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

Juvenile Idiopathic Arthritis Clinical Trial

— 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)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03841357
• Other study ID #: Pro00100523
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: October 29, 2019
• Est. completion date: January 15, 2025

Study information

• Verified date: December 2023
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 121
• Est. completion date: January 15, 2025
• Est. primary completion date: January 15, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 16 Years

Eligibility

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.

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Juvenile
• Juvenile Idiopathic Arthritis

Intervention

Drug:
• Abatacept Injection
Supplied as a weekly injection via a pre-filled syringe

Other:
• Usual Care
Usual care will be defined by the clinical management team but includes steroid joint injections and non- steroidal anti-inflammatory drugs

Locations

Country	Name	City	State
United States	The Children's Hospital Colorado	Aurora	Colorado
United States	Boston Children's Hospital	Boston	Massachusetts
United States	Children's Hospital at Montefiore/ Albert Einstein University Hospital	Bronx	New York
United States	University of North Carolina	Chapel Hill	North Carolina
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio
United States	MetroHealth System	Cleveland	Ohio
United States	Nationwide Children's Hospital	Columbus	Ohio
United States	Shands at the University of Florida	Gainesville	Florida
United States	Hackensack University Medical Center	Hackensack	New Jersey
United States	Riley Hospital for Children at Indiana University Health	Indianapolis	Indiana
United States	University of Iowa Hospitals of Clinics	Iowa City	Iowa
United States	University of Louisville School of Medicine/ Norton Charities Pediatric Clinical Research Unit	Louisville	Kentucky
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	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania
United States	Mayo Clinic	Rochester	Minnesota
United States	University of Utah	Salt Lake City	Utah
United States	University of California at San Francisco Medical Center	San Francisco	California
United States	Seattle Children's Hospital	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Joint Count by Physician Exam (Part I)	The number of affected joints involved at protocol specified visits by physician exam.	Baseline, up to 18 months
Primary	Change in Joint Count by Physician Exam (Part II)	The number of affected joints involved at protocol specified visits by physician exam.	Baseline, up to 12 months
Primary	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	Baseline, up to 18 months
Primary	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	Baseline, up to 12 months
Secondary	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.	Baseline, up to 18 months
Secondary	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.	Baseline, up to 12 months
Secondary	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.	Baseline, up to 18 months
Secondary	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.	Baseline, up to 12 months
Secondary	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.	Baseline, up to 18 months
Secondary	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.	Baseline, up to 12 months
Secondary	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.	Baseline, up to 18 months
Secondary	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.	Baseline, up to 12 months
Secondary	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.	Baseline, up to 18 months
Secondary	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.	Baseline, up to 12 months
Secondary	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.	Baseline, up to 18 months
Secondary	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.	Baseline, up to 12 months
Secondary	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.	Baseline, up to 18 months
Secondary	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.	Baseline, up to 12 months
Secondary	Change in medications side effects by JAMAR (Part 1)		Baseline, up to 18 months
Secondary	Change in medications side effects by JAMAR (Part II)		Baseline, up to 12 months