Phase 4
Completed N=86
Rapidity of Response to Adalimumab Treatment in Patients With Crohn´s Disease
Moderate to Severe Crohn's Disease
Source: ClinicalTrials.gov NCT02148718 ↗
Enrolled (actual)
86
Serious AEs
2.3%
Results posted
Aug 2017
Primary outcomePrimary: Percentage of Participants With Clinical Response at Day 4 — 61.63 percentage of participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Clinical Response at Day 4 |
61.63 | — |
| SECONDARY Percentage of Participants With Clinical Response at Week 1 |
75.58 | — |
| SECONDARY Percentage of Participants With Clinical Remission at Weeks 2 and 4 |
54.65; 62.79 | — |
| SECONDARY European Quality of Life (EuroQol) 5 Dimensions 3 Levels Questionnaire (EQ-5D-3L) Index Score: Change From Baseline to Week 12 |
0.62; 0.14 | — |
| SECONDARY European Quality of Life (EuroQol) 5 Dimensions 3 Levels Questionnaire (EQ-5D-3L) Visual Analog Scale (VAS): Change From Baseline to Week 12 |
55.36; 15.37 | — |
| SECONDARY Inflammatory Bowel Disease Quality-36 (IBDQ-36) Questionnaire Overall Score: Change From Baseline to Week 12 |
145.1; 44.72 | — |
| SECONDARY Fatigue Impact Scale for Daily Use (D-FIS): Change From Baseline to Week 12 |
14.45; -4.69 | — |
| SECONDARY Change From Baseline to Week 12 in Analytic Markers of Inflammation: Hemoglobin |
13.01; 0.27 | — |
| SECONDARY Change From Baseline to Week 12 in Analytic Markers of Inflammation: Hematocrit |
39.47; 0.86 | — |
| SECONDARY Change From Baseline to Week 12 in Analytic Markers of Inflammation: Leukocytes, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, and Platelets |
8.11; -1.62; 5.61; -1.99; 1.80; 0.39 | — |
| SECONDARY Change From Baseline to Week 12 in Analytic Markers of Inflammation: Erythrocytes |
4.37; 0.052 | — |
| SECONDARY Change From Baseline to Week 12 in Analytic Markers of Inflammation: Sedimentation Rate (ESR) |
19.49; -7.48 | — |
| SECONDARY Change From Baseline to Week 12 in Analytic Markers of Inflammation: C-reactive Protein (CRP) |
11.06; -7.61 | — |
| SECONDARY Change From Baseline to Week 12 in Analytic Markers of Inflammation: Fecal Calprotectin |
1,550.4; -1,043.8 | — |
| SECONDARY Change From Baseline to Week 12 in Analytic Markers of Inflammation: Activated Partial Thromboplastin Time (aPTT) |
30.58; 0.76 | — |
| SECONDARY Change From Baseline to Week 12 in Analytic Markers of Inflammation: International Normalized Ratio (INR) |
1.05; 0.02 | — |
| SECONDARY Change From Baseline to Week 12 in Analytic Markers of Inflammation: Fibrinogen |
374.5; -43.6 | — |
| SECONDARY Percentage of Participants With Clinical Response at Day 4 or Week 12 and Clinical Remission at Week 12 |
58.90 | — |
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.
Data sourced from ClinicalTrials.gov (NCT02148718). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.