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.
Brief Title
Preventing Extension of Oligoarticular Juvenile Idiopathic Arthritis JIA (Limit-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.
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.
Completion Date
Completion Date Type
Actual
Conditions
Juvenile Idiopathic Arthritis
Eligibility 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 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.
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.
Inclusion 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 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.
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.
Gender
All
Gender Based
false
Keywords
Polyarthritis
abatacept
uveitis
prevention
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Maximum Age
16 Years
Minimum Age
2 Years
NCT Id
NCT03841357
Org Class
Other
Org Full Name
Duke University
Org Study Id
Pro00100523
Overall Status
Completed
Phases
Phase 3
Primary Completion Date
Primary Completion Date Type
Actual
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)
Primary Outcomes
Outcome Description
The number of affected joints involved at protocol specified visits by physician exam.
Outcome Measure
Change in Joint Count by Physician Exam (Part I)
Outcome Time Frame
Baseline, up to 18 months
Outcome Description
The number of affected joints involved at protocol specified visits by physician exam.
Outcome Measure
Change in Joint Count by Physician Exam (Part II)
Outcome Time Frame
Baseline, up to 12 months
Outcome 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
Outcome Measure
Change in Number of participants with active anterior uveitis (Part I)
Outcome Time Frame
Baseline, up to 18 months
Outcome 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
Outcome Measure
Change in Number of participants with active anterior uveitis (Part II)
Outcome Time Frame
Baseline, up to 12 months
Secondary Outcomes
Outcome 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.
Outcome Time Frame
Baseline, up to 18 months
Outcome Measure
Change in pain score as measured by PROMIS (patient reported outcome measurement system) (Part I)
Outcome 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.
Outcome Time Frame
Baseline, up to 12 months
Outcome Measure
Change in pain score as measured by PROMIS (patient reported outcome measurement system) (Part II)
Outcome 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.
Outcome Time Frame
Baseline, up to 18 months
Outcome Measure
Change in fatigue level as measured by PROMIS (Part I)
Outcome 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.
Outcome Time Frame
Baseline, up to 12 months
Outcome Measure
Change in fatigue level as measured by PROMIS (Part II)
Outcome 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.
Outcome Time Frame
Baseline, up to 18 months
Outcome Measure
Change in functional ability by PROMIS (Part I)
Outcome 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.
Outcome Time Frame
Baseline, up to 12 months
Outcome Measure
Change in functional ability by PROMIS (Part II)
Outcome 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.
Outcome Time Frame
Baseline, up to 18 months
Outcome Measure
Change in anxiety by PROMIS (Part I)
Outcome 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.
Outcome Time Frame
Baseline, up to 12 months
Outcome Measure
Change in anxiety by PROMIS (Part II)
Outcome 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.
Outcome Time Frame
Baseline, up to 18 months
Outcome Measure
Change in depression by PROMIS (Part I)
Outcome 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.
Outcome Time Frame
Baseline, up to 12 months
Outcome Measure
Change in depression by PROMIS (Part II)
Outcome 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.
Outcome Time Frame
Baseline, up to 18 months
Outcome Measure
Change in global health by PROMIS (Part I)
Outcome 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.
Outcome Time Frame
Baseline, up to 12 months
Outcome Measure
Change in global health by PROMIS (Part II)
Outcome 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.
Outcome Time Frame
Baseline, up to 18 months
Outcome Measure
Change in family impact by PedsQL (Part I)
Outcome 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.
Outcome Time Frame
Baseline, up to 12 months
Outcome Measure
Change in family impact by PedsQL (Part II)
Outcome Time Frame
Baseline, up to 18 months
Outcome Measure
Change in medications side effects by JAMAR (Part 1)
Outcome Time Frame
Baseline, up to 12 months
Outcome Measure
Change in medications side effects by JAMAR (Part II)
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Child
Locked Fields
Render the field
Maximum Age Number (converted to Years and rounded down)
16
Minimum Age Number (converted to Years and rounded down)
2
Investigators
Investigator Type
Principal Investigator
Investigator Name
Dawn Wahezi
Investigator Email
dwahezi@montefiore.org
Investigator Phone
718-696-2405