| Primary | Composite of All Primary Endpoints | 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. | Modified intent-to-treat (mITT) population. | Posted | | Count of Participants | | Participants | | From randomization to day 410 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 | | OG002 | 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 | | OG003 | 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 | | OG004 | 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 | | OG005 | 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 |
| | Units | Counts |
|---|
| Participants | - OG00020
- OG00120
- OG00276
- OG003
|
| | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG00013
- OG00114
- OG00241
- OG003
|
|
| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| The null hypothesis was the proportions of the patients with composite of primary endpoints were the same between two groups. | Cochran-Mantel-Haenszel | | 0.7357 | | Relative Risk | 0.929 | Standard Error of the Mean | 0.220 | 2-Sided | 95 | 0.603 | 1.429 | | | | | Superiority | | | | |
|
| Primary | Number of Participants With Polyarthritis | Polyarthritis is defined as >=5 cumulative active joint count. | Modified intent-to-treat (mITT) population. | Posted | | Count of Participants | | Participants | | From randomization to day 592 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 | | OG002 | 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 |
|
| Primary | Number of Participants With Uveitis | | Modified intent-to-treat (mITT) population. | Posted | | Count of Participants | | Participants | | From randomization to day 410 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 | | OG002 | 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 |
|
| Primary | Number of Participants With Systemic Medications | Systemic glucocorticoids, Disease-Modifying Antirheumatic Drugs (DMARDs) or biologics. | Modified intent-to-treat (mITT) population. | Posted | | Count of Participants | | Participants | | From randomization day 410 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 | | OG002 | 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 |
|
| Secondary | Number of Participants With Clinically Inactive Disease or Remission | 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. | Intent-to-treat (ITT) population. | Posted | | Count of Participants | | Participants | | From baseline up to 12 months | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
|
| Secondary | Number of Participants With Disease Extension | Disease extension defined as development of polyarthritis or uveitis. | Intent-to-treat (ITT) population. | Posted | | Count of Participants | | Participants | | From baseline up to 12 months | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 | | OG002 | 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 |
|
| Secondary | Number of New Active Joints Per Participant | Total number of joints that were not active prior to or at baseline, and became active after randomization. | Intent-to-treat (ITT) population. | Posted | | Mean | Standard Error | joints | | From baseline up to 12 months | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 | | OG002 | 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 |
|
| Secondary | Number of Intra-articular Glucocorticoid Joint Injections Per Participant | Intra-articular glucocorticoid joint injections are reported in the CARRA Registry CRF at each Limit-JIA or CARRA Registry visit. | Intent-to-treat (ITT) population. | Posted | | Mean | Standard Error | injections | | From baseline up to 12 months | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 | | OG002 | 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 |
|
| Secondary | PROMIS (Patient-Reported Outcomes Measurement Information System) Pediatric Pain Interference | 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. | Pooled intent-to-treat (ITT) population with data collected at each timepoint. | Posted | | Mean | Standard Error | score on a scale | | 6 months and 12 months | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
| |
| Secondary | PROMIS (Patient-Reported Outcomes Measurement Information System) Pediatric Fatigue | 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. | Pooled intent-to-treat (ITT) population with data collected at each timepoint. | Posted | | Mean | Standard Error | score on a scale | | 6 months and 12 months | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
| |
| Secondary | PROMIS (Patient-Reported Outcomes Measurement Information System) Upper Extremity Function | 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. | Pooled intent-to-treat (ITT) population with data collected at each timepoint. | Posted | | Mean | Standard Error | score on a scale | | 6 months and 12 months | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
| |
| Secondary | PROMIS (Patient-Reported Outcomes Measurement Information System) Mobility | 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. | Pooled intent-to-treat (ITT) population with data collected at each timepoint. | Posted | | Mean | Standard Error | score on a scale | | 6 months and 12 months | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
| |
| Secondary | PROMIS (Patient-Reported Outcomes Measurement Information System) Anxiety | 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. | Pooled intent-to-treat (ITT) population with data collected. | Posted | | Mean | Standard Deviation | score on a scale | | 6 months | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
| |
| Secondary | PROMIS (Patient-Reported Outcomes Measurement Information System) Depression | 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. | Pooled intent-to-treat (ITT) population with data collected. | Posted | | Mean | Standard Deviation | score on a scale | | 6 months | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
| |
| Secondary | PROMIS (Patient-Reported Outcomes Measurement Information System) Global Health | 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. | Pooled intent-to-treat (ITT) population with data collected at each timepoint. | Posted | | Mean | Standard Error | score on a scale | | 6 months and 12 months | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
| |
| Secondary | Juvenile Arthritis Disease Activity Score (JADAS) | 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. | Pooled intent-to-treat (ITT) population with data collected at each timepoint. | Posted | | Mean | Standard Error | score on a scale | | 6 months and 12 months | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
| |
| Other Pre-specified | Elapsed Time From Randomization to Primary Endpoint | Time 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). | | Not Posted | | | | | | From randomization up to 12 months | | Participants | | | | |