search
Back to results

Rapidity of Response to Adalimumab Treatment in Patients With Crohn´s Disease (RAPIDA)

Primary Purpose

Moderate to Severe Crohn's Disease

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
adalimumab
Sponsored by
AbbVie
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Moderate to Severe Crohn's Disease focused on measuring Crohn's Disease

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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:

    • Aminosalicylates for, at least, the last 4 weeks
    • Probiotics for, at least, the last 4 weeks
    • Analgesics for, at least, the last 4 weeks
    • Antidiarrheals for, at least, the last 4 weeks
    • CD-related antibiotics for, at least, the last 4 weeks
    • Azathioprine, 6-mercaptopurine or methotrexate for, at least, the last 12 weeks

  • If receiving any of the following treatments, their dose should not have been increase in the past two weeks (the dose reduction is permitted):

    • Oral budesonide (maximum dose of 9 mg/day)
    • Oral prednisone or equivalent (maximum dose of 40mg/day)

Exclusion Criteria:

  • Previous treatment with any anti-Tumor Necrosis Factor agent
  • Surgical bowel resection within the previous 6 months, ostomy, extensive bowel resection (> 100 cm), short bowel syndrome
  • Fistulising Crohn's disease
  • Treatment with cyclosporine or tacrolimus within the previous 8 weeks
  • Clinically significant cardiac disease including unstable angina, acute myocardial infarction within six months from screening, congestive heart failure of worse than grade II New York criteria (New York Heart Association Functional Classification).
  • Subject with an ostomy or ileoanal pouch, proctocolectomy, total colectomy, ileostomy, stoma or ileal pouch-anal anastomosis (Subjects with a previous ileo-rectal anastomosis are not excluded).
  • Screening laboratory values (according to central laboratory)
  • Known hepatitis C (HC) infection.
  • Serologic evidence of hepatitis B (HB) infection based on the results of testing for hepatitis B surface antigen (HBsAg), hepatitis B core antibody (anti-HBc) and hepatitis B surface antibody (anti-HBs) antibodies.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Adalimumab

    Arm Description

    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).

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    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.
    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.
    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: The EQ-5D-3L Index Score has five dimensions of health (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) with 3 levels of severity for each dimension ('no problems', 'some problems', and 'extreme problems'). The level of severity reported on each of the EQ-5D-3L dimensions determines a unique health state. Health states are converted into a weighted health state index. These weights lie on a scale on which full health has a value of 1 and dead has a value of 0. The EQ-5D visual analog scale (VAS) is a 20-cm scale with endpoints labeled "best imaginable health" and "worst imaginable health" anchored at 100 and 0, respectively. 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.
    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: The EQ-5D-3L Index Score has five dimensions of health (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) with 3 levels of severity for each dimension ('no problems', 'some problems', and 'extreme problems'). The level of severity reported on each of the EQ-5D-3L dimensions determines a unique health state. Health states are converted into a weighted health state index. These weights lie on a scale on which full health has a value of 1 and dead has a value of 0. The EQ-5D VAS is a 20-cm scale with endpoints labeled "best imaginable health" and "worst imaginable health" anchored at 100 and 0, respectively. 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.
    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.
    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.
    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.
    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.
    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.
    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.
    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.
    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.
    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.
    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.
    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.
    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.
    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.

    Full Information

    First Posted
    May 23, 2014
    Last Updated
    February 2, 2018
    Sponsor
    AbbVie
    Collaborators
    Laboratorio Echevarne, Pivotal S.L.
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT02148718
    Brief Title
    Rapidity of Response to Adalimumab Treatment in Patients With Crohn´s Disease
    Acronym
    RAPIDA
    Official Title
    Rapidity of Onset of Response to Adalimumab in Luminal Crohn's Disease (RAPIDA Study)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    June 2014 (Actual)
    Primary Completion Date
    August 2016 (Actual)
    Study Completion Date
    January 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    AbbVie
    Collaborators
    Laboratorio Echevarne, Pivotal S.L.

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Moderate to Severe Crohn's Disease
    Keywords
    Crohn's Disease

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    100 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Adalimumab
    Arm Type
    Experimental
    Arm Description
    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).
    Intervention Type
    Biological
    Intervention Name(s)
    adalimumab
    Other Intervention Name(s)
    Humira, ABT-D2E7
    Intervention Description
    Adalimumab pre-filled syringe, administered by subcutaneous injection
    Primary Outcome Measure Information:
    Title
    Percentage of Participants With Clinical Response at Day 4
    Description
    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.
    Time Frame
    Day 4
    Secondary Outcome Measure Information:
    Title
    Percentage of Participants With Clinical Response at Week 1
    Description
    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.
    Time Frame
    Week 1
    Title
    Percentage of Participants With Clinical Remission at Weeks 2 and 4
    Description
    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.
    Time Frame
    Weeks 2 and 4
    Title
    European Quality of Life (EuroQol) 5 Dimensions 3 Levels Questionnaire (EQ-5D-3L) Index Score: Change From Baseline to Week 12
    Description
    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: The EQ-5D-3L Index Score has five dimensions of health (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) with 3 levels of severity for each dimension ('no problems', 'some problems', and 'extreme problems'). The level of severity reported on each of the EQ-5D-3L dimensions determines a unique health state. Health states are converted into a weighted health state index. These weights lie on a scale on which full health has a value of 1 and dead has a value of 0. The EQ-5D visual analog scale (VAS) is a 20-cm scale with endpoints labeled "best imaginable health" and "worst imaginable health" anchored at 100 and 0, respectively. 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.
    Time Frame
    Baseline (Week 0) and Week 12
    Title
    European Quality of Life (EuroQol) 5 Dimensions 3 Levels Questionnaire (EQ-5D-3L) Visual Analog Scale (VAS): Change From Baseline to Week 12
    Description
    The EQ-5D-3L is a standardized instrument for use as a measure of HRQoL and consists of 2 components: The EQ-5D-3L Index Score has five dimensions of health (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) with 3 levels of severity for each dimension ('no problems', 'some problems', and 'extreme problems'). The level of severity reported on each of the EQ-5D-3L dimensions determines a unique health state. Health states are converted into a weighted health state index. These weights lie on a scale on which full health has a value of 1 and dead has a value of 0. The EQ-5D VAS is a 20-cm scale with endpoints labeled "best imaginable health" and "worst imaginable health" anchored at 100 and 0, respectively. 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.
    Time Frame
    Baseline (Week 0) and Week 12
    Title
    Inflammatory Bowel Disease Quality-36 (IBDQ-36) Questionnaire Overall Score: Change From Baseline to Week 12
    Description
    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.
    Time Frame
    Baseline (Week 0) and Week 12
    Title
    Fatigue Impact Scale for Daily Use (D-FIS): Change From Baseline to Week 12
    Description
    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.
    Time Frame
    Baseline (Week 0) and Week 12
    Title
    Change From Baseline to Week 12 in Analytic Markers of Inflammation: Hemoglobin
    Description
    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.
    Time Frame
    Baseline (Week 0) and Week 12
    Title
    Change From Baseline to Week 12 in Analytic Markers of Inflammation: Hematocrit
    Description
    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.
    Time Frame
    Baseline (Week 0) and Week 12
    Title
    Change From Baseline to Week 12 in Analytic Markers of Inflammation: Leukocytes, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, and Platelets
    Description
    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.
    Time Frame
    Baseline (Week 0) and Week 12
    Title
    Change From Baseline to Week 12 in Analytic Markers of Inflammation: Erythrocytes
    Description
    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.
    Time Frame
    Baseline (Week 0) and Week 12
    Title
    Change From Baseline to Week 12 in Analytic Markers of Inflammation: Sedimentation Rate (ESR)
    Description
    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.
    Time Frame
    Baseline (Week 0) and Week 12
    Title
    Change From Baseline to Week 12 in Analytic Markers of Inflammation: C-reactive Protein (CRP)
    Description
    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.
    Time Frame
    Baseline (Week 0) and Week 12
    Title
    Change From Baseline to Week 12 in Analytic Markers of Inflammation: Fecal Calprotectin
    Description
    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.
    Time Frame
    Baseline (Week 0) and Week 12
    Title
    Change From Baseline to Week 12 in Analytic Markers of Inflammation: Activated Partial Thromboplastin Time (aPTT)
    Description
    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.
    Time Frame
    Baseline (Week 0) and Week 12
    Title
    Change From Baseline to Week 12 in Analytic Markers of Inflammation: International Normalized Ratio (INR)
    Description
    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.
    Time Frame
    Baseline (Week 0) and Week 12
    Title
    Change From Baseline to Week 12 in Analytic Markers of Inflammation: Fibrinogen
    Description
    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.
    Time Frame
    Baseline (Week 0) and Week 12
    Title
    Percentage of Participants With Clinical Response at Day 4 or Week 12 and Clinical Remission at Week 12
    Description
    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.
    Time Frame
    Up to Week 12

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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: Aminosalicylates for, at least, the last 4 weeks Probiotics for, at least, the last 4 weeks Analgesics for, at least, the last 4 weeks Antidiarrheals for, at least, the last 4 weeks CD-related antibiotics for, at least, the last 4 weeks Azathioprine, 6-mercaptopurine or methotrexate for, at least, the last 12 weeks If receiving any of the following treatments, their dose should not have been increase in the past two weeks (the dose reduction is permitted): Oral budesonide (maximum dose of 9 mg/day) Oral prednisone or equivalent (maximum dose of 40mg/day) Exclusion Criteria: Previous treatment with any anti-Tumor Necrosis Factor agent Surgical bowel resection within the previous 6 months, ostomy, extensive bowel resection (> 100 cm), short bowel syndrome Fistulising Crohn's disease Treatment with cyclosporine or tacrolimus within the previous 8 weeks Clinically significant cardiac disease including unstable angina, acute myocardial infarction within six months from screening, congestive heart failure of worse than grade II New York criteria (New York Heart Association Functional Classification). Subject with an ostomy or ileoanal pouch, proctocolectomy, total colectomy, ileostomy, stoma or ileal pouch-anal anastomosis (Subjects with a previous ileo-rectal anastomosis are not excluded). Screening laboratory values (according to central laboratory) Known hepatitis C (HC) infection. Serologic evidence of hepatitis B (HB) infection based on the results of testing for hepatitis B surface antigen (HBsAg), hepatitis B core antibody (anti-HBc) and hepatitis B surface antibody (anti-HBs) antibodies.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Ignacio Marín, PhD
    Organizational Affiliation
    Hospital General Universitario Gregorio Marañon
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Links:
    URL
    http://rxabbvie.com
    Description
    Related info.

    Learn more about this trial

    Rapidity of Response to Adalimumab Treatment in Patients With Crohn´s Disease

    We'll reach out to this number within 24 hrs