A Phase II Efficacy Study in Fistulizing Crohn's Disease Patients

• 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

Countries of recruitment

Germany, Switzerland

Contacts

• Name: Medizinischer Infoservice
• Affiliation: Novartis Pharma GmbH

• Name: Medizinischer Infoservice
• 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 ]

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.

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

Timepoint(s) of evaluation of this end point: 52 weeks

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: 52 weeks

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

Secondary ID(s)

CQAX576A2209

NCT01355614

Source(s) of Monetary Support

Novartis Pharma Servives AG