NCT02148718CompletedPhase 4
Rapidity of Onset of Response to Adalimumab in Luminal Crohn's Disease (RAPIDA Study)
AbbVie0 sites100 target enrollmentStarted: June 2014Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Enrollment
- 100
- Primary Endpoint
- Percentage of Participants With Clinical Response at Day 4
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
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).
Intervention: adalimumab (Biological)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Percentage of Participants With Clinical Response at Week 1(Week 1)
- Percentage of Participants With Clinical Remission at Weeks 2 and 4(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(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(Baseline (Week 0) and Week 12)
- Inflammatory Bowel Disease Quality-36 (IBDQ-36) Questionnaire Overall Score: Change From Baseline to Week 12(Baseline (Week 0) and Week 12)
- Fatigue Impact Scale for Daily Use (D-FIS): Change From Baseline to Week 12(Baseline (Week 0) and Week 12)
- Change From Baseline to Week 12 in Analytic Markers of Inflammation: Hemoglobin(Baseline (Week 0) and Week 12)
- Change From Baseline to Week 12 in Analytic Markers of Inflammation: Hematocrit(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(Baseline (Week 0) and Week 12)
- Change From Baseline to Week 12 in Analytic Markers of Inflammation: Erythrocytes(Baseline (Week 0) and Week 12)
- Change From Baseline to Week 12 in Analytic Markers of Inflammation: Sedimentation Rate (ESR)(Baseline (Week 0) and Week 12)
- Change From Baseline to Week 12 in Analytic Markers of Inflammation: C-reactive Protein (CRP)(Baseline (Week 0) and Week 12)
- Change From Baseline to Week 12 in Analytic Markers of Inflammation: Fecal Calprotectin(Baseline (Week 0) and Week 12)
- Change From Baseline to Week 12 in Analytic Markers of Inflammation: Activated Partial Thromboplastin Time (aPTT)(Baseline (Week 0) and Week 12)
- Change From Baseline to Week 12 in Analytic Markers of Inflammation: International Normalized Ratio (INR)(Baseline (Week 0) and Week 12)
- Change From Baseline to Week 12 in Analytic Markers of Inflammation: Fibrinogen(Baseline (Week 0) and Week 12)
- Percentage of Participants With Clinical Response at Day 4 or Week 12 and Clinical Remission at Week 12(Up to Week 12)
Investigators
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