Rapidity of response to adalimumab treatment in patients with Crohn´s Disease.

Phase 1

Conditions: Crohn's disease
MedDRA version: 16.1Level: PTClassification code 10011401Term: Crohn's diseaseSystem Organ Class: 10017947 - Gastrointestinal disorders
Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Registration Number: EUCTR2013-004781-34-ES

Lead Sponsor: AbbVie Farmacéutica S.L.U.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 100

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

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:

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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<br>? To evaluate the improvement in analytic and fecal markers of inflammation in patients with Crohn's disease treated with adalimumab in the short term<br>? 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 Outcome Measures

Name	Time	Method
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<br>?Proportion of patients with clinical remission at weeks 2 and 4 (Harvey-Bradshaw Index <5)<br>?Change in Quality of Life, assessed with the EQ-5D and IBDQ36 questionnaires from baseline to week 12<br>?Change in Fatigue, assessed through the Fatigue Impact Scale for Daily Use (D-FIS), from baseline to week 12<br>?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)<br>?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

Related Trials