Estudio multicéntrico abierto randomizado que compara ciclosporina e infliximab para el tratamiento de la colitis ulcerosa grave corticorrefractaria.A randomized multicenter open label study comparing cyclosporine with infliximab in steroid-refractory severe attacks of ulcerative colitis - CYSIF

• Conditions: Brote grave de colitis ulcerosa (Severe flare of ulcerative colitis)

• Registration Number: EUCTR2006-005299-42-ES
• Lead Sponsor: GETECCU (Grupo Español para el estudio de la enfermedad de Crohn y la colitis ulcerosa)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-03-03
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

?Age > 18 years.
?Diagnosis of UC according to Lennard-Jones criteria (Appendix 1).
?Endoscopically demonstrated colorectal lesions localized above the anal margin and extending at least up to 15cm proximally.
?Severe acute flare of UC with a Lichtiger Index score > 10 (Appendix 2).
?Refractoriness to high dose intravenous steroid therapy (= 0.8 mg/kg/d of methylprednisolone or equivalent) given for at least 5 days.
?Adequate contraception for male or female subjects of childbearing potential, which will be continued throughout the study and at least 3 months after study termination.

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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

?Pregnant or breast-feeding woman.
?Previous treatment with cyclosporine or infliximab.
?Azathioprine or 6-mercaptopurine treatment initiated more than 4 weeks before inclusion.
?Indication for immediate surgery.
?History of colorectal dysplasia.
?Diagnosis of Crohn's disease.
?Positive stool tests for amoebiasis and/or positive bacteriological culture for Salmonella, Shigella, Yersinia and Campylobacter and/or presence of Clostridium difficile B toxin in the stools.
?Renal failure (creatininemia > upper limit of normal laboratory value).
?Uncontrolled high blood pressure.
?HIV, HBV viral infection (except the presence of positive anti-HBs antibodies) with serology not older than 3 months.
?Uncontrolled bacterial or active viral infection.
?Past medical history of malignant condition in the last 5 years (including leukaemia, lymphoma and myelodysplasia) except for baso-cellular cutaneous cancers.
?Past medical history of myocardial infarction or heart failure.
?Intradermal reaction to Tuberculin (Tubertest® 5 units) > 5mm.
?Active tuberculosis
?Untreated latent tuberculosis (see national recommendations. Appendix 3).
?Abnormal blood count with polynuclear neutrophils < 1,500 G/L or white cells < 3,000, or platelets < 100,000 G/L.
?Unexplained rise higher than 3 times the normal level for transaminases, alkaline phosphatases and/or higher than twice the normal level for bilirubin.
?Non-compliant subjects.
?Participation in another therapeutic study.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified