A Phase 3 Multi-center, Open-Label Study to Evaluate 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)
ClinicalTrials.gov processed this data on June 26, 2023. Link to the current ClinicalTrials.gov record.Recruitment Status
COMPLETED - HAS RESULTS(See Contacts and Locations)
Verified June 2023 by Bristol-Myers Squibb
Sponsor
Bristol-Myers SquibbInformation Provided by (Responsible Party)
Bristol-Myers SquibbClinicaltrials.gov Identifier
NCT01844518Other Study ID Numbers: IM101-301
First Submitted: April 29, 2013
First Posted: May 1, 2013
Results First Posted: March 24, 2016
Last Update Posted: July 12, 2023
Last Verified: June 2023
History of Changes
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Study Description
Not Provided| Condition or Disease | Intervention/Treatment |
|---|---|
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Study Design
| Study Type | Interventional |
|---|---|
| Actual Enrollment | 219 participants |
| Design Allocation | N/A |
| Interventional Model | Single Group Assignment |
| Masking | None (Open Label) |
| Primary Purpose | Treatment |
| Official Title | A Phase 3 Multi-center, Open-Label Study to Evaluate 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) |
| Study Start Date | August 30, 2013 |
| Actual Primary Completion Date | March 12, 2015 |
| Actual Study Completion Date | February 1, 2023 |
Groups and Cohorts
| Group/ Cohort | Intervention/ Treatment |
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Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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:
number of active joints
number of joints with limitation of motion (LOM)
physician global assessment of disease activity
parent global assessment of patient overall well-being
functional ability as measured by the Children's Health Assessment Questionnaire (CHAQ)
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. - 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.
- 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.
- 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.
- 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.
- 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.
Eligibility Criteria
| Ages Eligible for Study | 2 Years to 17 Years (Child) |
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| Sexes Eligible for Study | All |
| Accepts Healthy Volunteers | No |
| Inclusion Criteria |
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| Exclusion Criteria |
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Contacts and Locations
| Sponsors and Collaborators | Bristol-Myers Squibb |
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| Locations |
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| Investigators |
More Information
Additional Information
Publications
Additional Relevant MeSH Terms
- Arthritis
- Arthritis, Juvenile
- Joint Diseases
- Musculoskeletal Diseases
- Rheumatic Diseases
- Connective Tissue Diseases
- Autoimmune Diseases
- Immune System Diseases