BMS-188667 in Children and Adolescents With Juvenile Rheumatoid Arthritis

A Phase III, Multi-Center, Multi-National, Randomized Withdrawal Study to Evaluate the Safety and Efficacy of BMS-188667 in Children and Adolescents With Active Polyarticular Juvenile Rheumatoid Arthritis (JRA)

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00095173

Enrollment

214

Registered

2004-11-02

Start date

2003-12-31

Completion date

2011-11-30

Last updated

2017-01-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Juvenile Rheumatoid Arthritis

Keywords

Juvenile Idiopathic Arthritis

Brief summary

The primary purpose of the clinical research study is to assess the safety of treating children and juvenile subjects with BMS-188667 (Abatacept). In addition, the study will assess the effectiveness of BMS-188667 in reducing disease activity of Juvenile Rheumatoid Arthritis (JRA) or Juvenile Idiopathic Arthritis (JIA) as measured by the time to occurrence of disease flare.

Interventions

DRUGAbatacept

IV infusions, IV, 10mg/kg body weight, every 4 weeks, 6 months (unless a disease flare discontinued the patient earlier).

DRUGPlacebo

IV infusions, IV, N/A, every 4 weeks, 6 months.

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

6 Years to 17 Years

Healthy volunteers

Inclusion criteria

* Diagnosis of Juvenile Rheumatoid Arthritis or Juvenile Idiopathic Arthritis; * Current active arthritis; * Failed treatment with at least one disease modifying anti-rheumatic drug (DMARD); * Subjects must discontinue use of any DMARD other than methotrexate prior to the first dose of study medication

Exclusion criteria

* Presence of infection or history of frequent acute or chronic infections; * Joint replacement surgery required during the study or history of surgery on more than 5 joints; * Live vaccines within 3 months of the first dose of study medication; * Unresolved serious bacterial infection or chronic bacterial infection; * Subjects who currently have intermittent fever due to JRA/JIA, rheumatoid rash, hepato-splenomegaly, pleuritis, pericarditis, or macrophage activation syndrome.

Design outcomes

Primary

Measure	Time frame	Description
Time to Occurrence of Juvenile Rheumatoid Arthritis/Juvenile Idiopathic Arthritis (JRA/JIA) Disease Flare During Double-Blind Phase (Period B)	Period B (Day 113 to Day 282)	Time to flare is defined as the elapsed number of days between the first dose date in Period B and the study day that disease flare is confirmed. All of the following criteria must be met to be defined as a flare: * \> 30% worsening in at least 3 of the 6 JRA/JIA core response variables * \> 30% improvement in not more than 1 of the 6 JRA/JIA core set variables * ≥ 2 cm of worsening must be present if the Physician or Parent Global Assessment is used to define flare * worsening in ≥ 2 joints must be present if the number of active joints or joints with limitation of motion is used to define flare based on changes in the surrogate marker, erythrocyte sedimentation rate (ESR)

Secondary

Measure	Time frame	Description
Number of Participants With Serious Adverse Events (SAEs), Treatment-Related AEs, Deaths, Discontinuation of Study Drug Due to AEs During Open-Label Lead-In Phase (Period A)	Period A (Day 1 to Day 113)	AE=any new unfavorable symptom, sign or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity or drug dependency/abuse; is life-threatening, an important medical event or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible or missing relationship to study drug. Death=during the study and up to 28 days past study discontinuation. The select AEs were determined using the Medical Dictionary for Regulatory Activities (MedDRA, v14.1).
Number of Participants With Serious Adverse Events (SAEs), Treatment-Related AEs, Deaths, Discontinuation of Study Drug Due to AEs During Double-Blind Phase (Period B)	Period B (Day 113 to Day 282)	AE=any new unfavorable symptom, sign or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity or drug dependency/abuse; is life-threatening, an important medical event or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible or missing relationship to study drug. Death=during the study and up to 28 days past study discontinuation. The select AEs were determined using the Medical Dictionary for Regulatory Activities (MedDRA, v14.1).
Number of Participants With Serious Adverse Events (SAEs), Treatment-Related AEs, Deaths, Discontinuation of Study Drug Due to AEs During Open-Label Phase (Period C)	Period C (Day 282 to end of study)	AE=any new unfavorable symptom, sign or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity or drug dependency/abuse; is life-threatening, an important medical event or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible or missing relationship to study drug. Death=during the study and up to 85 days past study discontinuation. The select AEs were determined using the Medical Dictionary for Regulatory Activities (MedDRA, v14.1).
Median Percent Change From Baseline in JRA/JIA Core Set Variables During Double-Blind Phase (Period B)	Period B (Day 113 to Day 282)	Percent change from baseline was calculated from the difference between post-baseline and baseline divided by baseline multiplied by 100 and reported as the range between 25th and 75th percentile, not full range; American College of Rheumatology (ACR) Pediatric 30 JRA/JIA core set variables include active joints, limited range of motion, physician global assessment of disease severity, parent global assessment of overall well-being, change in physical function as measured by the Childhood Health Assessment Questionnaire (CHAQ), erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP). Disease activity was assessed by the physician and parent on a 0-100 mm visual analog scale (VAS). Low values represent low severity of disease and good well-being whereas high values represent highly severe disease and very poor well-being.
Median Percent Change From Baseline in JRA/JIA Core Set Variables During Open-Label Phase (Period C)	Period C (Day 282 to end of study)	Percent change from baseline was calculated from the difference between post-baseline and baseline divided by baseline multiplied by 100 and reported as the range between 25th and 75th percentile, not full range; American College of Rheumatology (ACR) Pediatric 30 JRA/JIA core set variables include active joints, limited range of motion, physician's global assessment of disease severity, parent global assessment of overall well-being, change in physical function as measured by the Childhood Health Assessment Questionnaire (CHAQ), erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP). Disease activity was assessed by the physician and parent on a 0-100 mm visual analog scale (VAS). Low values represent low severity of disease and good well-being whereas high values represent highly severe disease and very poor well-being.
Events of Special Interest During Open-Label Lead-In Phase (Period A), Including Infections, Peri-Infusional Adverse Events (AEs), Autoimmune Disorders and Malignancies	Period A (Day 1 to Day 113)	The sponsor prospectively identified categories of AEs that may be associated with the use of immunomodulatory drugs including infections, peri-infusional AEs, autoimmune disorders, malignancies. Peri-infusional AEs are defined as those AEs of special interest occurring during the first 24 hours after the start of study drug infusion. Malignancies definitions were based on events in the MedDRA Maintenance and Support Services Organization (MSSO) malignancies Structured MedDRA Query (SMQ).Autoimmune disorders are in alignment with the pre-specified MedDRA codes of autoimmune disorders events of interest.
Number of Participants With a Juvenile Rheumatoid Arthritis/Juvenile Idiopathic Arthritis (JRA/JIA) Disease With a Flare During Double-Blind Phase (Period B)	Period B (Day 113 to Day 282)	All of the following criteria must be met to be defined as a flare: * \> 30% worsening in at least 3 of the 6 JRA/JIA core response variables * \> 30% improvement in not more than 1 of the 6 JRA/JIA core set variables * ≥ 2 cm of worsening must be present if the Physician or Parent Global Assessment is used to define flare * worsening in ≥ 2 joints must be present if the number of active joints or joints with limitation of motion is used to define flare based on changes in the surrogate marker, erythrocyte sedimentation rate (ESR)
Events of Special Interest During Open-Label Phase (Period C), Including Infections, Peri-Infusional Adverse Events (AEs), Autoimmune Disorders and Malignancies	Period C (Day 282 up to 56 days after the last dose of study medication)	The sponsor prospectively identified categories of AEs that may be associated with the use of immunomodulatory drugs including infections, peri-infusional AEs, autoimmune disorders, malignancies. Peri-infusional AEs are defined as those AEs of special interest occurring during the first 24 hours after the start of study drug infusion. Malignancies definitions were based on events in the MedDRA Maintenance and Support Services Organization (MSSO) malignancies Structured MedDRA Query (SMQ).Autoimmune disorders are in alignment with the pre-specified MedDRA codes of autoimmune disorders events of interest.
Percentage of Participants Achieving American College of Rheumatology (ACR) Pediatric 30 (ACRP30), ACR Pediatric 50, ACR Pediatric 70, ACR Pediatric 90, and Inactive Disease Status Erythrocyte Sedimentation Rate (ESR) Response Rate	Day 113, Day 282, and Day 2047	The ACRP30 response criteria were defined as a ≥ 30% improvement over baseline in ESR. ACRP 50, 70, and 90 responses were defined similarly with 50%, 70%, and 90% improvements required, respectively.
Number of Treated Participants With Marked Laboratory Abnormalities During Open-Label Lead-In Phase (Period A)	Period A (Day 1 to Day 113)	Marked abnormalities were pre-defined as changes in lab tests that occurred after drug infusion and were reported relative to the normal range for each analyte. Hemoglobin, 11.6-14.8 grams per deciliter (g/dL);Hematocrit, 36.0-50.0 percent;Erythrocytes, 3.80-5.10x10\*6 cells per microliter (c/uL);Platelets, 140-44 cells per liter (c/L);Leukocytes, 4.00-12.50 c/uL;Absolute Neutrophils + Bands, if \<1.00x10\^3 c/uL;Absolute Lymphocytes, if \<0.72x10\^3 or \>7.50x10\^3 c/uL;Absolute Eosinophils, if \>0.750X10\^3 c/uL;Alanine Aminotransferase, 0-40 units per liter (U/L);G-Glutamyl Transferase, 0-60 U/L;Bilirubin, 0.1-1.2 milligrams per deciliter (mg/dL);Blood Urea Nitrogen, 5.9-26.0 mg/dL;Creatinine, 0.50-1.50 mg/dL;Serum Potassium, 3.5-5.5 milliequivalents per liter (mEq/L);Serum Glucose, 65-99 mg/dL;Fasting Serum Glucose, 65-99 mg/dL;Total Protein, 6.0-8.5 g/dL;Albumin, 3.5-5.5 g/dL;Urine Protein, \>=4;Urine Glucose, \>=4;Urine Blood, \>=4;Urine Red Blood Cells \>=4;Urine White Blood Cells, \>=4.
Number of Treated Participants With Marked Laboratory Abnormalities During Double-Blind Phase (Period B)	Period B (Day 113 to Day 282)	Marked abnormalities were pre-defined as changes in lab tests that occurred after drug infusion and were reported relative to the normal range for each analyte. Hemoglobin, 11.6-14.8 grams per deciliter (g/dL);Hematocrit, 36.0-50.0 percent;Erythrocytes, 3.80-5.10x10\*6 cells per microliter (c/uL);Platelets, 140-44 cells per liter (c/L);Leukocytes, 4.00-12.50 c/uL;Absolute Neutrophils + Bands, if \<1.00x10\^3 c/uL;Absolute Lymphocytes, if \<0.72x10\^3 or \>7.50x10\^3 c/uL;Absolute Eosinophils, if \>0.750X10\^3 c/uL;Aspartate Aminotransferase, 0-40 units per liter (U/L); Alanine Aminotransferase, 0-40 U/L;Blood Urea Nitrogen, 5.9-26.0 mg/dL;Serum Sodium, 135-148 milliequivalents per liter (mEq/L);Serum Potassium, 3.5-5.5 mEq/L;Serum Glucose, 65-99 mg/dL;Fasting Serum Glucose, 65-99 mg/dL;Urine Protein, \>=4;Urine Blood, \>=4;Urine Red Blood Cells \>=4;Urine White Blood Cells, \>=4.
Number of Treated Participants With Marked Laboratory Abnormalities During Open-Label Phase (Period C)	Period C (Day 282 to end of study)	Marked abnormalities were pre-defined as changes in lab tests after drug infusion and relative to normal range. Hemoglobin,11.6-14.8grams per deciliter(g/dL);Hematocrit,36.0-50.0 percent;Erythrocytes,3.80-5.10x10\*6 cells per microliter(c/uL);Platelets,140-44 cells per liter(c/L);Leukocytes,4.00-12.50c/uL;Absolute(Abs)Neutrophils+Bands,\<1.00x10\^3 c/uL;Abs Lymphocytes,\<0.72x10\^3 or\>7.50x10\^3 c/uL;Abs Eosinophils,\>0.750X10\^3 c/uL;Alkaline Phosphatase,0-40 units per liter(U/L);Aspartate Aminotransferase,0-40 U/L;Alanine Aminotransferase,0-40U/L;G-Glutamyl Transferase,0-60 U/L;Bilirubin, 0.1-1.2 milligrams per deciliter(mg/dL);Blood Urea Nitrogen,5.9-26.0 mg/dL;Creatinine, 0.50-1.50mg/dL;Inorganic Phosphorus,2.8-6.2 U/L;Serum Potassium,3.5-5.5 milliequivalents per liter(mEq/L);Serum Glucose,65-99 mg/dL;Fasting Serum Glucose,65-99 mg/dL;Total Protein, 6.0-8.5 g/dL;Albumin,3.5-5.5 g/dL;Urine Protein,\>=4;Urine Glucose,\>=4;Urine Blood,\>=4;Urine Red Blood Cells\>=4;Urine White Blood Cells,\>=4.
Number of Participants With Anti-Abatacept or Anti-CTLA4 Positive Responses Over Time During Open-Label Phase (Period C)	Period C (Day 282 to 85 days after the last dose of study medication)	During Period C, blood samples for immunogenicity assessments were obtained just prior to the start of the IV infusion of abatacept at 3-month intervals during the first 2 years of Period C, at 6-month intervals thereafter, and again 28, 56, and 85 days after the last infusion. Direct-format, enzyme-linked immunosorbent assays (ELISAs) were used to evaluate the cytotoxic T-lymphocyte antigen 4 (CTLA4) and the anti-CTLA4-T antibody.
Events of Special Interest During Double-Blind Phase (Period B), Including Infections, Peri-Infusional Adverse Events (AEs), Autoimmune Disorders and Malignancies	Period B (Day 113 to Day 282)	The sponsor prospectively identified categories of AEs that may be associated with the use of immunomodulatory drugs including infections, peri-infusional AEs, autoimmune disorders, malignancies. Peri-infusional AEs are defined as those AEs of special interest occurring during the first 24 hours after the start of study drug infusion. Malignancies definitions were based on events in the MedDRA Maintenance and Support Services Organization (MSSO) malignancies Structured MedDRA Query (SMQ).Autoimmune disorders are in alignment with the pre-specified MedDRA codes of autoimmune disorders events of interest.

Countries

Austria, Brazil, France, Germany, Italy, Mexico, Peru, Portugal, Spain, Switzerland, United States

Participant flow

Pre-assignment details

214 enrolled; in Per A, 190 treated; 24 not treated due to screening failures.170 completed Per A, 123 responders qualified to enter Per B. One subject did not enter Per B; 122 responders were randomized, 60 abatacept and 62 placebo. 36 of 47 Per A non-responders re-entered at Per C. Protocol violation occurred; 5yr old participant.

Participants by arm

Arm	Count
Abatacept (All Participants in Period A) Abatacept: 10 milligram per kilogram body weight (mg/kg), limited to a maximum 1000 mg for participants weighing \>100kg; solution infused intravenously (IV), over 90 minutes,once every 2 weeks for 3 doses, then monthly up to 6 months unless a disease flare discontinued the patient earlier.	190
Total	190

Withdrawals & dropouts

Period	Reason	FG000	FG001	FG002	FG003	FG004	FG005
Double-Blind Phase (Period B)	Lack of Efficacy	0	10	31	0	0	0
Double-Blind Phase (Period B)	Withdrawal by Subject	0	1	0	0	0	0
Open-Label Extension Phase (Period C)	Adverse Event	0	0	0	1	2	3
Open-Label Extension Phase (Period C)	Death	0	0	0	0	0	1
Open-Label Extension Phase (Period C)	Lack of Efficacy	0	0	0	11	5	8
Open-Label Extension Phase (Period C)	Lost to Follow-up	0	0	0	2	5	6
Open-Label Extension Phase (Period C)	No Longer Meets Study Criteria	0	0	0	0	1	1
Open-Label Extension Phase (Period C)	Other	0	0	0	4	6	8
Open-Label Extension Phase (Period C)	Poor/Non-Compliance	0	0	0	0	2	2
Open-Label Extension Phase (Period C)	Pregnancy	0	0	0	1	2	3
Open-Label Extension Phase (Period C)	Withdrawal by Subject	0	0	0	4	6	0
Open-Label Lead-In Phase (Period A)	Adverse Event	1	0	0	0	0	0
Open-Label Lead-In Phase (Period A)	Lack of Efficacy	17	0	0	0	0	0
Open-Label Lead-In Phase (Period A)	Other	1	0	0	0	0	0
Open-Label Lead-In Phase (Period A)	Withdrawal by Subject	1	0	0	0	0	0

Baseline characteristics

Characteristic	Abatacept (All Participants in Period A)
Age, Continuous	13.0 years
Gender Female	137 Participants
Gender Male	53 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk	EG003 affected / at risk
deaths Total, all-cause mortality	— / —	— / —	— / —	— / —
other Total, other adverse events	22 / 32	32 / 36	57 / 60	54 / 62
serious Total, serious adverse events	4 / 32	10 / 36	9 / 60	14 / 62

Outcome results

Primary

Time to Occurrence of Juvenile Rheumatoid Arthritis/Juvenile Idiopathic Arthritis (JRA/JIA) Disease Flare During Double-Blind Phase (Period B)

Time to flare is defined as the elapsed number of days between the first dose date in Period B and the study day that disease flare is confirmed. All of the following criteria must be met to be defined as a flare: * \> 30% worsening in at least 3 of the 6 JRA/JIA core response variables * \> 30% improvement in not more than 1 of the 6 JRA/JIA core set variables * ≥ 2 cm of worsening must be present if the Physician or Parent Global Assessment is used to define flare * worsening in ≥ 2 joints must be present if the number of active joints or joints with limitation of motion is used to define flare based on changes in the surrogate marker, erythrocyte sedimentation rate (ESR)

Time frame: Period B (Day 113 to Day 282)

Population: All treated participants

Arm	Measure	Value (MEDIAN)
Abatacept (Period B)	Time to Occurrence of Juvenile Rheumatoid Arthritis/Juvenile Idiopathic Arthritis (JRA/JIA) Disease Flare During Double-Blind Phase (Period B)	NA months
Placebo (Period B)	Time to Occurrence of Juvenile Rheumatoid Arthritis/Juvenile Idiopathic Arthritis (JRA/JIA) Disease Flare During Double-Blind Phase (Period B)	6 months

p-value: 0.000295% CI: [0.16, 0.59]Log Rank

Secondary

Events of Special Interest During Double-Blind Phase (Period B), Including Infections, Peri-Infusional Adverse Events (AEs), Autoimmune Disorders and Malignancies

The sponsor prospectively identified categories of AEs that may be associated with the use of immunomodulatory drugs including infections, peri-infusional AEs, autoimmune disorders, malignancies. Peri-infusional AEs are defined as those AEs of special interest occurring during the first 24 hours after the start of study drug infusion. Malignancies definitions were based on events in the MedDRA Maintenance and Support Services Organization (MSSO) malignancies Structured MedDRA Query (SMQ).Autoimmune disorders are in alignment with the pre-specified MedDRA codes of autoimmune disorders events of interest.

Time frame: Period B (Day 113 to Day 282)

Population: All treated participants in Period B

Arm	Measure	Group	Value (NUMBER)
Abatacept (Period B)	Events of Special Interest During Double-Blind Phase (Period B), Including Infections, Peri-Infusional Adverse Events (AEs), Autoimmune Disorders and Malignancies	Infections and Infestations	27 participants
Abatacept (Period B)	Events of Special Interest During Double-Blind Phase (Period B), Including Infections, Peri-Infusional Adverse Events (AEs), Autoimmune Disorders and Malignancies	Peri-Infusional AEs	2 participants
Abatacept (Period B)	Events of Special Interest During Double-Blind Phase (Period B), Including Infections, Peri-Infusional Adverse Events (AEs), Autoimmune Disorders and Malignancies	Autoimmune Disorders	0 participants
Abatacept (Period B)	Events of Special Interest During Double-Blind Phase (Period B), Including Infections, Peri-Infusional Adverse Events (AEs), Autoimmune Disorders and Malignancies	Malignancies	0 participants
Placebo (Period B)	Events of Special Interest During Double-Blind Phase (Period B), Including Infections, Peri-Infusional Adverse Events (AEs), Autoimmune Disorders and Malignancies	Malignancies	0 participants
Placebo (Period B)	Events of Special Interest During Double-Blind Phase (Period B), Including Infections, Peri-Infusional Adverse Events (AEs), Autoimmune Disorders and Malignancies	Infections and Infestations	27 participants
Placebo (Period B)	Events of Special Interest During Double-Blind Phase (Period B), Including Infections, Peri-Infusional Adverse Events (AEs), Autoimmune Disorders and Malignancies	Autoimmune Disorders	0 participants
Placebo (Period B)	Events of Special Interest During Double-Blind Phase (Period B), Including Infections, Peri-Infusional Adverse Events (AEs), Autoimmune Disorders and Malignancies	Peri-Infusional AEs	2 participants

Secondary

Events of Special Interest During Open-Label Lead-In Phase (Period A), Including Infections, Peri-Infusional Adverse Events (AEs), Autoimmune Disorders and Malignancies

Time frame: Period A (Day 1 to Day 113)

Population: All treated participants in Period A

Arm	Measure	Group	Value (NUMBER)
Abatacept (Period B)	Events of Special Interest During Open-Label Lead-In Phase (Period A), Including Infections, Peri-Infusional Adverse Events (AEs), Autoimmune Disorders and Malignancies	Infections and Infestations	68 participants
Abatacept (Period B)	Events of Special Interest During Open-Label Lead-In Phase (Period A), Including Infections, Peri-Infusional Adverse Events (AEs), Autoimmune Disorders and Malignancies	Peri-Infusional AEs	30 participants
Abatacept (Period B)	Events of Special Interest During Open-Label Lead-In Phase (Period A), Including Infections, Peri-Infusional Adverse Events (AEs), Autoimmune Disorders and Malignancies	Autoimmune Disorders	2 participants
Abatacept (Period B)	Events of Special Interest During Open-Label Lead-In Phase (Period A), Including Infections, Peri-Infusional Adverse Events (AEs), Autoimmune Disorders and Malignancies	Malignancies	0 participants

Secondary

Events of Special Interest During Open-Label Phase (Period C), Including Infections, Peri-Infusional Adverse Events (AEs), Autoimmune Disorders and Malignancies

Time frame: Period C (Day 282 up to 56 days after the last dose of study medication)

Population: All treated participants in Period C

Arm	Measure	Group	Value (NUMBER)
Abatacept (Period B)	Events of Special Interest During Open-Label Phase (Period C), Including Infections, Peri-Infusional Adverse Events (AEs), Autoimmune Disorders and Malignancies	Infections and Infestations	120 participants
Abatacept (Period B)	Events of Special Interest During Open-Label Phase (Period C), Including Infections, Peri-Infusional Adverse Events (AEs), Autoimmune Disorders and Malignancies	Peri-Infusional AEs	22 participants
Abatacept (Period B)	Events of Special Interest During Open-Label Phase (Period C), Including Infections, Peri-Infusional Adverse Events (AEs), Autoimmune Disorders and Malignancies	Autoimmune Disorders	7 participants
Abatacept (Period B)	Events of Special Interest During Open-Label Phase (Period C), Including Infections, Peri-Infusional Adverse Events (AEs), Autoimmune Disorders and Malignancies	Malignancies	1 participants

Secondary

Median Percent Change From Baseline in JRA/JIA Core Set Variables During Double-Blind Phase (Period B)

Percent change from baseline was calculated from the difference between post-baseline and baseline divided by baseline multiplied by 100 and reported as the range between 25th and 75th percentile, not full range; American College of Rheumatology (ACR) Pediatric 30 JRA/JIA core set variables include active joints, limited range of motion, physician global assessment of disease severity, parent global assessment of overall well-being, change in physical function as measured by the Childhood Health Assessment Questionnaire (CHAQ), erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP). Disease activity was assessed by the physician and parent on a 0-100 mm visual analog scale (VAS). Low values represent low severity of disease and good well-being whereas high values represent highly severe disease and very poor well-being.

Time frame: Period B (Day 113 to Day 282)

Population: All treated participants in Period B

Arm	Measure	Group	Value (MEDIAN)
Abatacept (Period B)	Median Percent Change From Baseline in JRA/JIA Core Set Variables During Double-Blind Phase (Period B)	Physician Global Assessment	-29.8 percentage change from baseline
Abatacept (Period B)	Median Percent Change From Baseline in JRA/JIA Core Set Variables During Double-Blind Phase (Period B)	CHAQ Disability Index	0.00 percentage change from baseline
Abatacept (Period B)	Median Percent Change From Baseline in JRA/JIA Core Set Variables During Double-Blind Phase (Period B)	Joints with LOM	0.00 percentage change from baseline
Abatacept (Period B)	Median Percent Change From Baseline in JRA/JIA Core Set Variables During Double-Blind Phase (Period B)	ESR	0.00 percentage change from baseline
Abatacept (Period B)	Median Percent Change From Baseline in JRA/JIA Core Set Variables During Double-Blind Phase (Period B)	Parent Global Assessment	-11.2 percentage change from baseline
Abatacept (Period B)	Median Percent Change From Baseline in JRA/JIA Core Set Variables During Double-Blind Phase (Period B)	CRP	0.00 percentage change from baseline
Abatacept (Period B)	Median Percent Change From Baseline in JRA/JIA Core Set Variables During Double-Blind Phase (Period B)	Active Joints	-20.9 percentage change from baseline
Placebo (Period B)	Median Percent Change From Baseline in JRA/JIA Core Set Variables During Double-Blind Phase (Period B)	CRP	6.25 percentage change from baseline
Placebo (Period B)	Median Percent Change From Baseline in JRA/JIA Core Set Variables During Double-Blind Phase (Period B)	Active Joints	50.00 percentage change from baseline
Placebo (Period B)	Median Percent Change From Baseline in JRA/JIA Core Set Variables During Double-Blind Phase (Period B)	Joints with LOM	50.00 percentage change from baseline
Placebo (Period B)	Median Percent Change From Baseline in JRA/JIA Core Set Variables During Double-Blind Phase (Period B)	Physician Global Assessment	55.95 percentage change from baseline
Placebo (Period B)	Median Percent Change From Baseline in JRA/JIA Core Set Variables During Double-Blind Phase (Period B)	Parent Global Assessment	8.39 percentage change from baseline
Placebo (Period B)	Median Percent Change From Baseline in JRA/JIA Core Set Variables During Double-Blind Phase (Period B)	CHAQ Disability Index	0.00 percentage change from baseline
Placebo (Period B)	Median Percent Change From Baseline in JRA/JIA Core Set Variables During Double-Blind Phase (Period B)	ESR	20.50 percentage change from baseline

Secondary

Median Percent Change From Baseline in JRA/JIA Core Set Variables During Open-Label Phase (Period C)

Percent change from baseline was calculated from the difference between post-baseline and baseline divided by baseline multiplied by 100 and reported as the range between 25th and 75th percentile, not full range; American College of Rheumatology (ACR) Pediatric 30 JRA/JIA core set variables include active joints, limited range of motion, physician's global assessment of disease severity, parent global assessment of overall well-being, change in physical function as measured by the Childhood Health Assessment Questionnaire (CHAQ), erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP). Disease activity was assessed by the physician and parent on a 0-100 mm visual analog scale (VAS). Low values represent low severity of disease and good well-being whereas high values represent highly severe disease and very poor well-being.

Time frame: Period C (Day 282 to end of study)

Population: All treated participants in Period C

Arm	Measure	Group	Value (MEDIAN)
Abatacept (Period B)	Median Percent Change From Baseline in JRA/JIA Core Set Variables During Open-Label Phase (Period C)	Joints with Limited Range of Motion	0.00 percentage change from baseline
Abatacept (Period B)	Median Percent Change From Baseline in JRA/JIA Core Set Variables During Open-Label Phase (Period C)	CHAQ Disability Index	14.14 percentage change from baseline
Abatacept (Period B)	Median Percent Change From Baseline in JRA/JIA Core Set Variables During Open-Label Phase (Period C)	Parent Global Assessment of Overall Well-Being	1.96 percentage change from baseline
Abatacept (Period B)	Median Percent Change From Baseline in JRA/JIA Core Set Variables During Open-Label Phase (Period C)	Active Joints	-26.7 percentage change from baseline
Abatacept (Period B)	Median Percent Change From Baseline in JRA/JIA Core Set Variables During Open-Label Phase (Period C)	CRP	0.00 percentage change from baseline
Abatacept (Period B)	Median Percent Change From Baseline in JRA/JIA Core Set Variables During Open-Label Phase (Period C)	ESR	20.87 percentage change from baseline
Abatacept (Period B)	Median Percent Change From Baseline in JRA/JIA Core Set Variables During Open-Label Phase (Period C)	Physician Global Assessment of Disease Severity	-31.9 percentage change from baseline
Placebo (Period B)	Median Percent Change From Baseline in JRA/JIA Core Set Variables During Open-Label Phase (Period C)	Parent Global Assessment of Overall Well-Being	-62.7 percentage change from baseline
Placebo (Period B)	Median Percent Change From Baseline in JRA/JIA Core Set Variables During Open-Label Phase (Period C)	Active Joints	-70.2 percentage change from baseline
Placebo (Period B)	Median Percent Change From Baseline in JRA/JIA Core Set Variables During Open-Label Phase (Period C)	Joints with Limited Range of Motion	-50.0 percentage change from baseline
Placebo (Period B)	Median Percent Change From Baseline in JRA/JIA Core Set Variables During Open-Label Phase (Period C)	Physician Global Assessment of Disease Severity	-75.0 percentage change from baseline
Placebo (Period B)	Median Percent Change From Baseline in JRA/JIA Core Set Variables During Open-Label Phase (Period C)	CHAQ Disability Index	-56.7 percentage change from baseline
Placebo (Period B)	Median Percent Change From Baseline in JRA/JIA Core Set Variables During Open-Label Phase (Period C)	ESR	-27.3 percentage change from baseline
Placebo (Period B)	Median Percent Change From Baseline in JRA/JIA Core Set Variables During Open-Label Phase (Period C)	CRP	-33.8 percentage change from baseline
Placebo (Period B) to Abatacept (Period C)	Median Percent Change From Baseline in JRA/JIA Core Set Variables During Open-Label Phase (Period C)	CHAQ Disability Index	-45.5 percentage change from baseline
Placebo (Period B) to Abatacept (Period C)	Median Percent Change From Baseline in JRA/JIA Core Set Variables During Open-Label Phase (Period C)	Joints with Limited Range of Motion	-71.4 percentage change from baseline
Placebo (Period B) to Abatacept (Period C)	Median Percent Change From Baseline in JRA/JIA Core Set Variables During Open-Label Phase (Period C)	CRP	-27.8 percentage change from baseline
Placebo (Period B) to Abatacept (Period C)	Median Percent Change From Baseline in JRA/JIA Core Set Variables During Open-Label Phase (Period C)	ESR	-24.2 percentage change from baseline
Placebo (Period B) to Abatacept (Period C)	Median Percent Change From Baseline in JRA/JIA Core Set Variables During Open-Label Phase (Period C)	Parent Global Assessment of Overall Well-Being	-63.9 percentage change from baseline
Placebo (Period B) to Abatacept (Period C)	Median Percent Change From Baseline in JRA/JIA Core Set Variables During Open-Label Phase (Period C)	Physician Global Assessment of Disease Severity	-81.8 percentage change from baseline
Placebo (Period B) to Abatacept (Period C)	Median Percent Change From Baseline in JRA/JIA Core Set Variables During Open-Label Phase (Period C)	Active Joints	-82.4 percentage change from baseline

Secondary

Number of Participants With a Juvenile Rheumatoid Arthritis/Juvenile Idiopathic Arthritis (JRA/JIA) Disease With a Flare During Double-Blind Phase (Period B)

All of the following criteria must be met to be defined as a flare: * \> 30% worsening in at least 3 of the 6 JRA/JIA core response variables * \> 30% improvement in not more than 1 of the 6 JRA/JIA core set variables * ≥ 2 cm of worsening must be present if the Physician or Parent Global Assessment is used to define flare * worsening in ≥ 2 joints must be present if the number of active joints or joints with limitation of motion is used to define flare based on changes in the surrogate marker, erythrocyte sedimentation rate (ESR)

Time frame: Period B (Day 113 to Day 282)

Population: All treated participants

Arm	Measure	Value (NUMBER)
Abatacept (Period B)	Number of Participants With a Juvenile Rheumatoid Arthritis/Juvenile Idiopathic Arthritis (JRA/JIA) Disease With a Flare During Double-Blind Phase (Period B)	12 participants
Placebo (Period B)	Number of Participants With a Juvenile Rheumatoid Arthritis/Juvenile Idiopathic Arthritis (JRA/JIA) Disease With a Flare During Double-Blind Phase (Period B)	33 participants

p-value: <0.001Chi-squared

Secondary

Number of Participants With Anti-Abatacept or Anti-CTLA4 Positive Responses Over Time During Open-Label Phase (Period C)

During Period C, blood samples for immunogenicity assessments were obtained just prior to the start of the IV infusion of abatacept at 3-month intervals during the first 2 years of Period C, at 6-month intervals thereafter, and again 28, 56, and 85 days after the last infusion. Direct-format, enzyme-linked immunosorbent assays (ELISAs) were used to evaluate the cytotoxic T-lymphocyte antigen 4 (CTLA4) and the anti-CTLA4-T antibody.

Time frame: Period C (Day 282 to 85 days after the last dose of study medication)

Population: All treated participants who were evaluated for immunogenicity during Period C

Arm	Measure	Group	Value (NUMBER)
Abatacept (Period B)	Number of Participants With Anti-Abatacept or Anti-CTLA4 Positive Responses Over Time During Open-Label Phase (Period C)	Anti-Abatacept, Overall on Treatment (n=31,54,54)	1 participants
Abatacept (Period B)	Number of Participants With Anti-Abatacept or Anti-CTLA4 Positive Responses Over Time During Open-Label Phase (Period C)	Anti-Abatacept, Post-Treatment (n=25,41,38)	0 participants
Abatacept (Period B)	Number of Participants With Anti-Abatacept or Anti-CTLA4 Positive Responses Over Time During Open-Label Phase (Period C)	Anti-CTLA4-T, Overall on Treatment (n=33,57,58)	4 participants
Abatacept (Period B)	Number of Participants With Anti-Abatacept or Anti-CTLA4 Positive Responses Over Time During Open-Label Phase (Period C)	Anti-CTLA4-T, Overall Post-Treatment (n=27,46,42)	4 participants
Placebo (Period B)	Number of Participants With Anti-Abatacept or Anti-CTLA4 Positive Responses Over Time During Open-Label Phase (Period C)	Anti-CTLA4-T, Overall Post-Treatment (n=27,46,42)	1 participants
Placebo (Period B)	Number of Participants With Anti-Abatacept or Anti-CTLA4 Positive Responses Over Time During Open-Label Phase (Period C)	Anti-Abatacept, Overall on Treatment (n=31,54,54)	5 participants
Placebo (Period B)	Number of Participants With Anti-Abatacept or Anti-CTLA4 Positive Responses Over Time During Open-Label Phase (Period C)	Anti-CTLA4-T, Overall on Treatment (n=33,57,58)	4 participants
Placebo (Period B)	Number of Participants With Anti-Abatacept or Anti-CTLA4 Positive Responses Over Time During Open-Label Phase (Period C)	Anti-Abatacept, Post-Treatment (n=25,41,38)	3 participants
Placebo (Period B) to Abatacept (Period C)	Number of Participants With Anti-Abatacept or Anti-CTLA4 Positive Responses Over Time During Open-Label Phase (Period C)	Anti-CTLA4-T, Overall Post-Treatment (n=27,46,42)	1 participants
Placebo (Period B) to Abatacept (Period C)	Number of Participants With Anti-Abatacept or Anti-CTLA4 Positive Responses Over Time During Open-Label Phase (Period C)	Anti-Abatacept, Post-Treatment (n=25,41,38)	3 participants
Placebo (Period B) to Abatacept (Period C)	Number of Participants With Anti-Abatacept or Anti-CTLA4 Positive Responses Over Time During Open-Label Phase (Period C)	Anti-CTLA4-T, Overall on Treatment (n=33,57,58)	4 participants
Placebo (Period B) to Abatacept (Period C)	Number of Participants With Anti-Abatacept or Anti-CTLA4 Positive Responses Over Time During Open-Label Phase (Period C)	Anti-Abatacept, Overall on Treatment (n=31,54,54)	2 participants

Secondary

Number of Participants With Serious Adverse Events (SAEs), Treatment-Related AEs, Deaths, Discontinuation of Study Drug Due to AEs During Double-Blind Phase (Period B)

AE=any new unfavorable symptom, sign or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity or drug dependency/abuse; is life-threatening, an important medical event or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible or missing relationship to study drug. Death=during the study and up to 28 days past study discontinuation. The select AEs were determined using the Medical Dictionary for Regulatory Activities (MedDRA, v14.1).

Time frame: Period B (Day 113 to Day 282)

Population: All treated participants in Periods B

Arm	Measure	Group	Value (NUMBER)
Abatacept (Period B)	Number of Participants With Serious Adverse Events (SAEs), Treatment-Related AEs, Deaths, Discontinuation of Study Drug Due to AEs During Double-Blind Phase (Period B)	Treatment-Related AE	0 participants
Abatacept (Period B)	Number of Participants With Serious Adverse Events (SAEs), Treatment-Related AEs, Deaths, Discontinuation of Study Drug Due to AEs During Double-Blind Phase (Period B)	Treatment-Related Deaths	0 participants
Abatacept (Period B)	Number of Participants With Serious Adverse Events (SAEs), Treatment-Related AEs, Deaths, Discontinuation of Study Drug Due to AEs During Double-Blind Phase (Period B)	All Deaths	0 participants
Abatacept (Period B)	Number of Participants With Serious Adverse Events (SAEs), Treatment-Related AEs, Deaths, Discontinuation of Study Drug Due to AEs During Double-Blind Phase (Period B)	Discontinuation of Study Drug due to AEs	0 participants
Abatacept (Period B)	Number of Participants With Serious Adverse Events (SAEs), Treatment-Related AEs, Deaths, Discontinuation of Study Drug Due to AEs During Double-Blind Phase (Period B)	SAE	0 participants
Placebo (Period B)	Number of Participants With Serious Adverse Events (SAEs), Treatment-Related AEs, Deaths, Discontinuation of Study Drug Due to AEs During Double-Blind Phase (Period B)	Discontinuation of Study Drug due to AEs	0 participants
Placebo (Period B)	Number of Participants With Serious Adverse Events (SAEs), Treatment-Related AEs, Deaths, Discontinuation of Study Drug Due to AEs During Double-Blind Phase (Period B)	SAE	2 participants
Placebo (Period B)	Number of Participants With Serious Adverse Events (SAEs), Treatment-Related AEs, Deaths, Discontinuation of Study Drug Due to AEs During Double-Blind Phase (Period B)	Treatment-Related AE	0 participants
Placebo (Period B)	Number of Participants With Serious Adverse Events (SAEs), Treatment-Related AEs, Deaths, Discontinuation of Study Drug Due to AEs During Double-Blind Phase (Period B)	All Deaths	0 participants
Placebo (Period B)	Number of Participants With Serious Adverse Events (SAEs), Treatment-Related AEs, Deaths, Discontinuation of Study Drug Due to AEs During Double-Blind Phase (Period B)	Treatment-Related Deaths	0 participants

Secondary

Number of Participants With Serious Adverse Events (SAEs), Treatment-Related AEs, Deaths, Discontinuation of Study Drug Due to AEs During Open-Label Lead-In Phase (Period A)

Time frame: Period A (Day 1 to Day 113)

Population: All treated participants in Periods A

Arm	Measure	Group	Value (NUMBER)
Abatacept (Period B)	Number of Participants With Serious Adverse Events (SAEs), Treatment-Related AEs, Deaths, Discontinuation of Study Drug Due to AEs During Open-Label Lead-In Phase (Period A)	SAE	6 participants
Abatacept (Period B)	Number of Participants With Serious Adverse Events (SAEs), Treatment-Related AEs, Deaths, Discontinuation of Study Drug Due to AEs During Open-Label Lead-In Phase (Period A)	Treatment-Related AE	0 participants
Abatacept (Period B)	Number of Participants With Serious Adverse Events (SAEs), Treatment-Related AEs, Deaths, Discontinuation of Study Drug Due to AEs During Open-Label Lead-In Phase (Period A)	All Deaths	0 participants
Abatacept (Period B)	Number of Participants With Serious Adverse Events (SAEs), Treatment-Related AEs, Deaths, Discontinuation of Study Drug Due to AEs During Open-Label Lead-In Phase (Period A)	Treatment-Related Deaths	0 participants
Abatacept (Period B)	Number of Participants With Serious Adverse Events (SAEs), Treatment-Related AEs, Deaths, Discontinuation of Study Drug Due to AEs During Open-Label Lead-In Phase (Period A)	Discontinuation of Study Drug due to AEs	1 participants

Secondary

Number of Participants With Serious Adverse Events (SAEs), Treatment-Related AEs, Deaths, Discontinuation of Study Drug Due to AEs During Open-Label Phase (Period C)

AE=any new unfavorable symptom, sign or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity or drug dependency/abuse; is life-threatening, an important medical event or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible or missing relationship to study drug. Death=during the study and up to 85 days past study discontinuation. The select AEs were determined using the Medical Dictionary for Regulatory Activities (MedDRA, v14.1).

Time frame: Period C (Day 282 to end of study)

Population: All treated participants in Period C

Arm	Measure	Group	Value (NUMBER)
Abatacept (Period B)	Number of Participants With Serious Adverse Events (SAEs), Treatment-Related AEs, Deaths, Discontinuation of Study Drug Due to AEs During Open-Label Phase (Period C)	Treatment-Related Deaths	0 participants
Abatacept (Period B)	Number of Participants With Serious Adverse Events (SAEs), Treatment-Related AEs, Deaths, Discontinuation of Study Drug Due to AEs During Open-Label Phase (Period C)	All Deaths	0 participants
Abatacept (Period B)	Number of Participants With Serious Adverse Events (SAEs), Treatment-Related AEs, Deaths, Discontinuation of Study Drug Due to AEs During Open-Label Phase (Period C)	SAE	9 participants
Abatacept (Period B)	Number of Participants With Serious Adverse Events (SAEs), Treatment-Related AEs, Deaths, Discontinuation of Study Drug Due to AEs During Open-Label Phase (Period C)	Treatment-Related AE	2 participants
Abatacept (Period B)	Number of Participants With Serious Adverse Events (SAEs), Treatment-Related AEs, Deaths, Discontinuation of Study Drug Due to AEs During Open-Label Phase (Period C)	Discontinuation of Study Drug due to AEs	1 participants
Placebo (Period B)	Number of Participants With Serious Adverse Events (SAEs), Treatment-Related AEs, Deaths, Discontinuation of Study Drug Due to AEs During Open-Label Phase (Period C)	All Deaths	0 participants
Placebo (Period B)	Number of Participants With Serious Adverse Events (SAEs), Treatment-Related AEs, Deaths, Discontinuation of Study Drug Due to AEs During Open-Label Phase (Period C)	SAE	9 participants
Placebo (Period B)	Number of Participants With Serious Adverse Events (SAEs), Treatment-Related AEs, Deaths, Discontinuation of Study Drug Due to AEs During Open-Label Phase (Period C)	Treatment-Related AE	4 participants
Placebo (Period B)	Number of Participants With Serious Adverse Events (SAEs), Treatment-Related AEs, Deaths, Discontinuation of Study Drug Due to AEs During Open-Label Phase (Period C)	Treatment-Related Deaths	0 participants
Placebo (Period B)	Number of Participants With Serious Adverse Events (SAEs), Treatment-Related AEs, Deaths, Discontinuation of Study Drug Due to AEs During Open-Label Phase (Period C)	Discontinuation of Study Drug due to AEs	2 participants
Placebo (Period B) to Abatacept (Period C)	Number of Participants With Serious Adverse Events (SAEs), Treatment-Related AEs, Deaths, Discontinuation of Study Drug Due to AEs During Open-Label Phase (Period C)	Discontinuation of Study Drug due to AEs	3 participants
Placebo (Period B) to Abatacept (Period C)	Number of Participants With Serious Adverse Events (SAEs), Treatment-Related AEs, Deaths, Discontinuation of Study Drug Due to AEs During Open-Label Phase (Period C)	Treatment-Related Deaths	0 participants
Placebo (Period B) to Abatacept (Period C)	Number of Participants With Serious Adverse Events (SAEs), Treatment-Related AEs, Deaths, Discontinuation of Study Drug Due to AEs During Open-Label Phase (Period C)	SAE	12 participants
Placebo (Period B) to Abatacept (Period C)	Number of Participants With Serious Adverse Events (SAEs), Treatment-Related AEs, Deaths, Discontinuation of Study Drug Due to AEs During Open-Label Phase (Period C)	All Deaths	1 participants
Placebo (Period B) to Abatacept (Period C)	Number of Participants With Serious Adverse Events (SAEs), Treatment-Related AEs, Deaths, Discontinuation of Study Drug Due to AEs During Open-Label Phase (Period C)	Treatment-Related AE	3 participants

Secondary

Number of Treated Participants With Marked Laboratory Abnormalities During Double-Blind Phase (Period B)

Marked abnormalities were pre-defined as changes in lab tests that occurred after drug infusion and were reported relative to the normal range for each analyte. Hemoglobin, 11.6-14.8 grams per deciliter (g/dL);Hematocrit, 36.0-50.0 percent;Erythrocytes, 3.80-5.10x10\*6 cells per microliter (c/uL);Platelets, 140-44 cells per liter (c/L);Leukocytes, 4.00-12.50 c/uL;Absolute Neutrophils + Bands, if \<1.00x10\^3 c/uL;Absolute Lymphocytes, if \<0.72x10\^3 or \>7.50x10\^3 c/uL;Absolute Eosinophils, if \>0.750X10\^3 c/uL;Aspartate Aminotransferase, 0-40 units per liter (U/L); Alanine Aminotransferase, 0-40 U/L;Blood Urea Nitrogen, 5.9-26.0 mg/dL;Serum Sodium, 135-148 milliequivalents per liter (mEq/L);Serum Potassium, 3.5-5.5 mEq/L;Serum Glucose, 65-99 mg/dL;Fasting Serum Glucose, 65-99 mg/dL;Urine Protein, \>=4;Urine Blood, \>=4;Urine Red Blood Cells \>=4;Urine White Blood Cells, \>=4.

Time frame: Period B (Day 113 to Day 282)

Population: All treated participants in Period B evaluated for a specific analyte.

Arm	Measure	Group	Value (NUMBER)
Abatacept (Period B)	Number of Treated Participants With Marked Laboratory Abnormalities During Double-Blind Phase (Period B)	Alanine Aminotransferase (ALT, High) n=60, 62	1 participants
Abatacept (Period B)	Number of Treated Participants With Marked Laboratory Abnormalities During Double-Blind Phase (Period B)	Hematocrit (Low) n=60, 61	1 participants
Abatacept (Period B)	Number of Treated Participants With Marked Laboratory Abnormalities During Double-Blind Phase (Period B)	Blood Urea Nitrogen (High) n=60, 62	1 participants
Abatacept (Period B)	Number of Treated Participants With Marked Laboratory Abnormalities During Double-Blind Phase (Period B)	Platelets (Low) n-60, 61	4 participants
Abatacept (Period B)	Number of Treated Participants With Marked Laboratory Abnormalities During Double-Blind Phase (Period B)	Serum Sodium (Low) n=60, 62	0 participants
Abatacept (Period B)	Number of Treated Participants With Marked Laboratory Abnormalities During Double-Blind Phase (Period B)	Absolute Neutrophils + Bands (Low) n=60, 62	0 participants
Abatacept (Period B)	Number of Treated Participants With Marked Laboratory Abnormalities During Double-Blind Phase (Period B)	Serum Potassium (High) n=60, 62	2 participants
Abatacept (Period B)	Number of Treated Participants With Marked Laboratory Abnormalities During Double-Blind Phase (Period B)	Hemoglobin (Low) n=60, 61	1 participants
Abatacept (Period B)	Number of Treated Participants With Marked Laboratory Abnormalities During Double-Blind Phase (Period B)	Serum Glucose (Low) n=60, 62	4 participants
Abatacept (Period B)	Number of Treated Participants With Marked Laboratory Abnormalities During Double-Blind Phase (Period B)	Absolute Lymphocytes (Low) n=60, 62	2 participants
Abatacept (Period B)	Number of Treated Participants With Marked Laboratory Abnormalities During Double-Blind Phase (Period B)	Serum Glucose (High) n=60, 62	0 participants
Abatacept (Period B)	Number of Treated Participants With Marked Laboratory Abnormalities During Double-Blind Phase (Period B)	Platelets (High) n=189	0 participants
Abatacept (Period B)	Number of Treated Participants With Marked Laboratory Abnormalities During Double-Blind Phase (Period B)	Fasting Serum Glucose (High) n=60, 62	1 participants
Abatacept (Period B)	Number of Treated Participants With Marked Laboratory Abnormalities During Double-Blind Phase (Period B)	Absolute Eosinophils (High) n=60, 62	6 participants
Abatacept (Period B)	Number of Treated Participants With Marked Laboratory Abnormalities During Double-Blind Phase (Period B)	Urine Protein (High) n=62	2 participants
Abatacept (Period B)	Number of Treated Participants With Marked Laboratory Abnormalities During Double-Blind Phase (Period B)	Erythrocytes (Low) n=60, 61	0 participants
Abatacept (Period B)	Number of Treated Participants With Marked Laboratory Abnormalities During Double-Blind Phase (Period B)	Urine Blood (High) n=60, 62	12 participants
Abatacept (Period B)	Number of Treated Participants With Marked Laboratory Abnormalities During Double-Blind Phase (Period B)	Aspartate Aminotransferase (AST, High) n=60, 62	1 participants
Abatacept (Period B)	Number of Treated Participants With Marked Laboratory Abnormalities During Double-Blind Phase (Period B)	Urine White Blood Cells (High) n=24, 20	5 participants
Abatacept (Period B)	Number of Treated Participants With Marked Laboratory Abnormalities During Double-Blind Phase (Period B)	Leukocytes (Low) n=60, 61	1 participants
Abatacept (Period B)	Number of Treated Participants With Marked Laboratory Abnormalities During Double-Blind Phase (Period B)	Urine Red Blood Cells (High) n=24, 20	6 participants
Abatacept (Period B)	Number of Treated Participants With Marked Laboratory Abnormalities During Double-Blind Phase (Period B)	Leukocytes (High) n=60, 61	1 participants
Placebo (Period B)	Number of Treated Participants With Marked Laboratory Abnormalities During Double-Blind Phase (Period B)	Urine Red Blood Cells (High) n=24, 20	4 participants
Placebo (Period B)	Number of Treated Participants With Marked Laboratory Abnormalities During Double-Blind Phase (Period B)	Hemoglobin (Low) n=60, 61	1 participants
Placebo (Period B)	Number of Treated Participants With Marked Laboratory Abnormalities During Double-Blind Phase (Period B)	Hematocrit (Low) n=60, 61	1 participants
Placebo (Period B)	Number of Treated Participants With Marked Laboratory Abnormalities During Double-Blind Phase (Period B)	Erythrocytes (Low) n=60, 61	1 participants
Placebo (Period B)	Number of Treated Participants With Marked Laboratory Abnormalities During Double-Blind Phase (Period B)	Platelets (Low) n-60, 61	0 participants
Placebo (Period B)	Number of Treated Participants With Marked Laboratory Abnormalities During Double-Blind Phase (Period B)	Platelets (High) n=189	1 participants
Placebo (Period B)	Number of Treated Participants With Marked Laboratory Abnormalities During Double-Blind Phase (Period B)	Leukocytes (Low) n=60, 61	1 participants
Placebo (Period B)	Number of Treated Participants With Marked Laboratory Abnormalities During Double-Blind Phase (Period B)	Leukocytes (High) n=60, 61	2 participants
Placebo (Period B)	Number of Treated Participants With Marked Laboratory Abnormalities During Double-Blind Phase (Period B)	Absolute Neutrophils + Bands (Low) n=60, 62	1 participants
Placebo (Period B)	Number of Treated Participants With Marked Laboratory Abnormalities During Double-Blind Phase (Period B)	Absolute Lymphocytes (Low) n=60, 62	3 participants
Placebo (Period B)	Number of Treated Participants With Marked Laboratory Abnormalities During Double-Blind Phase (Period B)	Absolute Eosinophils (High) n=60, 62	4 participants
Placebo (Period B)	Number of Treated Participants With Marked Laboratory Abnormalities During Double-Blind Phase (Period B)	Aspartate Aminotransferase (AST, High) n=60, 62	0 participants
Placebo (Period B)	Number of Treated Participants With Marked Laboratory Abnormalities During Double-Blind Phase (Period B)	Alanine Aminotransferase (ALT, High) n=60, 62	0 participants
Placebo (Period B)	Number of Treated Participants With Marked Laboratory Abnormalities During Double-Blind Phase (Period B)	Blood Urea Nitrogen (High) n=60, 62	1 participants
Placebo (Period B)	Number of Treated Participants With Marked Laboratory Abnormalities During Double-Blind Phase (Period B)	Serum Sodium (Low) n=60, 62	1 participants
Placebo (Period B)	Number of Treated Participants With Marked Laboratory Abnormalities During Double-Blind Phase (Period B)	Serum Potassium (High) n=60, 62	0 participants
Placebo (Period B)	Number of Treated Participants With Marked Laboratory Abnormalities During Double-Blind Phase (Period B)	Serum Glucose (Low) n=60, 62	5 participants
Placebo (Period B)	Number of Treated Participants With Marked Laboratory Abnormalities During Double-Blind Phase (Period B)	Serum Glucose (High) n=60, 62	1 participants
Placebo (Period B)	Number of Treated Participants With Marked Laboratory Abnormalities During Double-Blind Phase (Period B)	Fasting Serum Glucose (High) n=60, 62	1 participants
Placebo (Period B)	Number of Treated Participants With Marked Laboratory Abnormalities During Double-Blind Phase (Period B)	Urine Protein (High) n=62	2 participants
Placebo (Period B)	Number of Treated Participants With Marked Laboratory Abnormalities During Double-Blind Phase (Period B)	Urine Blood (High) n=60, 62	6 participants
Placebo (Period B)	Number of Treated Participants With Marked Laboratory Abnormalities During Double-Blind Phase (Period B)	Urine White Blood Cells (High) n=24, 20	2 participants

Secondary

Number of Treated Participants With Marked Laboratory Abnormalities During Open-Label Lead-In Phase (Period A)

Marked abnormalities were pre-defined as changes in lab tests that occurred after drug infusion and were reported relative to the normal range for each analyte. Hemoglobin, 11.6-14.8 grams per deciliter (g/dL);Hematocrit, 36.0-50.0 percent;Erythrocytes, 3.80-5.10x10\*6 cells per microliter (c/uL);Platelets, 140-44 cells per liter (c/L);Leukocytes, 4.00-12.50 c/uL;Absolute Neutrophils + Bands, if \<1.00x10\^3 c/uL;Absolute Lymphocytes, if \<0.72x10\^3 or \>7.50x10\^3 c/uL;Absolute Eosinophils, if \>0.750X10\^3 c/uL;Alanine Aminotransferase, 0-40 units per liter (U/L);G-Glutamyl Transferase, 0-60 U/L;Bilirubin, 0.1-1.2 milligrams per deciliter (mg/dL);Blood Urea Nitrogen, 5.9-26.0 mg/dL;Creatinine, 0.50-1.50 mg/dL;Serum Potassium, 3.5-5.5 milliequivalents per liter (mEq/L);Serum Glucose, 65-99 mg/dL;Fasting Serum Glucose, 65-99 mg/dL;Total Protein, 6.0-8.5 g/dL;Albumin, 3.5-5.5 g/dL;Urine Protein, \>=4;Urine Glucose, \>=4;Urine Blood, \>=4;Urine Red Blood Cells \>=4;Urine White Blood Cells, \>=4.

Time frame: Period A (Day 1 to Day 113)

Population: All treated participants in Period C evaluated for a specific analyte.

Arm	Measure	Group	Value (NUMBER)
Abatacept (Period B)	Number of Treated Participants With Marked Laboratory Abnormalities During Open-Label Lead-In Phase (Period A)	Potassium (High) n=190	4 participants
Abatacept (Period B)	Number of Treated Participants With Marked Laboratory Abnormalities During Open-Label Lead-In Phase (Period A)	Hemoglobin (Low) n=189	2 participants
Abatacept (Period B)	Number of Treated Participants With Marked Laboratory Abnormalities During Open-Label Lead-In Phase (Period A)	Hematocrit (Low) n=189	2 participants
Abatacept (Period B)	Number of Treated Participants With Marked Laboratory Abnormalities During Open-Label Lead-In Phase (Period A)	Erythrocytes (Low) n=189	1 participants
Abatacept (Period B)	Number of Treated Participants With Marked Laboratory Abnormalities During Open-Label Lead-In Phase (Period A)	Platelets (Low) n=189	1 participants
Abatacept (Period B)	Number of Treated Participants With Marked Laboratory Abnormalities During Open-Label Lead-In Phase (Period A)	Platelet Count (High) n=189	2 participants
Abatacept (Period B)	Number of Treated Participants With Marked Laboratory Abnormalities During Open-Label Lead-In Phase (Period A)	Leukocytes (Low) n=189	9 participants
Abatacept (Period B)	Number of Treated Participants With Marked Laboratory Abnormalities During Open-Label Lead-In Phase (Period A)	Leukocytes (High) n=189	10 participants
Abatacept (Period B)	Number of Treated Participants With Marked Laboratory Abnormalities During Open-Label Lead-In Phase (Period A)	Absolute Neutrophils + Bands (Low) n=189	5 participants
Abatacept (Period B)	Number of Treated Participants With Marked Laboratory Abnormalities During Open-Label Lead-In Phase (Period A)	Absolute Lymphocytes (Low) n=189	9 participants
Abatacept (Period B)	Number of Treated Participants With Marked Laboratory Abnormalities During Open-Label Lead-In Phase (Period A)	Absolute Eosinophils (High) n=189	16 participants
Abatacept (Period B)	Number of Treated Participants With Marked Laboratory Abnormalities During Open-Label Lead-In Phase (Period A)	Alanine Aminotransferase (ALT, High) n=190	2 participants
Abatacept (Period B)	Number of Treated Participants With Marked Laboratory Abnormalities During Open-Label Lead-In Phase (Period A)	G-Glutamyl Transferase (GGT, High) n=190	1 participants
Abatacept (Period B)	Number of Treated Participants With Marked Laboratory Abnormalities During Open-Label Lead-In Phase (Period A)	Bilirubin (Total, High) n=190	1 participants
Abatacept (Period B)	Number of Treated Participants With Marked Laboratory Abnormalities During Open-Label Lead-In Phase (Period A)	Blood Urea Nitrogen (High) n=190	6 participants
Abatacept (Period B)	Number of Treated Participants With Marked Laboratory Abnormalities During Open-Label Lead-In Phase (Period A)	Creatinine (High) n=190	12 participants
Abatacept (Period B)	Number of Treated Participants With Marked Laboratory Abnormalities During Open-Label Lead-In Phase (Period A)	Serum Glucose (Low) n=190	26 participants
Abatacept (Period B)	Number of Treated Participants With Marked Laboratory Abnormalities During Open-Label Lead-In Phase (Period A)	Serum Glucose (High) n=190	2 participants
Abatacept (Period B)	Number of Treated Participants With Marked Laboratory Abnormalities During Open-Label Lead-In Phase (Period A)	Fasting Serum Glucose (High) n=109	1 participants
Abatacept (Period B)	Number of Treated Participants With Marked Laboratory Abnormalities During Open-Label Lead-In Phase (Period A)	Total Protein (High) n=190	2 participants
Abatacept (Period B)	Number of Treated Participants With Marked Laboratory Abnormalities During Open-Label Lead-In Phase (Period A)	Albumin (Low) n=190	2 participants
Abatacept (Period B)	Number of Treated Participants With Marked Laboratory Abnormalities During Open-Label Lead-In Phase (Period A)	Urine Protein (High) n=190	12 participants
Abatacept (Period B)	Number of Treated Participants With Marked Laboratory Abnormalities During Open-Label Lead-In Phase (Period A)	Urine Glucose (High) n=190	1 participants
Abatacept (Period B)	Number of Treated Participants With Marked Laboratory Abnormalities During Open-Label Lead-In Phase (Period A)	Urine Blood (High) n=190	23 participants
Abatacept (Period B)	Number of Treated Participants With Marked Laboratory Abnormalities During Open-Label Lead-In Phase (Period A)	Urine White Blood Cells (High) n=75	9 participants
Abatacept (Period B)	Number of Treated Participants With Marked Laboratory Abnormalities During Open-Label Lead-In Phase (Period A)	Urine Red Blood Cells (High) n=75	25 participants

Secondary

Number of Treated Participants With Marked Laboratory Abnormalities During Open-Label Phase (Period C)

Marked abnormalities were pre-defined as changes in lab tests after drug infusion and relative to normal range. Hemoglobin,11.6-14.8grams per deciliter(g/dL);Hematocrit,36.0-50.0 percent;Erythrocytes,3.80-5.10x10\*6 cells per microliter(c/uL);Platelets,140-44 cells per liter(c/L);Leukocytes,4.00-12.50c/uL;Absolute(Abs)Neutrophils+Bands,\<1.00x10\^3 c/uL;Abs Lymphocytes,\<0.72x10\^3 or\>7.50x10\^3 c/uL;Abs Eosinophils,\>0.750X10\^3 c/uL;Alkaline Phosphatase,0-40 units per liter(U/L);Aspartate Aminotransferase,0-40 U/L;Alanine Aminotransferase,0-40U/L;G-Glutamyl Transferase,0-60 U/L;Bilirubin, 0.1-1.2 milligrams per deciliter(mg/dL);Blood Urea Nitrogen,5.9-26.0 mg/dL;Creatinine, 0.50-1.50mg/dL;Inorganic Phosphorus,2.8-6.2 U/L;Serum Potassium,3.5-5.5 milliequivalents per liter(mEq/L);Serum Glucose,65-99 mg/dL;Fasting Serum Glucose,65-99 mg/dL;Total Protein, 6.0-8.5 g/dL;Albumin,3.5-5.5 g/dL;Urine Protein,\>=4;Urine Glucose,\>=4;Urine Blood,\>=4;Urine Red Blood Cells\>=4;Urine White Blood Cells,\>=4.

Time frame: Period C (Day 282 to end of study)

Population: All treated participants in Period C evaluated for a specific analyte.

Arm	Measure	Group	Value (NUMBER)
Abatacept (Period B)	Number of Treated Participants With Marked Laboratory Abnormalities During Open-Label Phase (Period C)	Hemoglobin (Low) n=153	12 participants
Abatacept (Period B)	Number of Treated Participants With Marked Laboratory Abnormalities During Open-Label Phase (Period C)	Hematocrit (Low) n=153	8 participants
Abatacept (Period B)	Number of Treated Participants With Marked Laboratory Abnormalities During Open-Label Phase (Period C)	Erythrocytes (Low) n=153	4 participants
Abatacept (Period B)	Number of Treated Participants With Marked Laboratory Abnormalities During Open-Label Phase (Period C)	Platelet Count (Low) n=153	4 participants
Abatacept (Period B)	Number of Treated Participants With Marked Laboratory Abnormalities During Open-Label Phase (Period C)	Platelet Count (High) n=153	5 participants
Abatacept (Period B)	Number of Treated Participants With Marked Laboratory Abnormalities During Open-Label Phase (Period C)	Leukocytes (Low) n=153	20 participants
Abatacept (Period B)	Number of Treated Participants With Marked Laboratory Abnormalities During Open-Label Phase (Period C)	Leukocytes (High) n=153	18 participants
Abatacept (Period B)	Number of Treated Participants With Marked Laboratory Abnormalities During Open-Label Phase (Period C)	Absolute Neutrophils + Bands (Low)	14 participants
Abatacept (Period B)	Number of Treated Participants With Marked Laboratory Abnormalities During Open-Label Phase (Period C)	Absolute Lymphocytes (Low) n=153	21 participants
Abatacept (Period B)	Number of Treated Participants With Marked Laboratory Abnormalities During Open-Label Phase (Period C)	Absolute Lymphocytes (High) n=153	5 participants
Abatacept (Period B)	Number of Treated Participants With Marked Laboratory Abnormalities During Open-Label Phase (Period C)	Absolute Eosinophils (High) n=153	50 participants
Abatacept (Period B)	Number of Treated Participants With Marked Laboratory Abnormalities During Open-Label Phase (Period C)	Alkaline Phosphatase (ALP, High) n=153	2 participants
Abatacept (Period B)	Number of Treated Participants With Marked Laboratory Abnormalities During Open-Label Phase (Period C)	Aspartate Aminotransferase (AST, High)	5 participants
Abatacept (Period B)	Number of Treated Participants With Marked Laboratory Abnormalities During Open-Label Phase (Period C)	Alanine Aminotransferase (ALT, High) n=153	11 participants
Abatacept (Period B)	Number of Treated Participants With Marked Laboratory Abnormalities During Open-Label Phase (Period C)	G-Glutamyl Transferase (GGT, High) n=153	6 participants
Abatacept (Period B)	Number of Treated Participants With Marked Laboratory Abnormalities During Open-Label Phase (Period C)	Bilirubin (Total, High) n=153	3 participants
Abatacept (Period B)	Number of Treated Participants With Marked Laboratory Abnormalities During Open-Label Phase (Period C)	Blood Urea Nitrogen (High) n=153	15 participants
Abatacept (Period B)	Number of Treated Participants With Marked Laboratory Abnormalities During Open-Label Phase (Period C)	Creatinine (High) n=153	36 participants
Abatacept (Period B)	Number of Treated Participants With Marked Laboratory Abnormalities During Open-Label Phase (Period C)	Potassium (High) n=153	10 participants
Abatacept (Period B)	Number of Treated Participants With Marked Laboratory Abnormalities During Open-Label Phase (Period C)	Inorganic Phosphorus (High) n=153	4 participants
Abatacept (Period B)	Number of Treated Participants With Marked Laboratory Abnormalities During Open-Label Phase (Period C)	Serum Glucose (Low) n=153	54 participants
Abatacept (Period B)	Number of Treated Participants With Marked Laboratory Abnormalities During Open-Label Phase (Period C)	Serum Glucose (High) n=153	1 participants
Abatacept (Period B)	Number of Treated Participants With Marked Laboratory Abnormalities During Open-Label Phase (Period C)	Fasting Serum Glucose (Low) n=100	11 participants
Abatacept (Period B)	Number of Treated Participants With Marked Laboratory Abnormalities During Open-Label Phase (Period C)	Fasting Serum Glucose (High) n=100	7 participants
Abatacept (Period B)	Number of Treated Participants With Marked Laboratory Abnormalities During Open-Label Phase (Period C)	Total Protein (Low) n=153	1 participants
Abatacept (Period B)	Number of Treated Participants With Marked Laboratory Abnormalities During Open-Label Phase (Period C)	Total Protein (High) n=153	1 participants
Abatacept (Period B)	Number of Treated Participants With Marked Laboratory Abnormalities During Open-Label Phase (Period C)	Albumin (Low) n=153	9 participants
Abatacept (Period B)	Number of Treated Participants With Marked Laboratory Abnormalities During Open-Label Phase (Period C)	Urine Protein (High) n=153	35 participants
Abatacept (Period B)	Number of Treated Participants With Marked Laboratory Abnormalities During Open-Label Phase (Period C)	Urine Glucose (High) n=153	1 participants
Abatacept (Period B)	Number of Treated Participants With Marked Laboratory Abnormalities During Open-Label Phase (Period C)	Urine Blood (High) n=153	73 participants
Abatacept (Period B)	Number of Treated Participants With Marked Laboratory Abnormalities During Open-Label Phase (Period C)	Urine White Blood Cells (High) n=117	49 participants
Abatacept (Period B)	Number of Treated Participants With Marked Laboratory Abnormalities During Open-Label Phase (Period C)	Urine Red Blood Cells (High) n=117	86 participants

Secondary

Percentage of Participants Achieving American College of Rheumatology (ACR) Pediatric 30 (ACRP30), ACR Pediatric 50, ACR Pediatric 70, ACR Pediatric 90, and Inactive Disease Status Erythrocyte Sedimentation Rate (ESR) Response Rate

The ACRP30 response criteria were defined as a ≥ 30% improvement over baseline in ESR. ACRP 50, 70, and 90 responses were defined similarly with 50%, 70%, and 90% improvements required, respectively.

Time frame: Day 113, Day 282, and Day 2047

Population: All treated participants

Arm	Measure	Group	Value (NUMBER)
Abatacept (Period B)	Percentage of Participants Achieving American College of Rheumatology (ACR) Pediatric 30 (ACRP30), ACR Pediatric 50, ACR Pediatric 70, ACR Pediatric 90, and Inactive Disease Status Erythrocyte Sedimentation Rate (ESR) Response Rate	ACR Pediatric 30 (ESR) at Day 113	0 percentage of participants
Abatacept (Period B)	Percentage of Participants Achieving American College of Rheumatology (ACR) Pediatric 30 (ACRP30), ACR Pediatric 50, ACR Pediatric 70, ACR Pediatric 90, and Inactive Disease Status Erythrocyte Sedimentation Rate (ESR) Response Rate	ACR Pediatric 30 (ESR) at Day 282	NA percentage of participants
Abatacept (Period B)	Percentage of Participants Achieving American College of Rheumatology (ACR) Pediatric 30 (ACRP30), ACR Pediatric 50, ACR Pediatric 70, ACR Pediatric 90, and Inactive Disease Status Erythrocyte Sedimentation Rate (ESR) Response Rate	ACR Pediatric 30 (ESR) at Day 2047	69.2 percentage of participants
Abatacept (Period B)	Percentage of Participants Achieving American College of Rheumatology (ACR) Pediatric 30 (ACRP30), ACR Pediatric 50, ACR Pediatric 70, ACR Pediatric 90, and Inactive Disease Status Erythrocyte Sedimentation Rate (ESR) Response Rate	ACR Pediatric 50 (ESR) at Day 113	0 percentage of participants
Abatacept (Period B)	Percentage of Participants Achieving American College of Rheumatology (ACR) Pediatric 30 (ACRP30), ACR Pediatric 50, ACR Pediatric 70, ACR Pediatric 90, and Inactive Disease Status Erythrocyte Sedimentation Rate (ESR) Response Rate	ACR Pediatric 50 (ESR) at Day 282	NA percentage of participants
Abatacept (Period B)	Percentage of Participants Achieving American College of Rheumatology (ACR) Pediatric 30 (ACRP30), ACR Pediatric 50, ACR Pediatric 70, ACR Pediatric 90, and Inactive Disease Status Erythrocyte Sedimentation Rate (ESR) Response Rate	ACR Pediatric 50 (ESR) at Day 2047	69.2 percentage of participants
Abatacept (Period B)	Percentage of Participants Achieving American College of Rheumatology (ACR) Pediatric 30 (ACRP30), ACR Pediatric 50, ACR Pediatric 70, ACR Pediatric 90, and Inactive Disease Status Erythrocyte Sedimentation Rate (ESR) Response Rate	ACR Pediatric 70 (ESR) at Day 113	0 percentage of participants
Abatacept (Period B)	Percentage of Participants Achieving American College of Rheumatology (ACR) Pediatric 30 (ACRP30), ACR Pediatric 50, ACR Pediatric 70, ACR Pediatric 90, and Inactive Disease Status Erythrocyte Sedimentation Rate (ESR) Response Rate	ACR Pediatric 70 (ESR) at Day 282	NA percentage of participants
Abatacept (Period B)	Percentage of Participants Achieving American College of Rheumatology (ACR) Pediatric 30 (ACRP30), ACR Pediatric 50, ACR Pediatric 70, ACR Pediatric 90, and Inactive Disease Status Erythrocyte Sedimentation Rate (ESR) Response Rate	ACR Pediatric 70 (ESR) at Day 2047	53.8 percentage of participants
Abatacept (Period B)	Percentage of Participants Achieving American College of Rheumatology (ACR) Pediatric 30 (ACRP30), ACR Pediatric 50, ACR Pediatric 70, ACR Pediatric 90, and Inactive Disease Status Erythrocyte Sedimentation Rate (ESR) Response Rate	ACR Pediatric 90 (ESR) at Day 113	0 percentage of participants
Abatacept (Period B)	Percentage of Participants Achieving American College of Rheumatology (ACR) Pediatric 30 (ACRP30), ACR Pediatric 50, ACR Pediatric 70, ACR Pediatric 90, and Inactive Disease Status Erythrocyte Sedimentation Rate (ESR) Response Rate	ACR Pediatric 90 (ESR) at Day 282	NA percentage of participants
Abatacept (Period B)	Percentage of Participants Achieving American College of Rheumatology (ACR) Pediatric 30 (ACRP30), ACR Pediatric 50, ACR Pediatric 70, ACR Pediatric 90, and Inactive Disease Status Erythrocyte Sedimentation Rate (ESR) Response Rate	ACR Pediatric 90 (ESR) at Day 2047	38.5 percentage of participants
Placebo (Period B)	Percentage of Participants Achieving American College of Rheumatology (ACR) Pediatric 30 (ACRP30), ACR Pediatric 50, ACR Pediatric 70, ACR Pediatric 90, and Inactive Disease Status Erythrocyte Sedimentation Rate (ESR) Response Rate	ACR Pediatric 70 (ESR) at Day 113	37.9 percentage of participants
Placebo (Period B)	Percentage of Participants Achieving American College of Rheumatology (ACR) Pediatric 30 (ACRP30), ACR Pediatric 50, ACR Pediatric 70, ACR Pediatric 90, and Inactive Disease Status Erythrocyte Sedimentation Rate (ESR) Response Rate	ACR Pediatric 30 (ESR) at Day 113	100 percentage of participants
Placebo (Period B)	Percentage of Participants Achieving American College of Rheumatology (ACR) Pediatric 30 (ACRP30), ACR Pediatric 50, ACR Pediatric 70, ACR Pediatric 90, and Inactive Disease Status Erythrocyte Sedimentation Rate (ESR) Response Rate	ACR Pediatric 50 (ESR) at Day 2047	93.9 percentage of participants
Placebo (Period B)	Percentage of Participants Achieving American College of Rheumatology (ACR) Pediatric 30 (ACRP30), ACR Pediatric 50, ACR Pediatric 70, ACR Pediatric 90, and Inactive Disease Status Erythrocyte Sedimentation Rate (ESR) Response Rate	ACR Pediatric 70 (ESR) at Day 2047	78.8 percentage of participants
Placebo (Period B)	Percentage of Participants Achieving American College of Rheumatology (ACR) Pediatric 30 (ACRP30), ACR Pediatric 50, ACR Pediatric 70, ACR Pediatric 90, and Inactive Disease Status Erythrocyte Sedimentation Rate (ESR) Response Rate	ACR Pediatric 30 (ESR) at Day 282	84.5 percentage of participants
Placebo (Period B)	Percentage of Participants Achieving American College of Rheumatology (ACR) Pediatric 30 (ACRP30), ACR Pediatric 50, ACR Pediatric 70, ACR Pediatric 90, and Inactive Disease Status Erythrocyte Sedimentation Rate (ESR) Response Rate	ACR Pediatric 50 (ESR) at Day 282	79.3 percentage of participants
Placebo (Period B)	Percentage of Participants Achieving American College of Rheumatology (ACR) Pediatric 30 (ACRP30), ACR Pediatric 50, ACR Pediatric 70, ACR Pediatric 90, and Inactive Disease Status Erythrocyte Sedimentation Rate (ESR) Response Rate	ACR Pediatric 90 (ESR) at Day 2047	66.7 percentage of participants
Placebo (Period B)	Percentage of Participants Achieving American College of Rheumatology (ACR) Pediatric 30 (ACRP30), ACR Pediatric 50, ACR Pediatric 70, ACR Pediatric 90, and Inactive Disease Status Erythrocyte Sedimentation Rate (ESR) Response Rate	ACR Pediatric 30 (ESR) at Day 2047	97.0 percentage of participants
Placebo (Period B)	Percentage of Participants Achieving American College of Rheumatology (ACR) Pediatric 30 (ACRP30), ACR Pediatric 50, ACR Pediatric 70, ACR Pediatric 90, and Inactive Disease Status Erythrocyte Sedimentation Rate (ESR) Response Rate	ACR Pediatric 70 (ESR) at Day 282	55.2 percentage of participants
Placebo (Period B)	Percentage of Participants Achieving American College of Rheumatology (ACR) Pediatric 30 (ACRP30), ACR Pediatric 50, ACR Pediatric 70, ACR Pediatric 90, and Inactive Disease Status Erythrocyte Sedimentation Rate (ESR) Response Rate	ACR Pediatric 90 (ESR) at Day 113	17.2 percentage of participants
Placebo (Period B)	Percentage of Participants Achieving American College of Rheumatology (ACR) Pediatric 30 (ACRP30), ACR Pediatric 50, ACR Pediatric 70, ACR Pediatric 90, and Inactive Disease Status Erythrocyte Sedimentation Rate (ESR) Response Rate	ACR Pediatric 50 (ESR) at Day 113	65.5 percentage of participants
Placebo (Period B)	Percentage of Participants Achieving American College of Rheumatology (ACR) Pediatric 30 (ACRP30), ACR Pediatric 50, ACR Pediatric 70, ACR Pediatric 90, and Inactive Disease Status Erythrocyte Sedimentation Rate (ESR) Response Rate	ACR Pediatric 90 (ESR) at Day 282	41.4 percentage of participants
Placebo (Period B) to Abatacept (Period C)	Percentage of Participants Achieving American College of Rheumatology (ACR) Pediatric 30 (ACRP30), ACR Pediatric 50, ACR Pediatric 70, ACR Pediatric 90, and Inactive Disease Status Erythrocyte Sedimentation Rate (ESR) Response Rate	ACR Pediatric 50 (ESR) at Day 113	88.1 percentage of participants
Placebo (Period B) to Abatacept (Period C)	Percentage of Participants Achieving American College of Rheumatology (ACR) Pediatric 30 (ACRP30), ACR Pediatric 50, ACR Pediatric 70, ACR Pediatric 90, and Inactive Disease Status Erythrocyte Sedimentation Rate (ESR) Response Rate	ACR Pediatric 50 (ESR) at Day 282	52.5 percentage of participants
Placebo (Period B) to Abatacept (Period C)	Percentage of Participants Achieving American College of Rheumatology (ACR) Pediatric 30 (ACRP30), ACR Pediatric 50, ACR Pediatric 70, ACR Pediatric 90, and Inactive Disease Status Erythrocyte Sedimentation Rate (ESR) Response Rate	ACR Pediatric 90 (ESR) at Day 2047	40.0 percentage of participants
Placebo (Period B) to Abatacept (Period C)	Percentage of Participants Achieving American College of Rheumatology (ACR) Pediatric 30 (ACRP30), ACR Pediatric 50, ACR Pediatric 70, ACR Pediatric 90, and Inactive Disease Status Erythrocyte Sedimentation Rate (ESR) Response Rate	ACR Pediatric 50 (ESR) at Day 2047	80.0 percentage of participants
Placebo (Period B) to Abatacept (Period C)	Percentage of Participants Achieving American College of Rheumatology (ACR) Pediatric 30 (ACRP30), ACR Pediatric 50, ACR Pediatric 70, ACR Pediatric 90, and Inactive Disease Status Erythrocyte Sedimentation Rate (ESR) Response Rate	ACR Pediatric 70 (ESR) at Day 113	49.2 percentage of participants
Placebo (Period B) to Abatacept (Period C)	Percentage of Participants Achieving American College of Rheumatology (ACR) Pediatric 30 (ACRP30), ACR Pediatric 50, ACR Pediatric 70, ACR Pediatric 90, and Inactive Disease Status Erythrocyte Sedimentation Rate (ESR) Response Rate	ACR Pediatric 90 (ESR) at Day 282	15.3 percentage of participants
Placebo (Period B) to Abatacept (Period C)	Percentage of Participants Achieving American College of Rheumatology (ACR) Pediatric 30 (ACRP30), ACR Pediatric 50, ACR Pediatric 70, ACR Pediatric 90, and Inactive Disease Status Erythrocyte Sedimentation Rate (ESR) Response Rate	ACR Pediatric 70 (ESR) at Day 282	30.5 percentage of participants
Placebo (Period B) to Abatacept (Period C)	Percentage of Participants Achieving American College of Rheumatology (ACR) Pediatric 30 (ACRP30), ACR Pediatric 50, ACR Pediatric 70, ACR Pediatric 90, and Inactive Disease Status Erythrocyte Sedimentation Rate (ESR) Response Rate	ACR Pediatric 70 (ESR) at Day 2047	63.3 percentage of participants
Placebo (Period B) to Abatacept (Period C)	Percentage of Participants Achieving American College of Rheumatology (ACR) Pediatric 30 (ACRP30), ACR Pediatric 50, ACR Pediatric 70, ACR Pediatric 90, and Inactive Disease Status Erythrocyte Sedimentation Rate (ESR) Response Rate	ACR Pediatric 30 (ESR) at Day 113	100 percentage of participants
Placebo (Period B) to Abatacept (Period C)	Percentage of Participants Achieving American College of Rheumatology (ACR) Pediatric 30 (ACRP30), ACR Pediatric 50, ACR Pediatric 70, ACR Pediatric 90, and Inactive Disease Status Erythrocyte Sedimentation Rate (ESR) Response Rate	ACR Pediatric 30 (ESR) at Day 282	67.8 percentage of participants
Placebo (Period B) to Abatacept (Period C)	Percentage of Participants Achieving American College of Rheumatology (ACR) Pediatric 30 (ACRP30), ACR Pediatric 50, ACR Pediatric 70, ACR Pediatric 90, and Inactive Disease Status Erythrocyte Sedimentation Rate (ESR) Response Rate	ACR Pediatric 30 (ESR) at Day 2047	86.7 percentage of participants
Placebo (Period B) to Abatacept (Period C)	Percentage of Participants Achieving American College of Rheumatology (ACR) Pediatric 30 (ACRP30), ACR Pediatric 50, ACR Pediatric 70, ACR Pediatric 90, and Inactive Disease Status Erythrocyte Sedimentation Rate (ESR) Response Rate	ACR Pediatric 90 (ESR) at Day 113	22.0 percentage of participants

Source: ClinicalTrials.gov · Data processed: Apr 5, 2026

BMS-188667 in Children and Adolescents With Juvenile Rheumatoid Arthritis

Conditions

Keywords

Brief summary

Related papers

Interventions

Sponsors

Study design

Eligibility

Inclusion criteria

Exclusion criteria

Design outcomes

Primary

Secondary

Countries

Participant flow

Pre-assignment details

Participants by arm

Withdrawals & dropouts

Baseline characteristics

Adverse events

Outcome results

Time to Occurrence of Juvenile Rheumatoid Arthritis/Juvenile Idiopathic Arthritis (JRA/JIA) Disease Flare During Double-Blind Phase (Period B)

Events of Special Interest During Double-Blind Phase (Period B), Including Infections, Peri-Infusional Adverse Events (AEs), Autoimmune Disorders and Malignancies

Events of Special Interest During Open-Label Lead-In Phase (Period A), Including Infections, Peri-Infusional Adverse Events (AEs), Autoimmune Disorders and Malignancies

Events of Special Interest During Open-Label Phase (Period C), Including Infections, Peri-Infusional Adverse Events (AEs), Autoimmune Disorders and Malignancies

Median Percent Change From Baseline in JRA/JIA Core Set Variables During Double-Blind Phase (Period B)

Median Percent Change From Baseline in JRA/JIA Core Set Variables During Open-Label Phase (Period C)

Number of Participants With a Juvenile Rheumatoid Arthritis/Juvenile Idiopathic Arthritis (JRA/JIA) Disease With a Flare During Double-Blind Phase (Period B)

Number of Participants With Anti-Abatacept or Anti-CTLA4 Positive Responses Over Time During Open-Label Phase (Period C)

Number of Participants With Serious Adverse Events (SAEs), Treatment-Related AEs, Deaths, Discontinuation of Study Drug Due to AEs During Double-Blind Phase (Period B)

Number of Participants With Serious Adverse Events (SAEs), Treatment-Related AEs, Deaths, Discontinuation of Study Drug Due to AEs During Open-Label Lead-In Phase (Period A)

Number of Participants With Serious Adverse Events (SAEs), Treatment-Related AEs, Deaths, Discontinuation of Study Drug Due to AEs During Open-Label Phase (Period C)

Number of Treated Participants With Marked Laboratory Abnormalities During Double-Blind Phase (Period B)

Number of Treated Participants With Marked Laboratory Abnormalities During Open-Label Lead-In Phase (Period A)

Number of Treated Participants With Marked Laboratory Abnormalities During Open-Label Phase (Period C)

Percentage of Participants Achieving American College of Rheumatology (ACR) Pediatric 30 (ACRP30), ACR Pediatric 50, ACR Pediatric 70, ACR Pediatric 90, and Inactive Disease Status Erythrocyte Sedimentation Rate (ESR) Response Rate