Trial Outcomes & Findings for Preventing Extension of Oligoarticular Juvenile Idiopathic Arthritis JIA (Limit-JIA) (NCT NCT03841357)
NCT ID: NCT03841357
Last Updated: 2026-01-23
Results Overview
Any of the following from randomization to day 410: polyarthritis \[\>=5 cumulative active joint count\], uveitis, initiation of systemic glucocorticoids (IV or PO), DMARDs or biologics.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
121 participants
Primary outcome timeframe
From randomization to day 410
Results posted on
2026-01-23
Participant Flow
Usual Care (Part II) participants were historical controls used for analysis and not considered enrolled.
Participant milestones
| Measure |
Active Comparator: Usual Care (Part II)
Usual care includes steroid joint injections and treatment with non-steroidal anti-inflammatory drugs at the discretion of the treating provider.
Usual Care: Usual care will be defined by the clinical management team but includes steroid joint injections and non- steroidal anti-inflammatory drugs
|
Abatacept and Usual Care (Part I)
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 Injection: Supplied as a weekly injection via a pre-filled syringe
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 (Part I)
Usual care includes steroid joint injections and treatment with non-steroidal anti-inflammatory drugs at the discretion of the treating provider.
Usual Care: Usual care will be defined by the clinical management team but includes steroid joint injections and non- steroidal anti-inflammatory drugs
|
Abatacept and Usual Care (Part II)
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 Injection: Supplied as a weekly injection via a pre-filled syringe
Usual Care: Usual care will be defined by the clinical management team but includes steroid joint injections and non- steroidal anti-inflammatory drugs
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
662
|
20
|
20
|
81
|
|
Overall Study
COMPLETED
|
662
|
20
|
20
|
80
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Preventing Extension of Oligoarticular Juvenile Idiopathic Arthritis JIA (Limit-JIA)
Baseline characteristics by cohort
| Measure |
Abatacept and Usual Care (Part I)
n=20 Participants
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 Injection: Supplied as a weekly injection via a pre-filled syringe
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 (Part I)
n=20 Participants
Usual care includes steroid joint injections and treatment with non-steroidal anti-inflammatory drugs at the discretion of the treating provider.
Usual Care: Usual care will be defined by the clinical management team but includes steroid joint injections and non- steroidal anti-inflammatory drugs
|
Abatacept and Usual Care (Part II)
n=81 Participants
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 Injection: Supplied as a weekly injection via a pre-filled syringe
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 (Part II)
n=662 Participants
Usual care includes steroid joint injections and treatment with non-steroidal anti-inflammatory drugs at the discretion of the treating provider.
Usual Care: Usual care will be defined by the clinical management team but includes steroid joint injections and non- steroidal anti-inflammatory drugs
|
Total
n=783 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
7.90 years
STANDARD_DEVIATION 4.60 • n=270 Participants
|
6.10 years
STANDARD_DEVIATION 4.40 • n=4 Participants
|
7.60 years
STANDARD_DEVIATION 4.20 • n=9 Participants
|
7.60 years
STANDARD_DEVIATION 4.35 • n=220 Participants
|
7.57 years
STANDARD_DEVIATION 4.34 • n=3 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=270 Participants
|
12 Participants
n=4 Participants
|
55 Participants
n=9 Participants
|
438 Participants
n=220 Participants
|
516 Participants
n=3 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=270 Participants
|
8 Participants
n=4 Participants
|
26 Participants
n=9 Participants
|
224 Participants
n=220 Participants
|
267 Participants
n=3 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=270 Participants
|
2 Participants
n=4 Participants
|
16 Participants
n=9 Participants
|
66 Participants
n=220 Participants
|
87 Participants
n=3 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
17 Participants
n=270 Participants
|
18 Participants
n=4 Participants
|
65 Participants
n=9 Participants
|
594 Participants
n=220 Participants
|
694 Participants
n=3 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=270 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=9 Participants
|
2 Participants
n=220 Participants
|
2 Participants
n=3 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=270 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=9 Participants
|
2 Participants
n=220 Participants
|
2 Participants
n=3 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=270 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=9 Participants
|
17 Participants
n=220 Participants
|
18 Participants
n=3 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=270 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=9 Participants
|
2 Participants
n=220 Participants
|
2 Participants
n=3 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=270 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=9 Participants
|
28 Participants
n=220 Participants
|
32 Participants
n=3 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=270 Participants
|
13 Participants
n=4 Participants
|
56 Participants
n=9 Participants
|
486 Participants
n=220 Participants
|
569 Participants
n=3 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=270 Participants
|
2 Participants
n=4 Participants
|
10 Participants
n=9 Participants
|
55 Participants
n=220 Participants
|
70 Participants
n=3 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=270 Participants
|
3 Participants
n=4 Participants
|
13 Participants
n=9 Participants
|
72 Participants
n=220 Participants
|
90 Participants
n=3 Participants
|
|
Region of Enrollment
United States
|
20 Participants
n=270 Participants
|
20 Participants
n=4 Participants
|
81 Participants
n=9 Participants
|
662 Participants
n=220 Participants
|
783 Participants
n=3 Participants
|
PRIMARY outcome
Timeframe: From randomization to day 410Population: Modified intent-to-treat (mITT) population.
Any of the following from randomization to day 410: polyarthritis \[\>=5 cumulative active joint count\], uveitis, initiation of systemic glucocorticoids (IV or PO), DMARDs or biologics.
Outcome measures
| Measure |
Abatacept and Usual Care (Part I)
n=20 Participants
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 Injection: Supplied as a weekly injection via a pre-filled syringe
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 (Part I)
n=20 Participants
Usual care includes steroid joint injections and treatment with non-steroidal anti-inflammatory drugs at the discretion of the treating provider.
Usual Care: Usual care will be defined by the clinical management team but includes steroid joint injections and non-steroidal anti-inflammatory drugs
|
Abatacept and Usual Care (Part II)
n=76 Participants
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 Injection: Supplied as a weekly injection via a pre-filled syringe
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 (Part II)
n=596 Participants
Usual care includes steroid joint injections and treatment with non-steroidal anti-inflammatory drugs at the discretion of the treating provider.
Usual Care: Usual care will be defined by the clinical management team but includes steroid joint injections and non-steroidal anti-inflammatory drugs
|
Abatacept and Usual Care (Pooled Part I and Part II)
n=96 Participants
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 Injection: Supplied as a weekly injection via a pre-filled syringe
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 (Pooled Part I and Part II)
n=616 Participants
Usual care includes steroid joint injections and treatment with non-steroidal anti-inflammatory drugs at the discretion of the treating provider.
Usual Care: Usual care will be defined by the clinical management team but includes steroid joint injections and non-steroidal anti-inflammatory drugs
|
|---|---|---|---|---|---|---|
|
Composite of All Primary Endpoints
|
13 Participants
|
14 Participants
|
41 Participants
|
245 Participants
|
54 Participants
|
259 Participants
|
PRIMARY outcome
Timeframe: From randomization to day 592Population: Modified intent-to-treat (mITT) population.
Polyarthritis is defined as \>=5 cumulative active joint count.
Outcome measures
| Measure |
Abatacept and Usual Care (Part I)
n=20 Participants
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 Injection: Supplied as a weekly injection via a pre-filled syringe
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 (Part I)
n=20 Participants
Usual care includes steroid joint injections and treatment with non-steroidal anti-inflammatory drugs at the discretion of the treating provider.
Usual Care: Usual care will be defined by the clinical management team but includes steroid joint injections and non-steroidal anti-inflammatory drugs
|
Abatacept and Usual Care (Part II)
n=76 Participants
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 Injection: Supplied as a weekly injection via a pre-filled syringe
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 (Part II)
n=596 Participants
Usual care includes steroid joint injections and treatment with non-steroidal anti-inflammatory drugs at the discretion of the treating provider.
Usual Care: Usual care will be defined by the clinical management team but includes steroid joint injections and non-steroidal anti-inflammatory drugs
|
Abatacept and Usual Care (Pooled Part I and Part II)
n=96 Participants
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 Injection: Supplied as a weekly injection via a pre-filled syringe
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 (Pooled Part I and Part II)
n=616 Participants
Usual care includes steroid joint injections and treatment with non-steroidal anti-inflammatory drugs at the discretion of the treating provider.
Usual Care: Usual care will be defined by the clinical management team but includes steroid joint injections and non-steroidal anti-inflammatory drugs
|
|---|---|---|---|---|---|---|
|
Number of Participants With Polyarthritis
|
8 Participants
|
6 Participants
|
14 Participants
|
49 Participants
|
22 Participants
|
55 Participants
|
PRIMARY outcome
Timeframe: From randomization to day 410Population: Modified intent-to-treat (mITT) population.
Outcome measures
| Measure |
Abatacept and Usual Care (Part I)
n=20 Participants
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 Injection: Supplied as a weekly injection via a pre-filled syringe
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 (Part I)
n=20 Participants
Usual care includes steroid joint injections and treatment with non-steroidal anti-inflammatory drugs at the discretion of the treating provider.
Usual Care: Usual care will be defined by the clinical management team but includes steroid joint injections and non-steroidal anti-inflammatory drugs
|
Abatacept and Usual Care (Part II)
n=76 Participants
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 Injection: Supplied as a weekly injection via a pre-filled syringe
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 (Part II)
n=596 Participants
Usual care includes steroid joint injections and treatment with non-steroidal anti-inflammatory drugs at the discretion of the treating provider.
Usual Care: Usual care will be defined by the clinical management team but includes steroid joint injections and non-steroidal anti-inflammatory drugs
|
Abatacept and Usual Care (Pooled Part I and Part II)
n=96 Participants
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 Injection: Supplied as a weekly injection via a pre-filled syringe
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 (Pooled Part I and Part II)
n=616 Participants
Usual care includes steroid joint injections and treatment with non-steroidal anti-inflammatory drugs at the discretion of the treating provider.
Usual Care: Usual care will be defined by the clinical management team but includes steroid joint injections and non-steroidal anti-inflammatory drugs
|
|---|---|---|---|---|---|---|
|
Number of Participants With Uveitis
|
1 Participants
|
0 Participants
|
4 Participants
|
31 Participants
|
5 Participants
|
31 Participants
|
PRIMARY outcome
Timeframe: From randomization day 410Population: Modified intent-to-treat (mITT) population.
Systemic glucocorticoids, Disease-Modifying Antirheumatic Drugs (DMARDs) or biologics.
Outcome measures
| Measure |
Abatacept and Usual Care (Part I)
n=20 Participants
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 Injection: Supplied as a weekly injection via a pre-filled syringe
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 (Part I)
n=20 Participants
Usual care includes steroid joint injections and treatment with non-steroidal anti-inflammatory drugs at the discretion of the treating provider.
Usual Care: Usual care will be defined by the clinical management team but includes steroid joint injections and non-steroidal anti-inflammatory drugs
|
Abatacept and Usual Care (Part II)
n=76 Participants
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 Injection: Supplied as a weekly injection via a pre-filled syringe
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 (Part II)
n=596 Participants
Usual care includes steroid joint injections and treatment with non-steroidal anti-inflammatory drugs at the discretion of the treating provider.
Usual Care: Usual care will be defined by the clinical management team but includes steroid joint injections and non-steroidal anti-inflammatory drugs
|
Abatacept and Usual Care (Pooled Part I and Part II)
n=96 Participants
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 Injection: Supplied as a weekly injection via a pre-filled syringe
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 (Pooled Part I and Part II)
n=616 Participants
Usual care includes steroid joint injections and treatment with non-steroidal anti-inflammatory drugs at the discretion of the treating provider.
Usual Care: Usual care will be defined by the clinical management team but includes steroid joint injections and non-steroidal anti-inflammatory drugs
|
|---|---|---|---|---|---|---|
|
Number of Participants With Systemic Medications
|
11 Participants
|
14 Participants
|
41 Participants
|
229 Participants
|
52 Participants
|
243 Participants
|
SECONDARY outcome
Timeframe: From baseline up to 12 monthsPopulation: Intent-to-treat (ITT) population.
Clinical Inactive disease at any visit is a composite outcome consisting of all of: No active joints (Current Active Joint Count=0), No uveitis (Uveitis=No or not reported), Normal ESR (if obtained) (N/D or ESR≤ ULN or unrelated to JIA if \>ULN), Normal CRP (if obtained) (N/D or CRP≤ ULN or unrelated to JIA if \>ULN), AM stiffness duration=None or ≤ 15 minutes, Physician Global score=0.
Outcome measures
| Measure |
Abatacept and Usual Care (Part I)
n=20 Participants
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 Injection: Supplied as a weekly injection via a pre-filled syringe
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 (Part I)
n=20 Participants
Usual care includes steroid joint injections and treatment with non-steroidal anti-inflammatory drugs at the discretion of the treating provider.
Usual Care: Usual care will be defined by the clinical management team but includes steroid joint injections and non-steroidal anti-inflammatory drugs
|
Abatacept and Usual Care (Part II)
n=80 Participants
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 Injection: Supplied as a weekly injection via a pre-filled syringe
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 (Part II)
n=662 Participants
Usual care includes steroid joint injections and treatment with non-steroidal anti-inflammatory drugs at the discretion of the treating provider.
Usual Care: Usual care will be defined by the clinical management team but includes steroid joint injections and non-steroidal anti-inflammatory drugs
|
Abatacept and Usual Care (Pooled Part I and Part II)
n=100 Participants
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 Injection: Supplied as a weekly injection via a pre-filled syringe
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 (Pooled Part I and Part II)
n=682 Participants
Usual care includes steroid joint injections and treatment with non-steroidal anti-inflammatory drugs at the discretion of the treating provider.
Usual Care: Usual care will be defined by the clinical management team but includes steroid joint injections and non-steroidal anti-inflammatory drugs
|
|---|---|---|---|---|---|---|
|
Number of Participants With Clinically Inactive Disease or Remission
|
8 Participants
|
3 Participants
|
36 Participants
|
246 Participants
|
48 Participants
|
264 Participants
|
SECONDARY outcome
Timeframe: From baseline up to 12 monthsPopulation: Intent-to-treat (ITT) population.
Disease extension defined as development of polyarthritis or uveitis.
Outcome measures
| Measure |
Abatacept and Usual Care (Part I)
n=20 Participants
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 Injection: Supplied as a weekly injection via a pre-filled syringe
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 (Part I)
n=20 Participants
Usual care includes steroid joint injections and treatment with non-steroidal anti-inflammatory drugs at the discretion of the treating provider.
Usual Care: Usual care will be defined by the clinical management team but includes steroid joint injections and non-steroidal anti-inflammatory drugs
|
Abatacept and Usual Care (Part II)
n=80 Participants
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 Injection: Supplied as a weekly injection via a pre-filled syringe
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 (Part II)
n=662 Participants
Usual care includes steroid joint injections and treatment with non-steroidal anti-inflammatory drugs at the discretion of the treating provider.
Usual Care: Usual care will be defined by the clinical management team but includes steroid joint injections and non-steroidal anti-inflammatory drugs
|
Abatacept and Usual Care (Pooled Part I and Part II)
n=100 Participants
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 Injection: Supplied as a weekly injection via a pre-filled syringe
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 (Pooled Part I and Part II)
n=682 Participants
Usual care includes steroid joint injections and treatment with non-steroidal anti-inflammatory drugs at the discretion of the treating provider.
Usual Care: Usual care will be defined by the clinical management team but includes steroid joint injections and non-steroidal anti-inflammatory drugs
|
|---|---|---|---|---|---|---|
|
Number of Participants With Disease Extension
|
7 Participants
|
6 Participants
|
11 Participants
|
67 Participants
|
18 Participants
|
73 Participants
|
SECONDARY outcome
Timeframe: From baseline up to 12 monthsPopulation: Intent-to-treat (ITT) population.
Total number of joints that were not active prior to or at baseline, and became active after randomization.
Outcome measures
| Measure |
Abatacept and Usual Care (Part I)
n=20 Participants
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 Injection: Supplied as a weekly injection via a pre-filled syringe
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 (Part I)
n=20 Participants
Usual care includes steroid joint injections and treatment with non-steroidal anti-inflammatory drugs at the discretion of the treating provider.
Usual Care: Usual care will be defined by the clinical management team but includes steroid joint injections and non-steroidal anti-inflammatory drugs
|
Abatacept and Usual Care (Part II)
n=80 Participants
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 Injection: Supplied as a weekly injection via a pre-filled syringe
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 (Part II)
n=662 Participants
Usual care includes steroid joint injections and treatment with non-steroidal anti-inflammatory drugs at the discretion of the treating provider.
Usual Care: Usual care will be defined by the clinical management team but includes steroid joint injections and non-steroidal anti-inflammatory drugs
|
Abatacept and Usual Care (Pooled Part I and Part II)
n=100 Participants
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 Injection: Supplied as a weekly injection via a pre-filled syringe
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 (Pooled Part I and Part II)
n=682 Participants
Usual care includes steroid joint injections and treatment with non-steroidal anti-inflammatory drugs at the discretion of the treating provider.
Usual Care: Usual care will be defined by the clinical management team but includes steroid joint injections and non-steroidal anti-inflammatory drugs
|
|---|---|---|---|---|---|---|
|
Number of New Active Joints Per Participant
|
1.40 joints
Standard Error 1.67
|
1.50 joints
Standard Error 1.57
|
0.70 joints
Standard Error 1.69
|
0.40 joints
Standard Error 1.43
|
0.80 joints
Standard Error 1.70
|
0.50 joints
Standard Error 1.44
|
SECONDARY outcome
Timeframe: From baseline up to 12 monthsPopulation: Intent-to-treat (ITT) population.
Intra-articular glucocorticoid joint injections are reported in the CARRA Registry CRF at each Limit-JIA or CARRA Registry visit.
Outcome measures
| Measure |
Abatacept and Usual Care (Part I)
n=20 Participants
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 Injection: Supplied as a weekly injection via a pre-filled syringe
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 (Part I)
n=20 Participants
Usual care includes steroid joint injections and treatment with non-steroidal anti-inflammatory drugs at the discretion of the treating provider.
Usual Care: Usual care will be defined by the clinical management team but includes steroid joint injections and non-steroidal anti-inflammatory drugs
|
Abatacept and Usual Care (Part II)
n=80 Participants
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 Injection: Supplied as a weekly injection via a pre-filled syringe
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 (Part II)
n=662 Participants
Usual care includes steroid joint injections and treatment with non-steroidal anti-inflammatory drugs at the discretion of the treating provider.
Usual Care: Usual care will be defined by the clinical management team but includes steroid joint injections and non-steroidal anti-inflammatory drugs
|
Abatacept and Usual Care (Pooled Part I and Part II)
n=100 Participants
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 Injection: Supplied as a weekly injection via a pre-filled syringe
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 (Pooled Part I and Part II)
n=682 Participants
Usual care includes steroid joint injections and treatment with non-steroidal anti-inflammatory drugs at the discretion of the treating provider.
Usual Care: Usual care will be defined by the clinical management team but includes steroid joint injections and non-steroidal anti-inflammatory drugs
|
|---|---|---|---|---|---|---|
|
Number of Intra-articular Glucocorticoid Joint Injections Per Participant
|
0.90 injections
Standard Error 1.17
|
1.80 injections
Standard Error 2.61
|
0.40 injections
Standard Error 1.31
|
0.40 injections
Standard Error 0.85
|
0.50 injections
Standard Error 1.29
|
0.40 injections
Standard Error 0.97
|
SECONDARY outcome
Timeframe: 6 months and 12 monthsPopulation: Pooled intent-to-treat (ITT) population with data collected at each timepoint.
PROMIS is a set of person-centered measures that evaluates and monitors physical, mental, and social health in adults and children. PROMIS scores are T-scores and have a mean of 50 and standard deviation of 10.
Outcome measures
| Measure |
Abatacept and Usual Care (Part I)
n=44 Participants
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 Injection: Supplied as a weekly injection via a pre-filled syringe
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 (Part I)
n=234 Participants
Usual care includes steroid joint injections and treatment with non-steroidal anti-inflammatory drugs at the discretion of the treating provider.
Usual Care: Usual care will be defined by the clinical management team but includes steroid joint injections and non-steroidal anti-inflammatory drugs
|
Abatacept and Usual Care (Part II)
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 Injection: Supplied as a weekly injection via a pre-filled syringe
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 (Part II)
Usual care includes steroid joint injections and treatment with non-steroidal anti-inflammatory drugs at the discretion of the treating provider.
Usual Care: Usual care will be defined by the clinical management team but includes steroid joint injections and non-steroidal anti-inflammatory drugs
|
Abatacept and Usual Care (Pooled Part I and Part II)
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 Injection: Supplied as a weekly injection via a pre-filled syringe
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 (Pooled Part I and Part II)
Usual care includes steroid joint injections and treatment with non-steroidal anti-inflammatory drugs at the discretion of the treating provider.
Usual Care: Usual care will be defined by the clinical management team but includes steroid joint injections and non-steroidal anti-inflammatory drugs
|
|---|---|---|---|---|---|---|
|
PROMIS (Patient-Reported Outcomes Measurement Information System) Pediatric Pain Interference
6 months
|
49.00 score on a scale
Standard Error 9.81
|
50.90 score on a scale
Standard Error 8.72
|
—
|
—
|
—
|
—
|
|
PROMIS (Patient-Reported Outcomes Measurement Information System) Pediatric Pain Interference
12 months
|
46.90 score on a scale
Standard Error 9.87
|
49.60 score on a scale
Standard Error 9.91
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 6 months and 12 monthsPopulation: Pooled intent-to-treat (ITT) population with data collected at each timepoint.
PROMIS is a set of person-centered measures that evaluates and monitors physical, mental, and social health in adults and children. PROMIS scores are T-scores and have a mean of 50 and standard deviation of 10.
Outcome measures
| Measure |
Abatacept and Usual Care (Part I)
n=65 Participants
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 Injection: Supplied as a weekly injection via a pre-filled syringe
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 (Part I)
n=10 Participants
Usual care includes steroid joint injections and treatment with non-steroidal anti-inflammatory drugs at the discretion of the treating provider.
Usual Care: Usual care will be defined by the clinical management team but includes steroid joint injections and non-steroidal anti-inflammatory drugs
|
Abatacept and Usual Care (Part II)
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 Injection: Supplied as a weekly injection via a pre-filled syringe
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 (Part II)
Usual care includes steroid joint injections and treatment with non-steroidal anti-inflammatory drugs at the discretion of the treating provider.
Usual Care: Usual care will be defined by the clinical management team but includes steroid joint injections and non-steroidal anti-inflammatory drugs
|
Abatacept and Usual Care (Pooled Part I and Part II)
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 Injection: Supplied as a weekly injection via a pre-filled syringe
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 (Pooled Part I and Part II)
Usual care includes steroid joint injections and treatment with non-steroidal anti-inflammatory drugs at the discretion of the treating provider.
Usual Care: Usual care will be defined by the clinical management team but includes steroid joint injections and non-steroidal anti-inflammatory drugs
|
|---|---|---|---|---|---|---|
|
PROMIS (Patient-Reported Outcomes Measurement Information System) Pediatric Fatigue
6 months
|
39.60 score on a scale
Standard Error 8.94
|
43.50 score on a scale
Standard Error 13.85
|
—
|
—
|
—
|
—
|
|
PROMIS (Patient-Reported Outcomes Measurement Information System) Pediatric Fatigue
12 months
|
39.80 score on a scale
Standard Error 9.12
|
47.10 score on a scale
Standard Error 16.85
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 6 months and 12 monthsPopulation: Pooled intent-to-treat (ITT) population with data collected at each timepoint.
PROMIS is a set of person-centered measures that evaluates and monitors physical, mental, and social health in adults and children. PROMIS scores are T-scores and have a mean of 50 and standard deviation of 10.
Outcome measures
| Measure |
Abatacept and Usual Care (Part I)
n=59 Participants
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 Injection: Supplied as a weekly injection via a pre-filled syringe
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 (Part I)
n=221 Participants
Usual care includes steroid joint injections and treatment with non-steroidal anti-inflammatory drugs at the discretion of the treating provider.
Usual Care: Usual care will be defined by the clinical management team but includes steroid joint injections and non-steroidal anti-inflammatory drugs
|
Abatacept and Usual Care (Part II)
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 Injection: Supplied as a weekly injection via a pre-filled syringe
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 (Part II)
Usual care includes steroid joint injections and treatment with non-steroidal anti-inflammatory drugs at the discretion of the treating provider.
Usual Care: Usual care will be defined by the clinical management team but includes steroid joint injections and non-steroidal anti-inflammatory drugs
|
Abatacept and Usual Care (Pooled Part I and Part II)
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 Injection: Supplied as a weekly injection via a pre-filled syringe
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 (Pooled Part I and Part II)
Usual care includes steroid joint injections and treatment with non-steroidal anti-inflammatory drugs at the discretion of the treating provider.
Usual Care: Usual care will be defined by the clinical management team but includes steroid joint injections and non-steroidal anti-inflammatory drugs
|
|---|---|---|---|---|---|---|
|
PROMIS (Patient-Reported Outcomes Measurement Information System) Upper Extremity Function
6 months
|
44.30 score on a scale
Standard Error 12.73
|
42.20 score on a scale
Standard Error 12.61
|
—
|
—
|
—
|
—
|
|
PROMIS (Patient-Reported Outcomes Measurement Information System) Upper Extremity Function
12 months
|
44.10 score on a scale
Standard Error 11.87
|
42.30 score on a scale
Standard Error 12.82
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 6 months and 12 monthsPopulation: Pooled intent-to-treat (ITT) population with data collected at each timepoint.
PROMIS is a set of person-centered measures that evaluates and monitors physical, mental, and social health in adults and children. PROMIS scores are T-scores and have a mean of 50 and standard deviation of 10.
Outcome measures
| Measure |
Abatacept and Usual Care (Part I)
n=76 Participants
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 Injection: Supplied as a weekly injection via a pre-filled syringe
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 (Part I)
n=365 Participants
Usual care includes steroid joint injections and treatment with non-steroidal anti-inflammatory drugs at the discretion of the treating provider.
Usual Care: Usual care will be defined by the clinical management team but includes steroid joint injections and non-steroidal anti-inflammatory drugs
|
Abatacept and Usual Care (Part II)
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 Injection: Supplied as a weekly injection via a pre-filled syringe
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 (Part II)
Usual care includes steroid joint injections and treatment with non-steroidal anti-inflammatory drugs at the discretion of the treating provider.
Usual Care: Usual care will be defined by the clinical management team but includes steroid joint injections and non-steroidal anti-inflammatory drugs
|
Abatacept and Usual Care (Pooled Part I and Part II)
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 Injection: Supplied as a weekly injection via a pre-filled syringe
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 (Pooled Part I and Part II)
Usual care includes steroid joint injections and treatment with non-steroidal anti-inflammatory drugs at the discretion of the treating provider.
Usual Care: Usual care will be defined by the clinical management team but includes steroid joint injections and non-steroidal anti-inflammatory drugs
|
|---|---|---|---|---|---|---|
|
PROMIS (Patient-Reported Outcomes Measurement Information System) Mobility
6 months
|
51.00 score on a scale
Standard Error 9.28
|
49.20 score on a scale
Standard Error 8.77
|
—
|
—
|
—
|
—
|
|
PROMIS (Patient-Reported Outcomes Measurement Information System) Mobility
12 months
|
50.30 score on a scale
Standard Error 8.38
|
50.70 score on a scale
Standard Error 8.79
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Pooled intent-to-treat (ITT) population with data collected.
PROMIS is a set of person-centered measures that evaluates and monitors physical, mental, and social health in adults and children. PROMIS scores are T-scores and have a mean of 50 and standard deviation of 10.
Outcome measures
| Measure |
Abatacept and Usual Care (Part I)
n=73 Participants
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 Injection: Supplied as a weekly injection via a pre-filled syringe
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 (Part I)
n=12 Participants
Usual care includes steroid joint injections and treatment with non-steroidal anti-inflammatory drugs at the discretion of the treating provider.
Usual Care: Usual care will be defined by the clinical management team but includes steroid joint injections and non-steroidal anti-inflammatory drugs
|
Abatacept and Usual Care (Part II)
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 Injection: Supplied as a weekly injection via a pre-filled syringe
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 (Part II)
Usual care includes steroid joint injections and treatment with non-steroidal anti-inflammatory drugs at the discretion of the treating provider.
Usual Care: Usual care will be defined by the clinical management team but includes steroid joint injections and non-steroidal anti-inflammatory drugs
|
Abatacept and Usual Care (Pooled Part I and Part II)
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 Injection: Supplied as a weekly injection via a pre-filled syringe
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 (Pooled Part I and Part II)
Usual care includes steroid joint injections and treatment with non-steroidal anti-inflammatory drugs at the discretion of the treating provider.
Usual Care: Usual care will be defined by the clinical management team but includes steroid joint injections and non-steroidal anti-inflammatory drugs
|
|---|---|---|---|---|---|---|
|
PROMIS (Patient-Reported Outcomes Measurement Information System) Anxiety
|
40.60 score on a scale
Standard Deviation 8.23
|
43.60 score on a scale
Standard Deviation 10.87
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Pooled intent-to-treat (ITT) population with data collected.
PROMIS is a set of person-centered measures that evaluates and monitors physical, mental, and social health in adults and children. PROMIS scores are T-scores and have a mean of 50 and standard deviation of 10.
Outcome measures
| Measure |
Abatacept and Usual Care (Part I)
n=74 Participants
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 Injection: Supplied as a weekly injection via a pre-filled syringe
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 (Part I)
n=12 Participants
Usual care includes steroid joint injections and treatment with non-steroidal anti-inflammatory drugs at the discretion of the treating provider.
Usual Care: Usual care will be defined by the clinical management team but includes steroid joint injections and non-steroidal anti-inflammatory drugs
|
Abatacept and Usual Care (Part II)
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 Injection: Supplied as a weekly injection via a pre-filled syringe
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 (Part II)
Usual care includes steroid joint injections and treatment with non-steroidal anti-inflammatory drugs at the discretion of the treating provider.
Usual Care: Usual care will be defined by the clinical management team but includes steroid joint injections and non-steroidal anti-inflammatory drugs
|
Abatacept and Usual Care (Pooled Part I and Part II)
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 Injection: Supplied as a weekly injection via a pre-filled syringe
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 (Pooled Part I and Part II)
Usual care includes steroid joint injections and treatment with non-steroidal anti-inflammatory drugs at the discretion of the treating provider.
Usual Care: Usual care will be defined by the clinical management team but includes steroid joint injections and non-steroidal anti-inflammatory drugs
|
|---|---|---|---|---|---|---|
|
PROMIS (Patient-Reported Outcomes Measurement Information System) Depression
|
40.00 score on a scale
Standard Deviation 7.18
|
43.30 score on a scale
Standard Deviation 9.39
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 6 months and 12 monthsPopulation: Pooled intent-to-treat (ITT) population with data collected at each timepoint.
PROMIS is a set of person-centered measures that evaluates and monitors physical, mental, and social health in adults and children. PROMIS scores are T-scores and have a mean of 50 and standard deviation of 10.
Outcome measures
| Measure |
Abatacept and Usual Care (Part I)
n=77 Participants
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 Injection: Supplied as a weekly injection via a pre-filled syringe
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 (Part I)
n=399 Participants
Usual care includes steroid joint injections and treatment with non-steroidal anti-inflammatory drugs at the discretion of the treating provider.
Usual Care: Usual care will be defined by the clinical management team but includes steroid joint injections and non-steroidal anti-inflammatory drugs
|
Abatacept and Usual Care (Part II)
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 Injection: Supplied as a weekly injection via a pre-filled syringe
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 (Part II)
Usual care includes steroid joint injections and treatment with non-steroidal anti-inflammatory drugs at the discretion of the treating provider.
Usual Care: Usual care will be defined by the clinical management team but includes steroid joint injections and non-steroidal anti-inflammatory drugs
|
Abatacept and Usual Care (Pooled Part I and Part II)
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 Injection: Supplied as a weekly injection via a pre-filled syringe
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 (Pooled Part I and Part II)
Usual care includes steroid joint injections and treatment with non-steroidal anti-inflammatory drugs at the discretion of the treating provider.
Usual Care: Usual care will be defined by the clinical management team but includes steroid joint injections and non-steroidal anti-inflammatory drugs
|
|---|---|---|---|---|---|---|
|
PROMIS (Patient-Reported Outcomes Measurement Information System) Global Health
6 months
|
42.50 score on a scale
Standard Error 6.51
|
42.10 score on a scale
Standard Error 4.89
|
—
|
—
|
—
|
—
|
|
PROMIS (Patient-Reported Outcomes Measurement Information System) Global Health
12 months
|
43.00 score on a scale
Standard Error 5.84
|
42.70 score on a scale
Standard Error 5.41
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 6 months and 12 monthsPopulation: Pooled intent-to-treat (ITT) population with data collected at each timepoint.
The JADAS (Juvenile Arthritis Disease Activity Score) is a composite tool used to assess disease activity in children with Juvenile Idiopathic Arthritis (JIA). The total score ranges from 0 to 40, where a higher score indicates a more severe level of disease activity.
Outcome measures
| Measure |
Abatacept and Usual Care (Part I)
n=89 Participants
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 Injection: Supplied as a weekly injection via a pre-filled syringe
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 (Part I)
n=457 Participants
Usual care includes steroid joint injections and treatment with non-steroidal anti-inflammatory drugs at the discretion of the treating provider.
Usual Care: Usual care will be defined by the clinical management team but includes steroid joint injections and non-steroidal anti-inflammatory drugs
|
Abatacept and Usual Care (Part II)
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 Injection: Supplied as a weekly injection via a pre-filled syringe
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 (Part II)
Usual care includes steroid joint injections and treatment with non-steroidal anti-inflammatory drugs at the discretion of the treating provider.
Usual Care: Usual care will be defined by the clinical management team but includes steroid joint injections and non-steroidal anti-inflammatory drugs
|
Abatacept and Usual Care (Pooled Part I and Part II)
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 Injection: Supplied as a weekly injection via a pre-filled syringe
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 (Pooled Part I and Part II)
Usual care includes steroid joint injections and treatment with non-steroidal anti-inflammatory drugs at the discretion of the treating provider.
Usual Care: Usual care will be defined by the clinical management team but includes steroid joint injections and non-steroidal anti-inflammatory drugs
|
|---|---|---|---|---|---|---|
|
Juvenile Arthritis Disease Activity Score (JADAS)
6 months
|
2.60 score on a scale
Standard Error 3.23
|
3.00 score on a scale
Standard Error 3.29
|
—
|
—
|
—
|
—
|
|
Juvenile Arthritis Disease Activity Score (JADAS)
12 months
|
2.50 score on a scale
Standard Error 3.15
|
2.60 score on a scale
Standard Error 3.06
|
—
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From randomization up to 12 monthsTime from enrollment to the earliest of the following: Date of visit when polyarthritis is first noted, Date of eye exam when Uveitis is first reported, Date of first reported use of systemic DMARDs and/or Biologics, including systemic glucocorticoids (IV or PO).
Outcome measures
Outcome data not reported
Adverse Events
Abatacept and Usual Care (Part I)
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Active Comparator: Usual Care (Part I)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Abatacept and Usual Care (Part II)
Serious events: 3 serious events
Other events: 0 other events
Deaths: 0 deaths
Active Comparator: Usual Care (Part II)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Abatacept and Usual Care (Part I)
n=20 participants at risk
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 Injection: Supplied as a weekly injection via a pre-filled syringe
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 (Part I)
n=20 participants at risk
Usual care includes steroid joint injections and treatment with non-steroidal anti-inflammatory drugs at the discretion of the treating provider.
Usual Care: Usual care will be defined by the clinical management team but includes steroid joint injections and non-steroidal anti-inflammatory drugs
|
Abatacept and Usual Care (Part II)
n=80 participants at risk
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 Injection: Supplied as a weekly injection via a pre-filled syringe
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 (Part II)
n=662 participants at risk
Usual care includes steroid joint injections and treatment with non-steroidal anti-inflammatory drugs at the discretion of the treating provider.
Usual Care: Usual care will be defined by the clinical management team but includes steroid joint injections and non-steroidal anti-inflammatory drugs
|
|---|---|---|---|---|
|
Infections and infestations
Infection treated with IV anti-infectives
|
0.00%
0/20 • Up to 12 months
Only Events of Special Interest (ESIs), serious and non-serious, and SAEs were collected for this study.
|
0.00%
0/20 • Up to 12 months
Only Events of Special Interest (ESIs), serious and non-serious, and SAEs were collected for this study.
|
1.2%
1/80 • Up to 12 months
Only Events of Special Interest (ESIs), serious and non-serious, and SAEs were collected for this study.
|
0.00%
0/662 • Up to 12 months
Only Events of Special Interest (ESIs), serious and non-serious, and SAEs were collected for this study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignancy, B-cell acute lymphoblastic leukemia
|
0.00%
0/20 • Up to 12 months
Only Events of Special Interest (ESIs), serious and non-serious, and SAEs were collected for this study.
|
0.00%
0/20 • Up to 12 months
Only Events of Special Interest (ESIs), serious and non-serious, and SAEs were collected for this study.
|
1.2%
1/80 • Up to 12 months
Only Events of Special Interest (ESIs), serious and non-serious, and SAEs were collected for this study.
|
0.00%
0/662 • Up to 12 months
Only Events of Special Interest (ESIs), serious and non-serious, and SAEs were collected for this study.
|
|
Gastrointestinal disorders
Blood streaked emesis
|
0.00%
0/20 • Up to 12 months
Only Events of Special Interest (ESIs), serious and non-serious, and SAEs were collected for this study.
|
0.00%
0/20 • Up to 12 months
Only Events of Special Interest (ESIs), serious and non-serious, and SAEs were collected for this study.
|
1.2%
1/80 • Up to 12 months
Only Events of Special Interest (ESIs), serious and non-serious, and SAEs were collected for this study.
|
0.00%
0/662 • Up to 12 months
Only Events of Special Interest (ESIs), serious and non-serious, and SAEs were collected for this study.
|
|
Infections and infestations
COVID-19 infection
|
5.0%
1/20 • Up to 12 months
Only Events of Special Interest (ESIs), serious and non-serious, and SAEs were collected for this study.
|
0.00%
0/20 • Up to 12 months
Only Events of Special Interest (ESIs), serious and non-serious, and SAEs were collected for this study.
|
0.00%
0/80 • Up to 12 months
Only Events of Special Interest (ESIs), serious and non-serious, and SAEs were collected for this study.
|
0.00%
0/662 • Up to 12 months
Only Events of Special Interest (ESIs), serious and non-serious, and SAEs were collected for this study.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place