Moderate to Severe Crohn's DiseasePhase 4RAPIDANCT02148718
Rapidity of Response to Adalimumab Treatment in Patients With Crohn´s Disease
A Phase 4 study testing adalimumab in people with Moderate to Severe Crohn's Disease, run by AbbVie.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Moderate to Severe Crohn's Disease
- What is being tested?
- adalimumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Jun 2014to Jan 2017
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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)
Who cannot join
- 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).
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- 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.
About this study
Official title: Rapidity of Onset of Response to Adalimumab in Luminal Crohn's Disease (RAPIDA Study)
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.
- Conditions
- Moderate to Severe Crohn's Disease
- Being tested
- adalimumab
- Keywords
- Crohn's Disease
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
adalimumabBiological
Also called Humira, ABT-D2E7
Adalimumab pre-filled syringe, administered by subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Biological: adalimumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 4
Secondary outcomes (17)
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.
Measured: 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.
Measured: 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:
- 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.
Measured: 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:
- 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2014 (estimated)
- Study startJun 2014
- Primary completionAug 2016
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Moderate to Severe Crohn's DiseaseStudies of the same condition, open and under way.
- More trials run by AbbVieThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Laboratorio Echevarne, Pivotal S.L.
- Responsible party
- Sponsor
- Investigators
- Ignacio Marín, PhD, Principal investigator, Hospital General Universitario Gregorio Marañon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02148718
- Sponsor's protocol ID
- W13-984
- Other IDs
- 2013-004781-34
- Acronym
- RAPIDA
- Status last verified
- Feb 2018
- First submitted
- 23 May 2014
- Last updated
- 1 Mar 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rapidity of Onset of Response to Adalimumab in Luminal Crohn's Disease (RAPIDA Study)
- ClinicalTrials.gov ID
- NCT02148718
- Acronym / sponsor ID
- RAPIDA / W13-984
- Conditions
- Moderate to Severe Crohn's Disease
- Keywords
- Crohn's Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Collaborators
- Laboratorio Echevarne, Pivotal S.L.
- Study start
- Jun 2014 (actual)
- Primary completion
- Aug 2016 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 28 May 2014 (estimated)
- Results
- Posted 29 Aug 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adalimumab | Experimental | Biological: adalimumabParticipants 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). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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):
Key exclusion criteria (9 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| adalimumabAlso: Humira, ABT-D2E7Adalimumab pre-filled syringe, administered by subcutaneous injection | Biological | Adalimumab |
Primary outcome
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.
17 secondary outcomes
Percentage of Participants With Clinical Response at Week 1
Time frame: Week 1
Percentage of Participants With Clinical Remission at Weeks 2 and 4
Time frame: 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
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
Inflammatory Bowel Disease Quality-36 (IBDQ-36) Questionnaire Overall Score: Change From Baseline to Week 12
Time frame: 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
Change From Baseline to Week 12 in Analytic Markers of Inflammation: Hemoglobin
Time frame: 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
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
Change From Baseline to Week 12 in Analytic Markers of Inflammation: Erythrocytes
Time frame: 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
Change From Baseline to Week 12 in Analytic Markers of Inflammation: C-reactive Protein (CRP)
Time frame: 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
Change From Baseline to Week 12 in Analytic Markers of Inflammation: Activated Partial Thromboplastin Time (aPTT)
Time frame: 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
Change From Baseline to Week 12 in Analytic Markers of Inflammation: Fibrinogen
Time frame: 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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Related info.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ignacio Marín, PhD principal investigator
Hospital General Universitario Gregorio Marañon
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing adalimumab in people with Moderate to Severe Crohn's Disease, run by AbbVie.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Aug 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With Clinical Response at Day 4 (time frame: Day 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2018.