A Blinded Study to Evaluate the Efficacy and Safety of Two Adalimumab Doses in Subjects with Moderately to Severely Active Crohn's Disease and Evidence of Mucosal Ulceration

A Multicenter, Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of Two Adalimumab Induction Regimens in Subjects with Moderately to Severely Active Crohn's Disease and Evidence of Mucosal Ulceration

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-001746-33-ES

Enrollment

300

Registered

2014-04-25

Start date

2014-06-23

Completion date

Unknown

Last updated

2019-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Crohn's disease MedDRA version: 16.1 Level: PT Classification code 10011401 Term: Crohn's disease System Organ Class: 10017947 - Gastrointestinal disorders

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

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)Subject is between the ages of 18 to 75 years 2) Diagnosis of Crohn's disease (CD) for at least 90 days, confirmed by endoscopy during the Screening Period 3) Active CD with a Crohn's Disease Activity Index (CDAI) ? 220 and ? 450 despite treatment with oral corticosteroids and/or immunosuppressants 4) Mucosal ulceration on endoscopy 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 270 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 30

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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;Main Objective: The primary objective of this study is to assess the efficacy and safety of two adalimumab induction regimens in achieving clinical remission at Week 4 and endoscopic improvement at Week 12 in subjects with moderately to severely active Crohn's disease and evidence of mucosal ulceration.; 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. ? To assess pharmacokinetics (PK) and immunogenicity of two adalimumab induction regimens following subcutaneous (SC) administration.	—

Measure

Time frame

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;Main Objective: The primary objective of this study is to assess the efficacy and safety of two adalimumab induction regimens in achieving clinical remission at Week 4 and endoscopic improvement at Week 12 in subjects with moderately to severely active Crohn's disease and evidence of mucosal ulceration.; 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. ? To assess pharmacokinetics (PK) and immunogenicity of two adalimumab induction regimens following subcutaneous (SC) administration.

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Secondary

Measure	Time frame
Secondary end point(s): 1. Clinical remission at Week 12. 2. Proportion of subjects who discontinued corticosteroid use and achieved clinical remission at Week 12. 3. Proportion of subjects with clinical response at Week 4. 4. Proportion of subjects with clinical response at Week 12. 5. Proportion of subjects with endoscopic response at Week 12. 6. Change in IBDQ from Baseline at Week 4. 7. Change in IBDQ from Baseline at Week 12. ;Timepoint(s) of evaluation of this end point: Week 4 and 12 depending on the endpoints	—

Measure

Time frame

Secondary end point(s): 1. Clinical remission at Week 12. 2. Proportion of subjects who discontinued corticosteroid use and achieved clinical remission at Week 12. 3. Proportion of subjects with clinical response at Week 4. 4. Proportion of subjects with clinical response at Week 12. 5. Proportion of subjects with endoscopic response at Week 12. 6. Change in IBDQ from Baseline at Week 4. 7. Change in IBDQ from Baseline at Week 12. ;Timepoint(s) of evaluation of this end point: Week 4 and 12 depending on the endpoints

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Countries

Austria, Belgium, Canada, Czech Republic, Denmark, European Union, France, Germany, Hungary, Israel, Italy, Netherlands, Slovakia, Spain, Switzerland, United States

Contacts

Public ContactEU Clinical Trials Helpdesk

AbbVie Ltd

abbvie_reec@abbvie.com+34901 20 01 03

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026