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). ]

An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. If an AE meets any of the following criteria, it is considered a serious adverse event (SAE): Results in death, is life-threatening, results in hospitalization or the prolongation of hospitalization, is a congenital anomaly or a persistent or significant disability/incapacity, or is an important medical event requiring medical or surgical intervention to prevent a serious outcome. A treatment-emergent AE (TEAE) is defined as any AE with onset or worsening reported by a participant from the time that the first dose of adalimumab is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab administration (total of 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