Comparison of the human TNF-alpha antibody adalimumab with infliximab in induction and maintenance of steroid-free remission in patients with moderate to severe Crohn’s disease - CHAMP
- Conditions
- Moderate to severe Crohn’s disease
- Registration Number
- EUCTR2008-004926-18-DE
- Lead Sponsor
- IBD Center LMU Munich
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
•male and female patients with moderate to severe Crohn’s disease aged 18 to 65 years
•CDAI = 220 pts, = 450 pts
•written patient’s informed consent
•indication in accordance to the regulations for both medications
•prior or current medication: aminosalicylates (p.o., topical), azathioprine, 6-mercaptopurine, methotrexat, antibiotics, steroides (= 20 mg/day), budesonide (= 9 mg/day), topical steroides (foams, enema, suppository) in stable dose für at least 2 weeks prior inclusion
•in women: contraception
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) no
F.1.3.1 Number of subjects for this age range
•known hypersensitivity against one of the study medications or components
•participation in any other clinical study 12 weeks prior inclusion
•Sucht- oder sonstige Erkrankungen, die es dem Betreffenden nicht erlauben, Wesen und Tragweite sowie mögliche Folgen der klinischen Prüfung abzuschätzen
•Pregnant or lactating women
•Poor cooperation
•History of anti-TNF-a-therapy
•ulcerative colitis
•History of or active infectious disease (HIV, hepatitis B, hepatitis C, tuberculosis,listeriosis, positive clostridium-difficile-toxine in the stool)
•History of systemic lupus erythematodes
•History of demyelinating disease such as multiple sclerosis, optic neuritis)
•intraabdominal abscess
•severe kidney- or liver disease
•sever cardiac output failure
•History of malignoma
•History of bowel resection 6 month prior inclusion
•History of extensive bowel resection with more than >100 cm removed bowel
•Presence of a stoma
•History of ciclosporin- or tacrolimus-therapy 12 weeks prior inclusion
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method