EUCTR2014-002311-41-DEActive, not recruitingPhase 1
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
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- GETAID
- Enrollment
- 300
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •Signed informed consent
- •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 3 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 (lower dose than standard dose is also allowed if 6 TGN > 235 pmol); 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.
- •Use of highly effective contraception (Pearl-Index < 1) to prevent pregnancy in women of childbearing potential.
- •Patients able to understand the information provided to them and to give written informed consent for the study
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 300
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
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
- •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
- •Patients, who are institutionalized by order of a court or a government agency
- •Patients, who are employees of the sponsor, the study site, or the study personnel or in any other way dependent from them
- •Risk of acute or latent tuberculosis
- •The risk has to be assessed by the investigator in accordance with the Summary of Product Characteristics (SmPC, Fachinformation”). The investigator has to make sure that the recommendations from the SmPC have been followed before the initiation of treatment with infliximab. Patients that cannot be enrolled include
- •oPatients with any clinical signs or diagnostic imaging suggestive of active tuberculosis.
- •oPatients with a history or diagnostic tests suggestive of latent tuberculosis
- •-Patients with a positive interferon-gamma release assay or Mendel-Mantoux test
- •-Patients with a Chest X-ray suggestive of a history of tuberculosis
- •-Patients with possible previous contact with tuberculosis, in whom active or untreated latent tuberculosis cannot be ruled out, or a personal history of tuberculosis
- •Patients with previous latent tuberculosis are not excluded if a treatment for latent tuberculosis had been started at least one month earlier and no new exposure to tuberculosis has occurred in the meantime.
- •Hypersensitivity to infliximab, to other murine proteins, or to any of the excipients included in Remicade®, Remsima® or Inflectra®
- •severe infections such as sepsis, abscesses, and opportunistic infections
- •moderate or severe heart failure (NYHA class III/IV)
Investigators
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