Crohn DiseasePhase 3NCT01559142
Efficacy and Safety of Two Regimens of Maintenance Therapy in Children With Crohn Disease
A Phase 3 study testing Infliximab with azathioprine (IIFX + AZA) and Infliximab (IFX alone) in people with Crohn Disease, run by Children's Memorial Health Institute, Poland at 1 site in Poland.
Trial summary
The aim of the study is confirmation of efficacy of induction therapy with three doses of infliximab In patients with Crohn disease aged 7-17 years, and comparison of efficacy and safety of two regiment of maintenance therapy: 1. Infliximab with immunomodulation 2. Infliximab alone Read more about this study
- Who is it for?
- Ages 7 to 17 years
- Conditions the study is for
- Crohn Disease
- What is being tested?
- Infliximab with azathioprine (IIFX + AZA) and Infliximab (IFX alone)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 sitePoland
- Study dates
- Nov 2008to Dec 2012
- Phase
- Phase 3
- 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 7 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients with severe Crohn disease (PCDAI in anamnesis more than 51 points), with PCDAI currently over 30 points, with no or loss of response for previous therapy (except biological agents). Patients may have active fistulas.
- Efficient methods of contraception in patients of childbearing potential during study period and six months after.
- Patients will be enrolled to Part B of the study whether they finish Part A with clinical remission or clinical response.
Who cannot join
- Hypersensitivity to infliximab
- Pregnancy and breastfeeding
- Active tuberculosis or other severe infection: sepsis, opportunistic infections, active CMV, yersinia pseudotuberculosis, pneumocystis carini, atypical mycobacteriosis
- VZV infection, hepatitis, pneumonia during 3 months before Day 0 of the study
- pancytopaenia and aplastic anemia
- moderate and severe heart insufficiency (NYHA class III/IV), or unstable coronary heart disease
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- chronic pulmonary insufficiency, chronic renal insufficiency, chronic liver insufficiency
- HIV infection
- Presence of severe diseases of nervous system or severe endocrinological, hematological, psychiatric diseases.
- Demyelinisation syndrome or symptoms resembling Demyelinisation syndrome
- Malignancy or premalignant conditions during 5 years before Day 0 of the study.
- Severe infection currently present
- Malignancy currently present
Trial locations and contacts
1 site in 1 country.
Poland1 site
Department of Gastroenterology, Hepatology and Feeding Disorders
Warsaw, 04-730
About this study
Official title: Efficacy and Safety of Induction Therapy With Three Doses of Infliximab in Patients With Crohn Disease Aged 7-17 Years-multicenter Open Study. Efficacy and Safety of Two Regimens of Maintenance Therapy in Patients With Crohn Disease Aged 7-17 Years-multicenter Randomized Study
The aim of the study is confirmation of efficacy of induction therapy with three doses of infliximab In patients with Crohn disease aged 7-17 years, and comparison of efficacy and safety of two regiment of maintenance therapy:
- Infliximab with immunomodulation
- Infliximab alone
Read the detailed description
Study project Screening (Days -14 do 0): Laboratory and endoscopic (up to three months before Day 0) results will be obtained to check with inclusion/exclusion criteria.
Part A (Days 1 to 71): Induction therapy with 3 doses of infliximab 5 mg/kg will be applied on days 1 - 15 - 43. Simultaneously in patients receiving steroids, steroid tapering will be performed up to 71 Day. At Day 71 clinical (PCDAI) and endoscopic assessment will be done. Patients with no clinical response will be qualified to Follow-up surveillance group. Patients with clinical response present will be randomized to two groups of maintenance therapy:
- Infliximab with immunomodulation 2. Infliximab alone
Part B (Weeks 10 - 54): Patient with both groups will have scheduled visits at Weeks 14, 22, 30, 38, 46. Infliximab infusions and laboratory tests will be performed at each visit. At Week 54 clinical (PCDAI) and endoscopic assessment will be done.
Follow Up: 4 weeks after last visit - SAE monitoring Aim of the study
The aim of the study is confirmation of efficacy of induction therapy with three doses of infliximab In patients with Crohn disease aged 7-17 years, and comparison of efficacy and safety of two regiment of maintenance therapy:
- Infliximab with immunomodulation
- Infliximab alone Drug dosing in therapy regimens. Infliximab: 5 mg/kg mc In intravenous infusion lasting over 2 hrs. Azathioprine: 1,5 - 3 mg/kg/24h Methotrexate: 10 - 25 mg/week Safety assessment AE and SAE monitoring will be conducted during whole period of the study Efficacy assessment Primary endpoint Part A:
- Clinical response defined as: Decrease of PCDAI ≥ 15 points AND PCDAI less than 30 points
- Remission defined as: PCDAI ≤ 10 points Part B:
- Loss of clinical response defined as: Increase of PCDAI more than 15 points OR PCDAI > 30 points Secondary endpoints Part A:
- Time to steroid cessation Part B:
- Necessity to increase/change maintenance therapy with
- Surgery
- Increase of infliximab dose
- Increase of immunomodulator dose
- Steroids induction Statistical methods
- ITT analysis
- Primary endpoints: chi2 tests, Kaplan-Meier analysis
- Secondary endpoints: chi2 tests, Kaplan-Meier analysis, U Mann-Whitney analysis
- Conditions
- Crohn Disease
- Being tested
- Infliximab with azathioprine (IIFX + AZA), Infliximab (IFX alone)
- Keywords
- Crohn Disease, infliximab, azathioprine
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Infliximab with azathioprine (IIFX + AZA)Drug
Infliximab with azathioprine during whole one year study
Infliximab (IFX alone)Drug
Infliximab continuously; azathioprine stopped in 26 week
| Study group | Role | What they receive |
|---|---|---|
| IFX TG | Active comparator | Not described Receives: Drug: Infliximab with azathioprine (IIFX + AZA) |
| IFX alone | Active comparator | Not described Receives: Drug: Infliximab (IFX alone) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical disease activity
Measured: 14 week and one year
Secondary outcomes (1)
endoscopic disease activity
Measured: 14 week and one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2012 (estimated)
- Study startNov 2008
- Primary completionApr 2012 (estimated)
- Study completionDec 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn DiseaseStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Memorial Health Institute, Poland
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, JAROSLAW KIERKUS, Children's Memorial Health Institute, Poland
- Investigators
- Jaroslaw Kierkus, MD PhD, Principal investigator, The Children's Memorial Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01559142
- Sponsor's protocol ID
- IP CZD 2008-01-14
- Status last verified
- Apr 2012
- First submitted
- 19 Mar 2012
- Last updated
- 4 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Induction Therapy With Three Doses of Infliximab in Patients With Crohn Disease Aged 7-17 Years-multicenter Open Study. Efficacy and Safety of Two Regimens of Maintenance Therapy in Patients With Crohn Disease Aged 7-17 Years-multicenter Randomized Study
- ClinicalTrials.gov ID
- NCT01559142
- Acronym / sponsor ID
- IP CZD 2008-01-14
- Conditions
- Crohn Disease
- Keywords
- Crohn Disease, infliximab, azathioprine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Children's Memorial Health Institute, PolandUniversity, hospital or other
- Study start
- Nov 2008
- Primary completion
- Apr 2012 (estimated)
- Study completion
- Dec 2012 (estimated)
- First posted
- 21 Mar 2012 (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.
The aim of the study is confirmation of efficacy of induction therapy with three doses of infliximab In patients with Crohn disease aged 7-17 years, and comparison of efficacy and safety of two regiment of maintenance therapy:
- Infliximab with immunomodulation
- Infliximab alone
Detailed description
Study project Screening (Days -14 do 0): Laboratory and endoscopic (up to three months before Day 0) results will be obtained to check with inclusion/exclusion criteria.
Part A (Days 1 to 71): Induction therapy with 3 doses of infliximab 5 mg/kg will be applied on days 1 - 15 - 43. Simultaneously in patients receiving steroids, steroid tapering will be performed up to 71 Day. At Day 71 clinical (PCDAI) and endoscopic assessment will be done. Patients with no clinical response will be qualified to Follow-up surveillance group. Patients with clinical response present will be randomized to two groups of maintenance therapy:
- Infliximab with immunomodulation 2. Infliximab alone
Part B (Weeks 10 - 54): Patient with both groups will have scheduled visits at Weeks 14, 22, 30, 38, 46. Infliximab infusions and laboratory tests will be performed at each visit. At Week 54 clinical (PCDAI) and endoscopic assessment will be done.
Follow Up: 4 weeks after last visit - SAE monitoring Aim of the study
The aim of the study is confirmation of efficacy of induction therapy with three doses of infliximab In patients with Crohn disease aged 7-17 years, and comparison of efficacy and safety of two regiment of maintenance therapy:
- Infliximab with immunomodulation
- Infliximab alone Drug dosing in therapy regimens. Infliximab: 5 mg/kg mc In intravenous infusion lasting over 2 hrs. Azathioprine: 1,5 - 3 mg/kg/24h Methotrexate: 10 - 25 mg/week Safety assessment AE and SAE monitoring will be conducted during whole period of the study Efficacy assessment Primary endpoint Part A:
- Clinical response defined as: Decrease of PCDAI ≥ 15 points AND PCDAI less than 30 points
- Remission defined as: PCDAI ≤ 10 points Part B:
- Loss of clinical response defined as: Increase of PCDAI more than 15 points OR PCDAI > 30 points Secondary endpoints Part A:
- Time to steroid cessation Part B:
- Necessity to increase/change maintenance therapy with
- Surgery
- Increase of infliximab dose
- Increase of immunomodulator dose
- Steroids induction Statistical methods
- ITT analysis
- Primary endpoints: chi2 tests, Kaplan-Meier analysis
- Secondary endpoints: chi2 tests, Kaplan-Meier analysis, U Mann-Whitney analysis
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IFX TG | Active comparator | Drug: Infliximab with azathioprine (IIFX + AZA) |
| IFX alone | Active comparator | Drug: Infliximab (IFX alone) |
Who may qualify
- Ages
- 7 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Patients with severe Crohn disease (PCDAI in anamnesis more than 51 points), with PCDAI currently over 30 points, with no or loss of response for previous therapy (except biological agents). Patients may have active fistulas.
- Efficient methods of contraception in patients of childbearing potential during study period and six months after.
- Patients will be enrolled to Part B of the study whether they finish Part A with clinical remission or clinical response.
Key exclusion criteria (13 listed)
- Hypersensitivity to infliximab
- Pregnancy and breastfeeding
- Active tuberculosis or other severe infection: sepsis, opportunistic infections, active CMV, yersinia pseudotuberculosis, pneumocystis carini, atypical mycobacteriosis
- VZV infection, hepatitis, pneumonia during 3 months before Day 0 of the study
- pancytopaenia and aplastic anemia
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 |
|---|---|---|
| Infliximab with azathioprine (IIFX + AZA)Infliximab with azathioprine during whole one year study | Drug | IFX TG |
| Infliximab (IFX alone)Infliximab continuously; azathioprine stopped in 26 week | Drug | IFX alone |
Primary outcome
Clinical disease activity
Time frame: 14 week and one year
1 secondary outcome
endoscopic disease activity
Time frame: 14 week and one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2012.
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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.
Jaroslaw Kierkus, MD PhD principal investigator
The Children's Memorial Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Infliximab with azathioprine (IIFX + AZA) and Infliximab (IFX alone) in people with Crohn Disease, run by Children's Memorial Health Institute, Poland at 1 site in Poland.
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 3 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 4 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Clinical disease activity (time frame: 14 week and one year). 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 4 Apr 2012.