Arthritis, Juvenile Rheumatoid
Conditions
Keywords
Arthritis, Juvenile Rheumatoid
Brief summary
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: * Unknown adverse drug reactions (especially important adverse drug reactions) * Incidence and conditions of occurrence of adverse reactions in the clinical setting * Factors that may affect the safety and effectiveness of Humira
Interventions
None listed
Sponsors
AbbVie
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
No minimum to 99 Years
Healthy volunteers
No
Inclusion criteria
* All patients with Juvenile idiopathic arthritis who are not responding well to conventional therapy and receive Humira will be enrolled in the survey
Exclusion criteria
* Contraindications according to the Package Insert * Patients who have serious infections * Patients who have tuberculosis * Patients with a history of hypersensitivity to any ingredient of Humira * Patients who have demyelinating disease or with a history of demyelinating disease * Patients who have congestive cardiac failure
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Weight at Week 24 | Baseline, Week 24 | — |
| Change From Baseline in DAS28-4/ESR at Week 4 | Baseline, 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. |
| Change From Baseline in DAS28-4/ESR at Week 8 | Baseline, 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. |
| Change From Baseline in DAS28-4/ESR at Week 12 | Baseline, 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. |
| Change From Baseline in DAS28-4/ESR at Week 16 | Baseline, 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. |
| Change From Baseline in DAS28-4/ESR at Week 24 | Baseline, 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. |
| Change From Baseline in DAS28-4/CRP at Week 4 | Baseline, 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. |
| Change From Baseline in DAS28-4/CRP at Week 8 | Baseline, 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. |
| Change From Baseline in DAS28-4/CRP at Week 12 | Baseline, 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. |
| 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 DAS28-4/CRP at Week 16 | Baseline, 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. |
| Change From Baseline in DAS28-4/CRP at Week 24 | Baseline, 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. |
| 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 | Baseline, 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. |
| Change From Baseline in Physician Global Assessment (VAS) at Week 8 | Baseline, 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. |
| Change From Baseline in Physician Global Assessment (VAS) at Week 12 | Baseline, 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. |
| Change From Baseline in Physician Global Assessment (VAS) at Week 16 | Baseline, 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. |
| Change From Baseline in Physician Global Assessment (VAS) at Week 24 | Baseline, 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. |
| 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 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 | — |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adverse Drug Reactions (ADRs) | up to Week 24 | 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. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Humira Participants with juvenile idiopathic arthritis who received Humira (adalimumab). | 356 |
| Total | 356 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Case Report Forms Not Retrieved | 7 |
| Overall Study | Transferred to Other Hospital | 9 |
| Overall Study | Treatment Prior to Approval | 3 |
Baseline characteristics
| Characteristic | Humira |
|---|---|
| Age, Continuous | 12.8 years STANDARD_DEVIATION 4.8 |
| Anti-Cyclic Citullinated Peptide Antibody | 89.41 U/mL STANDARD_DEVIATION 158.34 |
| DAS28-4/C-Reactive Protein (CRP) | 3.42 units on a scale STANDARD_DEVIATION 1.32 |
| Disease Activity Scale 28 (DAS28)-4/Erythrocyte Sedimentation Rate (ESR) | 3.70 units on a scale STANDARD_DEVIATION 1.48 |
| Height | 143.86 cm STANDARD_DEVIATION 19.24 |
| Physician Global Assessment Visual Analog Scale (VAS) | 40.6 mm STANDARD_DEVIATION 25.1 |
| Race/Ethnicity, Customized Japanese | 352 Participants |
| Race/Ethnicity, Customized Other, Not Specified | 4 Participants |
| Serum Matrix Metalloprotease-3 (MMP3) Level | 162.68 ng/mL STANDARD_DEVIATION 191.3 |
| Sex: Female, Male Female | 241 Participants |
| Sex: Female, Male Male | 115 Participants |
| Weight | 40.54 kg STANDARD_DEVIATION 14.51 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 356 |
| other Total, other adverse events | 20 / 356 |
| serious Total, serious adverse events | 17 / 356 |
Outcome results
Primary
Change From Baseline in Anti-Cyclic Citrullinated Peptide Antibodies at Week 24
Time frame: Baseline, Week 24
Population: participants in the efficacy analysis set with an assessment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Humira | Change From Baseline in Anti-Cyclic Citrullinated Peptide Antibodies at Week 24 | -45.03 U/mL | Standard Deviation 98.58 |
p-value: 0.0132paired t-test
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.
Time frame: Baseline, Week 12
Population: participants in the efficacy analysis set with an assessment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Humira | Change From Baseline in DAS28-4/CRP at Week 12 | -1.29 units on a scale | Standard Deviation 1.12 |
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.
Time frame: Baseline, Week 16
Population: participants in the efficacy analysis set with an assessment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Humira | Change From Baseline in DAS28-4/CRP at Week 16 | -1.35 units on a scale | Standard Deviation 1.23 |
p-value: <0.0001paired t-test
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.
Time frame: Baseline, Week 24
Population: participants in the efficacy analysis set with an assessment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Humira | Change From Baseline in DAS28-4/CRP at Week 24 | -1.57 units on a scale | Standard Deviation 1.36 |
p-value: <0.0001paired t-test
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.
Time frame: Baseline, Week 4
Population: participants in the efficacy analysis set with an assessment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Humira | Change From Baseline in DAS28-4/CRP at Week 4 | -0.94 units on a scale | Standard Deviation 1.01 |
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.
Time frame: Baseline, Week 8
Population: participants in the efficacy analysis set with an assessment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Humira | Change From Baseline in DAS28-4/CRP at Week 8 | -1.24 units on a scale | Standard Deviation 1.14 |
p-value: <0.0001paired t-test
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.
Time frame: Baseline, Week 12
Population: participants in the efficacy analysis set with an assessment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Humira | Change From Baseline in DAS28-4/ESR at Week 12 | -1.39 units on a scale | Standard Deviation 1.28 |
p-value: <0.0001paired t-test
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.
Time frame: Baseline, Week 16
Population: participants in the efficacy analysis set with an assessment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Humira | Change From Baseline in DAS28-4/ESR at Week 16 | -1.46 units on a scale | Standard Deviation 1.4 |
p-value: <0.0001paired t-test
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.
Time frame: Baseline, Week 24
Population: participants in the efficacy analysis set with an assessment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Humira | Change From Baseline in DAS28-4/ESR at Week 24 | -1.64 units on a scale | Standard Deviation 1.52 |
p-value: <0.0001paired t-test
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.
Time frame: Baseline, Week 4
Population: participants in the efficacy analysis set with an assessment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Humira | Change From Baseline in DAS28-4/ESR at Week 4 | -1.01 units on a scale | Standard Deviation 1.08 |
p-value: <0.0001paired t-test
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.
Time frame: Baseline, Week 8
Population: participants in the efficacy analysis set with an assessment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Humira | Change From Baseline in DAS28-4/ESR at Week 8 | -1.39 units on a scale | Standard Deviation 1.26 |
p-value: <0.0001paired t-test
Primary
Change From Baseline in Height at Week 12
Time frame: Baseline, Week 12
Population: participants in the safety analysis set with an assessment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Humira | Change From Baseline in Height at Week 12 | 0.88 cm | Standard Deviation 0.96 |
p-value: <0.0001paired t-test
Primary
Change From Baseline in Height at Week 16
Time frame: Baseline, Week 16
Population: participants in the safety analysis set with an assessment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Humira | Change From Baseline in Height at Week 16 | 1.25 cm | Standard Deviation 1.4 |
p-value: <0.0001paired t-test
Primary
Change From Baseline in Height at Week 24
Time frame: Baseline, Week 24
Population: participants in the safety analysis set with an assessment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Humira | Change From Baseline in Height at Week 24 | 1.60 cm | Standard Deviation 1.63 |
p-value: <0.0001paired t-test
Primary
Change From Baseline in Height at Week 4
Time frame: Baseline, Week 4
Population: participants in the safety analysis set with an assessment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Humira | Change From Baseline in Height at Week 4 | 0.24 cm | Standard Deviation 0.65 |
p-value: <0.0001paired t-test
Primary
Change From Baseline in Height at Week 8
Time frame: Baseline, Week 8
Population: participants in the safety analysis set with an assessment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Humira | Change From Baseline in Height at Week 8 | 0.59 cm | Standard Deviation 0.92 |
p-value: <0.0001paired t-test
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.
Time frame: Baseline, Week 12
Population: participants in the efficacy analysis set with an assessment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Humira | Change From Baseline in Physician Global Assessment (VAS) at Week 12 | -21.8 mm | Standard Deviation 25.8 |
p-value: <0.0001paired t-test
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.
Time frame: Baseline, Week 16
Population: participants in the efficacy analysis set with an assessment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Humira | Change From Baseline in Physician Global Assessment (VAS) at Week 16 | -25.3 mm | Standard Deviation 24.9 |
p-value: <0.0001paired t-test
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.
Time frame: Baseline, Week 24
Population: participants in the efficacy analysis set with an assessment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Humira | Change From Baseline in Physician Global Assessment (VAS) at Week 24 | -27.0 mm | Standard Deviation 27.9 |
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.
Time frame: Baseline, Week 4
Population: participants in the efficacy analysis set with an assessment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Humira | Change From Baseline in Physician Global Assessment (VAS) at Week 4 | -15.5 mm | Standard Deviation 20.8 |
p-value: <0.0001paired t-test
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.
Time frame: Baseline, Week 8
Population: participants in the efficacy analysis set with an assessment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Humira | Change From Baseline in Physician Global Assessment (VAS) at Week 8 | -21.5 mm | Standard Deviation 23.7 |
p-value: <0.0001paired t-test
Primary
Change From Baseline in Serum MMP3 Level at Week 12
Time frame: Baseline, Week 12
Population: participants in the efficacy analysis set with an assessment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Humira | Change From Baseline in Serum MMP3 Level at Week 12 | -78.05 ng/mL | Standard Deviation 144.73 |
p-value: <0.0001paired t-test
Primary
Change From Baseline in Serum MMP3 Level at Week 16
Time frame: Baseline, Week 16
Population: participants in the efficacy analysis set with an assessment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Humira | Change From Baseline in Serum MMP3 Level at Week 16 | -86.28 ng/mL | Standard Deviation 178.51 |
p-value: <0.0001paired t-test
Primary
Change From Baseline in Serum MMP3 Level at Week 24
Time frame: Baseline, Week 24
Population: participants in the efficacy analysis set with an assessment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Humira | Change From Baseline in Serum MMP3 Level at Week 24 | -98.67 ng/mL | Standard Deviation 185.07 |
p-value: <0.0001paired t-test
Primary
Change From Baseline in Serum MMP3 Level at Week 4
Time frame: Baseline, Week 4
Population: participants in the efficacy analysis set with an assessment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Humira | Change From Baseline in Serum MMP3 Level at Week 4 | -72.18 ng/mL | Standard Deviation 138.24 |
p-value: <0.0001paired t-test
Primary
Change From Baseline in Serum MMP3 Level at Week 8
Time frame: Baseline, Week 8
Population: participants in the efficacy analysis set with an assessment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Humira | Change From Baseline in Serum MMP3 Level at Week 8 | -83.36 ng/mL | Standard Deviation 159.27 |
p-value: <0.0001paired t-test
Primary
Change From Baseline in Weight at Week 12
Time frame: Baseline, Week 12
Population: participants in the safety analysis set with an assessment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Humira | Change From Baseline in Weight at Week 12 | 1.10 kg | Standard Deviation 1.9 |
p-value: <0.0001paired t-test
Primary
Change From Baseline in Weight at Week 16
Time frame: Baseline, Week 16
Population: participants in the safety analysis set with an assessment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Humira | Change From Baseline in Weight at Week 16 | 1.37 kg | Standard Deviation 2.14 |
p-value: <0.0001paired t-test
Primary
Change From Baseline in Weight at Week 24
Time frame: Baseline, Week 24
Population: participants in the safety analysis set with an assessment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Humira | Change From Baseline in Weight at Week 24 | 1.76 kg | Standard Deviation 2.34 |
Primary
Change From Baseline in Weight at Week 4
Time frame: Baseline, Week 4
Population: participants in the safety analysis set with an assessment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Humira | Change From Baseline in Weight at Week 4 | 0.47 kg | Standard Deviation 1.22 |
p-value: <0.0001paired t-test
Primary
Change From Baseline in Weight at Week 8
Time frame: Baseline, Week 8
Population: participants in the safety analysis set with an assessment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Humira | Change From Baseline in Weight at Week 8 | 0.82 kg | Standard Deviation 1.56 |
p-value: <0.0001paired t-test
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.
Time frame: up to Week 24
Population: participants in the safety analysis set with an assessment
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Humira | Number of Participants With Adverse Drug Reactions (ADRs) | ADRs | 106 Participants |
| Humira | Number of Participants With Adverse Drug Reactions (ADRs) | Serious ADRs | 12 Participants |