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: 20.0Level: PTClassification code 10011401Term: Crohn's diseaseSystem Organ Class: 10017947 - Gastrointestinal disorders
Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Registration Number: EUCTR2013-001746-33-BE

Lead Sponsor: AbbVie Deutschland GmbH & Co. KG

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 514

Inclusion Criteria

1)Subject is between the ages of 18 to 75 years
2) 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.
3) 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

1) Subject with ulcerative colitis or indeterminate colitis
2) Subject who has had surgical bowel resections within the past 6 months or is planning resection
3) Subject with an ostomy or ileoanal pouch
4) Subject with bowel stricture or abdominal or peri-anal abscess
5) Subject who has short bowel syndrome
6) 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;Secondary Objective: • To assess the safety and efficacy 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>;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 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<br>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

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