Crohn'
Conditions
Interventions
Patients with Crohn'
s disease or ulcerative colitis Adalimumab administration subcutaneously for 52 weeks using the recommended dosing regimens.
Sponsors
Iwate Medical University Kochi Medical School Hospital Keio University School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients diagnosed with moderate to severe CD or moderate to severe UC (except proctitis type),and should meet the following criteria; CD : CDAI;220 or more UC : Mayo Score;6 or more 2. Of this study after having received enough explanation on participating, a document agreement by the free will of the patient person is provided after enough understanding. 3. Patients aged 15 or older (Need agreement for deputy for patients under 20 years old) 4. Patients with inadequate response to existing therapies
Exclusion criteria
Exclusion criteria: 1. Patients with history of following intestinal surgery. Patients who are scheduled for following surgery. CD : enterectomy within 12 weeks prior to enrollment pouch or stoma (except rectostomy) UC : subtotal colectomy with ileorectostomy or colectomy with ileoanal pouch, Kock pouch and ileostomy 2. Patients with history of adalimumab treatment 3. Patients who had not showed initial response to infliximab before and patients with secondary failure to infliximab 10 mg/kg 4. Patients with serious infections 5. Patients with active tuberculosis 6. Patients with a history of hypersensitivity toadalimumab 7. Patients with demyelinating disease (Multiple sclerosis, etc) or with history of demyelinating disease 8. Patients with congestive heart failure 9. Patients who is determined inappropriate to participate to this study by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| -Correlation between biomarkers and disease activity/endoscopic findings | — |
Secondary
| Measure | Time frame |
|---|---|
| - Change of biomarkers (LRG, fCal, CRP) and disease activity - Correlations between several biomarkers. - Cutoff value, sensitivity and specificity of biomarkers in the stage of disease activity (remission)/endscopic findings(healing) - Usefulness of biomarkers for predicting prognosis of IBD - Effects on adalimumab concentration and anti-drug antibody titer for disease activity/endoscopic findings and biomarker. | — |
Countries
Japan
Contacts
Public ContactYukimi Kokubun
RPM Co., Ltd. Clinical Development Div.
Outcome results
None listed