Trial · NCT01844518
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)
NCT01844518, Phase 3, Completed, Bristol-Myers Squibb; results first posted 2016-03-24
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. 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). Trials, record NCT01844518. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01844518
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- 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
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 219 participants, actual
- Lead sponsor
- Bristol-Myers Squibb
- Conditions
- Active Polyarticular Juvenile Idiopathic Arthritis
- Interventions
- Abatacept
- First posted
- 2013-05-01
- Last updated
- 2023-07-12
- Other registries' IDs
- eudract:2012-003195-39
- Results first posted
- 2016-03-24
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Abatacept Trough Concentration (Cmin) in Participants Ages 6 to 17 | Day 113 | Trough concentration of abatacept (reported as geometric mean of Cmin) in all pharmacokinetic (PK)-evaluable participants. Cmin is reported in microgram per milliliter (µg/mL). Desired target therapeutic Cmin should be \>= 10 µg/mL. |
| Secondary | Percentage of Participants (Ages 6 to 17) Achieving American College of Rheumatology Pediatric 30 Response (ACRp30) | Day 113 | ACRp30 is defined as ≥30% improvement in at least 3 of the 6 juvenile idiopathic arthritis (JIA) core set variables: 1. number of active joints 2. number of joints with limitation of motion (LOM) 3. physician global assessment of disease activity 4. parent global assessment of patient overall well-being 5. functional ability as measured by the Children's Health Assessment Questionnaire (CHAQ) 6. C-reactive protein (CRP). In addition to the above condition, to be considered a responder participants cannot have ≥30% worsening in more than 1 of the 3 remaining JIA core set variables for which improvement was not observed. |
| Secondary | Abatacept Trough Concentration (Cmin) in Participants Ages 6 to 17 by Weight Tier Dose | Days 57, 85 and 113 | Evaluation of the trough concentration of abatacept (reported as geometric mean of Cmin) in all pk-evaluable participants at Days 57, 85 and 113. Weight-tiered dosing groups are based on the first dose the participant received. Cmin is reported in microgram per milliliter (µg/mL). Here 'n' number analyzed signifies participants who were evaluable for each time point. |
| Secondary | Number of Participants With Adverse Events (AEs), Deaths, Serious AEs (SAEs) and AEs Leading to Discontinuation in the Short-Term Period for the 6-17 Year Age-Group Cohort | From first dose up to 56 days post last dose in the short-term period (initial 4-month treatment period) | An AE is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational (medicinal) product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory finding), symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product. A SAE is any untoward medical occurrence that at any dose which results in death, is life threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect. |
| Secondary | Number of Participants With Adverse Events (AEs), Deaths, Serious AEs and AEs Leading to Discontinuation in the Cumulative Period | From first dose up to 56 days after last dose ( up to approximately 2 years) | An AE is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational (medicinal) product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory finding), symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product. A SAE is any untoward medical occurrence that at any dose which results in death, is life threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect. |
| Secondary | Number of Participants With Positive Immunogenicity Response in the Short-Term Period for the 6-17 Year Age-Group Cohort | From first dose up to start of LT (for those continuing in long-term) or up to 168 days after the lost dose of study medication in the ST period (for those not entering in the long-term) | 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 for those subjects who discontinued from the short term (ST) period (initial 4-month treatment period) or completed the ST study without continuing abatacept treatment. |
| Secondary | Number of Participants With Positive Immunogenicity Response in the Cumulative Period | From first dose up to 6 months following treatment discontinuation (up to approximately 2 years) | 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. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Abatacept Trough Concentration (Cmin) in Participants Ages 6 to 17 | Day 113 | All treated participants with available PK measurements. Endpoint pre-specified to only be collected for 6-17 year age group. | µg/mL | GEOMETRIC_MEAN |
| SECONDARY | Percentage of Participants (Ages 6 to 17) Achieving American College of Rheumatology Pediatric 30 Response (ACRp30) | Day 113 | All treated participants in the 6-17 Year Age-Group Cohort. Endpoint prespecified to only be collected for 6-17 year age group. | Percentage of participants | NUMBER |
| SECONDARY | Abatacept Trough Concentration (Cmin) in Participants Ages 6 to 17 by Weight Tier Dose | Days 57, 85 and 113 | All treated participants with available PK measurements in the 6-17 Year Age-Group Cohort. Endpoint pre-specified to only be collected for 6-17 year age group. | microgram per milliliter (µg/mL) | GEOMETRIC_MEAN |
| SECONDARY | Number of Participants With Adverse Events (AEs), Deaths, Serious AEs (SAEs) and AEs Leading to Discontinuation in the Short-Term Period for the 6-17 Year Age-Group Cohort | From first dose up to 56 days post last dose in the short-term period (initial 4-month treatment period) | All treated participants in the short-term period in the 6-17 Year Age Group Cohort. Endpoint pre-specified to only be collected for 6-17 year age group. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Adverse Events (AEs), Deaths, Serious AEs and AEs Leading to Discontinuation in the Cumulative Period | From first dose up to 56 days after last dose ( up to approximately 2 years) | All treated participants in the cumulative period | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Positive Immunogenicity Response in the Short-Term Period for the 6-17 Year Age-Group Cohort | From first dose up to start of LT (for those continuing in long-term) or up to 168 days after the lost dose of study medication in the ST period (for those not entering in the long-term) | All treated participants in the short-term period with available immunogenicity measurements in the 6-17 Year Age-Group Cohort. Endpoint pre-specified to only be collected for 6-17 year age group. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Positive Immunogenicity Response in the Cumulative Period | From first dose up to 6 months following treatment discontinuation (up to approximately 2 years) | All treated participants in the cumulative period with available immunogenicity measurements. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group35
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Abatacept Trough Concentration (Cmin) in Participants Ages 6 to 17 | SC Abatacept Ages 6 to 17 | 39.7 | Geometric Coefficient of Variation 35 | µg/mL | |
| Percentage of Participants (Ages 6 to 17) Achieving American College of Rheumatology Pediatric 30 Response (ACRp30) | SC Abatacept Ages 6 to 17 | 83.2 | 95% Confidence Interval 77.7 to 88.8 | Percentage of participants | |
| Abatacept Trough Concentration (Cmin) in Participants Ages 6 to 17 by Weight Tier Dose | 10 to <25 kg Dosing Group | Day 57 | 29.5 | Geometric Coefficient of Variation 32 | microgram per milliliter (µg/mL) |
| Abatacept Trough Concentration (Cmin) in Participants Ages 6 to 17 by Weight Tier Dose | 25 to <50 kg Dosing Group | Day 57 | 36.2 | Geometric Coefficient of Variation 35 | microgram per milliliter (µg/mL) |
| Abatacept Trough Concentration (Cmin) in Participants Ages 6 to 17 by Weight Tier Dose | >=50 kg Dosing Group | Day 57 | 33.0 | Geometric Coefficient of Variation 33 | microgram per milliliter (µg/mL) |
| Abatacept Trough Concentration (Cmin) in Participants Ages 6 to 17 by Weight Tier Dose | 10 to <25 kg Dosing Group | Day 85 | 27.7 | Geometric Coefficient of Variation 38 | microgram per milliliter (µg/mL) |
| Abatacept Trough Concentration (Cmin) in Participants Ages 6 to 17 by Weight Tier Dose | 25 to <50 kg Dosing Group | Day 85 | 42.5 | Geometric Coefficient of Variation 32 | microgram per milliliter (µg/mL) |
| Abatacept Trough Concentration (Cmin) in Participants Ages 6 to 17 by Weight Tier Dose | >=50 kg Dosing Group | Day 85 | 36.0 | Geometric Coefficient of Variation 40 | microgram per milliliter (µg/mL) |
| Abatacept Trough Concentration (Cmin) in Participants Ages 6 to 17 by Weight Tier Dose | 10 to <25 kg Dosing Group | Day 113 | 34.3 | Geometric Coefficient of Variation 39 | microgram per milliliter (µg/mL) |
| Abatacept Trough Concentration (Cmin) in Participants Ages 6 to 17 by Weight Tier Dose | 25 to <50 kg Dosing Group | Day 113 | 44.2 | Geometric Coefficient of Variation 34 | microgram per milliliter (µg/mL) |
1 to 10 of 35Source ClinicalTrials.gov
See all 35 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | SC Abatacept Ages 6 to 17 | 173 | |
| Overall Study | STARTED | SC Abatacept Ages 2 to 5 | 46 | |
| Overall Study | COMPLETED | SC Abatacept Ages 6 to 17 | 132 | |
| Overall Study | COMPLETED | SC Abatacept Ages 2 to 5 | 39 | |
| Overall Study | NOT COMPLETED | SC Abatacept Ages 6 to 17 | 41 | |
| Overall Study | NOT COMPLETED | SC Abatacept Ages 2 to 5 | 7 |
Source ClinicalTrials.gov
Adverse events126
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | SC Abatacept Ages 6 to 17 | 7 | 173 | |
| other | Anaemia | Blood and lymphatic system disorders | SC Abatacept Ages 2 to 5 | 4 | 46 | |
| other | Abdominal pain | Gastrointestinal disorders | SC Abatacept Ages 6 to 17 | 16 | 173 | |
| other | Abdominal pain | Gastrointestinal disorders | SC Abatacept Ages 2 to 5 | 6 | 46 | |
| other | Aphthous ulcer | Gastrointestinal disorders | SC Abatacept Ages 6 to 17 | 5 | 173 | |
| other | Aphthous ulcer | Gastrointestinal disorders | SC Abatacept Ages 2 to 5 | 5 | 46 | |
| other | Constipation | Gastrointestinal disorders | SC Abatacept Ages 6 to 17 | 2 | 173 | |
| other | Constipation | Gastrointestinal disorders | SC Abatacept Ages 2 to 5 | 3 | 46 | |
| other | Dental caries | Gastrointestinal disorders | SC Abatacept Ages 6 to 17 | 8 | 173 | |
| other | Dental caries | Gastrointestinal disorders | SC Abatacept Ages 2 to 5 | 4 | 46 |
1 to 10 of 126Source ClinicalTrials.gov
See all 126 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | SC Abatacept Ages 6 to 17 | 0 | 173 |
| Total, all-cause mortality | SC Abatacept Ages 2 to 5 | 0 | 46 |
| Total, other adverse events | SC Abatacept Ages 6 to 17 | 127 | 173 |
| Total, other adverse events | SC Abatacept Ages 2 to 5 | 44 | 46 |
| Total, serious adverse events | SC Abatacept Ages 6 to 17 | 18 | 173 |
| Total, serious adverse events | SC Abatacept Ages 2 to 5 | 6 | 46 |
Source ClinicalTrials.gov
Papers6
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| 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 |
| SC Abatacept Ages 6 to 17 vs SC Abatacept Ages 2 to 5: deaths from any cause | Trial comparisons |
| SC Abatacept Ages 6 to 17 vs SC Abatacept Ages 2 to 5: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
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
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01844518
GET https://conductscience.org/api/trials/v1/NCT01844518/results?page=2