Ulcerative Colitis
Conditions
Interventions
The patients assigned to the True arm, each receives one Adacolumn GMA session every 4 weeks for up to 48 weeks. The circuit line was covered securely by a curtain to blind both the physician and th
Sponsors
Department of Lower Gastroenterology, Hyogo College of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Gender and Age; Men and women age 12-75years and body-weight more than 39kg Disease activity; Quiescent UC (less than 4 points in the clinical activity index established Lichtiger ,et al.) who have finished their remission induction therapy consisted 10 weekly GMA sessions for 10 consecutive weeks within 4 weeks prior to start study.
Exclusion criteria
Exclusion criteria: Exclusion criteria included therapy with cyclosporine, tacrolimus earlier than 4 weeks prior to start study, infliximab earlier than 8 weeks prior to start study. Also, patients with having granulocytopenia (neutrophil count <2,000/micro-liter), serious heart or kidney disease, coagulation disorder, history of hypersensitivity to heparin or heparin-induced thrombocytopenia, hypotension (<90/65mmHg) or uncontrolled hypertension (>180/ 120mmHg, despite medical therapy; anemia lower than 9.0g/dl in hemoglobin, and women being or wishing pregnant, were excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint of the study is a non-relapsing ratio at 48 weeks, relapse is defined if a patient have to start PSL or increase the ongoing dosage, Clinical Activity Index (CAI) &#8805; 5. | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate mucosal UC activity, colonoscopy is done in all patients before and after remission induction therapy. Also, patients who achieve sustained remission at week 48 have colonoscopy at the end of study. | — |
Countries
Japan
Contacts
Public ContactKen Fukunaga
Hyogo College of Medicine Department of Lower Gastroenterology
Outcome results
None listed