Ulcerative colitis
Conditions
Interventions
Administration of Adalimumab 160 mg at baseline, 80 mg at 2 weeks and 40 mg every 2 weeks.
In addition to Adalimumab Therapy, co-treatment of GMA 3times a week up to 2 weeks
Sponsors
Sakura Medical Center,Toho university
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients with moderate to severe activity Moderate or severe patients with UC with steroid-dependent or steroid-refractory
Exclusion criteria
Exclusion criteria: Adalimumab contraindication 1)Patients with severe infection (Sepsis, etc) 2)Patients with active tuberculosis 3)Patients with history of hypersensitivity to any of the other ingredients of Adalimumab 4)Patients with demyelinating disease (Multiple sclerosis, etc) or with history of demyelinating disease 5)Patients with congestive heart failure GMA contraindication 1)Granulocyte count is equal to or less than 2000/ mm3 2)Serious infectious disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Partial Mayo score remission rate at week 8 | — |
Secondary
| Measure | Time frame |
|---|---|
| Partial Mayo score response rate, endoscopic remission at week 8 Partial Mayo score remission, response rate at week 2,4,6,52 Safety until week 52 | — |
Countries
Japan
Contacts
Public ContactKen Takeuchi
Sakura Medical center, Toho University Internal Medicine
Outcome results
None listed