Moderate to severe Crohn’s disease
Conditions
Interventions
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
Sponsors
IBD Center LMU Munich
Eligibility
Sex/Gender
All
Inclusion 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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;Secondary Objective: ;Primary end point(s): steroidfree remission after 10 weeks, defined as CDAI = 150 pts. and no steroids (oral or topical) | — |
Countries
Germany
Outcome results
None listed