Crohn's disease MedDRA version: 16.1 Level: PT Classification code 10011401 Term: Crohn's disease System Organ Class: 10017947 - Gastrointestinal disorders
Conditions
Interventions
Trade Name: Humira 40 mg solution for injection in pre-filled syringe
Product Name: ADALIMUMAB
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: ADALIMUMAB
CAS Num
Sponsors
AbbVie Farmacéutica S.L.U.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Crohn?s disease diagnosed within, at least, the previous 4 months. 2. Patients with active luminal (Harvey-Bradshaw Index ?8) moderate-to-severe Crohn´s disease. 3. Adult patient 18-75 year-old. 4. No response to a full and adequate course of therapy with a corticosteroid and/or an immunosuppressant. 5. 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 ? Oral budesonide (maximum dose of 9 mg/day) for, at least, the last 2 weeks ? Oral prednisone or equivalent for, at least, the last 2 weeks ? CD-related antibiotics for, at least, the last 4 weeks ? Azathioprine, 6-mercaptopurine or methotrexate for, at least, the last 12 weeks Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 88 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
Exclusion criteria: 1. Previous treatment with any anti-TNF agent. 2. Surgical bowel resection within the previous 6 months, ostomy, extensive bowel resection (> 100 cm), short bowel syndrome. 3. Fistulising Crohn's disease. 4. Treatment with cyclosporine or tacrolimus within the previous 8 weeks. 5. 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 (NYHA Functional Classification). 6. Subject with an ostomy or ileoanal pouch. (Subjects with a previous ileo-rectal anastomosis are not excluded). 7. Proctocolectomy, total colectomy, ileostomy, stoma or ileal pouch-anal anastomosis. 8. Screening laboratory values (according to central laboratory) 9. Known of hepatitis C (HC) infection. 10. Serologic evidence of hepatitis B (HB) infection* based on the results of testing for HBsAg, anti-HBc and anti-HBs antibodies as follows:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the rapidity of onset of clinical response to adalimumab therapy in patients with luminal Crohn's disease;Secondary Objective: ?To evaluate the improvement of health-related quality of life and fatigue to adalimumab therapy in patients with Crohn's disease ? To evaluate the improvement in analytic and fecal markers of inflammation in patients with Crohn's disease treated with adalimumab in the short term ? To evaluate the correlation of a rapid response at day 4 and week 1 with remission at week 12;Primary end point(s): Proportion of patients with clinical response at day 4. Clinical response is defined as a decrease of at least 3 points in the Harvey-Bradshaw Index, at day 4;Timepoint(s) of evaluation of this end point: Day 4 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): ?Proportion of patients with clinical response at week 1. Clinical response is defined as a decrease of at least 3 points in the Harvey-Bradshaw Index, at week 1 ?Proportion of patients with clinical remission at weeks 2 and 4 (Harvey-Bradshaw Index <5) ?Change in Quality of Life, assessed with the EQ-5D and IBDQ36 questionnaires from baseline to week 12 ? Change in Fatigue, assessed through the Fatigue Impact Scale for Daily Use (D-FIS), from baseline to week 12 ?Change in analytic markers of inflammation from baseline to week 12: hemogram, erythrocyte sedimentation rate (ESR), C-reactive protein (CRP), fecal calprotectin and coagulation (including fibrinogen) ?Statistical analysis will be performed to evaluate the correlation between a clinical response at day 4 and week 1 with remission at week 12;Timepoint(s) of evaluation of this end point: Week 1, 2, 4 and 12 | — |
Countries
Spain
Contacts
Public ContactInvestigación Clinica
Abbvie Farmacéutica S.L.U.
Outcome results
None listed