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)
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|ClinicalTrials.gov Identifier: NCT02177071|
Recruitment Status : Active, not recruiting
First Posted : June 27, 2014
Last Update Posted : March 9, 2020
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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||211 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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
CONTINUING INFLIXIMAB AND discontinuing anti-metabolites
CONTINUING INFLIXIMAB AND DISCONTINUING ANTI METABOLITE
- 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.
- 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.
- Sustained clinical remission [ Time Frame: 2years ]Sustained clinical remission defined by CDAI<150 without steroids over two years.
- 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.
- 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).
- Endoscopic remission [ Time Frame: 2 years ]Endoscopic remission at the end of study
- disability index [ Time Frame: 2 YEARS ]disability index
- adverse events and SAE [ Time Frame: 2 YEARS ]adverse events and SAE, events related to re-infusions,
- BIOLOGICS [ Time Frame: 2 YEARS ]trough levels of infliximab, ATI , hsCRP, fecal calprotectin
- SCORES AND COST [ Time Frame: 2 YEARS ]direct medical costs, work productivity and activity index, short IBDQ
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
|Principal Investigator:||Benjamin PARIENTE, doctor||Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives|