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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-004781-34 | EudraCT Number |
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| Name | Class |
|---|---|
| Laboratorio Echevarne | INDUSTRY |
| Pivotal S.L. | INDUSTRY |
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The purpose of this study is to evaluate the rapidity of onset of clinical response to adalimumab therapy in patients with luminal Crohn's disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adalimumab | Experimental | Participants received adalimumab for 12 weeks (160 mg at Week 0; 80 mg at week 2; then adalimumab 40 mg every other week starting at Week 4). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| adalimumab | Biological | Adalimumab pre-filled syringe, administered by subcutaneous injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Clinical Response at Day 4 | Clinical response defined as a decrease of at least 3 points in Harvey-Bradshaw Index (HBI) score. The HBI consists of only clinical parameters (general well-being, abdominal pain, number of liquid stools per day, abdominal mass, and complications): The first 3 items are scored for the previous day. Patients with Crohn's disease who scored 3 or less on the HBI are very likely to be in remission. Patients with a score of 8 to 9 or higher are considered to have severe disease. | Day 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Clinical Response at Week 1 | Clinical response defined as a decrease of at least 3 points in HBI score. The HBI consists of only clinical parameters (general well-being, abdominal pain, number of liquid stools per day, abdominal mass, and complications): The first 3 items are scored for the previous day. Patients with Crohn's disease who scored 3 or less on the HBI are very likely to be in remission. Patients with a score of 8 to 9 or higher are considered to have severe disease. |
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Inclusion Criteria:
Crohn's disease (CD) diagnosed within, at least, the previous 4 months.
Patients with active luminal (Harvey-Bradshaw Index [HBI] ≥ 8) moderate to- severe CD.
No response to a full and adequate course of therapy with a corticosteroid and/or an immunosuppressant.
If receiving any of the following treatments, their dose should be stable during the periods indicated:
If receiving any of the following treatments, their dose should not have been increase in the past two weeks (the dose reduction is permitted):
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ignacio Marín, PhD | Hospital General Universitario Gregorio Marañon | Principal Investigator |
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| Label | URL |
|---|---|
| Related info. | View source |
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A total of 100 participants were enrolled in the study; 14 participants did not receive study drug and are excluded from the analyses.
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| ID | Title | Description |
|---|---|---|
| FG000 | Adalimumab | Participants received adalimumab for 12 weeks (160 mg at Week 0; 80 mg at week 2; then adalimumab 40 mg every other week starting at Week 4). |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Intent to Treat (ITT) population: all enrolled participants who received at least 1 dose of study drug
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| ID | Title | Description |
|---|---|---|
| BG000 | Adalimumab | Participants received adalimumab for 12 weeks (160 mg at Week 0; 80 mg at week 2; then adalimumab 40 mg every other week starting at Week 4). |
| 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 | Percentage of Participants With Clinical Response at Day 4 | Clinical response defined as a decrease of at least 3 points in Harvey-Bradshaw Index (HBI) score. The HBI consists of only clinical parameters (general well-being, abdominal pain, number of liquid stools per day, abdominal mass, and complications): The first 3 items are scored for the previous day. Patients with Crohn's disease who scored 3 or less on the HBI are very likely to be in remission. Patients with a score of 8 to 9 or higher are considered to have severe disease. | Intent to Treat (ITT) population: all enrolled participants who received at least 1 dose of study drug | Posted | Number | 95% Confidence Interval | percentage of participants | Day 4 |
|
Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration until 70 days after the last dose of study drug (up to 20 weeks).
TEAEs and TESAEs are defined as any AE or SAE with an onset date after the first dose of study drug until 70 days after the last dose of study drug and 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 | Participants received adalimumab for 12 weeks (160 mg at Week 0; 80 mg at week 2; then adalimumab 40 mg every other week starting at Week 4). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Crohn's disease | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (17.1) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Medical Services | AbbVie | 800-633-9110 |
| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System 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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| Week 1 |
| Percentage of Participants With Clinical Remission at Weeks 2 and 4 | Clinical remission defined as HBI < 5. The HBI consists of only clinical parameters (general well-being, abdominal pain, number of liquid stools per day, abdominal mass, and complications): The first 3 items are scored for the previous day. Patients with Crohn's disease who scored 3 or less on the HBI are very likely to be in remission. Patients with a score of 8 to 9 or higher are considered to have severe disease. | Weeks 2 and 4 |
| European Quality of Life (EuroQol) 5 Dimensions 3 Levels Questionnaire (EQ-5D-3L) Index Score: Change From Baseline to Week 12 | The EQ-5D-3L is a standardized instrument for use as a measure of health-related quality of life (HRQoL) and consists of 2 components:
A positive change represents an improvement in HRQoL. Mean Baseline and mean change from Baseline to Week 12 in the EQ-5D-3L Index Score are presented. | Baseline (Week 0) and Week 12 |
| European Quality of Life (EuroQol) 5 Dimensions 3 Levels Questionnaire (EQ-5D-3L) Visual Analog Scale (VAS): Change From Baseline to Week 12 | The EQ-5D-3L is a standardized instrument for use as a measure of HRQoL and consists of 2 components:
A positive change represents an improvement in HRQoL. Mean Baseline and mean change from Baseline to Week 12 in the EQ-5D-3L VAS are presented. | Baseline (Week 0) and Week 12 |
| Inflammatory Bowel Disease Quality-36 (IBDQ-36) Questionnaire Overall Score: Change From Baseline to Week 12 | The IBDQ-36 is used to assess the HRQoL related to bowel symptoms. The IBDQ-36 overall score is calculated as the sum of thirty-six items, each scored on a 1 to 7 likert point scale, and ranges from 7 to 252. The highest score indicates the best HRQoL related to bowel symptoms. A positive change in IBDQ-36 overall score indicates an improvement in HRQoL due to inflammatory bowel disease. Mean Baseline and mean change from Baseline to Week 12 in the EQ-5D-3L VAS are presented. | Baseline (Week 0) and Week 12 |
| Fatigue Impact Scale for Daily Use (D-FIS): Change From Baseline to Week 12 | The D-FIS is used to measure the impact of fatigue on the daily lives of persons. The D-FIS overall score was calculated as the sum of eight items, each scored on a 0 to 4 point scale, and ranges from 0 to 32. A higher score indicates a higher impact of fatigue on daily life. A negative change in D-FIS Overall Score means an improvement in HRQoL due to fatigue. Mean Baseline and mean change from Baseline to Week 12 are presented. | Baseline (Week 0) and Week 12 |
| Change From Baseline to Week 12 in Analytic Markers of Inflammation: Hemoglobin | Analytic markers of inflammation are hemogram (hemoglobin, hematocrit, leukocytes, neutrophils, lymphocytes, monocytes, eosinophils, basophils, and platelets), erythrocytes sedimentation rate (ESR), C-reactive protein (CRP), fecal calprotectin, and coagulation (activated partial thromboplastin time [aPTT], international normalized ratio [INR], and fibrinogen). Mean Baseline and mean change from Baseline to Week 12 are presented. | Baseline (Week 0) and Week 12 |
| Change From Baseline to Week 12 in Analytic Markers of Inflammation: Hematocrit | Analytic markers of inflammation are hemogram (hemoglobin, hematocrit, leukocytes, neutrophils, lymphocytes, monocytes, eosinophils, basophils, and platelets), erythrocytes, ESR, CRP, fecal calprotectin, and coagulation (aPTT, INR, and fibrinogen). Mean Baseline and mean change from Baseline to Week 12 for each parameter are presented. | Baseline (Week 0) and Week 12 |
| Change From Baseline to Week 12 in Analytic Markers of Inflammation: Leukocytes, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, and Platelets | Analytic markers of inflammation are hemogram (hemoglobin, hematocrit, leukocytes, neutrophils, lymphocytes, monocytes, eosinophils, basophils, and platelets), erythrocytes, ESR, CRP, fecal calprotectin, and coagulation (aPTT, INR, and fibrinogen). Mean Baseline and mean change from Baseline to Week 12 for each parameter are presented. | Baseline (Week 0) and Week 12 |
| Change From Baseline to Week 12 in Analytic Markers of Inflammation: Erythrocytes | Analytic markers of inflammation are hemogram (hemoglobin, hematocrit, leukocytes, neutrophils, lymphocytes, monocytes, eosinophils, basophils, and platelets), erythrocytes, ESR, CRP, fecal calprotectin, and coagulation (aPTT, INR, and fibrinogen). Mean Baseline and mean change from Baseline to Week 12 for each parameter are presented. | Baseline (Week 0) and Week 12 |
| Change From Baseline to Week 12 in Analytic Markers of Inflammation: Sedimentation Rate (ESR) | Analytic markers of inflammation are hemogram (hemoglobin, hematocrit, leukocytes, neutrophils, lymphocytes, monocytes, eosinophils, basophils, and platelets), erythrocytes, ESR, CRP, fecal calprotectin, and coagulation (aPTT, INR, and fibrinogen). Mean Baseline and mean change from Baseline to Week 12 for each parameter are presented. | Baseline (Week 0) and Week 12 |
| Change From Baseline to Week 12 in Analytic Markers of Inflammation: C-reactive Protein (CRP) | Analytic markers of inflammation are hemogram (hemoglobin, hematocrit, leukocytes, neutrophils, lymphocytes, monocytes, eosinophils, basophils, and platelets), erythrocytes, ESR, CRP, fecal calprotectin, and coagulation (aPTT, INR, and fibrinogen). Mean Baseline and mean change from Baseline to Week 12 for each parameter are presented. | Baseline (Week 0) and Week 12 |
| Change From Baseline to Week 12 in Analytic Markers of Inflammation: Fecal Calprotectin | Analytic markers of inflammation are hemogram (hemoglobin, hematocrit, leukocytes, neutrophils, lymphocytes, monocytes, eosinophils, basophils, and platelets), erythrocytes, ESR, CRP, fecal calprotectin, and coagulation (aPTT, INR, and fibrinogen). Mean Baseline and mean change from Baseline to Week 12 for each parameter are presented. | Baseline (Week 0) and Week 12 |
| Change From Baseline to Week 12 in Analytic Markers of Inflammation: Activated Partial Thromboplastin Time (aPTT) | Analytic markers of inflammation are hemogram (hemoglobin, hematocrit, leukocytes, neutrophils, lymphocytes, monocytes, eosinophils, basophils, and platelets), erythrocytes, ESR, CRP, fecal calprotectin, and coagulation (aPTT, INR, and fibrinogen). Mean Baseline and mean change from Baseline to Week 12 for each parameter are presented. | Baseline (Week 0) and Week 12 |
| Change From Baseline to Week 12 in Analytic Markers of Inflammation: International Normalized Ratio (INR) | Analytic markers of inflammation are hemogram (hemoglobin, hematocrit, leukocytes, neutrophils, lymphocytes, monocytes, eosinophils, basophils, and platelets), erythrocytes, ESR, CRP, fecal calprotectin, and coagulation (aPTT, INR, and fibrinogen). Mean Baseline and mean change from Baseline to Week 12 for each parameter are presented. | Baseline (Week 0) and Week 12 |
| Change From Baseline to Week 12 in Analytic Markers of Inflammation: Fibrinogen | Analytic markers of inflammation are hemogram (hemoglobin, hematocrit, leukocytes, neutrophils, lymphocytes, monocytes, eosinophils, basophils, and platelets), erythrocytes, ESR, CRP, fecal calprotectin, and coagulation (aPTT, INR, and fibrinogen). Mean Baseline and mean change from Baseline to Week 12 for each parameter are presented. | Baseline (Week 0) and Week 12 |
| Percentage of Participants With Clinical Response at Day 4 or Week 12 and Clinical Remission at Week 12 | The percentage of participants with clinical response (defined as decrease of at least 3 points in HBI score) at Day 4 or Week 1 and clinical remission (defined as a HBI < 5) at Week 12. | Up to Week 12 |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Percentage of Participants With Clinical Response at Week 1 | Clinical response defined as a decrease of at least 3 points in HBI score. The HBI consists of only clinical parameters (general well-being, abdominal pain, number of liquid stools per day, abdominal mass, and complications): The first 3 items are scored for the previous day. Patients with Crohn's disease who scored 3 or less on the HBI are very likely to be in remission. Patients with a score of 8 to 9 or higher are considered to have severe disease. | ITT population | Posted | Number | 95% Confidence Interval | percentage of participants | Week 1 |
|
|
|
| Secondary | Percentage of Participants With Clinical Remission at Weeks 2 and 4 | Clinical remission defined as HBI < 5. The HBI consists of only clinical parameters (general well-being, abdominal pain, number of liquid stools per day, abdominal mass, and complications): The first 3 items are scored for the previous day. Patients with Crohn's disease who scored 3 or less on the HBI are very likely to be in remission. Patients with a score of 8 to 9 or higher are considered to have severe disease. | ITT population | Posted | Number | 95% Confidence Interval | percentage of participants | Weeks 2 and 4 |
|
|
|
| Secondary | European Quality of Life (EuroQol) 5 Dimensions 3 Levels Questionnaire (EQ-5D-3L) Index Score: Change From Baseline to Week 12 | The EQ-5D-3L is a standardized instrument for use as a measure of health-related quality of life (HRQoL) and consists of 2 components:
A positive change represents an improvement in HRQoL. Mean Baseline and mean change from Baseline to Week 12 in the EQ-5D-3L Index Score are presented. | All participants in the ITT population with evaluable data | Posted | Mean | Standard Deviation | units on a scale | Baseline (Week 0) and Week 12 |
|
|
|
| Secondary | European Quality of Life (EuroQol) 5 Dimensions 3 Levels Questionnaire (EQ-5D-3L) Visual Analog Scale (VAS): Change From Baseline to Week 12 | The EQ-5D-3L is a standardized instrument for use as a measure of HRQoL and consists of 2 components:
A positive change represents an improvement in HRQoL. Mean Baseline and mean change from Baseline to Week 12 in the EQ-5D-3L VAS are presented. | All participants in the ITT population with evaluable data | Posted | Mean | Standard Deviation | units on a scale | Baseline (Week 0) and Week 12 |
|
|
|
| Secondary | Inflammatory Bowel Disease Quality-36 (IBDQ-36) Questionnaire Overall Score: Change From Baseline to Week 12 | The IBDQ-36 is used to assess the HRQoL related to bowel symptoms. The IBDQ-36 overall score is calculated as the sum of thirty-six items, each scored on a 1 to 7 likert point scale, and ranges from 7 to 252. The highest score indicates the best HRQoL related to bowel symptoms. A positive change in IBDQ-36 overall score indicates an improvement in HRQoL due to inflammatory bowel disease. Mean Baseline and mean change from Baseline to Week 12 in the EQ-5D-3L VAS are presented. | All participants in the ITT population with evaluable data | Posted | Mean | Standard Deviation | units on a scale | Baseline (Week 0) and Week 12 |
|
|
|
| Secondary | Fatigue Impact Scale for Daily Use (D-FIS): Change From Baseline to Week 12 | The D-FIS is used to measure the impact of fatigue on the daily lives of persons. The D-FIS overall score was calculated as the sum of eight items, each scored on a 0 to 4 point scale, and ranges from 0 to 32. A higher score indicates a higher impact of fatigue on daily life. A negative change in D-FIS Overall Score means an improvement in HRQoL due to fatigue. Mean Baseline and mean change from Baseline to Week 12 are presented. | All participants in the ITT population with evaluable data | Posted | Mean | Standard Deviation | units on a scale | Baseline (Week 0) and Week 12 |
|
|
|
| Secondary | Change From Baseline to Week 12 in Analytic Markers of Inflammation: Hemoglobin | Analytic markers of inflammation are hemogram (hemoglobin, hematocrit, leukocytes, neutrophils, lymphocytes, monocytes, eosinophils, basophils, and platelets), erythrocytes sedimentation rate (ESR), C-reactive protein (CRP), fecal calprotectin, and coagulation (activated partial thromboplastin time [aPTT], international normalized ratio [INR], and fibrinogen). Mean Baseline and mean change from Baseline to Week 12 are presented. | All participants in the ITT population with evaluable data | Posted | Mean | Standard Deviation | g/dL | Baseline (Week 0) and Week 12 |
|
|
|
| Secondary | Change From Baseline to Week 12 in Analytic Markers of Inflammation: Hematocrit | Analytic markers of inflammation are hemogram (hemoglobin, hematocrit, leukocytes, neutrophils, lymphocytes, monocytes, eosinophils, basophils, and platelets), erythrocytes, ESR, CRP, fecal calprotectin, and coagulation (aPTT, INR, and fibrinogen). Mean Baseline and mean change from Baseline to Week 12 for each parameter are presented. | All participants in the ITT population with evaluable data | Posted | Mean | Standard Deviation | % volume | Baseline (Week 0) and Week 12 |
|
|
|
| Secondary | Change From Baseline to Week 12 in Analytic Markers of Inflammation: Leukocytes, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, and Platelets | Analytic markers of inflammation are hemogram (hemoglobin, hematocrit, leukocytes, neutrophils, lymphocytes, monocytes, eosinophils, basophils, and platelets), erythrocytes, ESR, CRP, fecal calprotectin, and coagulation (aPTT, INR, and fibrinogen). Mean Baseline and mean change from Baseline to Week 12 for each parameter are presented. | All participants in the ITT population with evaluable data | Posted | Mean | Standard Deviation | cellsx10^3/uL | Baseline (Week 0) and Week 12 |
|
|
|
| Secondary | Change From Baseline to Week 12 in Analytic Markers of Inflammation: Erythrocytes | Analytic markers of inflammation are hemogram (hemoglobin, hematocrit, leukocytes, neutrophils, lymphocytes, monocytes, eosinophils, basophils, and platelets), erythrocytes, ESR, CRP, fecal calprotectin, and coagulation (aPTT, INR, and fibrinogen). Mean Baseline and mean change from Baseline to Week 12 for each parameter are presented. | All participants in the ITT population with evaluable data | Posted | Mean | Standard Deviation | cellsx10^6/uL | Baseline (Week 0) and Week 12 |
|
|
|
| Secondary | Change From Baseline to Week 12 in Analytic Markers of Inflammation: Sedimentation Rate (ESR) | Analytic markers of inflammation are hemogram (hemoglobin, hematocrit, leukocytes, neutrophils, lymphocytes, monocytes, eosinophils, basophils, and platelets), erythrocytes, ESR, CRP, fecal calprotectin, and coagulation (aPTT, INR, and fibrinogen). Mean Baseline and mean change from Baseline to Week 12 for each parameter are presented. | All participants in the ITT population with evaluable data | Posted | Mean | Standard Deviation | mm/1h | Baseline (Week 0) and Week 12 |
|
|
|
| Secondary | Change From Baseline to Week 12 in Analytic Markers of Inflammation: C-reactive Protein (CRP) | Analytic markers of inflammation are hemogram (hemoglobin, hematocrit, leukocytes, neutrophils, lymphocytes, monocytes, eosinophils, basophils, and platelets), erythrocytes, ESR, CRP, fecal calprotectin, and coagulation (aPTT, INR, and fibrinogen). Mean Baseline and mean change from Baseline to Week 12 for each parameter are presented. | All participants in the ITT population with evaluable data | Posted | Mean | Standard Deviation | U/L | Baseline (Week 0) and Week 12 |
|
|
|
| Secondary | Change From Baseline to Week 12 in Analytic Markers of Inflammation: Fecal Calprotectin | Analytic markers of inflammation are hemogram (hemoglobin, hematocrit, leukocytes, neutrophils, lymphocytes, monocytes, eosinophils, basophils, and platelets), erythrocytes, ESR, CRP, fecal calprotectin, and coagulation (aPTT, INR, and fibrinogen). Mean Baseline and mean change from Baseline to Week 12 for each parameter are presented. | All participants in the ITT population with evaluable data | Posted | Mean | Standard Deviation | mg/kg | Baseline (Week 0) and Week 12 |
|
|
|
| Secondary | Change From Baseline to Week 12 in Analytic Markers of Inflammation: Activated Partial Thromboplastin Time (aPTT) | Analytic markers of inflammation are hemogram (hemoglobin, hematocrit, leukocytes, neutrophils, lymphocytes, monocytes, eosinophils, basophils, and platelets), erythrocytes, ESR, CRP, fecal calprotectin, and coagulation (aPTT, INR, and fibrinogen). Mean Baseline and mean change from Baseline to Week 12 for each parameter are presented. | All participants in the ITT population with evaluable data | Posted | Mean | Standard Deviation | sec | Baseline (Week 0) and Week 12 |
|
|
|
| Secondary | Change From Baseline to Week 12 in Analytic Markers of Inflammation: International Normalized Ratio (INR) | Analytic markers of inflammation are hemogram (hemoglobin, hematocrit, leukocytes, neutrophils, lymphocytes, monocytes, eosinophils, basophils, and platelets), erythrocytes, ESR, CRP, fecal calprotectin, and coagulation (aPTT, INR, and fibrinogen). Mean Baseline and mean change from Baseline to Week 12 for each parameter are presented. | All participants in the ITT population with evaluable data | Posted | Mean | Standard Deviation | ratio | Baseline (Week 0) and Week 12 |
|
|
|
| Secondary | Change From Baseline to Week 12 in Analytic Markers of Inflammation: Fibrinogen | Analytic markers of inflammation are hemogram (hemoglobin, hematocrit, leukocytes, neutrophils, lymphocytes, monocytes, eosinophils, basophils, and platelets), erythrocytes, ESR, CRP, fecal calprotectin, and coagulation (aPTT, INR, and fibrinogen). Mean Baseline and mean change from Baseline to Week 12 for each parameter are presented. | All participants in the ITT population with evaluable data | Posted | Mean | Standard Deviation | mg/dL | Baseline (Week 0) and Week 12 |
|
|
|
| Secondary | Percentage of Participants With Clinical Response at Day 4 or Week 12 and Clinical Remission at Week 12 | The percentage of participants with clinical response (defined as decrease of at least 3 points in HBI score) at Day 4 or Week 1 and clinical remission (defined as a HBI < 5) at Week 12. | ITT population | Posted | Number | percentage of participants | Up to Week 12 |
|
|
|
| 2 |
| 86 |
| 35 |
| 86 |
| Pyrexia | General disorders | MedDRA (17.1) | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
|
| Ear pain | Ear and labyrinth disorders | MedDRA (17.1) | Systematic Assessment |
|
| Eyelid disorder | Eye disorders | MedDRA (17.1) | Systematic Assessment |
|
| Lacrimation increased | Eye disorders | MedDRA (17.1) | Systematic Assessment |
|
| Presbyopia | Eye disorders | MedDRA (17.1) | Systematic Assessment |
|
| Abdominal mass | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
|
| Aphthous ulcer | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
|
| Crohn's disease | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
|
| Haemorrhoids | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
|
| Subileus | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA (17.1) | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA (17.1) | Systematic Assessment |
|
| General physical health deterioration | General disorders | MedDRA (17.1) | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA (17.1) | Systematic Assessment |
|
| Drug hypersensitivity | Immune system disorders | MedDRA (17.1) | Systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
|
| Conjunctivitis | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
|
| Folliculitis | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
|
| Herpes virus infection | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
|
| Pharyngotonsillitis | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
|
| Rash pustular | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
|
| Respiratory tract infection | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
|
| Rotavirus infection | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
|
| Tooth infection | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
|
| Blood triglycerides increased | Investigations | MedDRA (17.1) | Systematic Assessment |
|
| Transaminases increased | Investigations | MedDRA (17.1) | Systematic Assessment |
|
| Weight decreased | Investigations | MedDRA (17.1) | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | Systematic Assessment |
|
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | Systematic Assessment |
|
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | Systematic Assessment |
|
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | Systematic Assessment |
|
| Sacroiliitis | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (17.1) | Systematic Assessment |
|
| Migraine | Nervous system disorders | MedDRA (17.1) | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA (17.1) | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | Systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA (17.1) | Systematic Assessment |
|
| Eczema | Skin and subcutaneous tissue disorders | MedDRA (17.1) | Systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA (17.1) | Systematic Assessment |
|
| Psoriasis | Skin and subcutaneous tissue disorders | MedDRA (17.1) | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA (17.1) | Systematic Assessment |
|
| Skin lesion | Skin and subcutaneous tissue disorders | MedDRA (17.1) | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA (17.1) | 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.
| D007410 | Intestinal Diseases |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
|
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| Neutrophils Baseline |
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| Neutrophils Change from Baseline to Week 12 |
|
|
| Lymphocytes Baseline |
|
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| Lymphocytes Change from Baseline to Week 12 |
|
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| Monocytes Baseline |
|
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| Monocytes Change from Baseline to Week 12 |
|
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| Eosinophils Baseline |
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| Eosinophils Change from Baseline to Week 12 |
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| Basophils Baseline |
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| Basophils Change from Baseline to Week 12 |
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| Platelets Baseline |
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| Platelets Change from Baseline to Week 12 |
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