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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT02177071
Registration number
NCT02177071
Ethics application status
Date submitted
26/06/2014
Date registered
27/06/2014
Date last updated
3/08/2022
Titles & IDs
Public 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
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Scientific 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
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Secondary ID [1]
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GETAID 2014-03
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Universal Trial Number (UTN)
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Trial acronym
SPARE
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Crohn's Disease
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Condition category
Condition code
Oral and Gastrointestinal
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Inflammatory bowel disease
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Inflammatory and Immune System
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Other inflammatory or immune system disorders
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Oral and Gastrointestinal
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Crohn's disease
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - INFLIXIMAB
Treatment: Drugs - AZATHIOPRINE
Treatment: Drugs - MERCAPTOPURINE
Treatment: Drugs - Methotrexate
No Intervention: INFLIXIMAB AND ANTI METABOLITE - continuing scheduled infliximab treatment and anti-metabolite
Other: STOP INFLIXIMAB CONTINUING ANTI METABOLITE - discontinuing infliximab and continuing the anti-metabolite
Other: CONTINUING INFLIXIMAB AND discontinuing anti-metabolites - CONTINUING INFLIXIMAB AND DISCONTINUING ANTI METABOLITE
Treatment: Drugs: INFLIXIMAB
Treatment: Drugs: AZATHIOPRINE
Treatment: Drugs: MERCAPTOPURINE
Treatment: Drugs: Methotrexate
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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co-primary efficacy end points
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Assessment method [1]
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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.
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Timepoint [1]
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2 ans
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Secondary outcome [1]
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relapse in each arm.
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Assessment method [1]
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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.
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Timepoint [1]
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2 years
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Secondary outcome [2]
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Sustained clinical remission
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Assessment method [2]
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Sustained clinical remission defined by CDAI<150 without steroids over two years.
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Timepoint [2]
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2years
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Secondary outcome [3]
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Treatment failure
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Assessment method [3]
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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.
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Timepoint [3]
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2 years
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Secondary outcome [4]
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Tissue damage progression
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Assessment method [4]
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- Tissue damage progression will be assessed by the Lémann Score absolute and relative change between baseline and en of the study (2 years).
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Timepoint [4]
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2 years
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Secondary outcome [5]
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Endoscopic remission
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Assessment method [5]
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Endoscopic remission at the end of study
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Timepoint [5]
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2 years
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Eligibility
Key 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
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Minimum age
18
Years
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Maximum age
65
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 4
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
9/10/2015
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/10/2021
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Sample size
Target
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Accrual to date
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Final
211
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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St Vincent Hospital - Melbourne
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Recruitment postcode(s) [1]
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- Melbourne
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Recruitment outside Australia
Country [1]
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Belgium
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State/province [1]
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Province De Liège
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Country [2]
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Belgium
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State/province [2]
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Gent
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Country [3]
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France
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State/province [3]
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Auvergne Rhone Alpes
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Country [4]
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France
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State/province [4]
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Bourgogne-Franche-Comte
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Country [5]
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France
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State/province [5]
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Bretagne
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Country [6]
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France
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State/province [6]
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Centre Val De Loire
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Country [7]
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France
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State/province [7]
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Grand Est
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Country [8]
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France
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State/province [8]
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Hauts De France
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Country [9]
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France
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State/province [9]
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Ile De France
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Country [10]
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France
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State/province [10]
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Normandie
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Country [11]
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France
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State/province [11]
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Nouvelle-aquitaine
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Country [12]
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France
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State/province [12]
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Occitanie
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Country [13]
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France
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State/province [13]
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Pays De La Loire
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Country [14]
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France
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State/province [14]
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Provences Alpes Cote d'Azur
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Country [15]
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France
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State/province [15]
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Paris
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Funding & Sponsors
Primary sponsor type
Other
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Name
Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
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Address
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Other collaborator category [1]
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Other
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Name [1]
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Saint-Louis Hospital, Paris, France
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Address [1]
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Ethics approval
Ethics application status
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Summary
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
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02177071
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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David Laharie
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Address
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Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02177071
Download to PDF