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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-013091-40 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adalimumab | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adalimumab | Drug | Adalimumab solution for injection for subcutaneous use. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Weeks 0, 12, and 24 |
| Hemoglobin: Mean Change From Baseline to Each Visit |
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Inclusion Criteria:
Exclusion Criteria:
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.
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.
Subject has undergone joint surgery within the preceding two months of the Screening Visit (at joints to be assessed within the study).
Subject has a previous diagnosis of a condition that could cause arthritis other than polyarticular JIA.
Subject has a history of an allergic reaction or significant sensitivity to constituents of the study drug, adalimumab.
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.
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.
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.
Subject is considered by the Investigator, for any reason, to be an unsuitable candidate for the study.
Subject has evidence of active TB infection.
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.
Evidence of dysplasia or history of malignancy (including lymphoma and leukemia).
History of demyelinating disease (including myelitis) or neurologic symptoms suggestive of central nervous system [CNS] demyelinating disease.
History of invasive fungal infection (e.g., listeriosis, histoplasmosis), active viral disorders, human immunodeficiency virus (HIV) infection.
Positive Hepatitis B test result.
Chronic recurring infections or active TB.
Screening laboratory and other analyses show any of the following abnormal results:
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.
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| Name | Affiliation | Role |
|---|---|---|
| Aileen L. Pangan, MD | AbbVie | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30054164 | Derived | Horneff G, Seyger MMB, Arikan D, Kalabic J, Anderson JK, Lazar A, Williams DA, Wang C, Tarzynski-Potempa R, Hyams JS. Safety of Adalimumab in Pediatric Patients with Polyarticular Juvenile Idiopathic Arthritis, Enthesitis-Related Arthritis, Psoriasis, and Crohn's Disease. J Pediatr. 2018 Oct;201:166-175.e3. doi: 10.1016/j.jpeds.2018.05.042. Epub 2018 Jul 25. | |
| 24487484 |
| Label | URL |
|---|---|
| Related Info | View source |
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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 were enrolled at 14 investigative sites in the Czech Republic, France, Germany, and the United States.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | Posted | Number | participants | 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). |
|
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); SAEs were collected from the time informed consent was obtained (33.5 months).
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. TEAEs were collected whether elicited or spontaneously reported by the participant.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dental caries | Gastrointestinal disorders | MedDRA (15.1) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA (15.1) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Medical Information | AbbVie | 800-633-9110 |
| ID | Term |
|---|---|
| D001171 | Arthritis, Juvenile |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D000068879 | Adalimumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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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. |
| Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120 |
| 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. | Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120 |
| 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. | Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120 |
| 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. | Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120 |
| 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. | Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120 |
| 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. | Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120 |
| 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. | Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120 |
| 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. | Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120 |
| 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. | Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120 |
| 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. | Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120 |
| 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. | Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120 |
| 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. | Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120 |
| 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. | Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120 |
| 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. | Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120 |
| 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. | Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120 |
| 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. | Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120 |
| 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. | Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120 |
| 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. | Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120 |
| 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. | Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120 |
| 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. | Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120 |
| 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. | Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120 |
| 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. | Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120 |
| 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. | Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120 |
| 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. | Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120 |
| 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. | Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 36, 48, 60, 72, 84, 96, 108, and 120 |
| 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. | Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 36, 48, 60, 72, 84, 96, 108, and 120 |
| 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. | Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120 |
| 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. | Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 36, 48, 60, 72, 84, 96, 108, and 120 |
| 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. | Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 36, 48, 60, 72, 84, 96, 108, and 120 |
| 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. | Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 36, 48, 60, 72, 84, 96, 108, and 120 |
| 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. | Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120 |
| 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. | Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120. |
| 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. | Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120 |
| 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. | Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120 |
| 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. | Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120 |
| 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. | Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120 |
| 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. | Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120 |
| 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. | Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120 |
| 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. | Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120 |
| 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. | Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120 |
| 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. | Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120 |
| 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. | Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120 |
| 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. | Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120 |
| 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. | Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120 |
| 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. | Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120 |
| Kingsbury DJ, Bader-Meunier B, Patel G, Arora V, Kalabic J, Kupper H. Safety, effectiveness, and pharmacokinetics of adalimumab in children with polyarticular juvenile idiopathic arthritis aged 2 to 4 years. Clin Rheumatol. 2014;33(10):1433-41. doi: 10.1007/s10067-014-2498-1. Epub 2014 Feb 2. |
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| Age, Customized | Number | participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| OG000 | 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. |
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| 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. | All participants who had samples for pharmacokinetic analysis | Posted | Mean | Standard Deviation | µg/mL | Weeks 0, 12, and 24 |
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| 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. | Posted | Mean | Standard Deviation | g/L | Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120 |
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| 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. | Posted | Mean | Standard Deviation | Fraction | Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120 |
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| 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. | Posted | Mean | Standard Deviation | x10˄12/L | Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120 |
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| 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. | Posted | Mean | Standard Deviation | x10˄9/L | Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120 |
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| 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. | Posted | Mean | Standard Deviation | x10^9/L | Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120 |
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| 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. | Posted | Mean | Standard Deviation | x10˄9/L | Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120 |
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| 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. | Posted | Mean | Standard Deviation | x10˄9/L | Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120 |
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| 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. | Posted | Mean | Standard Deviation | x10^9/L | Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120 |
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| 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. | Posted | Mean | Standard Deviation | x10^9/L | Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120 |
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| 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. | Posted | Mean | Standard Deviation | x10^9/L | Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120 |
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| 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. | Posted | Mean | Standard Deviation | U/L | Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120 |
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| 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. | Posted | Mean | Standard Deviation | U/L | Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120 |
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| 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. | Posted | Mean | Standard Deviation | U/L | Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120 |
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| 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. | Posted | Mean | Standard Deviation | U/L | Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120 |
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| 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. | Posted | Mean | Standard Deviation | µmol/L | Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120 |
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| 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. | Posted | Mean | Standard Deviation | µmol/L | Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120 |
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| 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. | Posted | Mean | Standard Deviation | µmol/L | Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120 |
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| 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. | Posted | Number | percentage of participants | Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120 |
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| 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. | Posted | Number | percentage of participants | Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120 |
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| 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. | Posted | Number | percentage of participants | Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120 |
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| 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. | Posted | Number | percentage of participants | Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120 |
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| 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120 |
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| 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120 |
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| 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120 |
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| 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 36, 48, 60, 72, 84, 96, 108, and 120 |
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| 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 36, 48, 60, 72, 84, 96, 108, and 120 |
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| 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. | Posted | Mean | Standard Deviation | mg/dL | Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120 |
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| 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 36, 48, 60, 72, 84, 96, 108, and 120 |
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| 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 36, 48, 60, 72, 84, 96, 108, and 120 |
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| 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 36, 48, 60, 72, 84, 96, 108, and 120 |
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| 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120 |
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| 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120. |
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| 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120 |
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| 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120 |
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| 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120 |
|
|
|
| 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120 |
|
|
|
| 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120 |
|
|
|
| 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120 |
|
|
|
| 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120 |
|
|
|
| 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120 |
|
|
|
| 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120 |
|
|
|
| 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120 |
|
|
|
| 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120 |
|
|
|
| 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120 |
|
|
|
| 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120 |
|
|
|
| 5 |
| 32 |
| 27 |
| 32 |
| Juvenile arthritis | Musculoskeletal and connective tissue disorders | MedDRA (15.1) | Systematic Assessment |
|
| Type 1 diabetes mellitus | Metabolism and nutrition disorders | MedDRA (15.1) | Systematic Assessment |
|
| Gastroenteritis rotavirus | Infections and infestations | MedDRA (15.1) | Systematic Assessment |
|
| Varicella | Infections and infestations | MedDRA (15.1) | Systematic Assessment |
|
| Body temperature increased | Investigations | MedDRA (15.1) | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (15.1) | Systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA (15.1) | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (15.1) | Systematic Assessment |
|
| Uveitis | Eye disorders | MedDRA (15.1) | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA (15.1) | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA (15.1) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (15.1) | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA (15.1) | Systematic Assessment |
|
| Juvenile arthritis | Musculoskeletal and connective tissue disorders | MedDRA (15.1) | Systematic Assessment |
|
| Acute tonsillitis | Infections and infestations | MedDRA (15.1) | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA (15.1) | Systematic Assessment |
|
| Cystitis | Infections and infestations | MedDRA (15.1) | Systematic Assessment |
|
| Ear infection | Infections and infestations | MedDRA (15.1) | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA (15.1) | Systematic Assessment |
|
| Gastroenteritis viral | Infections and infestations | MedDRA (15.1) | Systematic Assessment |
|
| H1N1 influenza | Infections and infestations | MedDRA (15.1) | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA (15.1) | Systematic Assessment |
|
| Otitis media | Infections and infestations | MedDRA (15.1) | Systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA (15.1) | Systematic Assessment |
|
| Pharyngitis streptococcal | Infections and infestations | MedDRA (15.1) | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA (15.1) | Systematic Assessment |
|
| Rhinitis | Infections and infestations | MedDRA (15.1) | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA (15.1) | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA (15.1) | Systematic Assessment |
|
AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Week 48 (n=24) |
|
| Week 60 (n=21) |
|
| Week 72 (n=17) |
|
| Week 84 (n=16) |
|
| Week 96 (n=11) |
|
| Week 108 (n=9) |
|
| Week 120 (n=3) |
|
| Title | Measurements |
|---|---|
|
| Week 48 (n=24) |
|
| Week 60 (n=21) |
|
| Week 72 (n=17) |
|
| Week 84 (n=16) |
|
| Week 96 (n=11) |
|
| Week 108 (n=9) |
|
| Week 120 (n=3) |
|
| Title | Measurements |
|---|---|
|
| Week 48 (n=24) |
|
| Week 60 (n=21) |
|
| Week 72 (n=17) |
|
| Week 84 (n=16) |
|
| Week 96 (n=11) |
|
| Week 108 (n=9) |
|
| Week 120 (n=3) |
|
| Title | Measurements |
|---|---|
|
| Week 48 (n=23) |
|
| Week 60 (n=21) |
|
| Week 72 (n=17) |
|
| Week 84 (n=15) |
|
| Week 96 (n=11) |
|
| Week 108 (n=9) |
|
| Week 120 (n=3) |
|
| Title | Measurements |
|---|---|
|
| Week 48 (n=24) |
|
| Week 60 (n=21) |
|
| Week 72 (n=17) |
|
| Week 84 (n=16) |
|
| Week 96 (n=11) |
|
| Week 108 (n=9) |
|
| Week 120 (n=3) |
|
| Title | Measurements |
|---|---|
|
| Week 48 (n=24) |
|
| Week 60 (n=21) |
|
| Week 72 (n=17) |
|
| Week 84 (n=16) |
|
| Week 96 (n=11) |
|
| Week 108 (n=9) |
|
| Week 120 (n=3) |
|
| Title | Measurements |
|---|---|
|
| Week 48 (n=24) |
|
| Week 60 (n=21) |
|
| Week 72 (n=17) |
|
| Week 84 (n=16) |
|
| Week 96 (n=11) |
|
| Week 108 (n=9) |
|
| Week 120 (n=3) |
|
| Title | Measurements |
|---|---|
|
| Week 48 (n=24) |
|
| Week 60 (n=21) |
|
| Week 72 (n=17) |
|
| Week 84 (n=16) |
|
| Week 96 (n=11) |
|
| Week 108 (n=9) |
|
| Week 120 (n=3) |
|
| Title | Measurements |
|---|---|
|
| Week 48 (n=24) |
|
| Week 60 (n=21) |
|
| Week 72 (n=17) |
|
| Week 84 (n=16) |
|
| Week 96 (n=11) |
|
| Week 108 (n=9) |
|
| Week 120 (n=3) |
|
| Title | Measurements |
|---|---|
|
| Week 48 (n=24) |
|
| Week 60 (n=21) |
|
| Week 72 (n=17) |
|
| Week 84 (n=16) |
|
| Week 96 (n=11) |
|
| Week 108 (n=9) |
|
| Week 120 (n=3) |
|
| Title | Measurements |
|---|---|
|
| Week 48 (n=24) |
|
| Week 60 (n=21) |
|
| Week 72 (n=16) |
|
| Week 84 (n=16) |
|
| Week 96 (n=11) |
|
| Week 108 (n=9) |
|
| Week 120 (n=3) |
|
| Title | Measurements |
|---|---|
|
| Week 48 (n=24) |
|
| Week 60 (n=21) |
|
| Week 72 (n=16) |
|
| Week 84 (n=16) |
|
| Week 96 (n=10) |
|
| Week 108 (n=9) |
|
| Week 120 (n=3) |
|
| Title | Measurements |
|---|---|
|
| Week 48 (n=24) |
|
| Week 60 (n=21) |
|
| Week 72 (n=16) |
|
| Week 84 (n=16) |
|
| Week 96 (n=11) |
|
| Week 108 (n=9) |
|
| Week 120 (n=3) |
|
| Title | Measurements |
|---|---|
|
| Week 48 (n=24) |
|
| Week 60 (n=21) |
|
| Week 72 (n=16) |
|
| Week 84 (n=16) |
|
| Week 96 (n=11) |
|
| Week 108 (n=9) |
|
| Week 120 (n=3) |
|
| Title | Measurements |
|---|---|
|
| Week 48 (n=24) |
|
| Week 60 (n=21) |
|
| Week 72 (n=16) |
|
| Week 84 (n=16) |
|
| Week 96 (n=11) |
|
| Week 108 (n=9) |
|
| Week 120 (n=3) |
|
| Title | Measurements |
|---|---|
|
| Week 48 (n=24) |
|
| Week 60 (n=21) |
|
| Week 72 (n=16) |
|
| Week 84 (n=16) |
|
| Week 96 (n=11) |
|
| Week 108 (n=9) |
|
| Week 120 (n=3) |
|
| Title | Measurements |
|---|---|
|
| Week 48 (n=24) |
|
| Week 60 (n=21) |
|
| Week 72 (n=16) |
|
| Week 84 (n=16) |
|
| Week 96 (n=11) |
|
| Week 108 (n=9) |
|
| Week 120 (n=3) |
|
| Title | Measurements |
|---|---|
|
| Week 24 Observed (n=30) |
|
| Week 24 NRI (n=32) |
|
| Week 24 LOCF (n=31) |
|
| Week 36 Observed (n=27) |
|
| Week 36 NRI (n=32) |
|
| Week 36 LOCF (n=31) |
|
| Week 48 Observed (n=24) |
|
| Week 48 NRI (n=32) |
|
| Week 48 LOCF (n=31) |
|
| Week 60 Observed (n=20) |
|
| Week 60 NRI (n=32) |
|
| Week 60 LOCF (n=31) |
|
| Week 72 Observed (n=17) |
|
| Week 84 Observed (n=17) |
|
| Week 96 Observed (n=13) |
|
| Week 108 Observed (n=9) |
|
| Week 120 Observed (n=3) |
|
| Title | Measurements |
|---|---|
|
| Week 24 Observed (n=30) |
|
| Week 24 NRI (n=32) |
|
| Week 24 LOCF (n=31) |
|
| Week 36 Observed (n=27) |
|
| Week 36 NRI (n=32) |
|
| Week 36 LOCF (n=31) |
|
| Week 48 Observed (n=24) |
|
| Week 48 NRI (n=32) |
|
| Week 48 LOCF (n=31) |
|
| Week 60 Observed (n=20) |
|
| Week 60 NRI (n=32) |
|
| Week 60 LOCF (n=31) |
|
| Week 72 Observed (n=17) |
|
| Week 84 Observed (n=17) |
|
| Week 96 Observed (n=13) |
|
| Week 108 Observed (n=9) |
|
| Week 120 Observed (n=3) |
|
| Title | Measurements |
|---|---|
|
| Week 24 Observed (n=30) |
|
| Week 24 NRI (n=32) |
|
| Week 24 LOCF (n=31) |
|
| Week 36 Observed (n=27) |
|
| Week 36 NRI (n=32) |
|
| Week 36 LOCF (n=31) |
|
| Week 48 Observed (n=24) |
|
| Week 48 NRI (n=32) |
|
| Week 48 LOCF (n=31) |
|
| Week 60 Observed (n=20) |
|
| Week 60 NRI (n=32) |
|
| Week 60 LOCF (n=31) |
|
| Week 72 Observed (n=17) |
|
| Week 84 Observed (n=17) |
|
| Week 96 Observed (n=13) |
|
| Week 108 Observed (n=9) |
|
| Week 120 Observed (n=3) |
|
| Title | Measurements |
|---|---|
|
| Week 24 Observed (n=30) |
|
| Week 24 NRI (n=32) |
|
| Week 24 LOCF (n=31) |
|
| Week 36 Observed (n=27) |
|
| Week 36 NRI (n=32) |
|
| Week 36 LOCF (n=31) |
|
| Week 48 Observed (n=24) |
|
| Week 48 NRI (n=32) |
|
| Week 48 LOCF (n=31) |
|
| Week 60 Observed (n=20) |
|
| Week 60 NRI (n=32) |
|
| Week 60 LOCF (n=31) |
|
| Week 72 Observed (n=17) |
|
| Week 84 Observed (n=17) |
|
| Week 96 Observed (n=13) |
|
| Week 108 Observed (n=9) |
|
| Week 120 Observed (n=3) |
|
| Title | Measurements |
|---|---|
|
| Week 48 (n=24) |
|
| Week 60 (n=21) |
|
| Week 72 (n=17) |
|
| Week 84 (n=17) |
|
| Week 96 (n=13) |
|
| Week 108 (n=9) |
|
| Week 120 (n=3) |
|
| Title | Measurements |
|---|---|
|
| Week 48 (n=24) |
|
| Week 60 (n=21) |
|
| Week 72 (n=17) |
|
| Week 84 (n=17) |
|
| Week 96 (n=13) |
|
| Week 108 (n=9) |
|
| Week 120 (n=3) |
|
| Title | Measurements |
|---|---|
|
| Week 48 (n=24) |
|
| Week 60 (n=21) |
|
| Week 72 (n=16) |
|
| Week 84 (n=17) |
|
| Week 96 (n=13) |
|
| Week 108 (n=9) |
|
| Week 120 (n=3) |
|
| Title | Measurements |
|---|---|
|
| Week 12 (n=31) |
|
| Week 16 (n=31) |
|
| Week 20 (n=29) |
|
| Week 24 (n=30) |
|
| Week 36 (n=28) |
|
| Week 48 (n=24) |
|
| Week 60 (n=20) |
|
| Week 72 (n=17) |
|
| Week 84 (n=17) |
|
| Week 96 (n=13) |
|
| Week 108 (n=9) |
|
| Week 120 (n=3) |
|
| Title | Measurements |
|---|---|
|
| Week 12 (n=31) |
|
| Week 16 (n=31) |
|
| Week 20 (n=29) |
|
| Week 24 (n=30) |
|
| Week 36 (n=28) |
|
| Week 48 (n=24) |
|
| Week 60 (n=20) |
|
| Week 72 (n=17) |
|
| Week 84 (n=17) |
|
| Week 96 (n=13) |
|
| Week 108 (n=9) |
|
| Week 120 (n=3) |
|
| Title | Measurements |
|---|---|
|
| Week 48 (n=23) |
|
| Week 60 (n=20) |
|
| Week 72 (n=17) |
|
| Week 84 (n=17) |
|
| Week 96 (n=12) |
|
| Week 108 (n=9) |
|
| Week 120 (n=3) |
|
| Title | Measurements |
|---|---|
|
| Week 12 (n=31) |
|
| Week 16 (n=31) |
|
| Week 20 (n=29) |
|
| Week 24 (n=30) |
|
| Week 36 (n=28) |
|
| Week 48 (n=24) |
|
| Week 60 (n=20) |
|
| Week 72 (n=17) |
|
| Week 84 (n=17) |
|
| Week 96 (n=13) |
|
| Week 108 (n=9) |
|
| Week 120 (n=3) |
|
| Title | Measurements |
|---|---|
|
| Week 12 (n=31) |
|
| Week 16 (n=31) |
|
| Week 20 (n=29) |
|
| Week 24 (n=30) |
|
| Week 36 (n=28) |
|
| Week 48 (n=24) |
|
| Week 60 (n=20) |
|
| Week 72 (n=17) |
|
| Week 84 (n=17) |
|
| Week 96 (n=13) |
|
| Week 108 (n=9) |
|
| Week 120 (n=3) |
|
| Title | Measurements |
|---|---|
|
| Week 12 (n=31) |
|
| Week 16 (n=31) |
|
| Week 20 (n=29) |
|
| Week 24 (n=30) |
|
| Week 36 (n=28) |
|
| Week 48 (n=24) |
|
| Week 60 (n=20) |
|
| Week 72 (n=17) |
|
| Week 84 (n=17) |
|
| Week 96 (n=13) |
|
| Week 108 (n=9) |
|
| Week 120 (n=3) |
|
| Title | Measurements |
|---|---|
|
| Week 48 (n=22) |
|
| Week 60 (n=19) |
|
| Week 72 (n=17) |
|
| Week 84 (n=17) |
|
| Week 96 (n=11) |
|
| Week 108 (n=8) |
|
| Week 120 (n=3) |
|
| Title | Measurements |
|---|---|
|
| Week 48 (n=23) |
|
| Week 60 (n=21) |
|
| Week 72 (n=16) |
|
| Week 84 (n=17) |
|
| Week 96 (n=13) |
|
| Week 108 (n=9) |
|
| Week 120 (n=3) |
|
| Title | Measurements |
|---|---|
|
| Week 48 (n=18) |
|
| Week 60 (n=16) |
|
| Week 72 (n=13) |
|
| Week 84 (n=13) |
|
| Week 96 (n=9) |
|
| Week 108 (n=7) |
|
| Week 120 (n=2) |
|
| Title | Measurements |
|---|---|
|
| Week 48 (n=17) |
|
| Week 60 (n=15) |
|
| Week 72 (n=12) |
|
| Week 84 (n=12) |
|
| Week 96 (n=8) |
|
| Week 108 (n=6) |
|
| Week 120 (n=1) |
|
| Title | Measurements |
|---|---|
|
| Week 48 (n=23) |
|
| Week 60 (n=20) |
|
| Week 72 (n=17) |
|
| Week 84 (n=17) |
|
| Week 96 (n=13) |
|
| Week 108 (n=9) |
|
| Week 120 (n=3) |
|
| Title | Measurements |
|---|---|
|
| Week 48 (n=24) |
|
| Week 60 (n=21) |
|
| Week 72 (n=17) |
|
| Week 84 (n=17) |
|
| Week 96 (n=13) |
|
| Week 108 (n=9) |
|
| Week 120 (n=3) |
|
| Title | Measurements |
|---|---|
|
| Week 48 (n=16) |
|
| Week 60 (n=13) |
|
| Week 72 (n=10) |
|
| Week 84 (n=11) |
|
| Week 96 (n=9) |
|
| Week 108 (n=6) |
|
| Week 120 (n=1) |
|
| Title | Measurements |
|---|---|
|
| Week 48 (n=24) |
|
| Week 60 (n=21) |
|
| Week 72 (n=17) |
|
| Week 84 (n=17) |
|
| Week 96 (n=13) |
|
| Week 108 (n=9) |
|
| Week 120 (n=3) |
|
| Title | Measurements |
|---|---|
|
| Week 48 (n=16) |
|
| Week 60 (n=14) |
|
| Week 72 (n=13) |
|
| Week 84 (n=13) |
|
| Week 96 (n=9) |
|
| Week 108 (n=6) |
|
| Week 120 (n=1) |
|
| Title | Measurements |
|---|---|
|
| Week 48 (n=19) |
|
| Week 60 (n=18) |
|
| Week 72 (n=15) |
|
| Week 84 (n=15) |
|
| Week 96 (n=11) |
|
| Week 108 (n=7) |
|
| Week 120 (n=3) |
|
| Title | Measurements |
|---|---|
|
| Week 48 (n=22) |
|
| Week 60 (n=20) |
|
| Week 72 (n=16) |
|
| Week 84(n=16) |
|
| Week 96 (n=12) |
|
| Week 108 (n=8) |
|
| Week 120 (n=3) |
|
| Title | Measurements |
|---|---|
|
| Week 48 (n=23) |
|
| Week 60 (n=20) |
|
| Week 72 (n=16) |
|
| Week 84 (n=16) |
|
| Week 96 (n=11) |
|
| Week 108 (n=8) |
|
| Week 120 (n=2) |
|
| Title | Measurements |
|---|---|
|
| Week 48 (n=23) |
|
| Week 60 (n=20) |
|
| Week 72 (n=16) |
|
| Week 84 (n=16) |
|
| Week 96 (n=12) |
|
| Week 108 (n=8) |
|
| Week 120 (n=2) |
|
| Title | Measurements |
|---|---|
|
| Week 48 (n=23) |
|
| Week 60 (n=20) |
|
| Week 72 (n=16) |
|
| Week 84 (n=16) |
|
| Week 96 (n=12) |
|
| Week 108 (n=8) |
|
| Week 120 (n=2) |
|
| Title | Measurements |
|---|---|
|
| Week 48 (n=23) |
|
| Week 60 (n=20) |
|
| Week 72 (n=16) |
|
| Week 84 (n=16) |
|
| Week 96 (n=12) |
|
| Week 108 (n=8) |
|
| Week 120 (n=2) |
|