Phase 3 N=32 Treatment

Active Juvenile Idiopathic Arthritis (JIA) Compassionate Use

Juvenile Idiopathic Arthritis

Bottom Line

View on ClinicalTrials.gov: NCT00775437 ↗

Enrolled (actual)

Serious AEs

15.6%

Results posted

Jan 2016

Primary outcome: Primary: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) — 29; 5 participants

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Adalimumab (Drug)
Age: Pediatric · 2+ yrs
Sex: All
Sponsor: AbbVie (prior sponsor, Abbott)
Primary completion: Mar 2013

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	29; 5	—
SECONDARY Mean Serum Adalimumab Trough Concentrations at Week 0, Week 12, and Week 24	0; 6.97; 7.78	—
SECONDARY Hemoglobin: Mean Change From Baseline to Each Visit	6.7; 6.7; 5.5; 5.3; 6; 9.5	—
SECONDARY Hematocrit: Mean Change From Baseline to Each Visit	0.018; 0.016; 0.017; 0.011; 0.009; 0.024	—
SECONDARY Red Blood Cell (RBC) Count: Mean Change From Baseline to Each Visit	0.15; 0.08; 0.098; 0.05; 0.07; 0.1	—
SECONDARY Platelets: Mean Change From Baseline to Each Visit	-35; -57.7; -75.2; -21; -46.7; -51.1	—
SECONDARY White Blood Cell (WBC) Count: Mean Change From Baseline to Each Visit	0.19; -0.25; -0.42; 0.3; 0.25; 0.66	—
SECONDARY Neutrophils: Mean Change From Baseline to Each Visit	-0.138; -0.619; -0.586; 0.065; 0.222; -0.169	—
SECONDARY Lymphocytes: Mean Change From Baseline to Each Visit	0.371; 0.292; 0.176; 0.186; -0.034; 0.636	—
SECONDARY Monocytes: Mean Change From Baseline to Each Visit	-0.032; 0.081; 0.028; -0.006; 0.08; 0.113	—
SECONDARY Eosinophils: Mean Change From Baseline to Each Visit	-0.004; -0.006; -0.052; 0.056; -0.015; 0.069	—
SECONDARY Basophils: Mean Change From Baseline to Each Visit	-0.012; -0.002; 0.003; 0.005; -0.003; 0.007	—
SECONDARY Alanine Aminotransferase (SGPT/ALT): Mean Change From Baseline to Each Visit	0.5; -1.1; 0; -4.5; -2; -1.8	—
SECONDARY Aspartate Aminotransferase (SGOT/AST): Mean Change From Baseline to Each Visit	2.8; -0.6; 2; -0.7; -0.4; 0.3	—
SECONDARY Alkaline Phosphatase (ALP): Mean Change From Baseline to Each Visit	15.7; 10.6; 23.2; 21.7; 17.9; 17.9	—
SECONDARY Creatine Phosphokinase: Mean Change From Baseline to Each Visit	17.2; 7; 24.8; 18.4; 26.6; 41.6	—
SECONDARY Total Bilirubin: Mean Change From Baseline to Each Visit	1.2; 0.6; 0.6; 0.9; 1; 0.2	—
SECONDARY Creatinine: Mean Change From Baseline to Each Visit	1.7; 0.5; 0.3; 2.5; 2.8; 3.4	—
SECONDARY Uric Acid: Mean Change From Baseline to Each Visit	1.7; 6.5; 2.5; 5.6; 1.9; -0.9	—
SECONDARY Percentage of Participants Achieving Pediatric American College of Rheumatology (PedACR) 30% Response (PedACR30)	93.5; 90.6; 93.5; 90; 84.4; 90.3	—
SECONDARY Percentage of Participants Achieving Pediatric American College of Rheumatology (PedACR) 50% Response (PedACR50)	90.3; 87.5; 90.3; 83.3; 78.1; 83.9	—
SECONDARY Percentage of Participants Achieving Pediatric American College of Rheumatology (PedACR) 70% Response (PedACR70)	61.3; 59.4; 61.3; 73.3; 68.8; 74.2	—
SECONDARY Percentage of Participants Achieving Pediatric American College of Rheumatology (PedACR) 90% Response (PedACR90)	38.7; 37.5; 38.7; 36.7; 34.4; 35.5	—
SECONDARY Physician's Global Assessment of Disease Activity: Mean Change From Baseline to Each Visit	-41.4; -45.3; -43; -46.5; -42.7; -51.1	—
SECONDARY Parent's Global Assessment of Disease Activity: Mean Change From Baseline to Each Visit	-28.1; -32.2; -35.1; -35.6; -34.5; -43.8	—
SECONDARY Disability Index of Child Health Assessment Questionnaire (DICHAQ): Mean Change From Baseline to Each Visit	-0.5; -0.5; -0.6; -0.6; -0.6; -0.9	—
SECONDARY Active Joint Counts (AJC73): Mean Change From Baseline to Each Visit	-5; -6.1; -7; -7.3; -7.1; -8	—
SECONDARY Limitation of Passive Motion (LOM69) Joint Count: Mean Change From Baseline to Each Visit	-4.5; -5.4; -5.3; -5.6; -6.3; -6.8	—
SECONDARY C-reactive Protein (CRP): Mean Change From Baseline to Each Visit	-0.6; -0.2; -0.4; 0.4; -0.3; -0.7	—
SECONDARY Tender Joint Count (TJC75): Mean Change From Baseline to Each Visit	-2.3; -2.8; -3.1; -2.7; -3.5; -3.9	—
SECONDARY Swollen Joint Count (SJC66): Mean Change From Baseline to Each Visit	-4.5; -5.3; -6; -6.2; -6.1; -6.9	—
SECONDARY Pain on Passive Motion (POM75) Joint Count: Mean Change From Baseline to Each Visit	-3.3; -4; -4.6; -4.9; -4.9; -5.4	—
SECONDARY Child's Health Questionnaire Parent Form (CHQ-PF50) Global Health Category: Mean Change From Baseline to Each Visit	17.1; 24.3; 25; 30.9; 21.8; 31.5	—
SECONDARY Child's Health Questionnaire Parent Form (CHQ-PF50) Physical Functioning Category: Mean Change From Baseline to Each Visit	30.6; 31.6; 36.4; 31.5; 29; 40.6	—
SECONDARY Child's Health Questionnaire Parent Form (CHQ-PF50) Role/Social Limitations/Emotional/Behavioral Category: Mean Change From Baseline to Each Visit	20.8; 17.7; 17.2; 16; 20.8; 26.5	—
SECONDARY Child's Health Questionnaire Parent Form (CHQ-PF50) Role/Social Limitations - Physical Category: Mean Change From Baseline to Each Visit	28.6; 31.7; 30.6; 27.5; 34.4; 36.1	—
SECONDARY Child's Health Questionnaire Parent Form (CHQ-PF50) Bodily Pain/Discomfort Category: Mean Change From Baseline to Each Visit	35; 36.2; 38.8; 41.7; 39; 48.2	—
SECONDARY Child's Health Questionnaire Parent Form (CHQ-PF50) Behavior Category: Mean Change From Baseline to Each Visit	5.6; 4.2; 0.4; 3.6; -0.3; 0.1	—
SECONDARY Child's Health Questionnaire Parent Form (CHQ-PF50) Global Behavior Item: Mean Change From Baseline to Each Visit	4.5; 10.8; 9.2; 4.1; -3.5; 2	—
SECONDARY Child's Health Questionnaire Parent Form (CHQ-PF50) Mental Health Category: Mean Change From Baseline to Each Visit	3.5; 3.5; 4.1; 5.4; 2.1; 5	—
SECONDARY Child's Health Questionnaire Parent Form (CHQ-PF50) Self Esteem Category: Mean Change From Baseline to Each Visit	10.6; 10.5; 16.8; 15.2; 10.2; -2.8	—
SECONDARY Child's Health Questionnaire Parent Form (CHQ-PF50) General Health Perceptions Category: Mean Change From Baseline to Each Visit	0.7; 3.8; 6.2; 7.2; 0.7; 9.1	—
SECONDARY Child's Health Questionnaire Parent Form (CHQ-PF50) Change in Health Category: Mean Change From Baseline to Each Visit	1.4; 1.7; 1.7; 1.7; 1.3; 1.6	—
SECONDARY Child's Health Questionnaire Parent Form (CHQ-PF50) Parental Impact - Emotional Category: Mean Change From Baseline to Each Visit	11.4; 19; 29.2; 34.1; 31.7; 34.4	—
SECONDARY Child's Health Questionnaire Parent Form (CHQ-PF50) Parental Impact - Time Category: Mean Change From Baseline to Each Visit	4.6; 13.5; 21.8; 18.4; 13.3; 22.2	—
SECONDARY Child's Health Questionnaire Parent Form (CHQ-PF50) Family Activities Category: Mean Change From Baseline to Each Visit	8.3; 17.6; 20; 16.8; 14.8; 17.2	—
SECONDARY Child's Health Questionnaire Parent Form (CHQ-PF50) Family Cohesion Category: Mean Change From Baseline to Each Visit	2.5; 4.3; 5.6; 3.7; 4.8; 7.2	—

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.

Eligibility Criteria

Inclusion Criteria

A parent or guardian has voluntarily signed and dated an informed consent form, approved by an Institutional Review Board (IRB)/Independent Ethics Committee (IEC), after the nature of the study has been explained and the subject's parent or legal guardian has had the opportunity to ask questions. The informed consent must be signed before any study-specific procedures are performed or before any medication is discontinued for the purpose of this study. The parent must also be willing to comply with all the requirements of this study protocol.
Subject has a disease diagnosis of moderately to severely active polyarticular or polyarticular course juvenile idiopathic arthritis (JIA; defined as arthritis affecting > = 5 joints at the time of treatment initiation). This corresponds to the International League of Associations for Rheumatology categories of polyarticular rheumatoid factor positive (RF+), polyarticular Rheumatoid factor negative (RF-) disease, and extended oligoarthritis disease.
Subject must be aged 2 to 1.75 the upper limit of the reference range;
Total bilirubin >=3 mg/dL;
Serum creatinine > 1.6 mg/dL (convert to mmol/L).
Evidence of dysplasia or history of malignancy (including lymphoma and leukemia) other than a successfully treated non-metastatic cutaneous squamous cell or basal cell carcinoma.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00775437). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.