Juvenile Idiopathic Arthritis
Conditions
Keywords
juvenile idiopathic arthritis, compassionate use, open label
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.
Interventions
DRUGAdalimumab
Adalimumab solution for injection for subcutaneous use.
Sponsors
AbbVie (prior sponsor, Abbott)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to 4 Years
Healthy volunteers
No
Inclusion criteria
1. 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. 2. 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. 3. Subject must be aged 2 to \< 4 years old with moderately to severely active polyarticular JIA or polyarticular course JIA or age 4 or greater weighing \< 15 kg with moderately to severely active polyarticular JIA or polyarticular course JIA, per International League of Associations for Rheumatology (ILAR) criteria. 4. Subject is judged to be in generally good health as determined by the Investigator based upon the results of medical history, laboratory profile, and physical examination performed at Screening and confirmed at Baseline. This includes, but is not limited to, a normal cardiopulmonary and normal neurological exam result. 5. Parent or legal guardian must be able and willing to administer subcutaneous (SC) injections or have a qualified person available to administer SC injections. 6. Parent or legal guardian must be willing to actively supervise storage and administration of study drug and to ensure that the time of each dose is accurately recorded in the subject's diary. 7. Subject must have negative purified protein derivative (PPD) test (or equivalent) at Screening. If subject has a positive (greater than or equal to 5mm induration) PPD test result, a chest x-ray (posterior-anterior \[PA\] and lateral view) must be performed. If subject has a positive test (or equivalent), has had a past ulcerative reaction to PPD placement, and/or a chest x ray consistent with tuberculosis \[TB\] exposure, subject may not be enrolled into the study. 8. For subjects in the European Union \[EU\], subject must have previously failed, had an insufficient response, or have been intolerant to at least one Disease-Modifying Anti Rheumatic Drug (DMARD).
Exclusion criteria
1. Subject has had prior exposure to Tysabri® (natalizumab) or Raptiva® (efalizumab) or any other biologic therapy, such as Orencia® (abatacept), Kineret® (anakinra), Actemra® (tocilizumab), Rituxan® (rituximab). Any previous use of anti-tumor necrosis factor \[TNF\] agents, including Enbrel® (etanercept), Remicade® (infliximab), Cimzia® (certolizumab pegol), Simponi® (golimumab), and adalimumab is also prohibited. 2. Infection(s) requiring treatment with intravenous (IV) anti-infectives within 30 days prior to Baseline Visit or oral anti-infectives within 14 days prior to the Baseline Visit. 3. Subject has undergone joint surgery within the preceding two months of the Screening Visit (at joints to be assessed within the study). 4. Subject has a previous diagnosis of a condition that could cause arthritis other than polyarticular JIA. 5. Subject has a history of an allergic reaction or significant sensitivity to constituents of the study drug, adalimumab. 6. Subject has been treated with any investigational drug of chemical or biologic nature within a minimum of 30 days or 5 half lives (whichever is longer) of the drug prior to Baseline visit. Should these biologics become approved, they would continue to be excluded. 7. Subject has a poorly controlled medical condition, such as uncontrolled diabetes, unstable heart disease, recent cerebrovascular accidents, seizure disorder, and any other condition which, in the opinion of the Investigator, would put the subject at risk by participation in the study. 8. Subject has a history of clinically significant hematologic (e.g., severe anemia, leukopenia, thrombocytopenia, a clotting disorder), renal, liver disease (e.g., fibrosis, cirrhosis, hepatitis), or active gastroenteric ulcer. 9. Subject is considered by the Investigator, for any reason, to be an unsuitable candidate for the study. 10. Subject has evidence of active TB infection. 11. Subject has history of moderate to severe congestive heart failure (New York Heart Association \[NYHA\] class III or IV), recent cerebrovascular accident or thrombotic event and any other condition which, in the opinion of the investigator, would put the subject at risk by participation in the protocol. 12. Evidence of dysplasia or history of malignancy (including lymphoma and leukemia). 13. History of demyelinating disease (including myelitis) or neurologic symptoms suggestive of central nervous system \[CNS\] demyelinating disease. 14. History of invasive fungal infection (e.g., listeriosis, histoplasmosis), active viral disorders, human immunodeficiency virus (HIV) infection. 15. Positive Hepatitis B test result. 16. Chronic recurring infections or active TB. 17. Screening laboratory and other analyses show any of the following abnormal results: * electrocardiogram \[ECG\] - with clinically significant abnormalities; * Aspartate transaminases (AST) or alanine transaminase (ALT) \> 1.75 the upper limit of the reference range; * Total bilirubin \>=3 mg/dL; * Serum creatinine \> 1.6 mg/dL (convert to mmol/L). 18. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hemoglobin: Mean Change From Baseline to Each Visit | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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. |
| Alkaline Phosphatase (ALP): Mean Change From Baseline to Each Visit | 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. |
| Creatine Phosphokinase: Mean Change From Baseline to Each Visit | 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. |
| Total Bilirubin: Mean Change From Baseline to Each Visit | 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. |
| Creatinine: Mean Change From Baseline to Each Visit | 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. |
| Uric Acid: Mean Change From Baseline to Each Visit | 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. |
| Percentage of Participants Achieving Pediatric American College of Rheumatology (PedACR) 30% Response (PedACR30) | Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120 | The PedACR30 response is defined by the PedACR as ≥30% improvement in at least 3 of 6 JIA core set criteria, and ≥30% worsening in ≤1 of 6 JIA core set criteria. The 6 variables for the JIA core set criteria are Physician's Global Assessment (PGA) of participant's disease activity, Parent's Global Assessment of participant's disease activity, number of active joints (joints with swelling not due to deformity or joints with loss of passive motion \[LOM\] and joints with pain on passive motion \[POM\], tenderness, or both), number of joints with LOM, Disability Index of Child Health Assessment Questionnaire (DICHAQ), and C-reactive protein (CRP). Baseline is the last value prior to the first dose of study drug. Missing data were imputed up to Week 60 using last observation carried forward (LOCF) and non-responder imputation (NRI); observed values are presented for timepoints past Week 60. n=number of participants for either observed or imputed methods at given time point. |
| Percentage of Participants Achieving Pediatric American College of Rheumatology (PedACR) 50% Response (PedACR50) | Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120 | The PedACR50 response is defined by the PedACR as ≥ 50% improvement in at least 3 of 6 JIA core set criteria, and ≥ 30% worsening in not more than 1 of 6 JIA core set criteria. The 6 variables for the JIA core set criteria include PGA of participant's disease activity, Parent's Global Assessment of participant's disease activity, number of active joints (joints with swelling not due to deformity or joints with LOM and joints with POM, tenderness, or both), number of joints with LOM, DICHAQ, and CRP. Baseline is the last value prior to the first dose of study drug. Missing data were imputed up to Week 60 using LOCF and by NRI; observed values are presented for timepoints past Week 60. n=number of participants for either observed or imputed methods at given time point. |
| Percentage of Participants Achieving Pediatric American College of Rheumatology (PedACR) 70% Response (PedACR70) | Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120 | The PedACR70 response is defined by the PedACR as ≥ 70% improvement in at least 3 of 6 JIA core set criteria, and ≥ 30% worsening in not more than 1 of 6 JIA core set criteria. The 6 variables for the JIA core set criteria include PGA of participant's disease activity, Parent's Global Assessment of participant's disease activity, number of active joints (joints with swelling not due to deformity or joints with LOM and joints with POM, tenderness, or both), number of joints with LOM, DICHAQ, and CRP. Baseline is the last value prior to the first dose of study drug. Missing data were imputed up to Week 60 using LOCF and by NRI; observed values are presented for timepoints past Week 60. n=number of participants for either observed or imputed methods at given time point. |
| Percentage of Participants Achieving Pediatric American College of Rheumatology (PedACR) 90% Response (PedACR90) | Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120 | The PedACR90 response is defined by the PedACR as ≥ 90% improvement in at least 3 of 6 JIA core set criteria, and ≥ 30% worsening in not more than 1 of 6 JIA core set criteria. The 6 variables for the JIA core set criteria include PGA of participant's disease activity, Parent's Global Assessment of participant's disease activity, number of active joints (joints with swelling not due to deformity or joints with LOM and joints with POM, tenderness, or both), number of joints with LOM, DICHAQ, and CRP. Baseline is the last value prior to the first dose of study drug. Missing data were imputed up to Week 60 using LOCF and by NRI; observed values are presented for timepoints past Week 60. n=number of participants for either observed or imputed methods at given time point. |
| Physician's Global Assessment of Disease Activity: Mean Change From Baseline to Each Visit | Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120 | The physician's assessment of participant's overall disease activity on a visual analog scale (VAS). The VAS is a 100 mm scale, with scores ranging from 0 (very good) to 100 (very bad). Baseline is defined as the last nonmissing value prior to the first dose of study drug. Participants with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=participants with a nonmissing value at baseline and each visit. |
| Parent's Global Assessment of Disease Activity: Mean Change From Baseline to Each Visit | Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120 | The parent's assessment of how the participant's arthritis is doing overall on a VAS. The VAS is a 100 mm scale, with scores ranging from 0 (very good) to 100 (very bad). Baseline is defined as the last nonmissing value prior to the first dose of study drug. Participants with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=participants with a nonmissing value at baseline and each visit. |
| Disability Index of Child Health Assessment Questionnaire (DICHAQ): Mean Change From Baseline to Each Visit | Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120 | The DICHAQ is a self-reported participant-oriented outcome measure, calculated as the mean of the following 8 category scores (range: 0 to 3): Dressing and Grooming, Arising, Eating, Walking, Hygiene, Reach, Grip, and Activities. The score of each category is calculated as the maximum of the scores for the questions within that category. If aids and devices and/or help from another person are used for a category, a lower category score is adjusted to 2 for that category. A participant must have scores for at least 6 categories in order to compute the DICHAQ score. Total score is derived as average of all categories: 0 (no disability) to 3 (complete disability). Baseline is the last value prior to the first dose of study drug. Baseline is defined as the last nonmissing value prior to the first dose of study drug. Participants with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=participants with a nonmissing value at baseline and each visit. |
| Active Joint Counts (AJC73): Mean Change From Baseline to Each Visit | Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 36, 48, 60, 72, 84, 96, 108, and 120 | A joint assessment was recorded at all study visits to assess the number of active joints, with a total possible score of 0 (no active joints) to 73 (all active joints). Active joints are defined as joints with positive results for tenderness, swelling, pain on passive motion, or limitation of passive motion. Baseline is defined as the last nonmissing value prior to the first dose of study drug. Participants with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=participants with a nonmissing value at baseline and each visit. |
| Limitation of Passive Motion (LOM69) Joint Count: Mean Change From Baseline to Each Visit | Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 36, 48, 60, 72, 84, 96, 108, and 120 | Sixty-nine joints were assessed by physical examination. The joints to be examined for LOM were the same as those examined for tenderness, except that the sacroiliac, sternoclavicular, and acromio clavicular joints were excluded. LOM of the joint was classified as present (1), absent (0), or replaced/injected (9). Scores range from 0 to 621, with higher scores representing higher disease activity. Baseline is defined as the last nonmissing value prior to the first dose of study drug. Participants with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=participants with a nonmissing value at baseline and each visit. |
| C-reactive Protein (CRP): Mean Change From Baseline to Each Visit | Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120 | CRP is a laboratory parameter and considered as an efficacy variable. CRP is a general marker of inflammation that is sensitive to acute changes in inflammatory response. CRP is reported using mg/dL. Baseline is defined as the last nonmissing value prior to the first dose of study drug. Participants with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=participants with a nonmissing value at baseline and each visit. |
| Tender Joint Count (TJC75): Mean Change From Baseline to Each Visit | Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 36, 48, 60, 72, 84, 96, 108, and 120 | Seventy-five joints or regions were assessed by pressure and joint manipulation on physical examination. Joint tenderness was classified as either present (1), absent (0) or replaced/injected (9). Scores range from 0 to 675, with higher scores representing higher disease activity. Baseline is defined as the last nonmissing value prior to the first dose of study drug. Participants with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=participants with a nonmissing value at baseline and each visit. |
| Swollen Joint Count (SJC66): Mean Change From Baseline to Each Visit | Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 36, 48, 60, 72, 84, 96, 108, and 120 | Sixty-six joints were assessed by physical examination. The joints to be examined for swelling were the same as those examined for tenderness, except that the hip, subtalar, sacroiliac, lumbar spine, thoracic spine, and cervical spine joints were excluded. Joint swelling was classified as present (1), absent (0) or replaced/injected (9). Scores range from 0 to 594, with higher scores representing higher disease activity. Baseline is defined as the last nonmissing value prior to the first dose of study drug. Participants with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=participants with a nonmissing value at baseline and each visit. |
| Pain on Passive Motion (POM75) Joint Count: Mean Change From Baseline to Each Visit | Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 36, 48, 60, 72, 84, 96, 108, and 120 | Seventy-five joints were assessed by physical examination. The joints to be examined for POM were the same as those examined for tenderness. POM of the joint was classified as present (1), absent (0), or replaced/injected (9). Scores range from 0 to 675, with higher scores representing higher disease activity. Baseline is defined as the last nonmissing value prior to the first dose of study drug. Participants with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=participants with a nonmissing value at baseline and each visit. |
| Child's Health Questionnaire Parent Form (CHQ-PF50) Global Health Category: Mean Change From Baseline to Each Visit | Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120 | The CHQ-PF50 is a participant-reported outcome measure that includes 50 questions related to physical and mental health, social limitations, and impact on parents and family. Scores for each category were converted to a scale from 0 (implies higher disease activity) to 100 (implies lower disease activity). Baseline is defined as the last nonmissing value prior to the first dose of study drug. Participants with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=participants with a nonmissing value at baseline and each visit. |
| Child's Health Questionnaire Parent Form (CHQ-PF50) Physical Functioning Category: Mean Change From Baseline to Each Visit | Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120. | The CHQ-PF50 is a participant-reported outcome measure that includes 50 questions related to physical and mental health, social limitations, and impact on parents and family. Scores for each category were converted to a scale from 0 (implies higher disease activity) to 100 (implies lower disease activity). Baseline is defined as the last nonmissing value prior to the first dose of study drug. Participants with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=participants with a nonmissing value at baseline and each visit. |
| Child's Health Questionnaire Parent Form (CHQ-PF50) Role/Social Limitations/Emotional/Behavioral Category: Mean Change From Baseline to Each Visit | Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120 | The CHQ-PF50 is a participant-reported outcome measure that includes 50 questions related to physical and mental health, social limitations, and impact on parents and family. Scores for each category were converted to a scale from 0 (implies higher disease activity) to 100 (implies lower disease activity). Baseline is defined as the last nonmissing value prior to the first dose of study drug. Participants with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=participants with a nonmissing value at baseline and each visit. |
| Child's Health Questionnaire Parent Form (CHQ-PF50) Role/Social Limitations - Physical Category: Mean Change From Baseline to Each Visit | Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120 | The CHQ-PF50 is a participant-reported outcome measure that includes 50 questions related to physical and mental health, social limitations, and impact on parents and family. Scores for each category were converted to a scale from 0 (implies higher disease activity) to 100 (implies lower disease activity). Baseline is defined as the last nonmissing value prior to the first dose of study drug. Participants with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=participants with a nonmissing value at baseline and each visit. |
| Child's Health Questionnaire Parent Form (CHQ-PF50) Bodily Pain/Discomfort Category: Mean Change From Baseline to Each Visit | Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120 | The CHQ-PF50 is a participant-reported outcome measure that includes 50 questions related to physical and mental health, social limitations, and impact on parents and family. Scores for each category were converted to a scale from 0 (implies higher disease activity) to 100 (implies lower disease activity). Baseline is defined as the last nonmissing value prior to the first dose of study drug. Participants with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=participants with a nonmissing value at baseline and each visit. |
| Child's Health Questionnaire Parent Form (CHQ-PF50) Behavior Category: Mean Change From Baseline to Each Visit | Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120 | The CHQ-PF50 is a participant-reported outcome measure that includes 50 questions related to physical and mental health, social limitations, and impact on parents and family. Scores for each category were converted to a scale from 0 (implies higher disease activity) to 100 (implies lower disease activity). Baseline is defined as the last nonmissing value prior to the first dose of study drug. Participants with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=participants with a nonmissing value at baseline and each visit. |
| Child's Health Questionnaire Parent Form (CHQ-PF50) Global Behavior Item: Mean Change From Baseline to Each Visit | Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120 | The CHQ-PF50 is a participant-reported outcome measure that includes 50 questions related to physical and mental health, social limitations, and impact on parents and family. Scores for each category were converted to a scale from 0 (implies higher disease activity) to 100 (implies lower disease activity). Baseline is defined as the last nonmissing value prior to the first dose of study drug. Participants with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=participants with a nonmissing value at baseline and each visit. |
| Child's Health Questionnaire Parent Form (CHQ-PF50) Mental Health Category: Mean Change From Baseline to Each Visit | Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120 | The CHQ-PF50 is a participant-reported outcome measure that includes 50 questions related to physical and mental health, social limitations, and impact on parents and family. Scores for each category were converted to a scale from 0 (implies higher disease activity) to 100 (implies lower disease activity). Baseline is defined as the last nonmissing value prior to the first dose of study drug. Participants with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=participants with a nonmissing value at baseline and each visit. |
| Child's Health Questionnaire Parent Form (CHQ-PF50) Self Esteem Category: Mean Change From Baseline to Each Visit | Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120 | The CHQ-PF50 is a participant-reported outcome measure that includes 50 questions related to physical and mental health, social limitations, and impact on parents and family. Scores for each category were converted to a scale from 0 (implies higher disease activity) to 100 (implies lower disease activity). Baseline is defined as the last nonmissing value prior to the first dose of study drug. Participants with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=participants with a nonmissing value at baseline and each visit. |
| Child's Health Questionnaire Parent Form (CHQ-PF50) General Health Perceptions Category: Mean Change From Baseline to Each Visit | Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120 | The CHQ-PF50 is a participant-reported outcome measure that includes 50 questions related to physical and mental health, social limitations, and impact on parents and family. Scores for each category were converted to a scale from 0 (implies higher disease activity) to 100 (implies lower disease activity). Baseline is defined as the last nonmissing value prior to the first dose of study drug. Participants with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=participants with a nonmissing value at baseline and each visit. |
| Mean Serum Adalimumab Trough Concentrations at Week 0, Week 12, and Week 24 | 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. |
| Child's Health Questionnaire Parent Form (CHQ-PF50) Parental Impact - Emotional Category: Mean Change From Baseline to Each Visit | Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120 | The CHQ-PF50 is a participant-reported outcome measure that includes 50 questions related to physical and mental health, social limitations, and impact on parents and family. Scores for each category were converted to a scale from 0 (implies higher disease activity) to 100 (implies lower disease activity). Baseline is defined as the last nonmissing value prior to the first dose of study drug. Participants with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=participants with a nonmissing value at baseline and each visit. |
| Child's Health Questionnaire Parent Form (CHQ-PF50) Parental Impact - Time Category: Mean Change From Baseline to Each Visit | Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120 | The CHQ-PF50 is a participant-reported outcome measure that includes 50 questions related to physical and mental health, social limitations, and impact on parents and family. Scores for each category were converted to a scale from 0 (implies higher disease activity) to 100 (implies lower disease activity). Baseline is defined as the last nonmissing value prior to the first dose of study drug. Participants with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=participants with a nonmissing value at baseline and each visit. |
| Child's Health Questionnaire Parent Form (CHQ-PF50) Family Activities Category: Mean Change From Baseline to Each Visit | Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120 | The CHQ-PF50 is a participant-reported outcome measure that includes 50 questions related to physical and mental health, social limitations, and impact on parents and family. Scores for each category were converted to a scale from 0 (implies higher disease activity) to 100 (implies lower disease activity). Baseline is defined as the last nonmissing value prior to the first dose of study drug. Participants with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=participants with a nonmissing value at baseline and each visit. |
| Child's Health Questionnaire Parent Form (CHQ-PF50) Family Cohesion Category: Mean Change From Baseline to Each Visit | Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120 | The CHQ-PF50 is a participant-reported outcome measure that includes 50 questions related to physical and mental health, social limitations, and impact on parents and family. Scores for each category were converted to a scale from 0 (implies higher disease activity) to 100 (implies lower disease activity). Baseline is defined as the last nonmissing value prior to the first dose of study drug. Participants with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=participants with a nonmissing value at baseline and each visit. |
| Child's Health Questionnaire Parent Form (CHQ-PF50) Change in Health Category: Mean Change From Baseline to Each Visit | Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120 | The CHQ-PF50 is a participant-reported outcome measure that includes 50 questions related to physical and mental health, social limitations, and impact on parents and family. Scores for each category were converted to a scale from 0 (implies higher disease activity) to 100 (implies lower disease activity). Baseline is defined as the last nonmissing value prior to the first dose of study drug. Participants with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=participants with a nonmissing value at baseline and each visit. |
Participant flow
Recruitment details
Participants were enrolled at 14 investigative sites in the Czech Republic, France, Germany, and the United States.
Pre-assignment details
Participants age 2 to \< 4 years or ≥ 4 years and under 15 kg with moderately to severely active polyarticular or polyarticular-course JIA with a parent/guardian to administer injections. The screening visit occurred between Day -28 and Day 0.
Participants by arm
| Arm | Count |
|---|---|
| Adalimumab Adalimumab 24 mg/m\^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study. | 32 |
| Total | 32 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Loss of efficacy | 2 |
| Overall Study | Lost to Follow-up | 1 |
| Overall Study | Withdrawal by Subject | 3 |
Baseline characteristics
| Characteristic | Adalimumab |
|---|---|
| Age, Continuous | 3.04 years STANDARD_DEVIATION 0.723 |
| Age, Customized < 4 years | 28 participants |
| Age, Customized ≥ 4 years | 4 participants |
| Sex: Female, Male Female | 28 Participants |
| Sex: Female, Male Male | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 27 / 32 |
| serious Total, serious adverse events | 5 / 32 |
Outcome results
Primary
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
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).
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).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Adalimumab | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | Any Treatment-emergent AE | 29 participants |
| Adalimumab | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | Any Treatment-emergent SAE | 5 participants |
Secondary
Active Joint Counts (AJC73): Mean Change From Baseline to Each Visit
A joint assessment was recorded at all study visits to assess the number of active joints, with a total possible score of 0 (no active joints) to 73 (all active joints). Active joints are defined as joints with positive results for tenderness, swelling, pain on passive motion, or limitation of passive motion. Baseline is defined as the last nonmissing value prior to the first dose of study drug. Participants with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=participants with a nonmissing value at baseline and each visit.
Time frame: Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 36, 48, 60, 72, 84, 96, 108, and 120
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Adalimumab | Active Joint Counts (AJC73): Mean Change From Baseline to Each Visit | Week 2 (n=32) | -5 units on a scale | Standard Deviation 6.58 |
| Adalimumab | Active Joint Counts (AJC73): Mean Change From Baseline to Each Visit | Week 4 (n=32) | -6.1 units on a scale | Standard Deviation 6.69 |
| Adalimumab | Active Joint Counts (AJC73): Mean Change From Baseline to Each Visit | Week 8 (n=32) | -7 units on a scale | Standard Deviation 5.24 |
| Adalimumab | Active Joint Counts (AJC73): Mean Change From Baseline to Each Visit | Week 12 (n=31) | -7.3 units on a scale | Standard Deviation 4.52 |
| Adalimumab | Active Joint Counts (AJC73): Mean Change From Baseline to Each Visit | Week 16 (n=31) | -7.1 units on a scale | Standard Deviation 5.87 |
| Adalimumab | Active Joint Counts (AJC73): Mean Change From Baseline to Each Visit | Week 20 (n=29) | -8 units on a scale | Standard Deviation 5.68 |
| Adalimumab | Active Joint Counts (AJC73): Mean Change From Baseline to Each Visit | Week 24 (n=30) | -7.2 units on a scale | Standard Deviation 5.6 |
| Adalimumab | Active Joint Counts (AJC73): Mean Change From Baseline to Each Visit | Week 36 (n=28) | -7.3 units on a scale | Standard Deviation 5.21 |
| Adalimumab | Active Joint Counts (AJC73): Mean Change From Baseline to Each Visit | Week 48 (n=24) | -8 units on a scale | Standard Deviation 5.5 |
| Adalimumab | Active Joint Counts (AJC73): Mean Change From Baseline to Each Visit | Week 60 (n=20) | -9.5 units on a scale | Standard Deviation 7.5 |
| Adalimumab | Active Joint Counts (AJC73): Mean Change From Baseline to Each Visit | Week 72 (n=17) | -10.2 units on a scale | Standard Deviation 6.64 |
| Adalimumab | Active Joint Counts (AJC73): Mean Change From Baseline to Each Visit | Week 84 (n=17) | -10.4 units on a scale | Standard Deviation 7.57 |
| Adalimumab | Active Joint Counts (AJC73): Mean Change From Baseline to Each Visit | Week 96 (n=13) | -8.9 units on a scale | Standard Deviation 7.04 |
| Adalimumab | Active Joint Counts (AJC73): Mean Change From Baseline to Each Visit | Week 108 (n=9) | -5.9 units on a scale | Standard Deviation 3.33 |
| Adalimumab | Active Joint Counts (AJC73): Mean Change From Baseline to Each Visit | Week 120 (n=3) | -7.3 units on a scale | Standard Deviation 2.08 |
Secondary
Alanine Aminotransferase (SGPT/ALT): Mean Change From Baseline to Each Visit
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.
Time frame: Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Adalimumab | Alanine Aminotransferase (SGPT/ALT): Mean Change From Baseline to Each Visit | Week 12 (n=27) | 0.5 U/L | Standard Deviation 9.96 |
| Adalimumab | Alanine Aminotransferase (SGPT/ALT): Mean Change From Baseline to Each Visit | Week 24 (n=28) | -1.1 U/L | Standard Deviation 17.13 |
| Adalimumab | Alanine Aminotransferase (SGPT/ALT): Mean Change From Baseline to Each Visit | Week 36 (n=25) | 0 U/L | Standard Deviation 29.82 |
| Adalimumab | Alanine Aminotransferase (SGPT/ALT): Mean Change From Baseline to Each Visit | Week 48 (n=24) | -4.5 U/L | Standard Deviation 24.81 |
| Adalimumab | Alanine Aminotransferase (SGPT/ALT): Mean Change From Baseline to Each Visit | Week 60 (n=21) | -2 U/L | Standard Deviation 10.25 |
| Adalimumab | Alanine Aminotransferase (SGPT/ALT): Mean Change From Baseline to Each Visit | Week 72 (n=16) | -1.8 U/L | Standard Deviation 10.1 |
| Adalimumab | Alanine Aminotransferase (SGPT/ALT): Mean Change From Baseline to Each Visit | Week 84 (n=16) | -0.5 U/L | Standard Deviation 14.56 |
| Adalimumab | Alanine Aminotransferase (SGPT/ALT): Mean Change From Baseline to Each Visit | Week 96 (n=11) | -3.9 U/L | Standard Deviation 15.4 |
| Adalimumab | Alanine Aminotransferase (SGPT/ALT): Mean Change From Baseline to Each Visit | Week 108 (n=9) | -2.4 U/L | Standard Deviation 6.31 |
| Adalimumab | Alanine Aminotransferase (SGPT/ALT): Mean Change From Baseline to Each Visit | Week 120 (n=3) | -14.3 U/L | Standard Deviation 23.12 |
Secondary
Alkaline Phosphatase (ALP): Mean Change From Baseline to Each Visit
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.
Time frame: Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Adalimumab | Alkaline Phosphatase (ALP): Mean Change From Baseline to Each Visit | Week 12 (n=27) | 15.7 U/L | Standard Deviation 64.65 |
| Adalimumab | Alkaline Phosphatase (ALP): Mean Change From Baseline to Each Visit | Week 24 (n=28) | 10.6 U/L | Standard Deviation 68.75 |
| Adalimumab | Alkaline Phosphatase (ALP): Mean Change From Baseline to Each Visit | Week 36 (n=25) | 23.2 U/L | Standard Deviation 73.28 |
| Adalimumab | Alkaline Phosphatase (ALP): Mean Change From Baseline to Each Visit | Week 48 (n=24) | 21.7 U/L | Standard Deviation 73.03 |
| Adalimumab | Alkaline Phosphatase (ALP): Mean Change From Baseline to Each Visit | Week 60 (n=21) | 17.9 U/L | Standard Deviation 85.55 |
| Adalimumab | Alkaline Phosphatase (ALP): Mean Change From Baseline to Each Visit | Week 72 (n=16) | 17.9 U/L | Standard Deviation 83.52 |
| Adalimumab | Alkaline Phosphatase (ALP): Mean Change From Baseline to Each Visit | Week 84 (n=16) | 31.5 U/L | Standard Deviation 89.3 |
| Adalimumab | Alkaline Phosphatase (ALP): Mean Change From Baseline to Each Visit | Week 96 (n=11) | 59.4 U/L | Standard Deviation 57.65 |
| Adalimumab | Alkaline Phosphatase (ALP): Mean Change From Baseline to Each Visit | Week 108 (n=9) | -6.3 U/L | Standard Deviation 100.72 |
| Adalimumab | Alkaline Phosphatase (ALP): Mean Change From Baseline to Each Visit | Week 120 (n=3) | -72.3 U/L | Standard Deviation 169.19 |
Secondary
Aspartate Aminotransferase (SGOT/AST): Mean Change From Baseline to Each Visit
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.
Time frame: Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Adalimumab | Aspartate Aminotransferase (SGOT/AST): Mean Change From Baseline to Each Visit | Week 12 (n=26) | 2.8 U/L | Standard Deviation 7.56 |
| Adalimumab | Aspartate Aminotransferase (SGOT/AST): Mean Change From Baseline to Each Visit | Week 24 (n=28) | -0.6 U/L | Standard Deviation 8.82 |
| Adalimumab | Aspartate Aminotransferase (SGOT/AST): Mean Change From Baseline to Each Visit | Week 36 (n=25) | 2 U/L | Standard Deviation 23.26 |
| Adalimumab | Aspartate Aminotransferase (SGOT/AST): Mean Change From Baseline to Each Visit | Week 48 (n=24) | -0.7 U/L | Standard Deviation 16.13 |
| Adalimumab | Aspartate Aminotransferase (SGOT/AST): Mean Change From Baseline to Each Visit | Week 60 (n=21) | -0.4 U/L | Standard Deviation 7.63 |
| Adalimumab | Aspartate Aminotransferase (SGOT/AST): Mean Change From Baseline to Each Visit | Week 72 (n=16) | 0.3 U/L | Standard Deviation 7.36 |
| Adalimumab | Aspartate Aminotransferase (SGOT/AST): Mean Change From Baseline to Each Visit | Week 84 (n=16) | -0.4 U/L | Standard Deviation 6.89 |
| Adalimumab | Aspartate Aminotransferase (SGOT/AST): Mean Change From Baseline to Each Visit | Week 96 (n=10) | 1.5 U/L | Standard Deviation 11.48 |
| Adalimumab | Aspartate Aminotransferase (SGOT/AST): Mean Change From Baseline to Each Visit | Week 108 (n=9) | 0.4 U/L | Standard Deviation 6.21 |
| Adalimumab | Aspartate Aminotransferase (SGOT/AST): Mean Change From Baseline to Each Visit | Week 120 (n=3) | -8.3 U/L | Standard Deviation 11.93 |
Secondary
Basophils: Mean Change From Baseline to Each Visit
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.
Time frame: Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Adalimumab | Basophils: Mean Change From Baseline to Each Visit | Week 12 (n=29) | -0.012 x10^9/L | Standard Deviation 0.0299 |
| Adalimumab | Basophils: Mean Change From Baseline to Each Visit | Week 24 (n=29) | -0.002 x10^9/L | Standard Deviation 0.0272 |
| Adalimumab | Basophils: Mean Change From Baseline to Each Visit | Week 36 (n=25) | 0.003 x10^9/L | Standard Deviation 0.0244 |
| Adalimumab | Basophils: Mean Change From Baseline to Each Visit | Week 48 (n=24) | 0.005 x10^9/L | Standard Deviation 0.0412 |
| Adalimumab | Basophils: Mean Change From Baseline to Each Visit | Week 60 (n=21) | -0.003 x10^9/L | Standard Deviation 0.0256 |
| Adalimumab | Basophils: Mean Change From Baseline to Each Visit | Week 72 (n=17) | 0.007 x10^9/L | Standard Deviation 0.031 |
| Adalimumab | Basophils: Mean Change From Baseline to Each Visit | Week 84 (n=16) | -0.001 x10^9/L | Standard Deviation 0.0171 |
| Adalimumab | Basophils: Mean Change From Baseline to Each Visit | Week 96 (n=11) | -0.003 x10^9/L | Standard Deviation 0.0205 |
| Adalimumab | Basophils: Mean Change From Baseline to Each Visit | Week 108 (n=9) | -0.001 x10^9/L | Standard Deviation 0.0117 |
| Adalimumab | Basophils: Mean Change From Baseline to Each Visit | Week 120 (n=3) | 0.003 x10^9/L | Standard Deviation 0.0306 |
Secondary
Child's Health Questionnaire Parent Form (CHQ-PF50) Behavior Category: Mean Change From Baseline to Each Visit
The CHQ-PF50 is a participant-reported outcome measure that includes 50 questions related to physical and mental health, social limitations, and impact on parents and family. Scores for each category were converted to a scale from 0 (implies higher disease activity) to 100 (implies lower disease activity). Baseline is defined as the last nonmissing value prior to the first dose of study drug. Participants with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=participants with a nonmissing value at baseline and each visit.
Time frame: Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Adalimumab | Child's Health Questionnaire Parent Form (CHQ-PF50) Behavior Category: Mean Change From Baseline to Each Visit | Week 12 (n=29) | 5.6 units on a scale | Standard Deviation 15.78 |
| Adalimumab | Child's Health Questionnaire Parent Form (CHQ-PF50) Behavior Category: Mean Change From Baseline to Each Visit | Week 24 (n=28) | 4.2 units on a scale | Standard Deviation 13.58 |
| Adalimumab | Child's Health Questionnaire Parent Form (CHQ-PF50) Behavior Category: Mean Change From Baseline to Each Visit | Week 36 (n=27) | 0.4 units on a scale | Standard Deviation 16.87 |
| Adalimumab | Child's Health Questionnaire Parent Form (CHQ-PF50) Behavior Category: Mean Change From Baseline to Each Visit | Week 48 (n=24) | 3.6 units on a scale | Standard Deviation 17.04 |
| Adalimumab | Child's Health Questionnaire Parent Form (CHQ-PF50) Behavior Category: Mean Change From Baseline to Each Visit | Week 60 (n=21) | -0.3 units on a scale | Standard Deviation 13.95 |
| Adalimumab | Child's Health Questionnaire Parent Form (CHQ-PF50) Behavior Category: Mean Change From Baseline to Each Visit | Week 72 (n=17) | 0.1 units on a scale | Standard Deviation 16.44 |
| Adalimumab | Child's Health Questionnaire Parent Form (CHQ-PF50) Behavior Category: Mean Change From Baseline to Each Visit | Week 84 (n=17) | 1.5 units on a scale | Standard Deviation 13.97 |
| Adalimumab | Child's Health Questionnaire Parent Form (CHQ-PF50) Behavior Category: Mean Change From Baseline to Each Visit | Week 96 (n=13) | 7.1 units on a scale | Standard Deviation 11.81 |
| Adalimumab | Child's Health Questionnaire Parent Form (CHQ-PF50) Behavior Category: Mean Change From Baseline to Each Visit | Week 108 (n=9) | 8.9 units on a scale | Standard Deviation 10.46 |
| Adalimumab | Child's Health Questionnaire Parent Form (CHQ-PF50) Behavior Category: Mean Change From Baseline to Each Visit | Week 120 (n=3) | -6.1 units on a scale | Standard Deviation 31.28 |
Secondary
Child's Health Questionnaire Parent Form (CHQ-PF50) Bodily Pain/Discomfort Category: Mean Change From Baseline to Each Visit
The CHQ-PF50 is a participant-reported outcome measure that includes 50 questions related to physical and mental health, social limitations, and impact on parents and family. Scores for each category were converted to a scale from 0 (implies higher disease activity) to 100 (implies lower disease activity). Baseline is defined as the last nonmissing value prior to the first dose of study drug. Participants with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=participants with a nonmissing value at baseline and each visit.
Time frame: Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Adalimumab | Child's Health Questionnaire Parent Form (CHQ-PF50) Bodily Pain/Discomfort Category: Mean Change From Baseline to Each Visit | Week 12 (n=30) | 35 units on a scale | Standard Deviation 30.6 |
| Adalimumab | Child's Health Questionnaire Parent Form (CHQ-PF50) Bodily Pain/Discomfort Category: Mean Change From Baseline to Each Visit | Week 24 (n=29) | 36.2 units on a scale | Standard Deviation 32.99 |
| Adalimumab | Child's Health Questionnaire Parent Form (CHQ-PF50) Bodily Pain/Discomfort Category: Mean Change From Baseline to Each Visit | Week 36 (n=26) | 38.8 units on a scale | Standard Deviation 27.76 |
| Adalimumab | Child's Health Questionnaire Parent Form (CHQ-PF50) Bodily Pain/Discomfort Category: Mean Change From Baseline to Each Visit | Week 48 (n=23) | 41.7 units on a scale | Standard Deviation 29.64 |
| Adalimumab | Child's Health Questionnaire Parent Form (CHQ-PF50) Bodily Pain/Discomfort Category: Mean Change From Baseline to Each Visit | Week 60 (n=20) | 39 units on a scale | Standard Deviation 34.78 |
| Adalimumab | Child's Health Questionnaire Parent Form (CHQ-PF50) Bodily Pain/Discomfort Category: Mean Change From Baseline to Each Visit | Week 72 (n=17) | 48.2 units on a scale | Standard Deviation 20.38 |
| Adalimumab | Child's Health Questionnaire Parent Form (CHQ-PF50) Bodily Pain/Discomfort Category: Mean Change From Baseline to Each Visit | Week 84 (n=17) | 41.2 units on a scale | Standard Deviation 25.47 |
| Adalimumab | Child's Health Questionnaire Parent Form (CHQ-PF50) Bodily Pain/Discomfort Category: Mean Change From Baseline to Each Visit | Week 96 (n=13) | 42.3 units on a scale | Standard Deviation 23.51 |
| Adalimumab | Child's Health Questionnaire Parent Form (CHQ-PF50) Bodily Pain/Discomfort Category: Mean Change From Baseline to Each Visit | Week 108 (n=9) | 41.1 units on a scale | Standard Deviation 37.56 |
| Adalimumab | Child's Health Questionnaire Parent Form (CHQ-PF50) Bodily Pain/Discomfort Category: Mean Change From Baseline to Each Visit | Week 120 (n=3) | 50 units on a scale | Standard Deviation 17.32 |
Secondary
Child's Health Questionnaire Parent Form (CHQ-PF50) Change in Health Category: Mean Change From Baseline to Each Visit
The CHQ-PF50 is a participant-reported outcome measure that includes 50 questions related to physical and mental health, social limitations, and impact on parents and family. Scores for each category were converted to a scale from 0 (implies higher disease activity) to 100 (implies lower disease activity). Baseline is defined as the last nonmissing value prior to the first dose of study drug. Participants with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=participants with a nonmissing value at baseline and each visit.
Time frame: Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Adalimumab | Child's Health Questionnaire Parent Form (CHQ-PF50) Change in Health Category: Mean Change From Baseline to Each Visit | Week 12 (n=30) | 1.4 units on a scale | Standard Deviation 1.75 |
| Adalimumab | Child's Health Questionnaire Parent Form (CHQ-PF50) Change in Health Category: Mean Change From Baseline to Each Visit | Week 24 (n=29) | 1.7 units on a scale | Standard Deviation 1.67 |
| Adalimumab | Child's Health Questionnaire Parent Form (CHQ-PF50) Change in Health Category: Mean Change From Baseline to Each Visit | Week 36 (n=25) | 1.7 units on a scale | Standard Deviation 1.8 |
| Adalimumab | Child's Health Questionnaire Parent Form (CHQ-PF50) Change in Health Category: Mean Change From Baseline to Each Visit | Week 48 (n=22) | 1.7 units on a scale | Standard Deviation 2.4 |
| Adalimumab | Child's Health Questionnaire Parent Form (CHQ-PF50) Change in Health Category: Mean Change From Baseline to Each Visit | Week 60 (n=20) | 1.3 units on a scale | Standard Deviation 2.57 |
| Adalimumab | Child's Health Questionnaire Parent Form (CHQ-PF50) Change in Health Category: Mean Change From Baseline to Each Visit | Week 72 (n=16) | 1.6 units on a scale | Standard Deviation 2.13 |
| Adalimumab | Child's Health Questionnaire Parent Form (CHQ-PF50) Change in Health Category: Mean Change From Baseline to Each Visit | Week 84(n=16) | 1.3 units on a scale | Standard Deviation 1.98 |
| Adalimumab | Child's Health Questionnaire Parent Form (CHQ-PF50) Change in Health Category: Mean Change From Baseline to Each Visit | Week 96 (n=12) | 1.5 units on a scale | Standard Deviation 2.02 |
| Adalimumab | Child's Health Questionnaire Parent Form (CHQ-PF50) Change in Health Category: Mean Change From Baseline to Each Visit | Week 108 (n=8) | 0.9 units on a scale | Standard Deviation 2.7 |
| Adalimumab | Child's Health Questionnaire Parent Form (CHQ-PF50) Change in Health Category: Mean Change From Baseline to Each Visit | Week 120 (n=3) | 2.3 units on a scale | Standard Deviation 0.58 |
Secondary
Child's Health Questionnaire Parent Form (CHQ-PF50) Family Activities Category: Mean Change From Baseline to Each Visit
The CHQ-PF50 is a participant-reported outcome measure that includes 50 questions related to physical and mental health, social limitations, and impact on parents and family. Scores for each category were converted to a scale from 0 (implies higher disease activity) to 100 (implies lower disease activity). Baseline is defined as the last nonmissing value prior to the first dose of study drug. Participants with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=participants with a nonmissing value at baseline and each visit.
Time frame: Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Adalimumab | Child's Health Questionnaire Parent Form (CHQ-PF50) Family Activities Category: Mean Change From Baseline to Each Visit | Week 12 (n=30) | 8.3 units on a scale | Standard Deviation 28.41 |
| Adalimumab | Child's Health Questionnaire Parent Form (CHQ-PF50) Family Activities Category: Mean Change From Baseline to Each Visit | Week 24 (n=28) | 17.6 units on a scale | Standard Deviation 24.15 |
| Adalimumab | Child's Health Questionnaire Parent Form (CHQ-PF50) Family Activities Category: Mean Change From Baseline to Each Visit | Week 36 (n=26) | 20 units on a scale | Standard Deviation 28.5 |
| Adalimumab | Child's Health Questionnaire Parent Form (CHQ-PF50) Family Activities Category: Mean Change From Baseline to Each Visit | Week 48 (n=23) | 16.8 units on a scale | Standard Deviation 26.43 |
| Adalimumab | Child's Health Questionnaire Parent Form (CHQ-PF50) Family Activities Category: Mean Change From Baseline to Each Visit | Week 60 (n=20) | 14.8 units on a scale | Standard Deviation 30.9 |
| Adalimumab | Child's Health Questionnaire Parent Form (CHQ-PF50) Family Activities Category: Mean Change From Baseline to Each Visit | Week 72 (n=16) | 17.2 units on a scale | Standard Deviation 31.43 |
| Adalimumab | Child's Health Questionnaire Parent Form (CHQ-PF50) Family Activities Category: Mean Change From Baseline to Each Visit | Week 84 (n=16) | 18.2 units on a scale | Standard Deviation 30.27 |
| Adalimumab | Child's Health Questionnaire Parent Form (CHQ-PF50) Family Activities Category: Mean Change From Baseline to Each Visit | Week 96 (n=12) | 19.4 units on a scale | Standard Deviation 27.6 |
| Adalimumab | Child's Health Questionnaire Parent Form (CHQ-PF50) Family Activities Category: Mean Change From Baseline to Each Visit | Week 108 (n=8) | 20.8 units on a scale | Standard Deviation 29.38 |
| Adalimumab | Child's Health Questionnaire Parent Form (CHQ-PF50) Family Activities Category: Mean Change From Baseline to Each Visit | Week 120 (n=2) | 68.8 units on a scale | Standard Deviation 20.62 |
Secondary
Child's Health Questionnaire Parent Form (CHQ-PF50) Family Cohesion Category: Mean Change From Baseline to Each Visit
The CHQ-PF50 is a participant-reported outcome measure that includes 50 questions related to physical and mental health, social limitations, and impact on parents and family. Scores for each category were converted to a scale from 0 (implies higher disease activity) to 100 (implies lower disease activity). Baseline is defined as the last nonmissing value prior to the first dose of study drug. Participants with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=participants with a nonmissing value at baseline and each visit.
Time frame: Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Adalimumab | Child's Health Questionnaire Parent Form (CHQ-PF50) Family Cohesion Category: Mean Change From Baseline to Each Visit | Week 12 (n=30) | 2.5 units on a scale | Standard Deviation 14 |
| Adalimumab | Child's Health Questionnaire Parent Form (CHQ-PF50) Family Cohesion Category: Mean Change From Baseline to Each Visit | Week 24 (n=28) | 4.3 units on a scale | Standard Deviation 23.28 |
| Adalimumab | Child's Health Questionnaire Parent Form (CHQ-PF50) Family Cohesion Category: Mean Change From Baseline to Each Visit | Week 36 (n=26) | 5.6 units on a scale | Standard Deviation 20.66 |
| Adalimumab | Child's Health Questionnaire Parent Form (CHQ-PF50) Family Cohesion Category: Mean Change From Baseline to Each Visit | Week 48 (n=23) | 3.7 units on a scale | Standard Deviation 15.61 |
| Adalimumab | Child's Health Questionnaire Parent Form (CHQ-PF50) Family Cohesion Category: Mean Change From Baseline to Each Visit | Week 60 (n=20) | 4.8 units on a scale | Standard Deviation 16.66 |
| Adalimumab | Child's Health Questionnaire Parent Form (CHQ-PF50) Family Cohesion Category: Mean Change From Baseline to Each Visit | Week 72 (n=16) | 7.2 units on a scale | Standard Deviation 29.15 |
| Adalimumab | Child's Health Questionnaire Parent Form (CHQ-PF50) Family Cohesion Category: Mean Change From Baseline to Each Visit | Week 84 (n=16) | 8.4 units on a scale | Standard Deviation 39.19 |
| Adalimumab | Child's Health Questionnaire Parent Form (CHQ-PF50) Family Cohesion Category: Mean Change From Baseline to Each Visit | Week 96 (n=12) | 18.8 units on a scale | Standard Deviation 35.36 |
| Adalimumab | Child's Health Questionnaire Parent Form (CHQ-PF50) Family Cohesion Category: Mean Change From Baseline to Each Visit | Week 108 (n=8) | 19.4 units on a scale | Standard Deviation 35.3 |
| Adalimumab | Child's Health Questionnaire Parent Form (CHQ-PF50) Family Cohesion Category: Mean Change From Baseline to Each Visit | Week 120 (n=2) | -27.5 units on a scale | Standard Deviation 38.89 |
Secondary
Child's Health Questionnaire Parent Form (CHQ-PF50) General Health Perceptions Category: Mean Change From Baseline to Each Visit
The CHQ-PF50 is a participant-reported outcome measure that includes 50 questions related to physical and mental health, social limitations, and impact on parents and family. Scores for each category were converted to a scale from 0 (implies higher disease activity) to 100 (implies lower disease activity). Baseline is defined as the last nonmissing value prior to the first dose of study drug. Participants with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=participants with a nonmissing value at baseline and each visit.
Time frame: Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Adalimumab | Child's Health Questionnaire Parent Form (CHQ-PF50) General Health Perceptions Category: Mean Change From Baseline to Each Visit | Week 12 (n=26) | 0.7 units on a scale | Standard Deviation 14.27 |
| Adalimumab | Child's Health Questionnaire Parent Form (CHQ-PF50) General Health Perceptions Category: Mean Change From Baseline to Each Visit | Week 24 (n=25) | 3.8 units on a scale | Standard Deviation 14.98 |
| Adalimumab | Child's Health Questionnaire Parent Form (CHQ-PF50) General Health Perceptions Category: Mean Change From Baseline to Each Visit | Week 36 (n=22) | 6.2 units on a scale | Standard Deviation 15.99 |
| Adalimumab | Child's Health Questionnaire Parent Form (CHQ-PF50) General Health Perceptions Category: Mean Change From Baseline to Each Visit | Week 48 (n=19) | 7.2 units on a scale | Standard Deviation 13.36 |
| Adalimumab | Child's Health Questionnaire Parent Form (CHQ-PF50) General Health Perceptions Category: Mean Change From Baseline to Each Visit | Week 60 (n=18) | 0.7 units on a scale | Standard Deviation 10.65 |
| Adalimumab | Child's Health Questionnaire Parent Form (CHQ-PF50) General Health Perceptions Category: Mean Change From Baseline to Each Visit | Week 72 (n=15) | 9.1 units on a scale | Standard Deviation 10.1 |
| Adalimumab | Child's Health Questionnaire Parent Form (CHQ-PF50) General Health Perceptions Category: Mean Change From Baseline to Each Visit | Week 84 (n=15) | 7.2 units on a scale | Standard Deviation 13.03 |
| Adalimumab | Child's Health Questionnaire Parent Form (CHQ-PF50) General Health Perceptions Category: Mean Change From Baseline to Each Visit | Week 96 (n=11) | 10.9 units on a scale | Standard Deviation 16 |
| Adalimumab | Child's Health Questionnaire Parent Form (CHQ-PF50) General Health Perceptions Category: Mean Change From Baseline to Each Visit | Week 108 (n=7) | 9 units on a scale | Standard Deviation 16.61 |
| Adalimumab | Child's Health Questionnaire Parent Form (CHQ-PF50) General Health Perceptions Category: Mean Change From Baseline to Each Visit | Week 120 (n=3) | 4.7 units on a scale | Standard Deviation 12.92 |
Secondary
Child's Health Questionnaire Parent Form (CHQ-PF50) Global Behavior Item: Mean Change From Baseline to Each Visit
The CHQ-PF50 is a participant-reported outcome measure that includes 50 questions related to physical and mental health, social limitations, and impact on parents and family. Scores for each category were converted to a scale from 0 (implies higher disease activity) to 100 (implies lower disease activity). Baseline is defined as the last nonmissing value prior to the first dose of study drug. Participants with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=participants with a nonmissing value at baseline and each visit.
Time frame: Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Adalimumab | Child's Health Questionnaire Parent Form (CHQ-PF50) Global Behavior Item: Mean Change From Baseline to Each Visit | Week 72 (n=10) | 2 units on a scale | Standard Deviation 15.31 |
| Adalimumab | Child's Health Questionnaire Parent Form (CHQ-PF50) Global Behavior Item: Mean Change From Baseline to Each Visit | Week 12 (n=19) | 4.5 units on a scale | Standard Deviation 18.17 |
| Adalimumab | Child's Health Questionnaire Parent Form (CHQ-PF50) Global Behavior Item: Mean Change From Baseline to Each Visit | Week 24 (n=19) | 10.8 units on a scale | Standard Deviation 17.66 |
| Adalimumab | Child's Health Questionnaire Parent Form (CHQ-PF50) Global Behavior Item: Mean Change From Baseline to Each Visit | Week 36 (n=18) | 9.2 units on a scale | Standard Deviation 25.04 |
| Adalimumab | Child's Health Questionnaire Parent Form (CHQ-PF50) Global Behavior Item: Mean Change From Baseline to Each Visit | Week 48 (n=16) | 4.1 units on a scale | Standard Deviation 18.55 |
| Adalimumab | Child's Health Questionnaire Parent Form (CHQ-PF50) Global Behavior Item: Mean Change From Baseline to Each Visit | Week 60 (n=13) | -3.5 units on a scale | Standard Deviation 20.35 |
| Adalimumab | Child's Health Questionnaire Parent Form (CHQ-PF50) Global Behavior Item: Mean Change From Baseline to Each Visit | Week 84 (n=11) | -5 units on a scale | Standard Deviation 14.32 |
| Adalimumab | Child's Health Questionnaire Parent Form (CHQ-PF50) Global Behavior Item: Mean Change From Baseline to Each Visit | Week 96 (n=9) | 0 units on a scale | Standard Deviation 17.68 |
| Adalimumab | Child's Health Questionnaire Parent Form (CHQ-PF50) Global Behavior Item: Mean Change From Baseline to Each Visit | Week 108 (n=6) | -4.2 units on a scale | Standard Deviation 10.21 |
| Adalimumab | Child's Health Questionnaire Parent Form (CHQ-PF50) Global Behavior Item: Mean Change From Baseline to Each Visit | Week 120 (n=1) | -25 units on a scale | Standard Deviation 0 |
Secondary
Child's Health Questionnaire Parent Form (CHQ-PF50) Global Health Category: Mean Change From Baseline to Each Visit
The CHQ-PF50 is a participant-reported outcome measure that includes 50 questions related to physical and mental health, social limitations, and impact on parents and family. Scores for each category were converted to a scale from 0 (implies higher disease activity) to 100 (implies lower disease activity). Baseline is defined as the last nonmissing value prior to the first dose of study drug. Participants with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=participants with a nonmissing value at baseline and each visit.
Time frame: Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Adalimumab | Child's Health Questionnaire Parent Form (CHQ-PF50) Global Health Category: Mean Change From Baseline to Each Visit | Week 12 (n=29) | 17.1 units on a scale | Standard Deviation 29.48 |
| Adalimumab | Child's Health Questionnaire Parent Form (CHQ-PF50) Global Health Category: Mean Change From Baseline to Each Visit | Week 24 (n=28) | 24.3 units on a scale | Standard Deviation 25.77 |
| Adalimumab | Child's Health Questionnaire Parent Form (CHQ-PF50) Global Health Category: Mean Change From Baseline to Each Visit | Week 36 (n=24) | 25 units on a scale | Standard Deviation 27.27 |
| Adalimumab | Child's Health Questionnaire Parent Form (CHQ-PF50) Global Health Category: Mean Change From Baseline to Each Visit | Week 48 (n=22) | 30.9 units on a scale | Standard Deviation 23.79 |
| Adalimumab | Child's Health Questionnaire Parent Form (CHQ-PF50) Global Health Category: Mean Change From Baseline to Each Visit | Week 60 (n=19) | 21.8 units on a scale | Standard Deviation 27.35 |
| Adalimumab | Child's Health Questionnaire Parent Form (CHQ-PF50) Global Health Category: Mean Change From Baseline to Each Visit | Week 72 (n=17) | 31.5 units on a scale | Standard Deviation 24.86 |
| Adalimumab | Child's Health Questionnaire Parent Form (CHQ-PF50) Global Health Category: Mean Change From Baseline to Each Visit | Week 84 (n=17) | 26.2 units on a scale | Standard Deviation 25.89 |
| Adalimumab | Child's Health Questionnaire Parent Form (CHQ-PF50) Global Health Category: Mean Change From Baseline to Each Visit | Week 96 (n=11) | 32.7 units on a scale | Standard Deviation 20.66 |
| Adalimumab | Child's Health Questionnaire Parent Form (CHQ-PF50) Global Health Category: Mean Change From Baseline to Each Visit | Week 108 (n=8) | 36.9 units on a scale | Standard Deviation 19.99 |
| Adalimumab | Child's Health Questionnaire Parent Form (CHQ-PF50) Global Health Category: Mean Change From Baseline to Each Visit | Week 120 (n=3) | 45 units on a scale | Standard Deviation 17.32 |
Secondary
Child's Health Questionnaire Parent Form (CHQ-PF50) Mental Health Category: Mean Change From Baseline to Each Visit
The CHQ-PF50 is a participant-reported outcome measure that includes 50 questions related to physical and mental health, social limitations, and impact on parents and family. Scores for each category were converted to a scale from 0 (implies higher disease activity) to 100 (implies lower disease activity). Baseline is defined as the last nonmissing value prior to the first dose of study drug. Participants with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=participants with a nonmissing value at baseline and each visit.
Time frame: Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Adalimumab | Child's Health Questionnaire Parent Form (CHQ-PF50) Mental Health Category: Mean Change From Baseline to Each Visit | Week 12 (n=31) | 3.5 units on a scale | Standard Deviation 11.12 |
| Adalimumab | Child's Health Questionnaire Parent Form (CHQ-PF50) Mental Health Category: Mean Change From Baseline to Each Visit | Week 24 (n=30) | 3.5 units on a scale | Standard Deviation 10.76 |
| Adalimumab | Child's Health Questionnaire Parent Form (CHQ-PF50) Mental Health Category: Mean Change From Baseline to Each Visit | Week 36 (n=27) | 4.1 units on a scale | Standard Deviation 14.01 |
| Adalimumab | Child's Health Questionnaire Parent Form (CHQ-PF50) Mental Health Category: Mean Change From Baseline to Each Visit | Week 48 (n=24) | 5.4 units on a scale | Standard Deviation 11.88 |
| Adalimumab | Child's Health Questionnaire Parent Form (CHQ-PF50) Mental Health Category: Mean Change From Baseline to Each Visit | Week 60 (n=21) | 2.1 units on a scale | Standard Deviation 14.02 |
| Adalimumab | Child's Health Questionnaire Parent Form (CHQ-PF50) Mental Health Category: Mean Change From Baseline to Each Visit | Week 72 (n=17) | 5 units on a scale | Standard Deviation 12.37 |
| Adalimumab | Child's Health Questionnaire Parent Form (CHQ-PF50) Mental Health Category: Mean Change From Baseline to Each Visit | Week 84 (n=17) | 2.6 units on a scale | Standard Deviation 8.5 |
| Adalimumab | Child's Health Questionnaire Parent Form (CHQ-PF50) Mental Health Category: Mean Change From Baseline to Each Visit | Week 96 (n=13) | 4.2 units on a scale | Standard Deviation 11.88 |
| Adalimumab | Child's Health Questionnaire Parent Form (CHQ-PF50) Mental Health Category: Mean Change From Baseline to Each Visit | Week 108 (n=9) | -0.8 units on a scale | Standard Deviation 15 |
| Adalimumab | Child's Health Questionnaire Parent Form (CHQ-PF50) Mental Health Category: Mean Change From Baseline to Each Visit | Week 120 (n=3) | -3.3 units on a scale | Standard Deviation 20.21 |
Secondary
Child's Health Questionnaire Parent Form (CHQ-PF50) Parental Impact - Emotional Category: Mean Change From Baseline to Each Visit
The CHQ-PF50 is a participant-reported outcome measure that includes 50 questions related to physical and mental health, social limitations, and impact on parents and family. Scores for each category were converted to a scale from 0 (implies higher disease activity) to 100 (implies lower disease activity). Baseline is defined as the last nonmissing value prior to the first dose of study drug. Participants with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=participants with a nonmissing value at baseline and each visit.
Time frame: Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Adalimumab | Child's Health Questionnaire Parent Form (CHQ-PF50) Parental Impact - Emotional Category: Mean Change From Baseline to Each Visit | Week 12 (n=30) | 11.4 units on a scale | Standard Deviation 26.12 |
| Adalimumab | Child's Health Questionnaire Parent Form (CHQ-PF50) Parental Impact - Emotional Category: Mean Change From Baseline to Each Visit | Week 24 (n=28) | 19 units on a scale | Standard Deviation 28.59 |
| Adalimumab | Child's Health Questionnaire Parent Form (CHQ-PF50) Parental Impact - Emotional Category: Mean Change From Baseline to Each Visit | Week 36 (n=26) | 29.2 units on a scale | Standard Deviation 33.1 |
| Adalimumab | Child's Health Questionnaire Parent Form (CHQ-PF50) Parental Impact - Emotional Category: Mean Change From Baseline to Each Visit | Week 48 (n=23) | 34.1 units on a scale | Standard Deviation 33.98 |
| Adalimumab | Child's Health Questionnaire Parent Form (CHQ-PF50) Parental Impact - Emotional Category: Mean Change From Baseline to Each Visit | Week 60 (n=20) | 31.7 units on a scale | Standard Deviation 32.4 |
| Adalimumab | Child's Health Questionnaire Parent Form (CHQ-PF50) Parental Impact - Emotional Category: Mean Change From Baseline to Each Visit | Week 72 (n=16) | 34.4 units on a scale | Standard Deviation 36.37 |
| Adalimumab | Child's Health Questionnaire Parent Form (CHQ-PF50) Parental Impact - Emotional Category: Mean Change From Baseline to Each Visit | Week 84 (n=16) | 27.6 units on a scale | Standard Deviation 41.69 |
| Adalimumab | Child's Health Questionnaire Parent Form (CHQ-PF50) Parental Impact - Emotional Category: Mean Change From Baseline to Each Visit | Week 96 (n=11) | 43.9 units on a scale | Standard Deviation 40.15 |
| Adalimumab | Child's Health Questionnaire Parent Form (CHQ-PF50) Parental Impact - Emotional Category: Mean Change From Baseline to Each Visit | Week 108 (n=8) | 46.9 units on a scale | Standard Deviation 40.81 |
| Adalimumab | Child's Health Questionnaire Parent Form (CHQ-PF50) Parental Impact - Emotional Category: Mean Change From Baseline to Each Visit | Week 120 (n=2) | 62.5 units on a scale | Standard Deviation 41.25 |
Secondary
Child's Health Questionnaire Parent Form (CHQ-PF50) Parental Impact - Time Category: Mean Change From Baseline to Each Visit
The CHQ-PF50 is a participant-reported outcome measure that includes 50 questions related to physical and mental health, social limitations, and impact on parents and family. Scores for each category were converted to a scale from 0 (implies higher disease activity) to 100 (implies lower disease activity). Baseline is defined as the last nonmissing value prior to the first dose of study drug. Participants with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=participants with a nonmissing value at baseline and each visit.
Time frame: Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Adalimumab | Child's Health Questionnaire Parent Form (CHQ-PF50) Parental Impact - Time Category: Mean Change From Baseline to Each Visit | Week 12 (n=30) | 4.6 units on a scale | Standard Deviation 24.5 |
| Adalimumab | Child's Health Questionnaire Parent Form (CHQ-PF50) Parental Impact - Time Category: Mean Change From Baseline to Each Visit | Week 24 (n=28) | 13.5 units on a scale | Standard Deviation 28.59 |
| Adalimumab | Child's Health Questionnaire Parent Form (CHQ-PF50) Parental Impact - Time Category: Mean Change From Baseline to Each Visit | Week 36 (n=26) | 21.8 units on a scale | Standard Deviation 24.24 |
| Adalimumab | Child's Health Questionnaire Parent Form (CHQ-PF50) Parental Impact - Time Category: Mean Change From Baseline to Each Visit | Week 48 (n=23) | 18.4 units on a scale | Standard Deviation 24.76 |
| Adalimumab | Child's Health Questionnaire Parent Form (CHQ-PF50) Parental Impact - Time Category: Mean Change From Baseline to Each Visit | Week 60 (n=20) | 13.3 units on a scale | Standard Deviation 31.55 |
| Adalimumab | Child's Health Questionnaire Parent Form (CHQ-PF50) Parental Impact - Time Category: Mean Change From Baseline to Each Visit | Week 72 (n=16) | 22.2 units on a scale | Standard Deviation 30.09 |
| Adalimumab | Child's Health Questionnaire Parent Form (CHQ-PF50) Parental Impact - Time Category: Mean Change From Baseline to Each Visit | Week 84 (n=16) | 17.4 units on a scale | Standard Deviation 35.13 |
| Adalimumab | Child's Health Questionnaire Parent Form (CHQ-PF50) Parental Impact - Time Category: Mean Change From Baseline to Each Visit | Week 96 (n=12) | 20.4 units on a scale | Standard Deviation 27.15 |
| Adalimumab | Child's Health Questionnaire Parent Form (CHQ-PF50) Parental Impact - Time Category: Mean Change From Baseline to Each Visit | Week 108 (n=8) | 15.3 units on a scale | Standard Deviation 25.85 |
| Adalimumab | Child's Health Questionnaire Parent Form (CHQ-PF50) Parental Impact - Time Category: Mean Change From Baseline to Each Visit | Week 120 (n=2) | 55.6 units on a scale | Standard Deviation 62.85 |
Secondary
Child's Health Questionnaire Parent Form (CHQ-PF50) Physical Functioning Category: Mean Change From Baseline to Each Visit
The CHQ-PF50 is a participant-reported outcome measure that includes 50 questions related to physical and mental health, social limitations, and impact on parents and family. Scores for each category were converted to a scale from 0 (implies higher disease activity) to 100 (implies lower disease activity). Baseline is defined as the last nonmissing value prior to the first dose of study drug. Participants with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=participants with a nonmissing value at baseline and each visit.
Time frame: Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Adalimumab | Child's Health Questionnaire Parent Form (CHQ-PF50) Physical Functioning Category: Mean Change From Baseline to Each Visit | Week 12 (n=31) | 30.6 units on a scale | Standard Deviation 32.14 |
| Adalimumab | Child's Health Questionnaire Parent Form (CHQ-PF50) Physical Functioning Category: Mean Change From Baseline to Each Visit | Week 24 (n=30) | 31.6 units on a scale | Standard Deviation 31.91 |
| Adalimumab | Child's Health Questionnaire Parent Form (CHQ-PF50) Physical Functioning Category: Mean Change From Baseline to Each Visit | Week 36 (n=27) | 36.4 units on a scale | Standard Deviation 31.26 |
| Adalimumab | Child's Health Questionnaire Parent Form (CHQ-PF50) Physical Functioning Category: Mean Change From Baseline to Each Visit | Week 48 (n=23) | 31.5 units on a scale | Standard Deviation 28.39 |
| Adalimumab | Child's Health Questionnaire Parent Form (CHQ-PF50) Physical Functioning Category: Mean Change From Baseline to Each Visit | Week 60 (n=21) | 29 units on a scale | Standard Deviation 32.3 |
| Adalimumab | Child's Health Questionnaire Parent Form (CHQ-PF50) Physical Functioning Category: Mean Change From Baseline to Each Visit | Week 72 (n=16) | 40.6 units on a scale | Standard Deviation 27 |
| Adalimumab | Child's Health Questionnaire Parent Form (CHQ-PF50) Physical Functioning Category: Mean Change From Baseline to Each Visit | Week 84 (n=17) | 40 units on a scale | Standard Deviation 30.44 |
| Adalimumab | Child's Health Questionnaire Parent Form (CHQ-PF50) Physical Functioning Category: Mean Change From Baseline to Each Visit | Week 96 (n=13) | 34.3 units on a scale | Standard Deviation 27.88 |
| Adalimumab | Child's Health Questionnaire Parent Form (CHQ-PF50) Physical Functioning Category: Mean Change From Baseline to Each Visit | Week 108 (n=9) | 37 units on a scale | Standard Deviation 27.92 |
| Adalimumab | Child's Health Questionnaire Parent Form (CHQ-PF50) Physical Functioning Category: Mean Change From Baseline to Each Visit | Week 120 (n=3) | 53.7 units on a scale | Standard Deviation 8.49 |
Secondary
Child's Health Questionnaire Parent Form (CHQ-PF50) Role/Social Limitations/Emotional/Behavioral Category: Mean Change From Baseline to Each Visit
The CHQ-PF50 is a participant-reported outcome measure that includes 50 questions related to physical and mental health, social limitations, and impact on parents and family. Scores for each category were converted to a scale from 0 (implies higher disease activity) to 100 (implies lower disease activity). Baseline is defined as the last nonmissing value prior to the first dose of study drug. Participants with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=participants with a nonmissing value at baseline and each visit.
Time frame: Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Adalimumab | Child's Health Questionnaire Parent Form (CHQ-PF50) Role/Social Limitations/Emotional/Behavioral Category: Mean Change From Baseline to Each Visit | Week 12 (n=23) | 20.8 units on a scale | Standard Deviation 32.53 |
| Adalimumab | Child's Health Questionnaire Parent Form (CHQ-PF50) Role/Social Limitations/Emotional/Behavioral Category: Mean Change From Baseline to Each Visit | Week 24 (n=22) | 17.7 units on a scale | Standard Deviation 29.43 |
| Adalimumab | Child's Health Questionnaire Parent Form (CHQ-PF50) Role/Social Limitations/Emotional/Behavioral Category: Mean Change From Baseline to Each Visit | Week 36 (n=20) | 17.2 units on a scale | Standard Deviation 25.86 |
| Adalimumab | Child's Health Questionnaire Parent Form (CHQ-PF50) Role/Social Limitations/Emotional/Behavioral Category: Mean Change From Baseline to Each Visit | Week 48 (n=18) | 16 units on a scale | Standard Deviation 27.28 |
| Adalimumab | Child's Health Questionnaire Parent Form (CHQ-PF50) Role/Social Limitations/Emotional/Behavioral Category: Mean Change From Baseline to Each Visit | Week 60 (n=16) | 20.8 units on a scale | Standard Deviation 31.91 |
| Adalimumab | Child's Health Questionnaire Parent Form (CHQ-PF50) Role/Social Limitations/Emotional/Behavioral Category: Mean Change From Baseline to Each Visit | Week 72 (n=13) | 26.5 units on a scale | Standard Deviation 32.25 |
| Adalimumab | Child's Health Questionnaire Parent Form (CHQ-PF50) Role/Social Limitations/Emotional/Behavioral Category: Mean Change From Baseline to Each Visit | Week 84 (n=13) | 20.5 units on a scale | Standard Deviation 33.29 |
| Adalimumab | Child's Health Questionnaire Parent Form (CHQ-PF50) Role/Social Limitations/Emotional/Behavioral Category: Mean Change From Baseline to Each Visit | Week 96 (n=9) | 30.9 units on a scale | Standard Deviation 32.76 |
| Adalimumab | Child's Health Questionnaire Parent Form (CHQ-PF50) Role/Social Limitations/Emotional/Behavioral Category: Mean Change From Baseline to Each Visit | Week 108 (n=7) | 23.8 units on a scale | Standard Deviation 25.2 |
| Adalimumab | Child's Health Questionnaire Parent Form (CHQ-PF50) Role/Social Limitations/Emotional/Behavioral Category: Mean Change From Baseline to Each Visit | Week 120 (n=2) | 33.3 units on a scale | Standard Deviation 47.14 |
Secondary
Child's Health Questionnaire Parent Form (CHQ-PF50) Role/Social Limitations - Physical Category: Mean Change From Baseline to Each Visit
The CHQ-PF50 is a participant-reported outcome measure that includes 50 questions related to physical and mental health, social limitations, and impact on parents and family. Scores for each category were converted to a scale from 0 (implies higher disease activity) to 100 (implies lower disease activity). Baseline is defined as the last nonmissing value prior to the first dose of study drug. Participants with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=participants with a nonmissing value at baseline and each visit.
Time frame: Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Adalimumab | Child's Health Questionnaire Parent Form (CHQ-PF50) Role/Social Limitations - Physical Category: Mean Change From Baseline to Each Visit | Week 12 (n=21) | 28.6 units on a scale | Standard Deviation 32.97 |
| Adalimumab | Child's Health Questionnaire Parent Form (CHQ-PF50) Role/Social Limitations - Physical Category: Mean Change From Baseline to Each Visit | Week 24 (n=20) | 31.7 units on a scale | Standard Deviation 35 |
| Adalimumab | Child's Health Questionnaire Parent Form (CHQ-PF50) Role/Social Limitations - Physical Category: Mean Change From Baseline to Each Visit | Week 36 (n=18) | 30.6 units on a scale | Standard Deviation 39.3 |
| Adalimumab | Child's Health Questionnaire Parent Form (CHQ-PF50) Role/Social Limitations - Physical Category: Mean Change From Baseline to Each Visit | Week 48 (n=17) | 27.5 units on a scale | Standard Deviation 37.24 |
| Adalimumab | Child's Health Questionnaire Parent Form (CHQ-PF50) Role/Social Limitations - Physical Category: Mean Change From Baseline to Each Visit | Week 60 (n=15) | 34.4 units on a scale | Standard Deviation 39.07 |
| Adalimumab | Child's Health Questionnaire Parent Form (CHQ-PF50) Role/Social Limitations - Physical Category: Mean Change From Baseline to Each Visit | Week 72 (n=12) | 36.1 units on a scale | Standard Deviation 41.34 |
| Adalimumab | Child's Health Questionnaire Parent Form (CHQ-PF50) Role/Social Limitations - Physical Category: Mean Change From Baseline to Each Visit | Week 84 (n=12) | 34.7 units on a scale | Standard Deviation 43.5 |
| Adalimumab | Child's Health Questionnaire Parent Form (CHQ-PF50) Role/Social Limitations - Physical Category: Mean Change From Baseline to Each Visit | Week 96 (n=8) | 41.7 units on a scale | Standard Deviation 37.8 |
| Adalimumab | Child's Health Questionnaire Parent Form (CHQ-PF50) Role/Social Limitations - Physical Category: Mean Change From Baseline to Each Visit | Week 108 (n=6) | 47.2 units on a scale | Standard Deviation 37.14 |
| Adalimumab | Child's Health Questionnaire Parent Form (CHQ-PF50) Role/Social Limitations - Physical Category: Mean Change From Baseline to Each Visit | Week 120 (n=1) | 66.7 units on a scale | Standard Deviation 0 |
Secondary
Child's Health Questionnaire Parent Form (CHQ-PF50) Self Esteem Category: Mean Change From Baseline to Each Visit
The CHQ-PF50 is a participant-reported outcome measure that includes 50 questions related to physical and mental health, social limitations, and impact on parents and family. Scores for each category were converted to a scale from 0 (implies higher disease activity) to 100 (implies lower disease activity). Baseline is defined as the last nonmissing value prior to the first dose of study drug. Participants with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=participants with a nonmissing value at baseline and each visit.
Time frame: Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Adalimumab | Child's Health Questionnaire Parent Form (CHQ-PF50) Self Esteem Category: Mean Change From Baseline to Each Visit | Week 12 (n=23) | 10.6 units on a scale | Standard Deviation 23.91 |
| Adalimumab | Child's Health Questionnaire Parent Form (CHQ-PF50) Self Esteem Category: Mean Change From Baseline to Each Visit | Week 24 (n=22) | 10.5 units on a scale | Standard Deviation 24.75 |
| Adalimumab | Child's Health Questionnaire Parent Form (CHQ-PF50) Self Esteem Category: Mean Change From Baseline to Each Visit | Week 36 (n=19) | 16.8 units on a scale | Standard Deviation 22.02 |
| Adalimumab | Child's Health Questionnaire Parent Form (CHQ-PF50) Self Esteem Category: Mean Change From Baseline to Each Visit | Week 48 (n=16) | 15.2 units on a scale | Standard Deviation 22.6 |
| Adalimumab | Child's Health Questionnaire Parent Form (CHQ-PF50) Self Esteem Category: Mean Change From Baseline to Each Visit | Week 60 (n=14) | 10.2 units on a scale | Standard Deviation 22.53 |
| Adalimumab | Child's Health Questionnaire Parent Form (CHQ-PF50) Self Esteem Category: Mean Change From Baseline to Each Visit | Week 72 (n=13) | -2.8 units on a scale | Standard Deviation 31.78 |
| Adalimumab | Child's Health Questionnaire Parent Form (CHQ-PF50) Self Esteem Category: Mean Change From Baseline to Each Visit | Week 84 (n=13) | 9.4 units on a scale | Standard Deviation 18.52 |
| Adalimumab | Child's Health Questionnaire Parent Form (CHQ-PF50) Self Esteem Category: Mean Change From Baseline to Each Visit | Week 96 (n=9) | 6.9 units on a scale | Standard Deviation 19.87 |
| Adalimumab | Child's Health Questionnaire Parent Form (CHQ-PF50) Self Esteem Category: Mean Change From Baseline to Each Visit | Week 108 (n=6) | -4.2 units on a scale | Standard Deviation 10.87 |
| Adalimumab | Child's Health Questionnaire Parent Form (CHQ-PF50) Self Esteem Category: Mean Change From Baseline to Each Visit | Week 120 (n=1) | 4.2 units on a scale | Standard Deviation 0 |
Secondary
C-reactive Protein (CRP): Mean Change From Baseline to Each Visit
CRP is a laboratory parameter and considered as an efficacy variable. CRP is a general marker of inflammation that is sensitive to acute changes in inflammatory response. CRP is reported using mg/dL. Baseline is defined as the last nonmissing value prior to the first dose of study drug. Participants with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=participants with a nonmissing value at baseline and each visit.
Time frame: Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Adalimumab | C-reactive Protein (CRP): Mean Change From Baseline to Each Visit | Week 12 (n=28) | -0.6 mg/dL | Standard Deviation 2.65 |
| Adalimumab | C-reactive Protein (CRP): Mean Change From Baseline to Each Visit | Week 24 (n=28) | -0.2 mg/dL | Standard Deviation 3.2 |
| Adalimumab | C-reactive Protein (CRP): Mean Change From Baseline to Each Visit | Week 36 (n=25) | -0.4 mg/dL | Standard Deviation 3.08 |
| Adalimumab | C-reactive Protein (CRP): Mean Change From Baseline to Each Visit | Week 48 (n=23) | 0.4 mg/dL | Standard Deviation 2.68 |
| Adalimumab | C-reactive Protein (CRP): Mean Change From Baseline to Each Visit | Week 60 (n=20) | -0.3 mg/dL | Standard Deviation 1.83 |
| Adalimumab | C-reactive Protein (CRP): Mean Change From Baseline to Each Visit | Week 72 (n=17) | -0.7 mg/dL | Standard Deviation 1.25 |
| Adalimumab | C-reactive Protein (CRP): Mean Change From Baseline to Each Visit | Week 84 (n=17) | -0.7 mg/dL | Standard Deviation 1.47 |
| Adalimumab | C-reactive Protein (CRP): Mean Change From Baseline to Each Visit | Week 96 (n=12) | 0.1 mg/dL | Standard Deviation 1.6 |
| Adalimumab | C-reactive Protein (CRP): Mean Change From Baseline to Each Visit | Week 108 (n=9) | 0.2 mg/dL | Standard Deviation 1.93 |
| Adalimumab | C-reactive Protein (CRP): Mean Change From Baseline to Each Visit | Week 120 (n=3) | 0.3 mg/dL | Standard Deviation 0.28 |
Secondary
Creatine Phosphokinase: Mean Change From Baseline to Each Visit
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.
Time frame: Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Adalimumab | Creatine Phosphokinase: Mean Change From Baseline to Each Visit | Week 12 (n=27) | 17.2 U/L | Standard Deviation 50.48 |
| Adalimumab | Creatine Phosphokinase: Mean Change From Baseline to Each Visit | Week 24 (n=27) | 7 U/L | Standard Deviation 30.79 |
| Adalimumab | Creatine Phosphokinase: Mean Change From Baseline to Each Visit | Week 36 (n=25) | 24.8 U/L | Standard Deviation 44.5 |
| Adalimumab | Creatine Phosphokinase: Mean Change From Baseline to Each Visit | Week 48 (n=24) | 18.4 U/L | Standard Deviation 54.02 |
| Adalimumab | Creatine Phosphokinase: Mean Change From Baseline to Each Visit | Week 60 (n=21) | 26.6 U/L | Standard Deviation 65.48 |
| Adalimumab | Creatine Phosphokinase: Mean Change From Baseline to Each Visit | Week 72 (n=16) | 41.6 U/L | Standard Deviation 40.63 |
| Adalimumab | Creatine Phosphokinase: Mean Change From Baseline to Each Visit | Week 84 (n=16) | 36.4 U/L | Standard Deviation 53.64 |
| Adalimumab | Creatine Phosphokinase: Mean Change From Baseline to Each Visit | Week 96 (n=11) | 28.7 U/L | Standard Deviation 41.79 |
| Adalimumab | Creatine Phosphokinase: Mean Change From Baseline to Each Visit | Week 108 (n=9) | 7.2 U/L | Standard Deviation 22.97 |
| Adalimumab | Creatine Phosphokinase: Mean Change From Baseline to Each Visit | Week 120 (n=3) | 14 U/L | Standard Deviation 40.73 |
Secondary
Creatinine: Mean Change From Baseline to Each Visit
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.
Time frame: Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Adalimumab | Creatinine: Mean Change From Baseline to Each Visit | Week 12 (n=27) | 1.7 µmol/L | Standard Deviation 5.98 |
| Adalimumab | Creatinine: Mean Change From Baseline to Each Visit | Week 24 (n=28) | 0.5 µmol/L | Standard Deviation 5.3 |
| Adalimumab | Creatinine: Mean Change From Baseline to Each Visit | Week 36 (n=25) | 0.3 µmol/L | Standard Deviation 5.84 |
| Adalimumab | Creatinine: Mean Change From Baseline to Each Visit | Week 48 (n=24) | 2.5 µmol/L | Standard Deviation 7.8 |
| Adalimumab | Creatinine: Mean Change From Baseline to Each Visit | Week 60 (n=21) | 2.8 µmol/L | Standard Deviation 5.79 |
| Adalimumab | Creatinine: Mean Change From Baseline to Each Visit | Week 72 (n=16) | 3.4 µmol/L | Standard Deviation 6.96 |
| Adalimumab | Creatinine: Mean Change From Baseline to Each Visit | Week 84 (n=16) | 4 µmol/L | Standard Deviation 6.37 |
| Adalimumab | Creatinine: Mean Change From Baseline to Each Visit | Week 96 (n=11) | 3.2 µmol/L | Standard Deviation 5.53 |
| Adalimumab | Creatinine: Mean Change From Baseline to Each Visit | Week 108 (n=9) | 6.2 µmol/L | Standard Deviation 6.7 |
| Adalimumab | Creatinine: Mean Change From Baseline to Each Visit | Week 120 (n=3) | 8.7 µmol/L | Standard Deviation 5.51 |
Secondary
Disability Index of Child Health Assessment Questionnaire (DICHAQ): Mean Change From Baseline to Each Visit
The DICHAQ is a self-reported participant-oriented outcome measure, calculated as the mean of the following 8 category scores (range: 0 to 3): Dressing and Grooming, Arising, Eating, Walking, Hygiene, Reach, Grip, and Activities. The score of each category is calculated as the maximum of the scores for the questions within that category. If aids and devices and/or help from another person are used for a category, a lower category score is adjusted to 2 for that category. A participant must have scores for at least 6 categories in order to compute the DICHAQ score. Total score is derived as average of all categories: 0 (no disability) to 3 (complete disability). Baseline is the last value prior to the first dose of study drug. Baseline is defined as the last nonmissing value prior to the first dose of study drug. Participants with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=participants with a nonmissing value at baseline and each visit.
Time frame: Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Adalimumab | Disability Index of Child Health Assessment Questionnaire (DICHAQ): Mean Change From Baseline to Each Visit | Week 12 (n=31) | -0.5 units on a scale | Standard Deviation 0.64 |
| Adalimumab | Disability Index of Child Health Assessment Questionnaire (DICHAQ): Mean Change From Baseline to Each Visit | Week 24 (n=30) | -0.5 units on a scale | Standard Deviation 0.69 |
| Adalimumab | Disability Index of Child Health Assessment Questionnaire (DICHAQ): Mean Change From Baseline to Each Visit | Week 36 (n=27) | -0.6 units on a scale | Standard Deviation 0.7 |
| Adalimumab | Disability Index of Child Health Assessment Questionnaire (DICHAQ): Mean Change From Baseline to Each Visit | Week 48 (n=24) | -0.6 units on a scale | Standard Deviation 0.68 |
| Adalimumab | Disability Index of Child Health Assessment Questionnaire (DICHAQ): Mean Change From Baseline to Each Visit | Week 60 (n=21) | -0.6 units on a scale | Standard Deviation 0.71 |
| Adalimumab | Disability Index of Child Health Assessment Questionnaire (DICHAQ): Mean Change From Baseline to Each Visit | Week 72 (n=16) | -0.9 units on a scale | Standard Deviation 0.64 |
| Adalimumab | Disability Index of Child Health Assessment Questionnaire (DICHAQ): Mean Change From Baseline to Each Visit | Week 84 (n=17) | -0.9 units on a scale | Standard Deviation 0.68 |
| Adalimumab | Disability Index of Child Health Assessment Questionnaire (DICHAQ): Mean Change From Baseline to Each Visit | Week 96 (n=13) | -0.8 units on a scale | Standard Deviation 0.56 |
| Adalimumab | Disability Index of Child Health Assessment Questionnaire (DICHAQ): Mean Change From Baseline to Each Visit | Week 108 (n=9) | -0.8 units on a scale | Standard Deviation 0.63 |
| Adalimumab | Disability Index of Child Health Assessment Questionnaire (DICHAQ): Mean Change From Baseline to Each Visit | Week 120 (n=3) | -0.8 units on a scale | Standard Deviation 1.09 |
Secondary
Eosinophils: Mean Change From Baseline to Each Visit
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.
Time frame: Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Adalimumab | Eosinophils: Mean Change From Baseline to Each Visit | Week 12 (n=29) | -0.004 x10^9/L | Standard Deviation 0.1771 |
| Adalimumab | Eosinophils: Mean Change From Baseline to Each Visit | Week 24 (n=29) | -0.006 x10^9/L | Standard Deviation 0.1545 |
| Adalimumab | Eosinophils: Mean Change From Baseline to Each Visit | Week 36 (n=25) | -0.052 x10^9/L | Standard Deviation 0.1374 |
| Adalimumab | Eosinophils: Mean Change From Baseline to Each Visit | Week 48 (n=24) | 0.056 x10^9/L | Standard Deviation 0.2773 |
| Adalimumab | Eosinophils: Mean Change From Baseline to Each Visit | Week 60 (n=21) | -0.015 x10^9/L | Standard Deviation 0.1363 |
| Adalimumab | Eosinophils: Mean Change From Baseline to Each Visit | Week 72 (n=17) | 0.069 x10^9/L | Standard Deviation 0.1886 |
| Adalimumab | Eosinophils: Mean Change From Baseline to Each Visit | Week 84 (n=16) | 0.016 x10^9/L | Standard Deviation 0.1631 |
| Adalimumab | Eosinophils: Mean Change From Baseline to Each Visit | Week 96 (n=11) | 0.158 x10^9/L | Standard Deviation 0.3207 |
| Adalimumab | Eosinophils: Mean Change From Baseline to Each Visit | Week 108 (n=9) | -0.002 x10^9/L | Standard Deviation 0.0864 |
| Adalimumab | Eosinophils: Mean Change From Baseline to Each Visit | Week 120 (n=3) | -0.063 x10^9/L | Standard Deviation 0.0929 |
Secondary
Hematocrit: Mean Change From Baseline to Each Visit
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.
Time frame: Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Adalimumab | Hematocrit: Mean Change From Baseline to Each Visit | Week 12 (n=29) | 0.018 Fraction | Standard Deviation 0.0206 |
| Adalimumab | Hematocrit: Mean Change From Baseline to Each Visit | Week 24 (n=29) | 0.016 Fraction | Standard Deviation 0.0289 |
| Adalimumab | Hematocrit: Mean Change From Baseline to Each Visit | Week 36 (n=25) | 0.017 Fraction | Standard Deviation 0.0292 |
| Adalimumab | Hematocrit: Mean Change From Baseline to Each Visit | Week 48 (n=24) | 0.011 Fraction | Standard Deviation 0.0288 |
| Adalimumab | Hematocrit: Mean Change From Baseline to Each Visit | Week 60 (n=21) | 0.009 Fraction | Standard Deviation 0.0275 |
| Adalimumab | Hematocrit: Mean Change From Baseline to Each Visit | Week 72 (n=17) | 0.024 Fraction | Standard Deviation 0.0264 |
| Adalimumab | Hematocrit: Mean Change From Baseline to Each Visit | Week 84 (n=16) | 0.026 Fraction | Standard Deviation 0.0366 |
| Adalimumab | Hematocrit: Mean Change From Baseline to Each Visit | Week 96 (n=11) | 0.023 Fraction | Standard Deviation 0.0319 |
| Adalimumab | Hematocrit: Mean Change From Baseline to Each Visit | Week 108 (n=9) | 0.018 Fraction | Standard Deviation 0.0273 |
| Adalimumab | Hematocrit: Mean Change From Baseline to Each Visit | Week 120 (n=3) | 0.008 Fraction | Standard Deviation 0.0082 |
Secondary
Hemoglobin: Mean Change From Baseline to Each Visit
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.
Time frame: Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Adalimumab | Hemoglobin: Mean Change From Baseline to Each Visit | Week 12 (n=29) | 6.7 g/L | Standard Deviation 7.32 |
| Adalimumab | Hemoglobin: Mean Change From Baseline to Each Visit | Week 24 (n=29) | 6.7 g/L | Standard Deviation 9.76 |
| Adalimumab | Hemoglobin: Mean Change From Baseline to Each Visit | Week 36 (n=25) | 5.5 g/L | Standard Deviation 9.31 |
| Adalimumab | Hemoglobin: Mean Change From Baseline to Each Visit | Week 48 (n=24) | 5.3 g/L | Standard Deviation 10.68 |
| Adalimumab | Hemoglobin: Mean Change From Baseline to Each Visit | Week 60 (n=21) | 6 g/L | Standard Deviation 10.96 |
| Adalimumab | Hemoglobin: Mean Change From Baseline to Each Visit | Week 72 (n=17) | 9.5 g/L | Standard Deviation 10.65 |
| Adalimumab | Hemoglobin: Mean Change From Baseline to Each Visit | Week 84 (n=16) | 10.5 g/L | Standard Deviation 13.69 |
| Adalimumab | Hemoglobin: Mean Change From Baseline to Each Visit | Week 96 (n=11) | 8.6 g/L | Standard Deviation 9.99 |
| Adalimumab | Hemoglobin: Mean Change From Baseline to Each Visit | Week 108 (n=9) | 7.7 g/L | Standard Deviation 8.08 |
| Adalimumab | Hemoglobin: Mean Change From Baseline to Each Visit | Week 120 (n=3) | 4.7 g/L | Standard Deviation 2.89 |
Secondary
Limitation of Passive Motion (LOM69) Joint Count: Mean Change From Baseline to Each Visit
Sixty-nine joints were assessed by physical examination. The joints to be examined for LOM were the same as those examined for tenderness, except that the sacroiliac, sternoclavicular, and acromio clavicular joints were excluded. LOM of the joint was classified as present (1), absent (0), or replaced/injected (9). Scores range from 0 to 621, with higher scores representing higher disease activity. Baseline is defined as the last nonmissing value prior to the first dose of study drug. Participants with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=participants with a nonmissing value at baseline and each visit.
Time frame: Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 36, 48, 60, 72, 84, 96, 108, and 120
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Adalimumab | Limitation of Passive Motion (LOM69) Joint Count: Mean Change From Baseline to Each Visit | Week 2 (n=32) | -4.5 units on a scale | Standard Deviation 7.14 |
| Adalimumab | Limitation of Passive Motion (LOM69) Joint Count: Mean Change From Baseline to Each Visit | Week 4 (n=32) | -5.4 units on a scale | Standard Deviation 6.48 |
| Adalimumab | Limitation of Passive Motion (LOM69) Joint Count: Mean Change From Baseline to Each Visit | Week 8 (n=32) | -5.3 units on a scale | Standard Deviation 5.02 |
| Adalimumab | Limitation of Passive Motion (LOM69) Joint Count: Mean Change From Baseline to Each Visit | Week 12 (n=31) | -5.6 units on a scale | Standard Deviation 4.8 |
| Adalimumab | Limitation of Passive Motion (LOM69) Joint Count: Mean Change From Baseline to Each Visit | Week 16 (n=31) | -6.3 units on a scale | Standard Deviation 6.31 |
| Adalimumab | Limitation of Passive Motion (LOM69) Joint Count: Mean Change From Baseline to Each Visit | Week 20 (n=29) | -6.8 units on a scale | Standard Deviation 6.63 |
| Adalimumab | Limitation of Passive Motion (LOM69) Joint Count: Mean Change From Baseline to Each Visit | Week 24 (n=30) | -5.6 units on a scale | Standard Deviation 5.54 |
| Adalimumab | Limitation of Passive Motion (LOM69) Joint Count: Mean Change From Baseline to Each Visit | Week 36 (n=28) | -5.1 units on a scale | Standard Deviation 5.29 |
| Adalimumab | Limitation of Passive Motion (LOM69) Joint Count: Mean Change From Baseline to Each Visit | Week 48 (n=24) | -5.5 units on a scale | Standard Deviation 7.06 |
| Adalimumab | Limitation of Passive Motion (LOM69) Joint Count: Mean Change From Baseline to Each Visit | Week 60 (n=20) | -5.5 units on a scale | Standard Deviation 8.31 |
| Adalimumab | Limitation of Passive Motion (LOM69) Joint Count: Mean Change From Baseline to Each Visit | Week 72 (n=17) | -6.9 units on a scale | Standard Deviation 7.84 |
| Adalimumab | Limitation of Passive Motion (LOM69) Joint Count: Mean Change From Baseline to Each Visit | Week 84 (n=17) | -8.4 units on a scale | Standard Deviation 6.9 |
| Adalimumab | Limitation of Passive Motion (LOM69) Joint Count: Mean Change From Baseline to Each Visit | Week 96 (n=13) | -7.5 units on a scale | Standard Deviation 6.73 |
| Adalimumab | Limitation of Passive Motion (LOM69) Joint Count: Mean Change From Baseline to Each Visit | Week 108 (n=9) | -5.2 units on a scale | Standard Deviation 3.96 |
| Adalimumab | Limitation of Passive Motion (LOM69) Joint Count: Mean Change From Baseline to Each Visit | Week 120 (n=3) | -6 units on a scale | Standard Deviation 2.65 |
Secondary
Lymphocytes: Mean Change From Baseline to Each Visit
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.
Time frame: Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Adalimumab | Lymphocytes: Mean Change From Baseline to Each Visit | Week 12 (n=29) | 0.371 x10˄9/L | Standard Deviation 2.3523 |
| Adalimumab | Lymphocytes: Mean Change From Baseline to Each Visit | Week 24 (n=29) | 0.292 x10˄9/L | Standard Deviation 1.9345 |
| Adalimumab | Lymphocytes: Mean Change From Baseline to Each Visit | Week 36 (n=25) | 0.176 x10˄9/L | Standard Deviation 1.962 |
| Adalimumab | Lymphocytes: Mean Change From Baseline to Each Visit | Week 48 (n=24) | 0.186 x10˄9/L | Standard Deviation 1.9584 |
| Adalimumab | Lymphocytes: Mean Change From Baseline to Each Visit | Week 60 (n=21) | -0.034 x10˄9/L | Standard Deviation 1.6129 |
| Adalimumab | Lymphocytes: Mean Change From Baseline to Each Visit | Week 72 (n=17) | 0.636 x10˄9/L | Standard Deviation 1.7404 |
| Adalimumab | Lymphocytes: Mean Change From Baseline to Each Visit | Week 84 (n=16) | 0.306 x10˄9/L | Standard Deviation 1.5143 |
| Adalimumab | Lymphocytes: Mean Change From Baseline to Each Visit | Week 96 (n=11) | 0.006 x10˄9/L | Standard Deviation 1.9402 |
| Adalimumab | Lymphocytes: Mean Change From Baseline to Each Visit | Week 108 (n=9) | -0.46 x10˄9/L | Standard Deviation 2.4315 |
| Adalimumab | Lymphocytes: Mean Change From Baseline to Each Visit | Week 120 (n=3) | -0.67 x10˄9/L | Standard Deviation 1.8041 |
Secondary
Mean Serum Adalimumab Trough Concentrations at Week 0, Week 12, and Week 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.
Time frame: Weeks 0, 12, and 24
Population: All participants who had samples for pharmacokinetic analysis
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Adalimumab | Mean Serum Adalimumab Trough Concentrations at Week 0, Week 12, and Week 24 | Week 0 | 0 µg/mL | Standard Deviation 0 |
| Adalimumab | Mean Serum Adalimumab Trough Concentrations at Week 0, Week 12, and Week 24 | Week 12 | 6.97 µg/mL | Standard Deviation 5.69 |
| Adalimumab | Mean Serum Adalimumab Trough Concentrations at Week 0, Week 12, and Week 24 | Week 24 | 7.78 µg/mL | Standard Deviation 5.85 |
Secondary
Monocytes: Mean Change From Baseline to Each Visit
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.
Time frame: Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Adalimumab | Monocytes: Mean Change From Baseline to Each Visit | Week 12 (n=29) | -0.032 x10^9/L | Standard Deviation 0.3051 |
| Adalimumab | Monocytes: Mean Change From Baseline to Each Visit | Week 24 (n=29) | 0.081 x10^9/L | Standard Deviation 0.4547 |
| Adalimumab | Monocytes: Mean Change From Baseline to Each Visit | Week 36 (n=25) | 0.028 x10^9/L | Standard Deviation 0.2978 |
| Adalimumab | Monocytes: Mean Change From Baseline to Each Visit | Week 48 (n=24) | -0.006 x10^9/L | Standard Deviation 0.2718 |
| Adalimumab | Monocytes: Mean Change From Baseline to Each Visit | Week 60 (n=21) | 0.08 x10^9/L | Standard Deviation 0.1831 |
| Adalimumab | Monocytes: Mean Change From Baseline to Each Visit | Week 72 (n=17) | 0.113 x10^9/L | Standard Deviation 0.2054 |
| Adalimumab | Monocytes: Mean Change From Baseline to Each Visit | Week 84 (n=16) | 0.061 x10^9/L | Standard Deviation 0.2594 |
| Adalimumab | Monocytes: Mean Change From Baseline to Each Visit | Week 96 (n=11) | 0.089 x10^9/L | Standard Deviation 0.2295 |
| Adalimumab | Monocytes: Mean Change From Baseline to Each Visit | Week 108 (n=9) | 0.096 x10^9/L | Standard Deviation 0.3248 |
| Adalimumab | Monocytes: Mean Change From Baseline to Each Visit | Week 120 (n=3) | 0.057 x10^9/L | Standard Deviation 0.0777 |
Secondary
Neutrophils: Mean Change From Baseline to Each Visit
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.
Time frame: Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Adalimumab | Neutrophils: Mean Change From Baseline to Each Visit | Week 12 (n=29) | -0.138 x10˄9/L | Standard Deviation 2.9819 |
| Adalimumab | Neutrophils: Mean Change From Baseline to Each Visit | Week 24 (n=29) | -0.619 x10˄9/L | Standard Deviation 3.0082 |
| Adalimumab | Neutrophils: Mean Change From Baseline to Each Visit | Week 36 (n=25) | -0.586 x10˄9/L | Standard Deviation 3.7363 |
| Adalimumab | Neutrophils: Mean Change From Baseline to Each Visit | Week 48 (n=24) | 0.065 x10˄9/L | Standard Deviation 3.4433 |
| Adalimumab | Neutrophils: Mean Change From Baseline to Each Visit | Week 60 (n=21) | 0.222 x10˄9/L | Standard Deviation 2.0937 |
| Adalimumab | Neutrophils: Mean Change From Baseline to Each Visit | Week 72 (n=17) | -0.169 x10˄9/L | Standard Deviation 2.6167 |
| Adalimumab | Neutrophils: Mean Change From Baseline to Each Visit | Week 84 (n=16) | -0.206 x10˄9/L | Standard Deviation 2.0077 |
| Adalimumab | Neutrophils: Mean Change From Baseline to Each Visit | Week 96 (n=11) | 0.293 x10˄9/L | Standard Deviation 2.511 |
| Adalimumab | Neutrophils: Mean Change From Baseline to Each Visit | Week 108 (n=9) | -0.39 x10˄9/L | Standard Deviation 3.1702 |
| Adalimumab | Neutrophils: Mean Change From Baseline to Each Visit | Week 120 (n=3) | 2.47 x10˄9/L | Standard Deviation 3.2658 |
Secondary
Pain on Passive Motion (POM75) Joint Count: Mean Change From Baseline to Each Visit
Seventy-five joints were assessed by physical examination. The joints to be examined for POM were the same as those examined for tenderness. POM of the joint was classified as present (1), absent (0), or replaced/injected (9). Scores range from 0 to 675, with higher scores representing higher disease activity. Baseline is defined as the last nonmissing value prior to the first dose of study drug. Participants with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=participants with a nonmissing value at baseline and each visit.
Time frame: Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 36, 48, 60, 72, 84, 96, 108, and 120
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Adalimumab | Pain on Passive Motion (POM75) Joint Count: Mean Change From Baseline to Each Visit | Week 2 (n=32) | -3.3 units on a scale | Standard Deviation 4.5 |
| Adalimumab | Pain on Passive Motion (POM75) Joint Count: Mean Change From Baseline to Each Visit | Week 4 (n=32) | -4 units on a scale | Standard Deviation 4.01 |
| Adalimumab | Pain on Passive Motion (POM75) Joint Count: Mean Change From Baseline to Each Visit | Week 8 (n=32) | -4.6 units on a scale | Standard Deviation 5.17 |
| Adalimumab | Pain on Passive Motion (POM75) Joint Count: Mean Change From Baseline to Each Visit | Week 12 (n=31) | -4.9 units on a scale | Standard Deviation 4.59 |
| Adalimumab | Pain on Passive Motion (POM75) Joint Count: Mean Change From Baseline to Each Visit | Week 16 (n=31) | -4.9 units on a scale | Standard Deviation 4.6 |
| Adalimumab | Pain on Passive Motion (POM75) Joint Count: Mean Change From Baseline to Each Visit | Week 20 (n=29) | -5.4 units on a scale | Standard Deviation 4.81 |
| Adalimumab | Pain on Passive Motion (POM75) Joint Count: Mean Change From Baseline to Each Visit | Week 24 (n=30) | -4.1 units on a scale | Standard Deviation 7.32 |
| Adalimumab | Pain on Passive Motion (POM75) Joint Count: Mean Change From Baseline to Each Visit | Week 36 (n=28) | -4.3 units on a scale | Standard Deviation 7.34 |
| Adalimumab | Pain on Passive Motion (POM75) Joint Count: Mean Change From Baseline to Each Visit | Week 48 (n=24) | -5.8 units on a scale | Standard Deviation 4.42 |
| Adalimumab | Pain on Passive Motion (POM75) Joint Count: Mean Change From Baseline to Each Visit | Week 60 (n=20) | -5.9 units on a scale | Standard Deviation 5.25 |
| Adalimumab | Pain on Passive Motion (POM75) Joint Count: Mean Change From Baseline to Each Visit | Week 72 (n=17) | -6.4 units on a scale | Standard Deviation 5.41 |
| Adalimumab | Pain on Passive Motion (POM75) Joint Count: Mean Change From Baseline to Each Visit | Week 84 (n=17) | -6.1 units on a scale | Standard Deviation 5.34 |
| Adalimumab | Pain on Passive Motion (POM75) Joint Count: Mean Change From Baseline to Each Visit | Week 96 (n=13) | 5.7 units on a scale | Standard Deviation 5.12 |
| Adalimumab | Pain on Passive Motion (POM75) Joint Count: Mean Change From Baseline to Each Visit | Week 108 (n=9) | -3.6 units on a scale | Standard Deviation 5.85 |
| Adalimumab | Pain on Passive Motion (POM75) Joint Count: Mean Change From Baseline to Each Visit | Week 120 (n=3) | -5.3 units on a scale | Standard Deviation 1.53 |
Secondary
Parent's Global Assessment of Disease Activity: Mean Change From Baseline to Each Visit
The parent's assessment of how the participant's arthritis is doing overall on a VAS. The VAS is a 100 mm scale, with scores ranging from 0 (very good) to 100 (very bad). Baseline is defined as the last nonmissing value prior to the first dose of study drug. Participants with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=participants with a nonmissing value at baseline and each visit.
Time frame: Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Adalimumab | Parent's Global Assessment of Disease Activity: Mean Change From Baseline to Each Visit | Week 108 (n=9) | -39.9 units on a scale | Standard Deviation 37.54 |
| Adalimumab | Parent's Global Assessment of Disease Activity: Mean Change From Baseline to Each Visit | Week 12 (n=31) | -28.1 units on a scale | Standard Deviation 29.91 |
| Adalimumab | Parent's Global Assessment of Disease Activity: Mean Change From Baseline to Each Visit | Week 24 (n=30) | -32.2 units on a scale | Standard Deviation 29.74 |
| Adalimumab | Parent's Global Assessment of Disease Activity: Mean Change From Baseline to Each Visit | Week 36 (n=27) | -35.1 units on a scale | Standard Deviation 27.42 |
| Adalimumab | Parent's Global Assessment of Disease Activity: Mean Change From Baseline to Each Visit | Week 48 (n=24) | -35.6 units on a scale | Standard Deviation 32.19 |
| Adalimumab | Parent's Global Assessment of Disease Activity: Mean Change From Baseline to Each Visit | Week 60 (n=21) | -34.5 units on a scale | Standard Deviation 33.31 |
| Adalimumab | Parent's Global Assessment of Disease Activity: Mean Change From Baseline to Each Visit | Week 72 (n=17) | -43.8 units on a scale | Standard Deviation 25.58 |
| Adalimumab | Parent's Global Assessment of Disease Activity: Mean Change From Baseline to Each Visit | Week 84 (n=17) | -42.6 units on a scale | Standard Deviation 28.62 |
| Adalimumab | Parent's Global Assessment of Disease Activity: Mean Change From Baseline to Each Visit | Week 96 (n=13) | -45.8 units on a scale | Standard Deviation 29.1 |
| Adalimumab | Parent's Global Assessment of Disease Activity: Mean Change From Baseline to Each Visit | Week 120 (n=3) | -47.7 units on a scale | Standard Deviation 34.96 |
Secondary
Percentage of Participants Achieving Pediatric American College of Rheumatology (PedACR) 30% Response (PedACR30)
The PedACR30 response is defined by the PedACR as ≥30% improvement in at least 3 of 6 JIA core set criteria, and ≥30% worsening in ≤1 of 6 JIA core set criteria. The 6 variables for the JIA core set criteria are Physician's Global Assessment (PGA) of participant's disease activity, Parent's Global Assessment of participant's disease activity, number of active joints (joints with swelling not due to deformity or joints with loss of passive motion \[LOM\] and joints with pain on passive motion \[POM\], tenderness, or both), number of joints with LOM, Disability Index of Child Health Assessment Questionnaire (DICHAQ), and C-reactive protein (CRP). Baseline is the last value prior to the first dose of study drug. Missing data were imputed up to Week 60 using last observation carried forward (LOCF) and non-responder imputation (NRI); observed values are presented for timepoints past Week 60. n=number of participants for either observed or imputed methods at given time point.
Time frame: Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Adalimumab | Percentage of Participants Achieving Pediatric American College of Rheumatology (PedACR) 30% Response (PedACR30) | Week 12 Observed (n=31) | 93.5 percentage of participants |
| Adalimumab | Percentage of Participants Achieving Pediatric American College of Rheumatology (PedACR) 30% Response (PedACR30) | Week 12 NRI (n=32) | 90.6 percentage of participants |
| Adalimumab | Percentage of Participants Achieving Pediatric American College of Rheumatology (PedACR) 30% Response (PedACR30) | Week 12 LOCF (n=31) | 93.5 percentage of participants |
| Adalimumab | Percentage of Participants Achieving Pediatric American College of Rheumatology (PedACR) 30% Response (PedACR30) | Week 24 Observed (n=30) | 90 percentage of participants |
| Adalimumab | Percentage of Participants Achieving Pediatric American College of Rheumatology (PedACR) 30% Response (PedACR30) | Week 24 NRI (n=32) | 84.4 percentage of participants |
| Adalimumab | Percentage of Participants Achieving Pediatric American College of Rheumatology (PedACR) 30% Response (PedACR30) | Week 24 LOCF (n=31) | 90.3 percentage of participants |
| Adalimumab | Percentage of Participants Achieving Pediatric American College of Rheumatology (PedACR) 30% Response (PedACR30) | Week 36 Observed (n=27) | 92.6 percentage of participants |
| Adalimumab | Percentage of Participants Achieving Pediatric American College of Rheumatology (PedACR) 30% Response (PedACR30) | Week 36 NRI (n=32) | 78.1 percentage of participants |
| Adalimumab | Percentage of Participants Achieving Pediatric American College of Rheumatology (PedACR) 30% Response (PedACR30) | Week 36 LOCF (n=31) | 93.5 percentage of participants |
| Adalimumab | Percentage of Participants Achieving Pediatric American College of Rheumatology (PedACR) 30% Response (PedACR30) | Week 48 Observed (n=24) | 83.3 percentage of participants |
| Adalimumab | Percentage of Participants Achieving Pediatric American College of Rheumatology (PedACR) 30% Response (PedACR30) | Week 48 NRI (n=32) | 62.5 percentage of participants |
| Adalimumab | Percentage of Participants Achieving Pediatric American College of Rheumatology (PedACR) 30% Response (PedACR30) | Week 48 LOCF (n=31) | 83.9 percentage of participants |
| Adalimumab | Percentage of Participants Achieving Pediatric American College of Rheumatology (PedACR) 30% Response (PedACR30) | Week 60 Observed (n=20) | 90 percentage of participants |
| Adalimumab | Percentage of Participants Achieving Pediatric American College of Rheumatology (PedACR) 30% Response (PedACR30) | Week 60 NRI (n=32) | 56.3 percentage of participants |
| Adalimumab | Percentage of Participants Achieving Pediatric American College of Rheumatology (PedACR) 30% Response (PedACR30) | Week 60 LOCF (n=31) | 87.1 percentage of participants |
| Adalimumab | Percentage of Participants Achieving Pediatric American College of Rheumatology (PedACR) 30% Response (PedACR30) | Week 72 Observed (n=17) | 100 percentage of participants |
| Adalimumab | Percentage of Participants Achieving Pediatric American College of Rheumatology (PedACR) 30% Response (PedACR30) | Week 84 Observed (n=17) | 100 percentage of participants |
| Adalimumab | Percentage of Participants Achieving Pediatric American College of Rheumatology (PedACR) 30% Response (PedACR30) | Week 96 Observed (n=13) | 92.3 percentage of participants |
| Adalimumab | Percentage of Participants Achieving Pediatric American College of Rheumatology (PedACR) 30% Response (PedACR30) | Week 108 Observed (n=9) | 88.9 percentage of participants |
| Adalimumab | Percentage of Participants Achieving Pediatric American College of Rheumatology (PedACR) 30% Response (PedACR30) | Week 120 Observed (n=3) | 100 percentage of participants |
Secondary
Percentage of Participants Achieving Pediatric American College of Rheumatology (PedACR) 50% Response (PedACR50)
The PedACR50 response is defined by the PedACR as ≥ 50% improvement in at least 3 of 6 JIA core set criteria, and ≥ 30% worsening in not more than 1 of 6 JIA core set criteria. The 6 variables for the JIA core set criteria include PGA of participant's disease activity, Parent's Global Assessment of participant's disease activity, number of active joints (joints with swelling not due to deformity or joints with LOM and joints with POM, tenderness, or both), number of joints with LOM, DICHAQ, and CRP. Baseline is the last value prior to the first dose of study drug. Missing data were imputed up to Week 60 using LOCF and by NRI; observed values are presented for timepoints past Week 60. n=number of participants for either observed or imputed methods at given time point.
Time frame: Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Adalimumab | Percentage of Participants Achieving Pediatric American College of Rheumatology (PedACR) 50% Response (PedACR50) | Week 12 Observed (n=31) | 90.3 percentage of participants |
| Adalimumab | Percentage of Participants Achieving Pediatric American College of Rheumatology (PedACR) 50% Response (PedACR50) | Week 12 NRI (n=32) | 87.5 percentage of participants |
| Adalimumab | Percentage of Participants Achieving Pediatric American College of Rheumatology (PedACR) 50% Response (PedACR50) | Week 12 LOCF (n=31) | 90.3 percentage of participants |
| Adalimumab | Percentage of Participants Achieving Pediatric American College of Rheumatology (PedACR) 50% Response (PedACR50) | Week 24 Observed (n=30) | 83.3 percentage of participants |
| Adalimumab | Percentage of Participants Achieving Pediatric American College of Rheumatology (PedACR) 50% Response (PedACR50) | Week 24 NRI (n=32) | 78.1 percentage of participants |
| Adalimumab | Percentage of Participants Achieving Pediatric American College of Rheumatology (PedACR) 50% Response (PedACR50) | Week 24 LOCF (n=31) | 83.9 percentage of participants |
| Adalimumab | Percentage of Participants Achieving Pediatric American College of Rheumatology (PedACR) 50% Response (PedACR50) | Week 36 Observed (n=27) | 88.9 percentage of participants |
| Adalimumab | Percentage of Participants Achieving Pediatric American College of Rheumatology (PedACR) 50% Response (PedACR50) | Week 36 NRI (n=32) | 75 percentage of participants |
| Adalimumab | Percentage of Participants Achieving Pediatric American College of Rheumatology (PedACR) 50% Response (PedACR50) | Week 36 LOCF (n=31) | 90.3 percentage of participants |
| Adalimumab | Percentage of Participants Achieving Pediatric American College of Rheumatology (PedACR) 50% Response (PedACR50) | Week 48 Observed (n=24) | 79.2 percentage of participants |
| Adalimumab | Percentage of Participants Achieving Pediatric American College of Rheumatology (PedACR) 50% Response (PedACR50) | Week 48 NRI (n=32) | 59.4 percentage of participants |
| Adalimumab | Percentage of Participants Achieving Pediatric American College of Rheumatology (PedACR) 50% Response (PedACR50) | Week 48 LOCF (n=31) | 80.6 percentage of participants |
| Adalimumab | Percentage of Participants Achieving Pediatric American College of Rheumatology (PedACR) 50% Response (PedACR50) | Week 60 Observed (n=20) | 80 percentage of participants |
| Adalimumab | Percentage of Participants Achieving Pediatric American College of Rheumatology (PedACR) 50% Response (PedACR50) | Week 60 NRI (n=32) | 50 percentage of participants |
| Adalimumab | Percentage of Participants Achieving Pediatric American College of Rheumatology (PedACR) 50% Response (PedACR50) | Week 60 LOCF (n=31) | 80.6 percentage of participants |
| Adalimumab | Percentage of Participants Achieving Pediatric American College of Rheumatology (PedACR) 50% Response (PedACR50) | Week 72 Observed (n=17) | 100 percentage of participants |
| Adalimumab | Percentage of Participants Achieving Pediatric American College of Rheumatology (PedACR) 50% Response (PedACR50) | Week 84 Observed (n=17) | 94.1 percentage of participants |
| Adalimumab | Percentage of Participants Achieving Pediatric American College of Rheumatology (PedACR) 50% Response (PedACR50) | Week 96 Observed (n=13) | 92.3 percentage of participants |
| Adalimumab | Percentage of Participants Achieving Pediatric American College of Rheumatology (PedACR) 50% Response (PedACR50) | Week 108 Observed (n=9) | 88.9 percentage of participants |
| Adalimumab | Percentage of Participants Achieving Pediatric American College of Rheumatology (PedACR) 50% Response (PedACR50) | Week 120 Observed (n=3) | 100 percentage of participants |
Secondary
Percentage of Participants Achieving Pediatric American College of Rheumatology (PedACR) 70% Response (PedACR70)
The PedACR70 response is defined by the PedACR as ≥ 70% improvement in at least 3 of 6 JIA core set criteria, and ≥ 30% worsening in not more than 1 of 6 JIA core set criteria. The 6 variables for the JIA core set criteria include PGA of participant's disease activity, Parent's Global Assessment of participant's disease activity, number of active joints (joints with swelling not due to deformity or joints with LOM and joints with POM, tenderness, or both), number of joints with LOM, DICHAQ, and CRP. Baseline is the last value prior to the first dose of study drug. Missing data were imputed up to Week 60 using LOCF and by NRI; observed values are presented for timepoints past Week 60. n=number of participants for either observed or imputed methods at given time point.
Time frame: Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Adalimumab | Percentage of Participants Achieving Pediatric American College of Rheumatology (PedACR) 70% Response (PedACR70) | Week 12 Observed (n=31) | 61.3 percentage of participants |
| Adalimumab | Percentage of Participants Achieving Pediatric American College of Rheumatology (PedACR) 70% Response (PedACR70) | Week 12 NRI (n=32) | 59.4 percentage of participants |
| Adalimumab | Percentage of Participants Achieving Pediatric American College of Rheumatology (PedACR) 70% Response (PedACR70) | Week 12 LOCF (n=31) | 61.3 percentage of participants |
| Adalimumab | Percentage of Participants Achieving Pediatric American College of Rheumatology (PedACR) 70% Response (PedACR70) | Week 24 Observed (n=30) | 73.3 percentage of participants |
| Adalimumab | Percentage of Participants Achieving Pediatric American College of Rheumatology (PedACR) 70% Response (PedACR70) | Week 24 NRI (n=32) | 68.8 percentage of participants |
| Adalimumab | Percentage of Participants Achieving Pediatric American College of Rheumatology (PedACR) 70% Response (PedACR70) | Week 24 LOCF (n=31) | 74.2 percentage of participants |
| Adalimumab | Percentage of Participants Achieving Pediatric American College of Rheumatology (PedACR) 70% Response (PedACR70) | Week 36 Observed (n=27) | 66.7 percentage of participants |
| Adalimumab | Percentage of Participants Achieving Pediatric American College of Rheumatology (PedACR) 70% Response (PedACR70) | Week 36 NRI (n=32) | 56.3 percentage of participants |
| Adalimumab | Percentage of Participants Achieving Pediatric American College of Rheumatology (PedACR) 70% Response (PedACR70) | Week 36 LOCF (n=31) | 67.7 percentage of participants |
| Adalimumab | Percentage of Participants Achieving Pediatric American College of Rheumatology (PedACR) 70% Response (PedACR70) | Week 48 Observed (n=24) | 75 percentage of participants |
| Adalimumab | Percentage of Participants Achieving Pediatric American College of Rheumatology (PedACR) 70% Response (PedACR70) | Week 48 NRI (n=32) | 56.3 percentage of participants |
| Adalimumab | Percentage of Participants Achieving Pediatric American College of Rheumatology (PedACR) 70% Response (PedACR70) | Week 48 LOCF (n=31) | 74.2 percentage of participants |
| Adalimumab | Percentage of Participants Achieving Pediatric American College of Rheumatology (PedACR) 70% Response (PedACR70) | Week 60 Observed (n=20) | 70 percentage of participants |
| Adalimumab | Percentage of Participants Achieving Pediatric American College of Rheumatology (PedACR) 70% Response (PedACR70) | Week 60 NRI (n=32) | 43.8 percentage of participants |
| Adalimumab | Percentage of Participants Achieving Pediatric American College of Rheumatology (PedACR) 70% Response (PedACR70) | Week 60 LOCF (n=31) | 71 percentage of participants |
| Adalimumab | Percentage of Participants Achieving Pediatric American College of Rheumatology (PedACR) 70% Response (PedACR70) | Week 72 Observed (n=17) | 76.5 percentage of participants |
| Adalimumab | Percentage of Participants Achieving Pediatric American College of Rheumatology (PedACR) 70% Response (PedACR70) | Week 84 Observed (n=17) | 82.4 percentage of participants |
| Adalimumab | Percentage of Participants Achieving Pediatric American College of Rheumatology (PedACR) 70% Response (PedACR70) | Week 96 Observed (n=13) | 76.9 percentage of participants |
| Adalimumab | Percentage of Participants Achieving Pediatric American College of Rheumatology (PedACR) 70% Response (PedACR70) | Week 108 Observed (n=9) | 77.8 percentage of participants |
| Adalimumab | Percentage of Participants Achieving Pediatric American College of Rheumatology (PedACR) 70% Response (PedACR70) | Week 120 Observed (n=3) | 100 percentage of participants |
Secondary
Percentage of Participants Achieving Pediatric American College of Rheumatology (PedACR) 90% Response (PedACR90)
The PedACR90 response is defined by the PedACR as ≥ 90% improvement in at least 3 of 6 JIA core set criteria, and ≥ 30% worsening in not more than 1 of 6 JIA core set criteria. The 6 variables for the JIA core set criteria include PGA of participant's disease activity, Parent's Global Assessment of participant's disease activity, number of active joints (joints with swelling not due to deformity or joints with LOM and joints with POM, tenderness, or both), number of joints with LOM, DICHAQ, and CRP. Baseline is the last value prior to the first dose of study drug. Missing data were imputed up to Week 60 using LOCF and by NRI; observed values are presented for timepoints past Week 60. n=number of participants for either observed or imputed methods at given time point.
Time frame: Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Adalimumab | Percentage of Participants Achieving Pediatric American College of Rheumatology (PedACR) 90% Response (PedACR90) | Week 12 Observed (n=31) | 38.7 percentage of participants |
| Adalimumab | Percentage of Participants Achieving Pediatric American College of Rheumatology (PedACR) 90% Response (PedACR90) | Week 12 NRI (n=32) | 37.5 percentage of participants |
| Adalimumab | Percentage of Participants Achieving Pediatric American College of Rheumatology (PedACR) 90% Response (PedACR90) | Week 12 LOCF (n=31) | 38.7 percentage of participants |
| Adalimumab | Percentage of Participants Achieving Pediatric American College of Rheumatology (PedACR) 90% Response (PedACR90) | Week 24 Observed (n=30) | 36.7 percentage of participants |
| Adalimumab | Percentage of Participants Achieving Pediatric American College of Rheumatology (PedACR) 90% Response (PedACR90) | Week 24 NRI (n=32) | 34.4 percentage of participants |
| Adalimumab | Percentage of Participants Achieving Pediatric American College of Rheumatology (PedACR) 90% Response (PedACR90) | Week 24 LOCF (n=31) | 35.5 percentage of participants |
| Adalimumab | Percentage of Participants Achieving Pediatric American College of Rheumatology (PedACR) 90% Response (PedACR90) | Week 36 Observed (n=27) | 51.9 percentage of participants |
| Adalimumab | Percentage of Participants Achieving Pediatric American College of Rheumatology (PedACR) 90% Response (PedACR90) | Week 36 NRI (n=32) | 43.8 percentage of participants |
| Adalimumab | Percentage of Participants Achieving Pediatric American College of Rheumatology (PedACR) 90% Response (PedACR90) | Week 36 LOCF (n=31) | 51.6 percentage of participants |
| Adalimumab | Percentage of Participants Achieving Pediatric American College of Rheumatology (PedACR) 90% Response (PedACR90) | Week 48 Observed (n=24) | 62.5 percentage of participants |
| Adalimumab | Percentage of Participants Achieving Pediatric American College of Rheumatology (PedACR) 90% Response (PedACR90) | Week 48 NRI (n=32) | 46.9 percentage of participants |
| Adalimumab | Percentage of Participants Achieving Pediatric American College of Rheumatology (PedACR) 90% Response (PedACR90) | Week 48 LOCF (n=31) | 58.1 percentage of participants |
| Adalimumab | Percentage of Participants Achieving Pediatric American College of Rheumatology (PedACR) 90% Response (PedACR90) | Week 60 Observed (n=20) | 50 percentage of participants |
| Adalimumab | Percentage of Participants Achieving Pediatric American College of Rheumatology (PedACR) 90% Response (PedACR90) | Week 60 NRI (n=32) | 31.3 percentage of participants |
| Adalimumab | Percentage of Participants Achieving Pediatric American College of Rheumatology (PedACR) 90% Response (PedACR90) | Week 60 LOCF (n=31) | 51.6 percentage of participants |
| Adalimumab | Percentage of Participants Achieving Pediatric American College of Rheumatology (PedACR) 90% Response (PedACR90) | Week 72 Observed (n=17) | 64.7 percentage of participants |
| Adalimumab | Percentage of Participants Achieving Pediatric American College of Rheumatology (PedACR) 90% Response (PedACR90) | Week 84 Observed (n=17) | 64.7 percentage of participants |
| Adalimumab | Percentage of Participants Achieving Pediatric American College of Rheumatology (PedACR) 90% Response (PedACR90) | Week 96 Observed (n=13) | 61.5 percentage of participants |
| Adalimumab | Percentage of Participants Achieving Pediatric American College of Rheumatology (PedACR) 90% Response (PedACR90) | Week 108 Observed (n=9) | 66.7 percentage of participants |
| Adalimumab | Percentage of Participants Achieving Pediatric American College of Rheumatology (PedACR) 90% Response (PedACR90) | Week 120 Observed (n=3) | 100 percentage of participants |
Secondary
Physician's Global Assessment of Disease Activity: Mean Change From Baseline to Each Visit
The physician's assessment of participant's overall disease activity on a visual analog scale (VAS). The VAS is a 100 mm scale, with scores ranging from 0 (very good) to 100 (very bad). Baseline is defined as the last nonmissing value prior to the first dose of study drug. Participants with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=participants with a nonmissing value at baseline and each visit.
Time frame: Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Adalimumab | Physician's Global Assessment of Disease Activity: Mean Change From Baseline to Each Visit | Week 12 (n=31) | -41.4 units on a scale | Standard Deviation 21.2 |
| Adalimumab | Physician's Global Assessment of Disease Activity: Mean Change From Baseline to Each Visit | Week 24 (n=30) | -45.3 units on a scale | Standard Deviation 21.32 |
| Adalimumab | Physician's Global Assessment of Disease Activity: Mean Change From Baseline to Each Visit | Week 36 (n=28) | -43 units on a scale | Standard Deviation 23.9 |
| Adalimumab | Physician's Global Assessment of Disease Activity: Mean Change From Baseline to Each Visit | Week 48 (n=24) | -46.5 units on a scale | Standard Deviation 18.35 |
| Adalimumab | Physician's Global Assessment of Disease Activity: Mean Change From Baseline to Each Visit | Week 60 (n=21) | -42.7 units on a scale | Standard Deviation 28.17 |
| Adalimumab | Physician's Global Assessment of Disease Activity: Mean Change From Baseline to Each Visit | Week 72 (n=17) | -51.1 units on a scale | Standard Deviation 19.53 |
| Adalimumab | Physician's Global Assessment of Disease Activity: Mean Change From Baseline to Each Visit | Week 84 (n=17) | -50.5 units on a scale | Standard Deviation 16.77 |
| Adalimumab | Physician's Global Assessment of Disease Activity: Mean Change From Baseline to Each Visit | Week 96 (n=13) | -47.5 units on a scale | Standard Deviation 24.42 |
| Adalimumab | Physician's Global Assessment of Disease Activity: Mean Change From Baseline to Each Visit | Week 108 (n=9) | -48.3 units on a scale | Standard Deviation 28.24 |
| Adalimumab | Physician's Global Assessment of Disease Activity: Mean Change From Baseline to Each Visit | Week 120 (n=3) | -56.3 units on a scale | Standard Deviation 5.13 |
Secondary
Platelets: Mean Change From Baseline to Each Visit
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.
Time frame: Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Adalimumab | Platelets: Mean Change From Baseline to Each Visit | Week 12 (n=29) | -35 x10˄9/L | Standard Deviation 145.44 |
| Adalimumab | Platelets: Mean Change From Baseline to Each Visit | Week 24 (n=29) | -57.7 x10˄9/L | Standard Deviation 140.82 |
| Adalimumab | Platelets: Mean Change From Baseline to Each Visit | Week 36 (n=25) | -75.2 x10˄9/L | Standard Deviation 148.51 |
| Adalimumab | Platelets: Mean Change From Baseline to Each Visit | Week 48 (n=23) | -21 x10˄9/L | Standard Deviation 174.17 |
| Adalimumab | Platelets: Mean Change From Baseline to Each Visit | Week 60 (n=21) | -46.7 x10˄9/L | Standard Deviation 125.71 |
| Adalimumab | Platelets: Mean Change From Baseline to Each Visit | Week 72 (n=17) | -51.1 x10˄9/L | Standard Deviation 111.11 |
| Adalimumab | Platelets: Mean Change From Baseline to Each Visit | Week 84 (n=15) | -58.5 x10˄9/L | Standard Deviation 127.29 |
| Adalimumab | Platelets: Mean Change From Baseline to Each Visit | Week 96 (n=11) | -49.2 x10˄9/L | Standard Deviation 142.73 |
| Adalimumab | Platelets: Mean Change From Baseline to Each Visit | Week 108 (n=9) | -30.4 x10˄9/L | Standard Deviation 137.84 |
| Adalimumab | Platelets: Mean Change From Baseline to Each Visit | Week 120 (n=3) | 20 x10˄9/L | Standard Deviation 185.95 |
Secondary
Red Blood Cell (RBC) Count: Mean Change From Baseline to Each Visit
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.
Time frame: Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Adalimumab | Red Blood Cell (RBC) Count: Mean Change From Baseline to Each Visit | Week 12 (n=29) | 0.15 x10˄12/L | Standard Deviation 0.231 |
| Adalimumab | Red Blood Cell (RBC) Count: Mean Change From Baseline to Each Visit | Week 24 (n=29) | 0.08 x10˄12/L | Standard Deviation 0.308 |
| Adalimumab | Red Blood Cell (RBC) Count: Mean Change From Baseline to Each Visit | Week 36 (n=25) | 0.098 x10˄12/L | Standard Deviation 0.277 |
| Adalimumab | Red Blood Cell (RBC) Count: Mean Change From Baseline to Each Visit | Week 48 (n=24) | 0.05 x10˄12/L | Standard Deviation 0.213 |
| Adalimumab | Red Blood Cell (RBC) Count: Mean Change From Baseline to Each Visit | Week 60 (n=21) | 0.07 x10˄12/L | Standard Deviation 0.296 |
| Adalimumab | Red Blood Cell (RBC) Count: Mean Change From Baseline to Each Visit | Week 72 (n=17) | 0.1 x10˄12/L | Standard Deviation 0.187 |
| Adalimumab | Red Blood Cell (RBC) Count: Mean Change From Baseline to Each Visit | Week 84 (n=16) | 0.06 x10˄12/L | Standard Deviation 0.228 |
| Adalimumab | Red Blood Cell (RBC) Count: Mean Change From Baseline to Each Visit | Week 96 (n=11) | 0.08 x10˄12/L | Standard Deviation 0.343 |
| Adalimumab | Red Blood Cell (RBC) Count: Mean Change From Baseline to Each Visit | Week 108 (n=9) | 0.1 x10˄12/L | Standard Deviation 0.32 |
| Adalimumab | Red Blood Cell (RBC) Count: Mean Change From Baseline to Each Visit | Week 120 (n=3) | 0.03 x10˄12/L | Standard Deviation 0.153 |
Secondary
Swollen Joint Count (SJC66): Mean Change From Baseline to Each Visit
Sixty-six joints were assessed by physical examination. The joints to be examined for swelling were the same as those examined for tenderness, except that the hip, subtalar, sacroiliac, lumbar spine, thoracic spine, and cervical spine joints were excluded. Joint swelling was classified as present (1), absent (0) or replaced/injected (9). Scores range from 0 to 594, with higher scores representing higher disease activity. Baseline is defined as the last nonmissing value prior to the first dose of study drug. Participants with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=participants with a nonmissing value at baseline and each visit.
Time frame: Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 36, 48, 60, 72, 84, 96, 108, and 120
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Adalimumab | Swollen Joint Count (SJC66): Mean Change From Baseline to Each Visit | Week 2 (n=32) | -4.5 units on a scale | Standard Deviation 6.46 |
| Adalimumab | Swollen Joint Count (SJC66): Mean Change From Baseline to Each Visit | Week 4 (n=32) | -5.3 units on a scale | Standard Deviation 6.63 |
| Adalimumab | Swollen Joint Count (SJC66): Mean Change From Baseline to Each Visit | Week 8 (n=32) | -6 units on a scale | Standard Deviation 5.32 |
| Adalimumab | Swollen Joint Count (SJC66): Mean Change From Baseline to Each Visit | Week 12 (n=31) | -6.2 units on a scale | Standard Deviation 4.24 |
| Adalimumab | Swollen Joint Count (SJC66): Mean Change From Baseline to Each Visit | Week 16 (n=31) | -6.1 units on a scale | Standard Deviation 6.59 |
| Adalimumab | Swollen Joint Count (SJC66): Mean Change From Baseline to Each Visit | Week 20 (n=29) | -6.9 units on a scale | Standard Deviation 5.62 |
| Adalimumab | Swollen Joint Count (SJC66): Mean Change From Baseline to Each Visit | Week 24 (n=30) | -6.3 units on a scale | Standard Deviation 5.83 |
| Adalimumab | Swollen Joint Count (SJC66): Mean Change From Baseline to Each Visit | Week 36 (n=28) | -6.2 units on a scale | Standard Deviation 4.73 |
| Adalimumab | Swollen Joint Count (SJC66): Mean Change From Baseline to Each Visit | Week 48 (n=24) | -6.7 units on a scale | Standard Deviation 5.34 |
| Adalimumab | Swollen Joint Count (SJC66): Mean Change From Baseline to Each Visit | Week 60 (n=20) | -8.4 units on a scale | Standard Deviation 7.15 |
| Adalimumab | Swollen Joint Count (SJC66): Mean Change From Baseline to Each Visit | Week 72 (n=17) | -8.9 units on a scale | Standard Deviation 6.06 |
| Adalimumab | Swollen Joint Count (SJC66): Mean Change From Baseline to Each Visit | Week 84 (n=17) | -9.4 units on a scale | Standard Deviation 7.15 |
| Adalimumab | Swollen Joint Count (SJC66): Mean Change From Baseline to Each Visit | Week 96 (n=13) | -8.5 units on a scale | Standard Deviation 6.89 |
| Adalimumab | Swollen Joint Count (SJC66): Mean Change From Baseline to Each Visit | Week 108 (n=9) | -5.8 units on a scale | Standard Deviation 3.31 |
| Adalimumab | Swollen Joint Count (SJC66): Mean Change From Baseline to Each Visit | Week 120 (n=3) | -7.3 units on a scale | Standard Deviation 2.08 |
Secondary
Tender Joint Count (TJC75): Mean Change From Baseline to Each Visit
Seventy-five joints or regions were assessed by pressure and joint manipulation on physical examination. Joint tenderness was classified as either present (1), absent (0) or replaced/injected (9). Scores range from 0 to 675, with higher scores representing higher disease activity. Baseline is defined as the last nonmissing value prior to the first dose of study drug. Participants with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=participants with a nonmissing value at baseline and each visit.
Time frame: Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 36, 48, 60, 72, 84, 96, 108, and 120
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Adalimumab | Tender Joint Count (TJC75): Mean Change From Baseline to Each Visit | Week 2 (n=32) | -2.3 units on a scale | Standard Deviation 4.62 |
| Adalimumab | Tender Joint Count (TJC75): Mean Change From Baseline to Each Visit | Week 4 (n=32) | -2.8 units on a scale | Standard Deviation 4.48 |
| Adalimumab | Tender Joint Count (TJC75): Mean Change From Baseline to Each Visit | Week 8 (n=32) | -3.1 units on a scale | Standard Deviation 4.31 |
| Adalimumab | Tender Joint Count (TJC75): Mean Change From Baseline to Each Visit | Week 12 (n=31) | -2.7 units on a scale | Standard Deviation 5.09 |
| Adalimumab | Tender Joint Count (TJC75): Mean Change From Baseline to Each Visit | Week 16 (n=31) | -3.5 units on a scale | Standard Deviation 4.77 |
| Adalimumab | Tender Joint Count (TJC75): Mean Change From Baseline to Each Visit | Week 20 (n=29) | -3.9 units on a scale | Standard Deviation 5.09 |
| Adalimumab | Tender Joint Count (TJC75): Mean Change From Baseline to Each Visit | Week 24 (n=30) | -3 units on a scale | Standard Deviation 5.54 |
| Adalimumab | Tender Joint Count (TJC75): Mean Change From Baseline to Each Visit | Week 36 (n=28) | -2.9 units on a scale | Standard Deviation 5.65 |
| Adalimumab | Tender Joint Count (TJC75): Mean Change From Baseline to Each Visit | Week 48 (n=24) | -4.4 units on a scale | Standard Deviation 4.85 |
| Adalimumab | Tender Joint Count (TJC75): Mean Change From Baseline to Each Visit | Week 60 (n=20) | -4.5 units on a scale | Standard Deviation 5.85 |
| Adalimumab | Tender Joint Count (TJC75): Mean Change From Baseline to Each Visit | Week 72 (n=17) | -5.3 units on a scale | Standard Deviation 5.53 |
| Adalimumab | Tender Joint Count (TJC75): Mean Change From Baseline to Each Visit | Week 84 (n=17) | -4.8 units on a scale | Standard Deviation 5.2 |
| Adalimumab | Tender Joint Count (TJC75): Mean Change From Baseline to Each Visit | Week 96 (n=13) | -4 units on a scale | Standard Deviation 5.46 |
| Adalimumab | Tender Joint Count (TJC75): Mean Change From Baseline to Each Visit | Week 108 (n=9) | -1.1 units on a scale | Standard Deviation 4.73 |
| Adalimumab | Tender Joint Count (TJC75): Mean Change From Baseline to Each Visit | Week 120 (n=3) | -1.3 units on a scale | Standard Deviation 2.31 |
Secondary
Total Bilirubin: Mean Change From Baseline to Each Visit
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.
Time frame: Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Adalimumab | Total Bilirubin: Mean Change From Baseline to Each Visit | Week 12 (n=27) | 1.2 µmol/L | Standard Deviation 2.42 |
| Adalimumab | Total Bilirubin: Mean Change From Baseline to Each Visit | Week 24 (n=28) | 0.6 µmol/L | Standard Deviation 1.59 |
| Adalimumab | Total Bilirubin: Mean Change From Baseline to Each Visit | Week 36 (n=25) | 0.6 µmol/L | Standard Deviation 1.61 |
| Adalimumab | Total Bilirubin: Mean Change From Baseline to Each Visit | Week 48 (n=24) | 0.9 µmol/L | Standard Deviation 2.4 |
| Adalimumab | Total Bilirubin: Mean Change From Baseline to Each Visit | Week 60 (n=21) | 1 µmol/L | Standard Deviation 2.09 |
| Adalimumab | Total Bilirubin: Mean Change From Baseline to Each Visit | Week 72 (n=16) | 0.2 µmol/L | Standard Deviation 1.25 |
| Adalimumab | Total Bilirubin: Mean Change From Baseline to Each Visit | Week 84 (n=16) | 0.5 µmol/L | Standard Deviation 2.36 |
| Adalimumab | Total Bilirubin: Mean Change From Baseline to Each Visit | Week 96 (n=11) | 0.7 µmol/L | Standard Deviation 1.62 |
| Adalimumab | Total Bilirubin: Mean Change From Baseline to Each Visit | Week 108 (n=9) | 1.1 µmol/L | Standard Deviation 2.71 |
| Adalimumab | Total Bilirubin: Mean Change From Baseline to Each Visit | Week 120 (n=3) | 2.3 µmol/L | Standard Deviation 0.58 |
Secondary
Uric Acid: Mean Change From Baseline to Each Visit
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.
Time frame: Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Adalimumab | Uric Acid: Mean Change From Baseline to Each Visit | Week 72 (n=16) | -0.9 µmol/L | Standard Deviation 43.53 |
| Adalimumab | Uric Acid: Mean Change From Baseline to Each Visit | Week 12 (n=27) | 1.7 µmol/L | Standard Deviation 48.24 |
| Adalimumab | Uric Acid: Mean Change From Baseline to Each Visit | Week 24 (n=27) | 6.5 µmol/L | Standard Deviation 47.93 |
| Adalimumab | Uric Acid: Mean Change From Baseline to Each Visit | Week 36 (n=25) | 2.5 µmol/L | Standard Deviation 41.77 |
| Adalimumab | Uric Acid: Mean Change From Baseline to Each Visit | Week 48 (n=24) | 5.6 µmol/L | Standard Deviation 45.62 |
| Adalimumab | Uric Acid: Mean Change From Baseline to Each Visit | Week 60 (n=21) | 1.9 µmol/L | Standard Deviation 30.86 |
| Adalimumab | Uric Acid: Mean Change From Baseline to Each Visit | Week 84 (n=16) | -4.5 µmol/L | Standard Deviation 46.76 |
| Adalimumab | Uric Acid: Mean Change From Baseline to Each Visit | Week 96 (n=11) | 13.3 µmol/L | Standard Deviation 36.39 |
| Adalimumab | Uric Acid: Mean Change From Baseline to Each Visit | Week 108 (n=9) | -10.1 µmol/L | Standard Deviation 33.55 |
| Adalimumab | Uric Acid: Mean Change From Baseline to Each Visit | Week 120 (n=3) | -7 µmol/L | Standard Deviation 27.78 |
Secondary
White Blood Cell (WBC) Count: Mean Change From Baseline to Each Visit
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.
Time frame: Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Adalimumab | White Blood Cell (WBC) Count: Mean Change From Baseline to Each Visit | Week 12 (n=29) | 0.19 x10^9/L | Standard Deviation 3.959 |
| Adalimumab | White Blood Cell (WBC) Count: Mean Change From Baseline to Each Visit | Week 24 (n=29) | -0.25 x10^9/L | Standard Deviation 3.756 |
| Adalimumab | White Blood Cell (WBC) Count: Mean Change From Baseline to Each Visit | Week 36 (n=25) | -0.42 x10^9/L | Standard Deviation 4.632 |
| Adalimumab | White Blood Cell (WBC) Count: Mean Change From Baseline to Each Visit | Week 48 (n=24) | 0.3 x10^9/L | Standard Deviation 4.804 |
| Adalimumab | White Blood Cell (WBC) Count: Mean Change From Baseline to Each Visit | Week 60 (n=21) | 0.25 x10^9/L | Standard Deviation 2.183 |
| Adalimumab | White Blood Cell (WBC) Count: Mean Change From Baseline to Each Visit | Week 72 (n=17) | 0.66 x10^9/L | Standard Deviation 3.225 |
| Adalimumab | White Blood Cell (WBC) Count: Mean Change From Baseline to Each Visit | Week 84 (n=16) | 0.18 x10^9/L | Standard Deviation 2.944 |
| Adalimumab | White Blood Cell (WBC) Count: Mean Change From Baseline to Each Visit | Week 96 (n=11) | 0.55 x10^9/L | Standard Deviation 2.757 |
| Adalimumab | White Blood Cell (WBC) Count: Mean Change From Baseline to Each Visit | Week 108 (n=9) | -0.76 x10^9/L | Standard Deviation 4.166 |
| Adalimumab | White Blood Cell (WBC) Count: Mean Change From Baseline to Each Visit | Week 120 (n=3) | 1.8 x10^9/L | Standard Deviation 3.651 |