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 Ulceration

• Register: EUCTR
• Last refreshed on: 4 May 2020
• Main ID: EUCTR2013-001746-33-DE
• Date of registration: 01/04/2014
• Prospective Registration: Yes
• Primary sponsor: AbbVie Deutschland GmbH & Co. KG
• Public title: 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 Ulceration
• Scientific title: A Multicenter, Randomized, Double-Blind Study to Evaluate Higher Versus Standard Adalimumab Dosing Regimens for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Crohn's Disease and Evidence of Mucosal Ulceration
• Date of first enrolment: 08/10/2014
• Target sample size: 500
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2013-001746-33
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: yes Other specify the comparator: two adalimumab induction and maintenance regimens are compared Number of treatment arms in the trial: 4
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

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

Contacts

• Name: EU Clinical Trials Helpdesk
• Affiliation: AbbVie Ltd

• Name: EU Clinical Trials Helpdesk
• Affiliation: AbbVie Ltd

Key inclusion & exclusion 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 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 485
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 15

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


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Crohn's disease
MedDRA version: 20.0 Level: PT Classification code 10011401 Term: Crohn's disease System Organ Class: 10017947 - Gastrointestinal disorders

Intervention(s)

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 Number: 331731-18-1
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 50-
Pharmaceutical form of the placebo: Solution for injection in pre-filled syringe
Route of administration of the placebo: Subcutaneous use

Primary Outcome(s)

Primary end point(s): Proportion of subjects who achieve clinical remission at Week 4 and proportion of subjects with endoscopic response (decrease > 50% SES-CD from Baseline [or for a Baseline SES-CD of 4, at least a 2 point reduction from Baseline]) at 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 (CDAI < 150) at Week 4 and endoscopic response defined as decrease in SES-CD > 50% from Baseline (or for a Baseline SES-CD of 4, at least a 2 point reduction from Baseline) at Week 12, in subjects with moderately to severely active Crohn's disease and evidence of mucosal ulceration at Baseline.

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 the efficacy and safety of two adalimumab maintenance
regimens in reducing signs and symptoms of Crohn's disease at Week 56.
• To assess pharmacokinetics (PK) and immunogenicity of two adalimumab induction regimens following subcutaneous (SC) administration.

Timepoint(s) of evaluation of this end point: Week 4 and Week 12

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: Week 4 and 12 depending on the endpoints

Secondary end point(s): • Proportion of subjects with clinical remission at weeks 4 and 12
• Proportion of subjects with CDAI < 150 at Week 4 and endoscopic response at Week 12
• Proportion of subjects with clinical remission at week 12
• Among subjects on corticosteroids at baseline, proportion of subjects who discontinued corticosteroid use and achieved clinical remission at week 12
• Proportion of subject with endoscopic remission (SES-CD = 4 and at least a 2 point reduction versus baseline and no subscore greater than 1 in any individual variable) at Week 12
• Change from Baseline in fecal calprotectin level at Week 4.
• Proportion of subjects with hs-CRP < 5 mg/L and fecal calprotectin < 250 µ/g at Week4.
• Proportion of subjects with CDAI < 150, hs-CRP < 5 mg/L, and fecal calprotectin 250 µg/g at Week 4.
• Proportion of subjects with CDAI < 150, hs-CRP < 5 mg/L, SES-CD = 4 and at least a 2 point reduction versus baseline and no subscore greater than 1 in any individual variable, and fecal calprotectin < 250 µg/g at Week 12.
• Proportion of subjects who achive an SES-CED = 2 at Week 12.
• Proportion of subjects with clinical response (decrease in CDAI = 70 points from Baseline) at Week 4.
• Proportion of subjects with clinical response (decrease in CDAI = 70 points from Baseline) at Week 12.
• Proportion of subjects achieving response in IBDQ Bowel Symptom domain (increase of IBDQ bowel symptom domain score = 8) at Week 4.
• Proportion of subjects achieving response in IBDQ Bowel Symptom domain (increase of IBDQ bowel symptom domain score = 8) at Week 12.
• Proportion of subjects achieving response in IBDQ fatigue item (increase of IBDQ fatigue item score = 1) at Week 12.

Secondary ID(s)

M14-115

Source(s) of Monetary Support

Abbvie Inc

Ethics review

Status: Approved
Approval date: 08/10/2014
Contact: