A randomized, multicenter open label study comparing cyclosporine with infliximab in steroid-refractory severe attacks of ulcerative colitis (CYSIF Study) - CYSIF

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2006-005299-42-FR

Enrollment

100

Registered

2007-03-06

Start date

2007-05-16

Completion date

Unknown

Last updated

2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Trade Name: REMICADE Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: INFLIXIMAB CAS Number: 170277313 Concentration unit: mg milligram(s) Concentration type: equal Co

Eligibility

Sex/Gender

All

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
Primary end point(s): • Percentage of patients with success, defined as: clinical response at D7 (Lichtiger Index score1) , without steroids. ;Main Objective: This randomized, open-label, multicenter trial aims to demonstrate that cyclosporine is more efficacious than infliximab to induce short-term response in steroid-refractory severe attacks of ulcerative colitis. PRIMARY END POINT •Percentage of patients with success, defined as: clinical response at D7 (Lichtiger Index score1) (Appendix 4), without steroids. ;Secondary Objective: - Percentage of patients in clinical response at D14, D28, D42 and D98 defined as Lichtiger Index score1. - Lichtiger Index score at D7, D14, D28, D42, D98. - Mayo Disease Activity Index score at D7, D14, D42. - Time to discharge. - Endoscopic response (using the subscore of the Mayo DAI) at D7, D42 and D98. - Colectomy rate at D98. - Steroid dosage at D7, D14, D28, D42, and D98 - Number of adverse events (see below) - CMV infection will be assessed at D7 and D98 After D98, patients will be followed up at least every 6 months until the end of the study to describe: - Relapse rate (during the follow-up, relapse will be defined as the need of a new course of UC treatment, including steroids, cyclosporine or infliximab) - Colectomy rate - Adverse events	—

Measure

Time frame

Primary end point(s): • Percentage of patients with success, defined as: clinical response at D7 (Lichtiger Index score1) , without steroids. ;Main Objective: This randomized, open-label, multicenter trial aims to demonstrate that cyclosporine is more efficacious than infliximab to induce short-term response in steroid-refractory severe attacks of ulcerative colitis. PRIMARY END POINT •Percentage of patients with success, defined as: clinical response at D7 (Lichtiger Index score1) (Appendix 4), without steroids. ;Secondary Objective: - Percentage of patients in clinical response at D14, D28, D42 and D98 defined as Lichtiger Index score1. - Lichtiger Index score at D7, D14, D28, D42, D98. - Mayo Disease Activity Index score at D7, D14, D42. - Time to discharge. - Endoscopic response (using the subscore of the Mayo DAI) at D7, D42 and D98. - Colectomy rate at D98. - Steroid dosage at D7, D14, D28, D42, and D98 - Number of adverse events (see below) - CMV infection will be assessed at D7 and D98 After D98, patients will be followed up at least every 6 months until the end of the study to describe: - Relapse rate (during the follow-up, relapse will be defined as the need of a new course of UC treatment, including steroids, cyclosporine or infliximab) - Colectomy rate - Adverse events

—

Countries

Belgium, Finland, France, Spain

Outcome results