Clinical trial NCT02148718: Rapidity of Response to Adalimumab Treatment in Patients With Crohn´s Disease
Official title: Rapidity of Onset of Response to Adalimumab in Luminal Crohn's Disease (RAPIDA Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Moderate to Severe Crohn's Disease
Keywords: Crohn's Disease
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
Collaborators: name: Laboratorio Echevarne
name: Pivotal S.L.
First posted: 2014-05-28
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Percentage of Participants With Clinical Response at Day 4
timeFrame: Day 4
Secondary outcomes:
measure: Percentage of Participants With Clinical Response at Week 1
timeFrame: Week 1
measure: Percentage of Participants With Clinical Remission at Weeks 2 and 4
timeFrame: Weeks 2 and 4
measure: European Quality of Life (EuroQol) 5 Dimensions 3 Levels Questionnaire (EQ-5D-3L) Index Score: Change From Baseline to Week 12
timeFrame: Baseline (Week 0) and Week 12
measure: European Quality of Life (EuroQol) 5 Dimensions 3 Levels Questionnaire (EQ-5D-3L) Visual Analog Scale (VAS): Change From Baseline to Week 12
timeFrame: Baseline (Week 0) and Week 12
measure: Inflammatory Bowel Disease Quality-36 (IBDQ-36) Questionnaire Overall Score: Change From Baseline to Week 12
timeFrame: Baseline (Week 0) and Week 12
measure: Fatigue Impact Scale for Daily Use (D-FIS): Change From Baseline to Week 12
timeFrame: Baseline (Week 0) and Week 12
measure: Change From Baseline to Week 12 in Analytic Markers of Inflammation: Hemoglobin
timeFrame: Baseline (Week 0) and Week 12
measure: Change From Baseline to Week 12 in Analytic Markers of Inflammation: Hematocrit
timeFrame: Baseline (Week 0) and Week 12
measure: Change From Baseline to Week 12 in Analytic Markers of Inflammation: Leukocytes, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, and Platelets
timeFrame: Baseline (Week 0) and Week 12
measure: Change From Baseline to Week 12 in Analytic Markers of Inflammation: Erythrocytes
timeFrame: Baseline (Week 0) and Week 12
measure: Change From Baseline to Week 12 in Analytic Markers of Inflammation: Sedimentation Rate (ESR)
timeFrame: Baseline (Week 0) and Week 12
measure: Change From Baseline to Week 12 in Analytic Markers of Inflammation: C-reactive Protein (CRP)
timeFrame: Baseline (Week 0) and Week 12
measure: Change From Baseline to Week 12 in Analytic Markers of Inflammation: Fecal Calprotectin
timeFrame: Baseline (Week 0) and Week 12
measure: Change From Baseline to Week 12 in Analytic Markers of Inflammation: Activated Partial Thromboplastin Time (aPTT)
timeFrame: Baseline (Week 0) and Week 12
measure: Change From Baseline to Week 12 in Analytic Markers of Inflammation: International Normalized Ratio (INR)
timeFrame: Baseline (Week 0) and Week 12
measure: Change From Baseline to Week 12 in Analytic Markers of Inflammation: Fibrinogen
timeFrame: Baseline (Week 0) and Week 12
measure: Percentage of Participants With Clinical Response at Day 4 or Week 12 and Clinical Remission at Week 12
timeFrame: Up to Week 12
Other outcomes:
Locations:
Study officials:
affiliation: Hospital General Universitario Gregorio Marañon
name: Ignacio Marín, PhD
role: PRINCIPAL_INVESTIGATOR
References: