- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02148718
Rapidity of Response to Adalimumab Treatment in Patients With Crohn´s Disease (RAPIDA)
Rapidity of Onset of Response to Adalimumab in Luminal Crohn's Disease (RAPIDA Study)
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 4
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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).
|
Adalimumab pre-filled syringe, administered by subcutaneous injection
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Participants With Clinical Response at Day 4
Time Frame: 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
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Participants With Clinical Response at Week 1
Time Frame: 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.
|
Week 1
|
Percentage of Participants With Clinical Remission at Weeks 2 and 4
Time Frame: 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
Time Frame: Baseline (Week 0) and 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
Time Frame: Baseline (Week 0) and 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
Time Frame: Baseline (Week 0) and 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
Time Frame: Baseline (Week 0) and 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
Time Frame: Baseline (Week 0) and Week 12
|
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
Time Frame: Baseline (Week 0) and Week 12
|
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
Time Frame: Baseline (Week 0) and Week 12
|
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
Time Frame: Baseline (Week 0) and Week 12
|
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)
Time Frame: Baseline (Week 0) and Week 12
|
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)
Time Frame: Baseline (Week 0) and Week 12
|
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
Time Frame: Baseline (Week 0) and Week 12
|
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)
Time Frame: Baseline (Week 0) and Week 12
|
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)
Time Frame: Baseline (Week 0) and Week 12
|
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
Time Frame: Baseline (Week 0) and Week 12
|
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
Time Frame: Up to 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
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ignacio Marín, PhD, Hospital General Universitario Gregorio Marañon
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- W13-984
- 2013-004781-34 (EudraCT Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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