AzTrials
AzTrials

Crohn DiseasePhase 3STORINCT00571337

Stop Infliximab in Patients With Crohn's Disease

A Phase 3 study testing Infliximab in people with Crohn Disease, run by Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives at 23 sites in 2 countries.

Completed

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

Official record
Search all trials

Trial summary

1 Project summary 1.1 Rational. Accent 1 study has demonstrated the superiority of Infliximab over placebo in a systematic treatment strategy of Crohn 's disease every 8 weeks during one year. However the optimal strategy beyond one year of treatment is not established. 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?
Infliximab
How many people
126 participants
Where
23 sitesin 2 countries
Study dates
Dec 2005to Jul 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

  • Crohn's disease.
  • Age > 18 years.
  • Patient written informed consent.
  • Patient having been treated with infliximab for confirmed Crohn's disease with active intestinal lesions.
  • Patient treated with infliximab for at least 1 year, associated with an immunosuppressor for at least one year, with a maximum interval between 2 infliximab infusions of 3 months.
  • Patient with continuous remission without steroids for at least 6 months, except IV steroids for infusion reaction prophylaxis.
  • CDAI<150.
  • Contraception all over the study.

Who cannot join

  • Patient having experienced an severe acute infusion reaction to infliximab, defined by an anaphylactoïd reaction (drop in blood pressure, bronchospasm, dyspnea) requiring the arrest of the infliximab infusion.
  • Patient having experienced a severe delayed infusion reaction to infliximab, defined by fever, arthralgia, myalgia, requiring a steroid treatment.
  • Patient with dominant perianal disease and absence of active intestinal disease at the time of infliximab induction.
  • Patient with active perianal disease at the time of inclusion.
  • Patient with stoma.
  • Patient with debilitating extra-intestinal manifestation at the time of inclusion.
  • Non cooperating subjects.
  • Pregnant or lactating women.

Trial locations and contacts

23 sites in 2 countries.

23 sites in 2 countries

France21 sites

  • Chu Amiens

    Amiens, 80054

  • Chu Besancon

    Besançon, 25030

  • Hopital Saint Andre

    Bordeaux, 33075

  • CHU CAEN

    Caen, 14033

  • Hopital Beaujon

    Clichy, 92110

  • Hopital Louis Mourier

    Colombes, 92700

  • Hopital Henri Mondor

    Créteil, 94010

  • CHRU Lille

    Lille

  • Chu Marseille - Hopital Nord

    Marseille, 13915

  • Ch Le Raincy Montfermeil

    Montfermeil, 93370

  • Chu Montpellier

    Montpellier, 34295

  • Chu Nantes

    Nantes, 44093

  • Hopital Lariboisiere

    Paris, 75010

  • Hopital Saint Louis

    Paris, 75010

  • Hopital Georges Pompidou

    Paris, 75015

  • Hopital Haut Leveque

    Pessac, 33604

  • CHU LYON

    Pierre-Bénite, 69495

  • Chu Rouen

    Rouen, 76031

  • Chu Strasbourg

    Strasbourg, 67091

  • Chu Toulouse

    Toulouse, 31403

  • Chu Tours

    Tours, 37044

Other trials in France

Belgium2 sites

  • Gent University Hospital

    Ghent, 9000

  • CHU LIEGE - Sart Tilman

    Liège, 4000

Other trials in Belgium

About this study

Official title: Prospective Study of Predictive Factors of Sustained Remission of Crohn's Disease After Stopping Infliximab

1 Project summary 1.1 Rational. Accent 1 study has demonstrated the superiority of Infliximab over placebo in a systematic treatment strategy of Crohn 's disease every 8 weeks during one year. However the optimal strategy beyond one year of treatment is not established. Particularly, the need for carrying on systematic treatment with infliximab in all the patients has not been demonstrated.

1.2 Primary objective. Determine factors associated with a low risk of clinical relapse after stopping infliximab in CD patients in remission (CDAI<150) and regularly treated with infliximab for at least one year.

Read more

1.3 Main objective and main judgement criteria. Determine predictive factors for relapse within one year after stopping infliximab. Main judgement criteria is the clinical relapse after stopping infliximab. Clinical relapse is defined either by a CDAI>250 or by a CDAI between 150 and 250 if this CDAI is confirmed over two consecutive weeks with an increase of at least 70 points over baseline for the two consecutive measures.

1.4 Secondary objectives and judgement criteria. Determine the time to-relapse Determine predictive factors for short-term relapse (<2 months)after stopping infliximab.

Determine response to infliximab retreatment in these patients. Determine tolerance to infliximab retreatment in these patients. Determine predictive factors for an absence of response to retreatment. Determine predictive factors for infliximab retreatment intolerance. Determine sustained response in the retreated patients.

1.5 Type of study Open-label prospective study of stopping regular treatment. Inclusion period: minimum one year, possibly prolonged to reach 100 patients. Patients will be followed up every two months for at least 18 months after stopping infliximab.

1.6 Justification of the number of patients Number of patients to include is at least 100. This recruitment should be reached within one year. This number should allow to disclose predictive factors associated with a relative risk of at least 2 if this factor is equilibrated (50% at risk patients) or 3 is this factor is disequilibrated (90% at risk patients).

Conditions
Crohn Disease
Being tested
Infliximab
Keywords
Stop infliximab.
Medical subject headings
Crohn Disease

What participants receive

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

  • InfliximabDrug

    Stopping infliximab in patients having been treated with this drug for at least one year and in stable remission for at least 6 month.

What is being measured

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

  1. Relapse of Crohn's disease assessed by a CDAI > 250 or a CDAI between 150 and 250 at two consecutive weeks, with an increase of at least 70 points over baseline.

    Measured: Time to relapse over one year

  2. Evaluation of demographic, clinical and endoscopic factors predictive of relapse of Crohn's disease after stopping infliximab, with univariate and multivariate analysis.

    Measured: Factors influencing time to relapse over one year.

Secondary outcomes (3)

  1. Tolerance and safety of infliximab retreatment in patients experiencing a relapse.

    Measured: Follow up over 4 months including 3 infliximab retreatment s.

  2. predictive factors of short term-relapse (<2 months) after stopping infliximab, in the follow up of the patients.

    Measured: at least 12 month and a maximum of 18 months.

  3. Clinical response to infliximab retreatment, assessed 4 weeks after retreatment using CDAI. A clinical response is defined by a 70 points drop (and at least 25%) as compared to relapse CDAI.

    Measured: 4 weeks

Timeline

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

  1. First posted12 Dec 2007 (estimated)
  2. Study startDec 2005
  3. Primary completionJul 2010
  4. Study completionJul 2010

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 3
Primary purpose
Treatment
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
126 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00571337
Sponsor's protocol ID
GETAID 2005-1
Acronym
STORI
Status last verified
Jul 2010
First submitted
25 Jul 2007
Last updated
23 Jul 2010
Results posted
No
Data monitoring committee
No

Publications

  • Vermeire S, Louis E, Carbonez A, Van Assche G, Noman M, Belaiche J, De Vos M, Van Gossum A, Pescatore P, Fiasse R, Pelckmans P, Reynaert H, D'Haens G, Rutgeerts P; Belgian Group of Infliximab Expanded Access Program in Crohn's Disease. Demographic and clinical parameters influencing the short-term outcome of anti-tumor necrosis factor (infliximab) treatment in Crohn's disease. Am J Gastroenterol. 2002 Sep;97(9):2357-63. doi: 10.1111/j.1572-0241.2002.05991.x.

    PubMed 12358256

  • Parsi MA, Achkar JP, Richardson S, Katz J, Hammel JP, Lashner BA, Brzezinski A. Predictors of response to infliximab in patients with Crohn's disease. Gastroenterology. 2002 Sep;123(3):707-13. doi: 10.1053/gast.2002.35390.

    PubMed 12198696

  • Farrell RJ, Alsahli M, Jeen YT, Falchuk KR, Peppercorn MA, Michetti P. Intravenous hydrocortisone premedication reduces antibodies to infliximab in Crohn's disease: a randomized controlled trial. Gastroenterology. 2003 Apr;124(4):917-24. doi: 10.1053/gast.2003.50145.

    PubMed 12671888

  • Baert F, Noman M, Vermeire S, Van Assche G, D' Haens G, Carbonez A, Rutgeerts P. Influence of immunogenicity on the long-term efficacy of infliximab in Crohn's disease. N Engl J Med. 2003 Feb 13;348(7):601-8. doi: 10.1056/NEJMoa020888.

    PubMed 12584368

  • Tampo Y, Yonaha M. Antioxidant mechanism of Mn(II) in phospholipid peroxidation. Free Radic Biol Med. 1992;13(2):115-20. doi: 10.1016/0891-5849(92)90072-o.

    PubMed 1516837

  • Parsi MA, Lashner BA. Safety of infliximab: primum non nocere. The safety profile of infliximab in patients with Crohn's disease: the Mayo Clinic experience in 500 patients. Inflamm Bowel Dis. 2004 Jul;10(4):486-7. doi: 10.1097/00054725-200407000-00028. No abstract available.

    PubMed 15475765

  • Keane J, Gershon S, Wise RP, Mirabile-Levens E, Kasznica J, Schwieterman WD, Siegel JN, Braun MM. Tuberculosis associated with infliximab, a tumor necrosis factor alpha-neutralizing agent. N Engl J Med. 2001 Oct 11;345(15):1098-104. doi: 10.1056/NEJMoa011110.

    PubMed 11596589

  • Pierre N, Huynh-Thu VA, Baiwir D, Mazzucchelli G, Fleron M, Trzpiot L, Eppe G, De Pauw E, Laharie D, Satsangi J, Bossuyt P, Vuitton L, Vieujean S, Colombel JF, Meuwis MA, Louis E; GETAID and the SPARE-Biocycle research group. External validation of serum biomarkers predicting short-term and mid/long-term relapse in patients with Crohn's disease stopping infliximab. Gut. 2024 Nov 11;73(12):1965-1973. doi: 10.1136/gutjnl-2024-332648.

    PubMed 39134391

  • Louis E, Mary JY, Vernier-Massouille G, Grimaud JC, Bouhnik Y, Laharie D, Dupas JL, Pillant H, Picon L, Veyrac M, Flamant M, Savoye G, Jian R, Devos M, Porcher R, Paintaud G, Piver E, Colombel JF, Lemann M; Groupe D'etudes Therapeutiques Des Affections Inflammatoires Digestives. Maintenance of remission among patients with Crohn's disease on antimetabolite therapy after infliximab therapy is stopped. Gastroenterology. 2012 Jan;142(1):63-70.e5; quiz e31. doi: 10.1053/j.gastro.2011.09.034. Epub 2011 Sep 22.

    PubMed 21945953

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Infliximab in people with Crohn Disease, run by Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives at 23 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 8 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 23 Jul 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 23 sites in France, Belgium. 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?

Relapse of Crohn's disease assessed by a CDAI > 250 or a CDAI between 150 and 250 at two consecutive weeks, with an increase of at least 70 points over baseline. (time frame: Time to relapse over one year). The study lists 2 primary outcomes in all. 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 NCT00571337, which also lists 9 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 23 Jul 2010.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in