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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: EUCTR
Last refreshed on: 3 September 2012
Main ID:  EUCTR2010-019973-13-DE
Date of registration: 30/09/2010
Prospective Registration: Yes
Primary sponsor: Novartis Pharma AG
Public title: A Phase II Efficacy Study in Fistulizing Crohn's Disease Patients
Scientific title: A multi-center, randomized, double-blind, active controlled study to assess efficacy, safety and tolerability of the anti-IL13 monoclonal antibody QAX576 in the treatment of perianal fistulas in patients suffering from Crohn’s disease
Date of first enrolment: 14/01/2011
Target sample size: 23
Recruitment status: Not Recruiting
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2010-019973-13
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: yes Placebo: no Other: yes Other specify the comparator: Infliximab  
Phase: 
Countries of recruitment
Germany Switzerland
Contacts
Name: Medizinischer Infoservice   
Address:  Roonstrasse 25 90429 Nürnberg Germany
Telephone: +491802232300
Email: infoservice.novartis@novartis.com
Affiliation:  Novartis Pharma GmbH
Name: Medizinischer Infoservice   
Address:  Roonstrasse 25 90429 Nürnberg Germany
Telephone: +491802232300
Email: infoservice.novartis@novartis.com
Affiliation:  Novartis Pharma GmbH
Key inclusion & exclusion criteria
Inclusion criteria:
• At least one draining enterocutaneous perianal fistula
• Diagnosis of Crohn's disease (CD) must have been established for at
least 6 months
• At least one ineffective fistula treatment (but no previously failed anti-
TNFa (tumour necrosis factor) antibody treatment)
• Patients should not suffer from any other health problems that may
jeopardize their participation in the study.
Additional details and inclusion criteria are available in the clinical study
protocol.
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
• Current or recent (within 30 days of enrollment, or 5 half-lives of the
compound, whichever is longer) use of anti-TNFa antibody treatment
• Active Crohn's disease
• Recent or pending abdominal or ano-rectal surgery, particularly
presence of stricture, or abscess, or retention for which surgery might be indicated
• Previously failed anti-TNFa antibody treatment
• Intercurrent bacterial or viral (intestinal) infection (serologically or
microbiologically confirmed)
Additional details and exclusion criteria are available in the clinical study
protocol.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
Health Condition(s) or Problem(s) studied
Treatment of perianal fistulas in patients suffering from Crohn's Disease.
MedDRA version: 14.0 Level: PT Classification code 10016717 Term: Fistula System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 14.0 Level: PT Classification code 10011401 Term: Crohn's disease System Organ Class: 10017947 - Gastrointestinal disorders
Intervention(s)

Product Code: QAX576
Pharmaceutical Form: Powder and solvent for solution for infusion
Current Sponsor code: QAX576
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 150-

Trade Name: Remicade
Pharmaceutical Form: Powder for concentrate for solution for infusion
INN or Proposed INN: INFLIXIMAB
CAS Number: 170277-31-3
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 10-

Primary Outcome(s)
Main Objective: • Assessment of efficacy of QAX576 to induce complete closure for at
least 4 weeks of all perianal fistulas in patients suffering from Crohn's
disease by: clinical observation and cutaneous photodocumentation [
Time Frame: 52 weeks ] [ Designated as safety issue: No ]
Primary end point(s): • Assessment of efficacy of QAX576 to induce complete closure for at
least 4 weeks of all perianal fistulas in patients suffering from Crohn's
disease by: clinical observation and cutaneous photodocumentation
Secondary Objective: • Assessment of safety and tolerability of QAX576 in patients suffering
from Crohn's disease as measured by lab assessments, ECG, physical
exam etc [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]
Other secondary objectives are listed in the clinical study protocol.
Timepoint(s) of evaluation of this end point: 52 weeks
Secondary Outcome(s)
Secondary end point(s): •Assessment of safety and tolerability of QAX576 in patients suffering
from Crohn's disease as measured by lab assessments, ECG, physical
exam etc
Timepoint(s) of evaluation of this end point: 52 weeks
Secondary ID(s)
CQAX576A2209
NCT01355614
Source(s) of Monetary Support
Novartis Pharma Servives AG
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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