Clinical Trial: Active Juvenile Idiopathic Arthritis (JIA) Compassionate Use
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Compassionate Use Study of Adalimumab in Children 2 to < 4 Years Old or Age 4 and Above Weighing Less Than 15 kg With Active Juvenile Idiopathic Arthritis (JIA)
Brief Summary: The main objective of this study is to evaluate the safety of adalimumab in patients 2 to < 4 years of age or ≥ 4 years of age weighing < 15 kg, with moderately to severely active polyarticular juvenile idiopathic arthritis (JIA) or polyarticular course JIA.
Detailed Summary:
Sponsor: AbbVie (prior sponsor, Abbott)
Current Primary Outcome: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) [ Time Frame: TEAEs were collected from first dose of study drug until 70 days after the last dose of study drug and before start of commercial adalimumab or other biologics (32.5 months). ]
Original Primary Outcome: Measure: Incidence of SAEs and AEs of Interest [ Time Frame: Duration of study ]
Current Secondary Outcome:
- Mean Serum Adalimumab Trough Concentrations at Week 0, Week 12, and Week 24 [ Time Frame: Weeks 0, 12, and 24 ]Adalimumab concentrations in serum were determined using a validated enzyme-linked immunoadsorbent assay (ELISA) method. The lower limit of quantitation (LLOQ) for adalimumab is 3.13 ng/mL.
- Hemoglobin: Mean Change From Baseline to Each Visit [ Time Frame: Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120 ]Baseline is the last value prior to the first dose of study drug. Participants with non-missing baseline and at least 1 post-baseline observation are included in the analysis. n=participants with evaluable data at given time point.
- Hematocrit: Mean Change From Baseline to Each Visit [ Time Frame: Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120 ]Baseline is the last value prior to the first dose of study drug. Participants with non-missing baseline and at least 1 post-baseline observation are included in the analysis. n=participants with evaluable data at given time point.
- Red Blood Cell (RBC) Count: Mean Change From Baseline to Each Visit [ Time Frame: Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120 ]Baseline is the last value prior to the first dose of study drug. Participants with non-missing baseline and at least 1 post-baseline observation are included in the analysis. n=participants with evaluable data at given time point.
- Platelets: Mean Change From Baseline to Each Visit [ Time Frame: Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120 ]Baseline is the last value prior to the first dose of study drug. Participants with non-missing baseline and at least 1 post-baseline observation are included in the analysis. n=participants with evaluable data at given time point.
- White Blood Cell (WBC) Count: Mean Change From Baseline to Each Visit [ Time Frame: Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120 ]Baseline is the last value prior to the first dose of study drug. Participants with non-missing baseline and at least 1 post-baseline observation are included in the analysis. n=participants with evaluable data at given time point.
- Neutrophils: Mean Change From Baseline to Each Visit [ Time Frame: Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120 ]Baseline is the last value prior to the first dose of study drug. Participants with non-missing baseline and at least 1 post-baseline observation are included in the analysis. n=participants with evaluable data at given time point.
- Lymphocytes: Mean Change From Baseline to Each Visit [ Time Frame: Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120 ]Baseline is the last value prior to the first dose of study drug. Participants with non-missing baseline and at least 1 post-baseline observation are included in the analysis. n=participants with evaluable data at given time point.
- Monocytes: Mean Change From Baseline to Each Visit [ Time Frame: Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120 ]Baseline is the last value prior to the first dose of study drug. Participants with non-missing baseline and at least 1 post-baseline observation are included in the analysis. n=participants with evaluable data at given time point.
- Eosinophils: Mean Change From Baseline to Each Visit [ Time Frame: Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120 ]Baseline is the last value prior to the first dose of study drug. Participants with non-missing baseline and at least 1 post-baseline observation are included in the analysis. n=participants with evaluable data at given time point.
- Basophils: Mean Change From Baseline to Each Visit [ Time Frame: Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120 ]Baseline is the last value prior to the first dose of study drug. Participants with non-missing baseline and at least 1 post-baseline observation are included in the analysis. n=participants with evaluable data at given time point.
- Alanine Aminotransferase (SGPT/ALT): Mean Change From Baseline to Each Visit [ Time Frame: Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120 ]Baseline is the last value prior to the first dose of study drug. Participants with non-missing baseline and at least 1 post-baseline observation are included in the analysis. n=participants with evaluable data at given time point.
- Aspartate Aminotransferase (SGOT/AST): Mean Change From Baseline to Each Visit [ Time Frame: Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120 ]Baseline is the last value prior to the first dose of study drug.Participants with non-mis
Original Secondary Outcome:
- Measure: PedACR30 [ Time Frame: Duration of study ]
- Measure: PedACR50 [ Time Frame: Duration of study ]
- Measure: PedACR70 [ Time Frame: Duration of study ]
- Measure: PedACR90 [ Time Frame: Duration of study ]
Information By: AbbVie
Dates:
Date Received: October 17, 2008
Date Started: March 2009
Date Completion:
Last Updated: December 17, 2015
Last Verified: December 2015