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This study of Humira will be conducted to clarify the following with regard to the treatment of juvenile idiopathic arthritis affecting multiple joints with this drug:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Humira | Participants with juvenile idiopathic arthritis who received Humira (adalimumab). |
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| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in DAS28-4/ESR at Week 4 | The DAS28 is a validated index of arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, ESR, and the Subject's Global Assessment of Disease Activity (subject rates disease activity using a Likert scale from 0 [low activity] to 10 [high activity]) are included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score >5.1 indicates high disease activity, a DAS28 score <3.2 indicates low disease activity, and a DAS28 score <2.6 indicates clinical remission. | Baseline, Week 4 |
| Change From Baseline in DAS28-4/ESR at Week 8 | The DAS28 is a validated index of arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, ESR, and the Subject's Global Assessment of Disease Activity (subject rates disease activity using a Likert scale from 0 [low activity] to 10 [high activity]) are included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score >5.1 indicates high disease activity, a DAS28 score <3.2 indicates low disease activity, and a DAS28 score <2.6 indicates clinical remission. | Baseline, Week 8 |
| Change From Baseline in DAS28-4/ESR at Week 12 | The DAS28 is a validated index of arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, ESR, and the Subject's Global Assessment of Disease Activity (subject rates disease activity using a Likert scale from 0 [low activity] to 10 [high activity]) are included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score >5.1 indicates high disease activity, a DAS28 score <3.2 indicates low disease activity, and a DAS28 score <2.6 indicates clinical remission. | Baseline, Week 12 |
| Change From Baseline in DAS28-4/ESR at Week 16 | The DAS28 is a validated index of arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, ESR, and the Subject's Global Assessment of Disease Activity (subject rates disease activity using a Likert scale from 0 [low activity] to 10 [high activity]) are included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score >5.1 indicates high disease activity, a DAS28 score <3.2 indicates low disease activity, and a DAS28 score <2.6 indicates clinical remission. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Drug Reactions (ADRs) | Adverse drug reactions are defined and totaled as collected adverse events whose causal relation with adalimumab cannot be ruled out. An adverse event refers to any unfavorable and unintended sign (including an abnormal laboratory finding), symptom or disease associated with the use of a drug, whether or not considered related to the drug. | up to Week 24 |
Inclusion Criteria:
Exclusion Criteria:
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All patients who receive Humira for the treatment of Juvenile idiopathic arthritis
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| Name | Affiliation | Role |
|---|---|---|
| AbbVie Inc. | AbbVie | Study Director |
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| Label | URL |
|---|---|
| Package Insert Information | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Humira | Participants with juvenile idiopathic arthritis who received Humira (adalimumab). |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
safety analysis set
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| ID | Title | Description |
|---|---|---|
| BG000 | Humira | Participants with juvenile idiopathic arthritis who received Humira (adalimumab). |
| Units | Counts |
|---|---|
| Participants |
|
| 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 | Change From Baseline in DAS28-4/ESR at Week 4 | The DAS28 is a validated index of arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, ESR, and the Subject's Global Assessment of Disease Activity (subject rates disease activity using a Likert scale from 0 [low activity] to 10 [high activity]) are included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score >5.1 indicates high disease activity, a DAS28 score <3.2 indicates low disease activity, and a DAS28 score <2.6 indicates clinical remission. | participants in the efficacy analysis set with an assessment | Posted | Mean | Standard Deviation | units on a scale | Baseline, Week 4 |
|
up to Week 24
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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 | Humira | Participants with juvenile idiopathic arthritis who received Humira (adalimumab). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Appendicitis | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper respiratory tract inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Medical Services | AbbVie | 800-633-9110 | abbvieclinicaltrials@abbvie.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 6, 2018 | Mar 27, 2019 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 28, 2018 | Mar 27, 2019 | SAP_001.pdf |
| ID | Term |
|---|---|
| D001171 | Arthritis, Juvenile |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| Baseline, Week 16 |
| Change From Baseline in DAS28-4/ESR at Week 24 | The DAS28 is a validated index of arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, ESR, and the Subject's Global Assessment of Disease Activity (subject rates disease activity using a Likert scale from 0 [low activity] to 10 [high activity]) are included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score >5.1 indicates high disease activity, a DAS28 score <3.2 indicates low disease activity, and a DAS28 score <2.6 indicates clinical remission. | Baseline, Week 24 |
| Change From Baseline in DAS28-4/CRP at Week 4 | The DAS28 is a validated index of arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, CRP, and the Subject's Global Assessment of Disease Activity (subject rates disease activity using a Likert scale from 0 [low activity] to 10 [high activity]) are included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score >5.1 indicates high disease activity, a DAS28 score <3.2 indicates low disease activity, and a DAS28 score <2.6 indicates clinical remission. | Baseline, Week 4 |
| Change From Baseline in DAS28-4/CRP at Week 8 | The DAS28 is a validated index of arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, CRP, and the Subject's Global Assessment of Disease Activity (subject rates disease activity using a Likert scale from 0 [low activity] to 10 [high activity]) are included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score >5.1 indicates high disease activity, a DAS28 score <3.2 indicates low disease activity, and a DAS28 score <2.6 indicates clinical remission. | Baseline, Week 8 |
| Change From Baseline in DAS28-4/CRP at Week 12 | The DAS28 is a validated index of arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, CRP, and the Subject's Global Assessment of Disease Activity (subject rates disease activity using a Likert scale from 0 [low activity] to 10 [high activity]) are included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score >5.1 indicates high disease activity, a DAS28 score <3.2 indicates low disease activity, and a DAS28 score <2.6 indicates clinical remission. | Baseline, Week 12 |
| Change From Baseline in DAS28-4/CRP at Week 16 | The DAS28 is a validated index of arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, CRP, and the Subject's Global Assessment of Disease Activity (subject rates disease activity using a Likert scale from 0 [low activity] to 10 [high activity]) are included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score >5.1 indicates high disease activity, a DAS28 score <3.2 indicates low disease activity, and a DAS28 score <2.6 indicates clinical remission. | Baseline, Week 16 |
| Change From Baseline in DAS28-4/CRP at Week 24 | The DAS28 is a validated index of arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, CRP, and the Subject's Global Assessment of Disease Activity (subject rates disease activity using a Likert scale from 0 [low activity] to 10 [high activity]) are included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score >5.1 indicates high disease activity, a DAS28 score <3.2 indicates low disease activity, and a DAS28 score <2.6 indicates clinical remission. | Baseline, Week 24 |
| Change From Baseline in Serum MMP3 Level at Week 4 | Baseline, Week 4 |
| Change From Baseline in Serum MMP3 Level at Week 8 | Baseline, Week 8 |
| Change From Baseline in Serum MMP3 Level at Week 12 | Baseline, Week 12 |
| Change From Baseline in Serum MMP3 Level at Week 16 | Baseline, Week 16 |
| Change From Baseline in Serum MMP3 Level at Week 24 | Baseline, Week 24 |
| Change From Baseline in Physician Global Assessment (VAS) at Week 4 | A VAS was used for the Physician Global Assessment of disease activity (current status). The left end of the VAS scale (0 mm) signifies the absence of symptoms and the right end (100 mm) signifies maximum disease activity. A negative change from baseline indicates improvement. | Baseline, Week 4 |
| Change From Baseline in Physician Global Assessment (VAS) at Week 8 | A VAS was used for the Physician Global Assessment of disease activity (current status). The left end of the VAS scale (0 mm) signifies the absence of symptoms and the right end (100 mm) signifies maximum disease activity. A negative change from baseline indicates improvement. | Baseline, Week 8 |
| Change From Baseline in Physician Global Assessment (VAS) at Week 12 | A VAS was used for the Physician Global Assessment of disease activity (current status). The left end of the VAS scale (0 mm) signifies the absence of symptoms and the right end (100 mm) signifies maximum disease activity. A negative change from baseline indicates improvement. | Baseline, Week 12 |
| Change From Baseline in Physician Global Assessment (VAS) at Week 16 | A VAS was used for the Physician Global Assessment of disease activity (current status). The left end of the VAS scale (0 mm) signifies the absence of symptoms and the right end (100 mm) signifies maximum disease activity. A negative change from baseline indicates improvement. | Baseline, Week 16 |
| Change From Baseline in Physician Global Assessment (VAS) at Week 24 | A VAS was used for the Physician Global Assessment of disease activity (current status). The left end of the VAS scale (0 mm) signifies the absence of symptoms and the right end (100 mm) signifies maximum disease activity. A negative change from baseline indicates improvement. | Baseline, Week 24 |
| Change From Baseline in Anti-Cyclic Citrullinated Peptide Antibodies at Week 24 | Baseline, Week 24 |
| Change From Baseline in Height at Week 4 | Baseline, Week 4 |
| Change From Baseline in Height at Week 8 | Baseline, Week 8 |
| Change From Baseline in Height at Week 12 | Baseline, Week 12 |
| Change From Baseline in Height at Week 16 | Baseline, Week 16 |
| Change From Baseline in Height at Week 24 | Baseline, Week 24 |
| Change From Baseline in Weight at Week 4 | Baseline, Week 4 |
| Change From Baseline in Weight at Week 8 | Baseline, Week 8 |
| Change From Baseline in Weight at Week 12 | Baseline, Week 12 |
| Change From Baseline in Weight at Week 16 | Baseline, Week 16 |
| Change From Baseline in Weight at Week 24 | Baseline, Week 24 |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Disease Activity Scale 28 (DAS28)-4/Erythrocyte Sedimentation Rate (ESR) | The DAS28 is a validated index of arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, ESR, and the Subject's Global Assessment of Disease Activity (subject rates disease activity using a Likert scale from 0 [low activity] to 10 [high activity]) are included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score >5.1 indicates high disease activity, a DAS28 score <3.2 indicates low disease activity, and a DAS28 score <2.6 indicates clinical remission. | participants in the efficacy analysis set with an assessment | Mean | Standard Deviation | units on a scale |
|
| DAS28-4/C-Reactive Protein (CRP) | The DAS28 is a validated index of arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, CRP, and the Subject's Global Assessment of Disease Activity (subject rates disease activity using a Likert scale from 0 [low activity] to 10 [high activity]) are included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score >5.1 indicates high disease activity, a DAS28 score <3.2 indicates low disease activity, and a DAS28 score <2.6 indicates clinical remission. | participants in the efficacy analysis set with an assessment | Mean | Standard Deviation | units on a scale |
|
| Serum Matrix Metalloprotease-3 (MMP3) Level | participants in the efficacy analysis set with an assessment | Mean | Standard Deviation | ng/mL |
|
| Physician Global Assessment Visual Analog Scale (VAS) | A VAS was used for the Physician Global Assessment of disease activity (current status). The left end of the VAS scale (0 mm) signifies the absence of symptoms and the right end (100 mm) signifies maximum disease activity. | participants in the efficacy analysis set with an assessment | Mean | Standard Deviation | mm |
|
| Anti-Cyclic Citullinated Peptide Antibody | participants in the efficacy analysis set with an assessment | Mean | Standard Deviation | U/mL |
|
| Height | participants in the safety analysis set with an assessment | Mean | Standard Deviation | cm |
|
| Weight | participants in the safety analysis set with an assessment | Mean | Standard Deviation | kg |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Primary | Change From Baseline in DAS28-4/ESR at Week 8 | The DAS28 is a validated index of arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, ESR, and the Subject's Global Assessment of Disease Activity (subject rates disease activity using a Likert scale from 0 [low activity] to 10 [high activity]) are included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score >5.1 indicates high disease activity, a DAS28 score <3.2 indicates low disease activity, and a DAS28 score <2.6 indicates clinical remission. | participants in the efficacy analysis set with an assessment | Posted | Mean | Standard Deviation | units on a scale | Baseline, Week 8 |
|
|
|
|
| Primary | Change From Baseline in DAS28-4/ESR at Week 12 | The DAS28 is a validated index of arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, ESR, and the Subject's Global Assessment of Disease Activity (subject rates disease activity using a Likert scale from 0 [low activity] to 10 [high activity]) are included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score >5.1 indicates high disease activity, a DAS28 score <3.2 indicates low disease activity, and a DAS28 score <2.6 indicates clinical remission. | participants in the efficacy analysis set with an assessment | Posted | Mean | Standard Deviation | units on a scale | Baseline, Week 12 |
|
|
|
|
| Primary | Change From Baseline in DAS28-4/ESR at Week 16 | The DAS28 is a validated index of arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, ESR, and the Subject's Global Assessment of Disease Activity (subject rates disease activity using a Likert scale from 0 [low activity] to 10 [high activity]) are included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score >5.1 indicates high disease activity, a DAS28 score <3.2 indicates low disease activity, and a DAS28 score <2.6 indicates clinical remission. | participants in the efficacy analysis set with an assessment | Posted | Mean | Standard Deviation | units on a scale | Baseline, Week 16 |
|
|
|
|
| Primary | Change From Baseline in DAS28-4/ESR at Week 24 | The DAS28 is a validated index of arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, ESR, and the Subject's Global Assessment of Disease Activity (subject rates disease activity using a Likert scale from 0 [low activity] to 10 [high activity]) are included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score >5.1 indicates high disease activity, a DAS28 score <3.2 indicates low disease activity, and a DAS28 score <2.6 indicates clinical remission. | participants in the efficacy analysis set with an assessment | Posted | Mean | Standard Deviation | units on a scale | Baseline, Week 24 |
|
|
|
|
| Primary | Change From Baseline in DAS28-4/CRP at Week 4 | The DAS28 is a validated index of arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, CRP, and the Subject's Global Assessment of Disease Activity (subject rates disease activity using a Likert scale from 0 [low activity] to 10 [high activity]) are included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score >5.1 indicates high disease activity, a DAS28 score <3.2 indicates low disease activity, and a DAS28 score <2.6 indicates clinical remission. | participants in the efficacy analysis set with an assessment | Posted | Mean | Standard Deviation | units on a scale | Baseline, Week 4 |
|
|
|
| Primary | Change From Baseline in DAS28-4/CRP at Week 8 | The DAS28 is a validated index of arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, CRP, and the Subject's Global Assessment of Disease Activity (subject rates disease activity using a Likert scale from 0 [low activity] to 10 [high activity]) are included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score >5.1 indicates high disease activity, a DAS28 score <3.2 indicates low disease activity, and a DAS28 score <2.6 indicates clinical remission. | participants in the efficacy analysis set with an assessment | Posted | Mean | Standard Deviation | units on a scale | Baseline, Week 8 |
|
|
|
|
| Primary | Change From Baseline in DAS28-4/CRP at Week 12 | The DAS28 is a validated index of arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, CRP, and the Subject's Global Assessment of Disease Activity (subject rates disease activity using a Likert scale from 0 [low activity] to 10 [high activity]) are included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score >5.1 indicates high disease activity, a DAS28 score <3.2 indicates low disease activity, and a DAS28 score <2.6 indicates clinical remission. | participants in the efficacy analysis set with an assessment | Posted | Mean | Standard Deviation | units on a scale | Baseline, Week 12 |
|
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|
| Primary | Change From Baseline in DAS28-4/CRP at Week 16 | The DAS28 is a validated index of arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, CRP, and the Subject's Global Assessment of Disease Activity (subject rates disease activity using a Likert scale from 0 [low activity] to 10 [high activity]) are included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score >5.1 indicates high disease activity, a DAS28 score <3.2 indicates low disease activity, and a DAS28 score <2.6 indicates clinical remission. | participants in the efficacy analysis set with an assessment | Posted | Mean | Standard Deviation | units on a scale | Baseline, Week 16 |
|
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|
| Primary | Change From Baseline in DAS28-4/CRP at Week 24 | The DAS28 is a validated index of arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, CRP, and the Subject's Global Assessment of Disease Activity (subject rates disease activity using a Likert scale from 0 [low activity] to 10 [high activity]) are included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score >5.1 indicates high disease activity, a DAS28 score <3.2 indicates low disease activity, and a DAS28 score <2.6 indicates clinical remission. | participants in the efficacy analysis set with an assessment | Posted | Mean | Standard Deviation | units on a scale | Baseline, Week 24 |
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| Primary | Change From Baseline in Serum MMP3 Level at Week 4 | participants in the efficacy analysis set with an assessment | Posted | Mean | Standard Deviation | ng/mL | Baseline, Week 4 |
|
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| Primary | Change From Baseline in Serum MMP3 Level at Week 8 | participants in the efficacy analysis set with an assessment | Posted | Mean | Standard Deviation | ng/mL | Baseline, Week 8 |
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| Primary | Change From Baseline in Serum MMP3 Level at Week 12 | participants in the efficacy analysis set with an assessment | Posted | Mean | Standard Deviation | ng/mL | Baseline, Week 12 |
|
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| Primary | Change From Baseline in Serum MMP3 Level at Week 16 | participants in the efficacy analysis set with an assessment | Posted | Mean | Standard Deviation | ng/mL | Baseline, Week 16 |
|
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| Primary | Change From Baseline in Serum MMP3 Level at Week 24 | participants in the efficacy analysis set with an assessment | Posted | Mean | Standard Deviation | ng/mL | Baseline, Week 24 |
|
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|
| Primary | Change From Baseline in Physician Global Assessment (VAS) at Week 4 | A VAS was used for the Physician Global Assessment of disease activity (current status). The left end of the VAS scale (0 mm) signifies the absence of symptoms and the right end (100 mm) signifies maximum disease activity. A negative change from baseline indicates improvement. | participants in the efficacy analysis set with an assessment | Posted | Mean | Standard Deviation | mm | Baseline, Week 4 |
|
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| Primary | Change From Baseline in Physician Global Assessment (VAS) at Week 8 | A VAS was used for the Physician Global Assessment of disease activity (current status). The left end of the VAS scale (0 mm) signifies the absence of symptoms and the right end (100 mm) signifies maximum disease activity. A negative change from baseline indicates improvement. | participants in the efficacy analysis set with an assessment | Posted | Mean | Standard Deviation | mm | Baseline, Week 8 |
|
|
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| Primary | Change From Baseline in Physician Global Assessment (VAS) at Week 12 | A VAS was used for the Physician Global Assessment of disease activity (current status). The left end of the VAS scale (0 mm) signifies the absence of symptoms and the right end (100 mm) signifies maximum disease activity. A negative change from baseline indicates improvement. | participants in the efficacy analysis set with an assessment | Posted | Mean | Standard Deviation | mm | Baseline, Week 12 |
|
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| Primary | Change From Baseline in Physician Global Assessment (VAS) at Week 16 | A VAS was used for the Physician Global Assessment of disease activity (current status). The left end of the VAS scale (0 mm) signifies the absence of symptoms and the right end (100 mm) signifies maximum disease activity. A negative change from baseline indicates improvement. | participants in the efficacy analysis set with an assessment | Posted | Mean | Standard Deviation | mm | Baseline, Week 16 |
|
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| Primary | Change From Baseline in Physician Global Assessment (VAS) at Week 24 | A VAS was used for the Physician Global Assessment of disease activity (current status). The left end of the VAS scale (0 mm) signifies the absence of symptoms and the right end (100 mm) signifies maximum disease activity. A negative change from baseline indicates improvement. | participants in the efficacy analysis set with an assessment | Posted | Mean | Standard Deviation | mm | Baseline, Week 24 |
|
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| Primary | Change From Baseline in Anti-Cyclic Citrullinated Peptide Antibodies at Week 24 | participants in the efficacy analysis set with an assessment | Posted | Mean | Standard Deviation | U/mL | Baseline, Week 24 |
|
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| Primary | Change From Baseline in Height at Week 4 | participants in the safety analysis set with an assessment | Posted | Mean | Standard Deviation | cm | Baseline, Week 4 |
|
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| Primary | Change From Baseline in Height at Week 8 | participants in the safety analysis set with an assessment | Posted | Mean | Standard Deviation | cm | Baseline, Week 8 |
|
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| Primary | Change From Baseline in Height at Week 12 | participants in the safety analysis set with an assessment | Posted | Mean | Standard Deviation | cm | Baseline, Week 12 |
|
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| Primary | Change From Baseline in Height at Week 16 | participants in the safety analysis set with an assessment | Posted | Mean | Standard Deviation | cm | Baseline, Week 16 |
|
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| Primary | Change From Baseline in Height at Week 24 | participants in the safety analysis set with an assessment | Posted | Mean | Standard Deviation | cm | Baseline, Week 24 |
|
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| Primary | Change From Baseline in Weight at Week 4 | participants in the safety analysis set with an assessment | Posted | Mean | Standard Deviation | kg | Baseline, Week 4 |
|
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|
| Primary | Change From Baseline in Weight at Week 8 | participants in the safety analysis set with an assessment | Posted | Mean | Standard Deviation | kg | Baseline, Week 8 |
|
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|
| Primary | Change From Baseline in Weight at Week 12 | participants in the safety analysis set with an assessment | Posted | Mean | Standard Deviation | kg | Baseline, Week 12 |
|
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| Primary | Change From Baseline in Weight at Week 16 | participants in the safety analysis set with an assessment | Posted | Mean | Standard Deviation | kg | Baseline, Week 16 |
|
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| Primary | Change From Baseline in Weight at Week 24 | participants in the safety analysis set with an assessment | Posted | Mean | Standard Deviation | kg | Baseline, Week 24 |
|
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| Other Pre-specified | Number of Participants With Adverse Drug Reactions (ADRs) | Adverse drug reactions are defined and totaled as collected adverse events whose causal relation with adalimumab cannot be ruled out. An adverse event refers to any unfavorable and unintended sign (including an abnormal laboratory finding), symptom or disease associated with the use of a drug, whether or not considered related to the drug. | participants in the safety analysis set with an assessment | Posted | Count of Participants | Participants | up to Week 24 |
|
|
|
| 0 |
| 356 |
| 17 |
| 356 |
| 20 |
| 356 |
| Bronchitis | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
|
| Disseminated tuberculosis | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
|
| Pulmonary tuberculosis | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
|
| Salpingitis | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
|
| Tonsillitis | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
|
| Lymphadenitis | Blood and lymphatic system disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Water intoxication | Metabolism and nutrition disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Epilepsy | Nervous system disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Febrile convulsion | Nervous system disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Papillophlebitis | Eye disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Adenoidal hypertrophy | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Tonsillar hypertrophy | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Gastric mucosal lesion | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Mixed connective tissue disease | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Osteonecrosis | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Temporomandibular joint syndrome | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Juvenile idiopathic arthritis | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Non-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 |