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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
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
Secondary ID [1] 0 0
GETAID 2014-03
Universal Trial Number (UTN)
Trial acronym
SPARE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Crohn's Disease 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Inflammatory bowel disease
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Oral and Gastrointestinal 0 0 0 0
Crohn's disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
co-primary efficacy end points
Timepoint [1] 0 0
2 ans
Secondary outcome [1] 0 0
relapse in each arm.
Timepoint [1] 0 0
2 years
Secondary outcome [2] 0 0
Sustained clinical remission
Timepoint [2] 0 0
2years
Secondary outcome [3] 0 0
Treatment failure
Timepoint [3] 0 0
2 years
Secondary outcome [4] 0 0
Tissue damage progression
Timepoint [4] 0 0
2 years
Secondary outcome [5] 0 0
Endoscopic remission
Timepoint [5] 0 0
2 years

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
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
9/10/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/10/2021
Sample size
Target
Accrual to date
Final
211
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
St Vincent Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
- Melbourne
Recruitment outside Australia
Country [1] 0 0
Belgium
State/province [1] 0 0
Province De Liège
Country [2] 0 0
Belgium
State/province [2] 0 0
Gent
Country [3] 0 0
France
State/province [3] 0 0
Auvergne Rhone Alpes
Country [4] 0 0
France
State/province [4] 0 0
Bourgogne-Franche-Comte
Country [5] 0 0
France
State/province [5] 0 0
Bretagne
Country [6] 0 0
France
State/province [6] 0 0
Centre Val De Loire
Country [7] 0 0
France
State/province [7] 0 0
Grand Est
Country [8] 0 0
France
State/province [8] 0 0
Hauts De France
Country [9] 0 0
France
State/province [9] 0 0
Ile De France
Country [10] 0 0
France
State/province [10] 0 0
Normandie
Country [11] 0 0
France
State/province [11] 0 0
Nouvelle-aquitaine
Country [12] 0 0
France
State/province [12] 0 0
Occitanie
Country [13] 0 0
France
State/province [13] 0 0
Pays De La Loire
Country [14] 0 0
France
State/province [14] 0 0
Provences Alpes Cote d'Azur
Country [15] 0 0
France
State/province [15] 0 0
Paris

Funding & Sponsors
Primary sponsor type
Other
Name
Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Saint-Louis Hospital, Paris, France
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

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
Trial website
https://clinicaltrials.gov/study/NCT02177071
Trial related presentations / publications
Hirten RP, Lakatos PL, Halfvarson J, Colombel JF. Reply. Clin Gastroenterol Hepatol. 2021 Jun;19(6):1301-1302. doi: 10.1016/j.cgh.2020.07.061. Epub 2020 Nov 26. No abstract available.
Public notes

Contacts
Principal investigator
Name 0 0
David Laharie
Address 0 0
Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT02177071