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Crohn's DiseasePhase 4RAPIDNCT00546546

Early Immunosuppressants in Crohn's Disease

A Phase 4 study testing early immunosuppressants (azathioprine, methotrexate) in people with Crohn's Disease, run by Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives at 26 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Pluricentric randomized study comparing two therapeutic strategies at beginning of Crohn's disease: early immunosuppressants (prescription within the six first months following diagnosis) vs. 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?
early immunosuppressants (azathioprine, methotrexate)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
26 sitesFrance
Study dates
Jul 2005to Jun 2013
Phase
Phase 4
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

  • > 18 yr old
  • diagnosis of Crohn's disease
  • intestinal lesions demonstrated during the last 6 months
  • disease duration < 6 months
  • patients at high risk of disabling disease (having 2 criteria out of the 3 following: age < 40, perinanal disease, steroid for the first flare)

Who cannot join

  • prior prescription of immunosuppressants
  • severe course requiring early immunosuppressants (steroid resistance, xtensive disease, disabling perianal disease)
  • intestinal resection
  • active infectious disease including HIV
  • hepatic failure
  • renal failure
  • pregnancy
  • high probability of poor compliance

Trial locations and contacts

26 sites in 1 country.

26 sites in 1 country

France26 sites

  • Chu Amiens

    Amiens, 80054

  • Chu Besancon

    Besançon, 25030

  • CHU CAEN

    Caen, 14033

  • Chu Clermont-Ferrand

    Clermont-Ferrand, 63003

  • Hopital Beaujon

    Clichy, 92110

  • Hopital Louis Mourrier

    Colombes, 92700

  • Hopital Bicetre

    Le Kremlin-Bicêtre, 94275

  • Chru Lille

    Lille, 59037

  • Chu Marseille - Hopital Nord

    Marseille, 13915

  • Ch Le Raincy Montfermeil

    Montfermeil, 93370

  • Chu Nantes

    Nantes, 44093

  • CHU NICE

    Nice, 06202

  • Hopital Lariboisiere

    Paris, 75010

  • Hopital Saint Louis

    Paris, 75010

  • Hopital St Antoine

    Paris, 75012

  • Hopital Cochin

    Paris, 75014

  • Hopital Georges Pompidou

    Paris, 75015

  • Hopital Bichat

    Paris, 75018

  • Institut Mutualiste Montsouris (Imm)

    Paris, 75674

  • Hopital Haut Leveque

    Pessac, 33604

  • CHU LYON

    Pierre-Bénite, 69495

  • Chu Reims

    Reims, 51092

  • Chu Rouen

    Rouen, 76031

  • Chu Strasbourg

    Strasbourg, 67091

  • Chu Toulouse

    Toulouse, 31403

  • Chu Tours

    Tours, 37044

Other trials in France

About this study

Official title: Effect of Early Prescription of Immunosuppressants on First Three-year Course of Crohn's Disease

Pluricentric randomized study comparing two therapeutic strategies at beginning of Crohn's disease: early immunosuppressants (prescription within the six first months following diagnosis) vs. conventional strategy (immunosuppressants given only in case of steroid failure, in a selected group of patients being at high risk of disabling course. The hypothesis is that immunosuppressants given early may improve the disease course during the 3 following years in this subset of patients.

Conditions
Crohn's Disease
Being tested
early immunosuppressants (azathioprine, methotrexate)
Keywords
Crohn, immunosuppressants, natural history, steroids
Medical subject headings
Crohn Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • early immunosuppressants (azathioprine, methotrexate)Drug

    Also called Azathioprine = brand name = Imurel

    azathioprine 2.5 mg/kg/day SC methotrexate 25 mg/week if aza not tolerated

Study groups in NCT00546546
Study groupRoleWhat they receive
control = conventional treatmentNo interventionconventional treatment: use of immunosuppressants only if steroid dependency or chronic active disease
Immunossuppresive treatmentExperimentalSwitch to different immunosuppresive treatment in case of relapse.
Receives: Drug: early immunosuppressants (azathioprine, methotrexate)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. number of 3-months periods with remission

    Measured: 3 yrs

Secondary outcomes (2)

  1. 3-yr cumulative steroid dose

    Measured: 3 years

  2. quality of life questionnaire

    Measured: 3 yrs

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Oct 2007 (estimated)
  2. Study startJul 2005
  3. Primary completionDec 2012
  4. Study completionJun 2013

Resources

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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
120 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00546546
Sponsor's protocol ID
GETAID 2004-2
Acronym
RAPID
Status last verified
Aug 2011
First submitted
18 Oct 2007
Last updated
28 Apr 2015
Results posted
No
Data monitoring committee
No

Publications

  • Beaugerie L, Seksik P, Nion-Larmurier I, Gendre JP, Cosnes J. Predictors of Crohn's disease. Gastroenterology. 2006 Mar;130(3):650-6. doi: 10.1053/j.gastro.2005.12.019.

    PubMed 16530505

  • Cosnes J, Nion-Larmurier I, Beaugerie L, Afchain P, Tiret E, Gendre JP. Impact of the increasing use of immunosuppressants in Crohn's disease on the need for intestinal surgery. Gut. 2005 Feb;54(2):237-41. doi: 10.1136/gut.2004.045294.

    PubMed 15647188

  • Cosnes J, Bourrier A, Laharie D, Nahon S, Bouhnik Y, Carbonnel F, Allez M, Dupas JL, Reimund JM, Savoye G, Jouet P, Moreau J, Mary JY, Colombel JF; Groupe d'Etude Therapeutique des Affections Inflammatoires du Tube Digestif (GETAID). Early administration of azathioprine vs conventional management of Crohn's Disease: a randomized controlled trial. Gastroenterology. 2013 Oct;145(4):758-65.e2; quiz e14-5. doi: 10.1053/j.gastro.2013.04.048. Epub 2013 Apr 30.

    PubMed 23644079

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing early immunosuppressants (azathioprine, methotrexate) in people with Crohn's Disease, run by Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives at 26 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 5 inclusion and 8 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 28 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 26 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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?

number of 3-months periods with remission (time frame: 3 yrs). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00546546, which also lists 3 linked publications.

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 28 Apr 2015.

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