A Double-Blind, Randomized, Multicenter Study of Higher Versus Standard Adalimumab Dosing Regimens for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis

• Register: EUCTR
• Last refreshed on: 30 November 2020
• Main ID: EUCTR2013-001682-16-IT
• Date of registration: 23/04/2014
• Prospective Registration: Yes
• Primary sponsor: AbbVie Deutschland GmbH & Co. KG
• Public title: A Double-Blind, Randomized, Multicenter Study of Higher Versus Standard Adalimumab Dosing Regimens for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis
• Scientific title: A Double-Blind, Randomized, Multicenter Study of Higher Versus Standard Adalimumab Dosing Regimens for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis
• Date of first enrolment: 02/09/2014
• Target sample size: 525
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2013-001682-16
• 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: Other doses of adalimumab Number of treatment arms in the trial: 5
• 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, Germany, Hungary, Israel, Italy, Japan, Netherlands, Poland, 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 UC for at least 90 days, confirmed by endoscopy with biopsy during the Screening Period
3) Active ulcerative colitis with a Mayo Score of 6 – 12 points and endoscopy subscore of 2 – 3 despite concurrent treatment with oral corticosteroids or immunosuppressants or both
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 472
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 53

Exclusion criteria:
1. Subject with Crohn's disease (CD) or indeterminate colitis (IC).
2. Current diagnosis of fulminant colitis and/or toxic megacolon.
3. Subjects with disease limited to the rectum (ulcerative proctitis) during the screening endoscopy.
4. Chronic recurring infections or active TB


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

Health Condition(s) or Problem(s) studied

Ulcerative colitis
MedDRA version: 16.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 100000004856

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

Intervention(s)

Trade Name: Humira 40 mg/0.8 ml solution for injection
Product Name: ADALIMUMAB
Product Code: 331731-18-1
Pharmaceutical Form: Solution for injection
INN or Proposed INN: ADALIMUMAB
CAS Number: 331731-18-1
Current Sponsor code: Humira
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 50-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use

Primary Outcome(s)

Main Objective: The primary objective is to evaluate safety and efficacy of higher induction and maintenance dosing regimens in subjects with moderately to severely active Ulcerative Colitis (UC).

Secondary Objective: not applicable

Primary end point(s): Proportion of subjects achieving clinical remission (per Full Mayo Score) at Week 8

Timepoint(s) of evaluation of this end point: Week 8

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: Week 8 and week 52

Secondary end point(s): 1. Proportion of subjects achieving endoscopic improvement (endoscopic subscore of 0 or 1) at Week 8.
2. Proportion of Week 8 responders (per Full Mayo Score) achieving clinical remission (per Full Mayo Score) at Week 52.
3. Proportion of Week 8 responders (per Full Mayo Score) achieving endoscopic improvement (endoscopic subscore of 0 or 1) at Week 52.

Secondary ID(s)

2013-001682-16-DE

M14-033

Source(s) of Monetary Support

AbbVie Inc.

Ethics review

Status: Approved
Approval date: 02/09/2014
Contact:

Results

• Results available: Yes
• Date Posted: 13/11/2020
• Date Completed: 11/11/2019
• URL: https://www.clinicaltrialsregister.eu/ctr-search/trial/2013-001682-16/results