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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: EUCTR
Last refreshed on: 19 March 2012
Main ID:  EUCTR2008-004926-18-DE
Date of registration: 30/10/2008
Prospective Registration: Yes
Primary sponsor: IBD Center LMU Munich
Public title: 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
Scientific title: 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
Date of first enrolment: 30/10/2008
Target sample size:
Recruitment status: Authorised-recruitment may be ongoing or finished
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2008-004926-18
Study type:  Interventional clinical trial of medicinal product
Study design:  Controlled: yes Randomised: yes Open: Single blind: no Double blind: yes Parallel group: no Cross over: no Other: If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: no  
Phase: 
Countries of recruitment
Germany
Contacts
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Key inclusion & exclusion criteria
Inclusion criteria:
• 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

Exclusion criteria:
• 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



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
Health Condition(s) or Problem(s) studied
Moderate to severe Crohn’s disease
Intervention(s)

Trade Name: Humira

Pharmaceutical Form: Solution for injection
Pharmaceutical form of the placebo: Intravenous infusion
Route of administration of the placebo: Intravenous use
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use

Trade Name: Remicade
Pharmaceutical Form: Powder for infusion*

Primary Outcome(s)
Main Objective: Aim of this study is to compare the human TNF-alpha antibody adalimumab with infliximab in respect to induction and maintenance of steroid-free remission in patients with moderate to severe Crohn’s disease
Primary end point(s): steroidfree remission after 10 weeks, defined as CDAI = 150 pts. and no steroids (oral or topical)
Secondary Objective:
Secondary Outcome(s)
Secondary ID(s)
00595
Source(s) of Monetary Support
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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