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A proSpective Randomized Controlled Trial comParing infliximAb-antimetabolites Combination Therapy to Anti-metabolites monotheRapy and Infliximab monothErapy in Crohn's Disease Patients in Sustained Steroid-free Remission on Combination Therapy (SPARE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02177071
Recruitment Status : Active, not recruiting
First Posted : June 27, 2014
Last Update Posted : March 9, 2020
Sponsor:
Collaborator:
Saint-Louis Hospital, Paris, France
Information provided by (Responsible Party):
Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

Brief Summary:

Phase IV

Design : Prospective, open-label, randomized three-arms study

Main Inclusion criteria Luminal Crohn's disease patients with steroid free remission for at least 6 months and a combination therapy with infliximab and anti-metabolites for at least 8 months

Primary objective To demonstrate that Infliximab scheduled maintenance with or without antimetabolites is superior to antimetabolites alone to maintain sustained steroid-free remission over 2 years, while the latter is non inferior with regards to the mean time spent in remission over the same duration

Main co-primary end points Clinical relapse rate at 2 years Mean remission duration within 2 years Study treatment Infliximab, Mercaptopurine, azathioprine, methotrexate.

Number of subjects 225 randomized patients (75 per arm)

Study duration: 3 + 2 years Enrollment: 3 years Follow-up: 2 years


Condition or disease Intervention/treatment Phase
Crohn's Disease Drug: INFLIXIMAB Drug: AZATHIOPRINE Drug: MERCAPTOPURINE Drug: Methotrexate Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 211 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A proSpective Randomized Controlled Trial comParing infliximAb-antimetabolites Combination Therapy to Anti-metabolites monotheRapy and Infliximab monothErapy in Crohn's Disease Patients in Sustained Steroid-free Remission on Combination Therapy
Actual Study Start Date : October 9, 2015
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : September 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease
Drug Information available for: Infliximab

Arm Intervention/treatment
No Intervention: INFLIXIMAB AND ANTI METABOLITE
continuing scheduled infliximab treatment and anti-metabolite
STOP INFLIXIMAB CONTINUING ANTI METABOLITE
discontinuing infliximab and continuing the anti-metabolite
Drug: INFLIXIMAB
CONTINUING INFLIXIMAB AND discontinuing anti-metabolites
CONTINUING INFLIXIMAB AND DISCONTINUING ANTI METABOLITE
Drug: AZATHIOPRINE
Drug: MERCAPTOPURINE
Drug: Methotrexate



Primary Outcome Measures :
  1. co-primary efficacy end points [ Time Frame: 2 ans ]

    There will be two co-primary efficacy end points

    Relapse rate at 2 years, relapse being defined by either one of the following events:

    • A CDAI>250 at any visit or between 150 and 250 with an increase of at least 70 points, over two consecutive visits one week apart associated with a CRP > 5 mg/l or a fecal calprotectin > 250 microg/g
    • A new opening fistula, perianal or entero-cutaneous.
    • An intra-abdominal abcess (size of at least 3 cm) or perianal abcess (size of at least 2 cm)
    • An episode of intestinal obstruction due to Crohn's lesions confirmed by medical imaging and requiring hospitalisation (also considered as treatment failure, see below)

    Mean restricted time spent in remission This time will be computed in all patients, from baseline (CDAI <150 and with absence of fistula drainage) until relapse, as defined above, within the 2 first years. First and subsequent remissions will be summed up within the two first years.



Secondary Outcome Measures :
  1. relapse in each arm. [ Time Frame: 2 years ]
    • Time to relapse in each arm.
    • Factors associated with time to relapse.
    • Time to relapse according to CRP and calprotectin value measured every 2 months over the follow up.

  2. Sustained clinical remission [ Time Frame: 2years ]
    Sustained clinical remission defined by CDAI<150 without steroids over two years.

  3. Treatment failure [ Time Frame: 2 years ]
    • Treatment failure rate. Treatment failure is defined by not achieving remission after treatment adaptation following a relapse according to protocol (CDAI<150 or, in case of relapse defined by the occurence of a new fistula, the absence of fistula closure). The occurence of an intra-abdominal or peri-anal abcess and the occurence of an intestinal obstruction due to Crohn's lesions and requiring a surgical resection or an endoscopic dilatation are also directly considered as treatment failure and will not be managed by treatment adaptation according to protocol.
    • Time to treatment failure.

  4. Tissue damage progression [ Time Frame: 2 years ]
    - Tissue damage progression will be assessed by the Lémann Score absolute and relative change between baseline and en of the study (2 years).

  5. Endoscopic remission [ Time Frame: 2 years ]
    Endoscopic remission at the end of study


Other Outcome Measures:
  1. disability index [ Time Frame: 2 YEARS ]
    disability index

  2. adverse events and SAE [ Time Frame: 2 YEARS ]
    adverse events and SAE, events related to re-infusions,

  3. BIOLOGICS [ Time Frame: 2 YEARS ]
    trough levels of infliximab, ATI , hsCRP, fecal calprotectin

  4. SCORES AND COST [ Time Frame: 2 YEARS ]
    direct medical costs, work productivity and activity index, short IBDQ



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of Crohn's disease.
  • Male or female, age > 18 years.
  • Currently treated with a combination therapy with infliximab and anti-metabolites for luminal Crohn's disease.
  • Combined therapy with scheduled infliximab and anti-metabolites for at least 8 months.
  • Scheduled administration of infliximab 5 mg/Kg every 8 weeks over the last 4 months.
  • Antimetabolites administered at a stable dosage for the last 3 months: at least 1 mg/Kg or 2 mg/Kg for mercaptopurine and azathioprine, respectively, or the highest tolerated dosage if intolerance to standard dose; at least 15 mg/week subcutaneously for methotrexate.
  • Patients in steroid free clinical remission for at least 6 months according to retrospective assessment of the patients' files.
  • CDAI < 150 at baseline.
  • A contraceptive during the whole study for childbearing potential female patients.
  • Patients able to understand the information provided to them and to give written informed consent for the study

Exclusion Criteria:

  • Patients who have presented a severe acute or delayed reaction to infliximab.
  • Perianal fistulae as the main indication for infliximab treatment
  • Active perianal/abdominal fistulae at time of inclusion, defined by active drainage
  • Patients with ostomy or ileoanal pouch
  • Pregnancy or planned pregnancy during the study
  • Inability to follow study procedures as judged by the investigator
  • Non-compliant subjects.
  • Participation in another therapeutic study
  • Steroid use ≤6 months prior to screening
  • Currently receiving steroids, immunosuppressive agents (other than purine, methotrexate), biologic treatment (other than infliximab) or thalidomide

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02177071


Locations
Show Show 27 study locations
Sponsors and Collaborators
Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
Saint-Louis Hospital, Paris, France
Investigators
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Principal Investigator: Benjamin PARIENTE, doctor Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
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Responsible Party: Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
ClinicalTrials.gov Identifier: NCT02177071    
Other Study ID Numbers: GETAID 2014-03
First Posted: June 27, 2014    Key Record Dates
Last Update Posted: March 9, 2020
Last Verified: December 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives:
CROHN DISEASE
INFLIXIMAB
COMBINATION THERAPY
steroid free remission
anti-metabolites
Additional relevant MeSH terms:
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Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Methotrexate
Mercaptopurine
Azathioprine
Infliximab
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors
Gastrointestinal Agents