An open label randomized controlled trial of combination therapy of Adalimumab and GMA for intractable ulcerative colitis
Not Applicable
- Conditions
- lcerative colitis
- Registration Number
- JPRN-UMIN000019066
- Lead Sponsor
- Sakura Medical Center,Toho university
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 58
Inclusion Criteria
Not provided
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Partial Mayo score remission rate at week 8
- Secondary Outcome Measures
Name Time Method 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