Crohn's DiseasePhase 2NCT01355614
A Phase II Efficacy Study in Fistulizing Crohn's Disease Patients
A Phase 2 study testing QAX576 and Infliximab in people with Crohn's Disease, run by Novartis Pharmaceuticals at 6 sites in 2 countries.
Trial summary
This study will assess the safety and efficacy of QAX576 if patients with fistulizing Crohn's disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Crohn's Disease
- What is being tested?
- QAX576 and Infliximab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 6 sitesin 2 countries
- Study dates
- Jun 2011to Mar 2013
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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-TNFα (tumour necrosis factor) antibody treatment)
- Patients should not suffer from any other health problems that may jeopardize their participation in the study.
Who cannot join
- Current or recent (within 30 days of enrollment, or 5 half-lives of the compound, whichever is longer) use of anti-TNFα 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-TNFα antibody treatment
- Intercurrent bacterial or viral (intestinal) infection (serologically or microbiologically confirmed)
- Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
6 sites in 2 countries.
6 sites in 2 countries
Germany5 sites
Novartis Investigative Site
Berlin, Germany, 12203
Novartis Investigative Site
Berlin, 13353
Novartis Investigative Site
Jena, 07740
Novartis Investigative Site
Kiel, Germany, 24105
Novartis Investigative Site
München, Germany, 93053
About this study
Official 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
This study will assess the safety and efficacy of QAX576 if patients with fistulizing Crohn's disease.
- Conditions
- Crohn's Disease
- Being tested
- QAX576, Infliximab
- Keywords
- Crohn's Disease, Fistula
- Medical subject headings
- Crohn Disease, Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QAX576Drug
InfliximabDrug
| Study group | Role | What they receive |
|---|---|---|
| QAX576 | Experimental | Not described Receives: Drug: QAX576 |
| Infliximab | Other | Not described Receives: Drug: Infliximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 52 weeks
Secondary outcomes (1)
Assessment of safety and tolerability of QAX576 in patients suffering from Crohn's disease as measured by lab assessments, ECG, physical exam etc
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2011 (estimated)
- Study startJun 2011
- Primary completionMar 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn's DiseaseStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01355614
- Sponsor's protocol ID
- CQAX576A2209
- Other IDs
- 2010-019973-13
- Status last verified
- Feb 2017
- First submitted
- 16 May 2011
- Last updated
- 23 Feb 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT01355614
- Acronym / sponsor ID
- CQAX576A2209
- Conditions
- Crohn's Disease
- Keywords
- Crohn's Disease, Fistula
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jun 2011
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 18 May 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will assess the safety and efficacy of QAX576 if patients with fistulizing Crohn's disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| QAX576 | Experimental | Drug: QAX576 |
| Infliximab | Other | Drug: Infliximab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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-TNFα (tumour necrosis factor) antibody treatment)
- Patients should not suffer from any other health problems that may jeopardize their participation in the study.
Key exclusion criteria (6 listed)
- Current or recent (within 30 days of enrollment, or 5 half-lives of the compound, whichever is longer) use of anti-TNFα 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-TNFα antibody treatment
- Intercurrent bacterial or viral (intestinal) infection (serologically or microbiologically confirmed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QAX576 | Drug | QAX576 |
| Infliximab | Drug | Infliximab |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2017.
- Results for CQAX576A2209 from the Novartis Results RepositoryLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing QAX576 and Infliximab in people with Crohn's Disease, run by Novartis Pharmaceuticals at 6 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Germany, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2017.