EUCTR2006-005299-42-FR
Active, not recruiting
Not Applicable
A randomized, multicenter open label study comparing cyclosporine with infliximab in steroid-refractory severe attacks of ulcerative colitis (CYSIF Study) - CYSIF
Conditions- Diagnosis of UC according to Lennard-Jones criteria - 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.- Refractoriness to high dose intravenous steroid therapy (= 0.8 mg/kg/d of methylprednisolone or equivalent) given for at least 5 days.MedDRA version: 9.1Level: LLTClassification code 10045282Term: UC
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- - Diagnosis of UC according to Lennard-Jones criteria - 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.- Refractoriness to high dose intravenous steroid therapy (= 0.8 mg/kg/d of methylprednisolone or equivalent) given for at least 5 days.
- Sponsor
- GETAID
- Enrollment
- 100
- Status
- Active, not recruiting
- Last Updated
- 14 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
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.
Outcomes
Primary Outcomes
Not specified
Similar Trials
Active, not recruiting
Not Applicable
A randomized, multicenter open label study comparing cyclosporine with infliximab in steroid-refractory severe attacks of ulcerative colitis (CYSIF Study) - CYSIFEUCTR2006-005299-42-BEGETAID100
Active, not recruiting
Not Applicable
A randomized, multicentre, open label study comparing cyclosporine with infliximab in steroid-refractory severe attacks of ulcerative colitisSatunnaistettu, avoin, vertaileva monikeskustutkimus siklosporiinista ja infliximabista kortikosteroidille reagoimattoman vaikean haavaisen paksusuolitulehduksen hoidossa. - CYSIF STUDYEUCTR2006-005299-42-FIGroupe d'Etude Thérapeutique des Affections Inflammatoires Digestives (G.E.T.A.I.D.)100
Active, not recruiting
Phase 1
Cabazitaxel versus Docetaxel both with Prednisone in Patients with Metastatic Castration Resistant Prostate CancerEUCTR2010-022064-12-SEsanofi-aventis R&D1,170
Active, not recruiting
Phase 1
Cabazitaxel versus Docetaxel both with Prednisone in Patients with Metastatic Castration Resistant Prostate Cancermetastatic Castration Resistant Prostate cancerMedDRA version: 14.1Level: PTClassification code 10060862Term: Prostate cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2010-022064-12-DEsanofi-aventis R&D1,170
Active, not recruiting
Phase 1
Cabazitaxel versus Docetaxel both with Prednisone in Patients with Metastatic Castration Resistant Prostate Cancermetastatic Castration Resistant Prostate cancerMedDRA version: 14.1Level: PTClassification code 10060862Term: Prostate cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2010-022064-12-PLsanofi-aventis R&D1,170