Crohn DiseasePhase 3IMURELPOSTNCT00976690
Comparison Azathioprine to Mesalazine for the Prevention of Postoperative Recurrence in the Crohn Disease
A Phase 3 study testing Azathioprine OR Mesalazine in people with Crohn Disease, run by Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives at 14 sites in France.
Trial summary
To show the superiority of Azathioprine comparing Mesalazine in the prevention of postoperative recurrence in Crohn's Disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Crohn Disease
- What is being tested?
- Azathioprine OR Mesalazine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 83 participants
- Where
- 14 sitesFrance
- Study dates
- Oct 2002to Dec 2010
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- more than 18 years old
- Clinical remission at inclusion time (CDAI<150)
- Having ileocolonic or colon resection 21 days before inclusion
- Resection > 50cm or subtotal colectomy with ileorectal anastomosis
Who cannot join
- Intolerance to one of both study treatment
- Liver failure (TP<60%)
- Renal Failure (Creatinine < Lab results)
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
France14 sites
Chu Amiens
Amiens, 80054
Chu Besancon
Besançon, 25030
CHU CAEN
Caen, 14033
Hopital Beaujon
Clichy, 92110
Chru Lille
Lille, 59037
Hopital Lariboisiere
Paris, 75010
Hopital Saint Louis
Paris, 75010
Hopital St Antoine
Paris, 75012
Hopital Cochin
Paris, 75014
Hopital Haut Leveque
Pessac, 33604
Chu Reims
Reims, 51000
Chu Rennes
Rennes, 35033
Chu Toulouse
Toulouse, 31403
Chu Tours
Tours, 37044
About this study
Official title: A Multicentre Randomized Open Study Comparing Azathioprine to Mesalazine for the Prevention of Postoperative Recurrence in the Crohn Disease
To show the superiority of Azathioprine comparing Mesalazine in the prevention of postoperative recurrence in Crohn's Disease.
- Conditions
- Crohn Disease
- Being tested
- Azathioprine OR Mesalazine
- Keywords
- Crohn's Disease, Ileocolic resection, Endoscopic recurrence, Ileocolic or colon resection (>50cm)
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Azathioprine OR MesalazineDrug
Azathioprine : 2mg/kg/day Mesalazine : 4g/day
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Azathioprine : 2mg/kg/day Receives: Drug: Azathioprine OR Mesalazine |
| 2 | Active comparator | Mesalazine : 4g/day Receives: Drug: Azathioprine OR Mesalazine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinically and endoscopically recurrence at 12 and 24 months
Measured: 12 and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2009 (estimated)
- Study startOct 2002
- Primary completionOct 2010
- Study completionDec 2010
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
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marc LEMANN, MD,PhD, Principal investigator, Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00976690
- Sponsor's protocol ID
- GETAID 2001-1
- Acronym
- IMURELPOST
- Status last verified
- Aug 2011
- First submitted
- 11 Sep 2009
- Last updated
- 31 Aug 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre Randomized Open Study Comparing Azathioprine to Mesalazine for the Prevention of Postoperative Recurrence in the Crohn Disease
- ClinicalTrials.gov ID
- NCT00976690
- Acronym / sponsor ID
- IMURELPOST / GETAID 2001-1
- Conditions
- Crohn Disease
- Keywords
- Crohn's Disease, Ileocolic resection, Endoscopic recurrence, Ileocolic or colon resection (>50cm)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Groupe d'Etude Therapeutique des Affections Inflammatoires DigestivesUniversity, hospital or other
- Study start
- Oct 2002
- Primary completion
- Oct 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 14 Sep 2009 (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.
To show the superiority of Azathioprine comparing Mesalazine in the prevention of postoperative recurrence in Crohn's Disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: Azathioprine OR MesalazineAzathioprine : 2mg/kg/day |
| 2 | Active comparator | Drug: Azathioprine OR MesalazineMesalazine : 4g/day |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- more than 18 years old
- Clinical remission at inclusion time (CDAI<150)
- Having ileocolonic or colon resection 21 days before inclusion
- Resection > 50cm or subtotal colectomy with ileorectal anastomosis
Key exclusion criteria (3 listed)
- Intolerance to one of both study treatment
- Liver failure (TP<60%)
- Renal Failure (Creatinine < Lab results)
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 |
|---|---|---|
| Azathioprine OR MesalazineAzathioprine : 2mg/kg/day Mesalazine : 4g/day | Drug | 1, 2 |
Primary outcome
Clinically and endoscopically recurrence at 12 and 24 months
Time frame: 12 and 24 months
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 31 Aug 2011.
- Related InfoLink 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.
Marc LEMANN, MD,PhD principal investigator
Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Azathioprine OR Mesalazine in people with Crohn Disease, run by Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives at 14 sites in France.
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 3 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 31 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in France. 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?
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?
Clinically and endoscopically recurrence at 12 and 24 months (time frame: 12 and 24 months). 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 31 Aug 2011.