome measurement system) (Part I) 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.
Change in functional ability by PROMIS (Part II) Baseline, up to 12 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.
Change in medications side effects by JAMAR (Part II) Baseline, up to 12 months Change in medications side effects by JAMAR (Part 1) Baseline, up to 18 months Change in anxiety by PROMIS (Part I) 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.
Change in depression by PROMIS (Part II) Baseline, up to 12 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.
Change in global health by PROMIS (Part II) Baseline, up to 12 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.
Trial Locations
- Locations (19)
Children's Hospital of Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
Riley Hospital for Children at Indiana University Health
🇺🇸Indianapolis, Indiana, United States
Seattle Children's Hospital
🇺🇸Seattle, Washington, United States
Shands at the University of Florida
🇺🇸Gainesville, Florida, United States
University of Iowa Hospitals of Clinics
🇺🇸Iowa City, Iowa, United States
Boston Children's Hospital
🇺🇸Boston, Massachusetts, United States
Children's Hospital at Montefiore/ Albert Einstein University Hospital
🇺🇸Bronx, New York, United States
MetroHealth System
🇺🇸Cleveland, Ohio, United States
University of California at San Francisco Medical Center
🇺🇸San Francisco, California, United States
Cincinnati Children's Hospital Medical Center
🇺🇸Cincinnati, Ohio, United States
University of Minnesota; Children's Hospital and Clinics of Minnesota
🇺🇸Minneapolis, Minnesota, United States
Monroe Carell Jr Children's Hospital at Vanderbilt
🇺🇸Nashville, Tennessee, United States
University of Utah
🇺🇸Salt Lake City, Utah, United States
Nationwide Children's Hospital
🇺🇸Columbus, Ohio, United States
Hackensack University Medical Center
🇺🇸Hackensack, New Jersey, United States
The Children's Hospital Colorado
🇺🇸Aurora, Colorado, United States
University of Louisville School of Medicine/ Norton Charities Pediatric Clinical Research Unit
🇺🇸Louisville, Kentucky, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
University of North Carolina
🇺🇸Chapel Hill, North Carolina, United States