A Blinded Study to Evaluate Higher Versus Standard Adalimumab doses for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Crohn's Disease and Evidence of Mucosal Ulceratio

Phase 1

• Conditions: Crohn's disease; MedDRA version: 19.0Level: PTClassification code 10011401Term: Crohn's diseaseSystem Organ Class: 10017947 - Gastrointestinal disorders; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2013-001746-33-CZ
• Lead Sponsor: AbbVie Deutschland GmbH & Co. KG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-05-15
• Last Update Posted: 4 July 2016

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

• Subject is between the ages of 18 to 75 years
• Diagnosis of colonic, ileocolonic, or ileal Crohn's disease for = 3 months prior to Baseline and confirmed by endoscopy during the Screening period or endoscopy performed within 45 days before Baseline.
• Crohn's Disease Activity Index (CDAI) = 220 and = 450 at Baseline despite concurrent or prior treatment with a full oral corticosteroids and/or immunosuppressants

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 540
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 60

Exclusion Criteria

• Subject with ulcerative colitis or indeterminate colitis
• Subject who has had surgical bowel resections within the past 6 months or is planning resection
• Subject with an ostomy or ileoanal pouch
• Subject with bowel stricture or abdominal or peri-anal abscess
• Subject who has short bowel syndrome
• Chronic recurring infections or active TB

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective of this study is to evaluate efficacy and safety of higher induction and maintenance dosing regimens in subjects with moderately to severely active Crohn's disease;Primary end point(s): Proportion of subjects who achieve clinical remission at Week 4 and proportion of subjects who achieve endoscopic response at Week 12.;Timepoint(s) of evaluation of this end point: Week 4 and Week 12;Secondary Objective: • To assess the efficacy and safety of two adalimumab induction regimens in reducing signs and symptoms of Crohn's disease at Week 12.<br>• To assess the efficacy and safety of two adalimumab maintenance regimens in reducing signs and symptoms of Crohn's disease at Week 56.<br>• To assess pharmacokinetics (PK) and immunogenicity of two adalimumab induction regimens following subcutaneous (SC) administration.<br>

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): • Proportion of subjects with clinical remission at weeks 4 and 12<br>• Proportion of subjects with clinical remission at week 4 and endoscopic improvement at week 12<br>• Proportion of subjects with clinical remission at week 12<br>• Among subjects on corticosteroids at baseline, proportion of subjects who discontinued corticosteroid use and achieved clinical remission at week 12<br>• Proportion of subject with endoscopic response at week 12<br>• Change from Baseline in fecal calprotectin level at Week 4.<br>• Proportion of subjects with normal hs-CRP and fecal calprotectin values at Week 4.;Timepoint(s) of evaluation of this end point: Week 4 and 12 depending on the endpoints