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Comparison · NCT01844518-55124a91

SC Abatacept Ages 6 to 17 vs SC Abatacept Ages 2 to 5: Number of Participants With Positive Immunogenicity Response in the Cumulative Period

Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.

2 sourcestrial-comparisons-2026-03-23-0.1.0

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ConductScience Library. SC Abatacept Ages 6 to 17 vs SC Abatacept Ages 2 to 5: Number of Participants With Positive Immunogenicity Response in the Cumulative Period. Trial comparisons, record NCT01844518-55124a91. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01844518-55124a91

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Measures6

Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.

MeasureValue95% interval, lower95% interval, upperMethodNote
Risk in group 10.04650.02380.0891wilson
Risk in group 20.1520.07570.282wilson
Risk difference, group 1 minus group 2-0.106-0.238-0.0182newcombe hybrid score
Risk ratio, group 1 over group 20.3060.1170.799log
Odds ratio, group 1 over group 20.2720.0930.795log
Number needed to treat, for one fewer participant with the outcome on SC Abatacept Ages 6 to 17 than on SC Abatacept Ages 2 to 59.464.2155.1from the risk difference interval

Groups2

Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.

GroupTitleDescriptionWith the outcomeAnalysedClinicalTrials.gov code
Group 1SC Abatacept Ages 6 to 17
Subcutaneous (SC) abatacept administered by prefilled syringe (PFS) once weekly according to the following weight-tiered dosing regimen: 10 to less than (\<) 25 kilogram (kg) (50 milligram \[mg\] in 0.4 milliliter \[mL\] PFS), 25 to \< 50 kg (87.5 mg in 0.7 mL PFS) and 50 kg (125 mg in 1 mL PFS).
8172OG000
Group 2SC Abatacept Ages 2 to 5
SC abatacept administered by PFS once weekly according to the following weight-tiered dosing regimen: 10 to \< 25 kg (50 mg in 0.4 mL PFS), 25 to \< 50 kg (87.5 mg in 0.7 mL PFS) and 50 kg (125 mg in 1 mL PFS).
746OG001

Outcome

Type
SECONDARY
Title
Number of Participants With Positive Immunogenicity Response in the Cumulative Period
Description
Overall number of participants with either a positive immunogenicity response for 'CTLA4 and possibly Ig' or 'Ig and/or Junction Region' relative to baseline. Sample draws for immunogenicity were scheduled at specific study days while on treatment for all subjects and at follow-up visits 28, 85, and 168 days after the last abatacept dose regardless of whether they discontinued early in the short term (ST) or long term (LT) period, elected not to enter the LT period, or completed both ST and LT periods.
Time frame
From first dose up to 6 months following treatment discontinuation (up to approximately 2 years)
Population
All treated participants in the cumulative period with available immunogenicity measurements.

Source ClinicalTrials.gov

Trial

Title
Pharmacokinetics, Efficacy and Safety of Abatacept Administered Subcutaneously (SC) in Children and Adolescents With Active Polyarticular Juvenile Idiopathic Arthritis (pJIA) and Inadequate Response (IR) to Biologic or Non Biologic Disease Modifying Anti-rheumatic Drugs (DMARDs)
NCT number
NCT01844518
Phases
PHASE3
Conditions
Active Polyarticular Juvenile Idiopathic Arthritis
Interventions
Abatacept
Lead sponsor
Bristol-Myers Squibb
Results first posted
2016-03-24

Source ClinicalTrials.gov

Source

Release
trial-comparisons-2026-03-23-0.1.0
Release manifest SHA-256
f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
AACT copy
2026-03-23
Tables read
outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet

Source ClinicalTrials.gov

Sources 2

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.

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