Efficacy of GMA in steroid naive patients with active ulcerative colitis. -a multicenter study

Not Applicable

Recruiting

• Conditions: lcerative colitis

• Registration Number: JPRN-UMIN000013702
• Lead Sponsor: Osaka Medical College Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-04-13
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

Not provided

Exclusion Criteria

1. Re-registered patients. 2. Patients whose granulocyte count below 2,000/mm3. 3. Patients with or suspected to have severe infection. 4. Patients with serious heart disease. 5. Patients with serious kidney disorder. 6. Patients with hypotension (mamimal blood pressure below 80mmHg). 7. Pregnant patients 8. Patients with serious dehydration, serious coagulation abnormality, or serious anemia (Hb below 8.0d/dL). 9. Patients with malignancy. 10. Patients who have artificial anus. 11. Patients who have undergone intestinal operation within 12 weeks. 12. Patients who have severe extraintestinal complications. 13. Patients who have received an initial dose or an increased dose of 5-ASA agents within 2 weeks before screening. 14. Patients who have received a dose of tacrolimus within 4 weeks before screening. 15. Patients who have received cytapheresis within 4 weeks before screening. 16. Patiens who have received an initial dose or an increased dose of immunomodulators within 8 weeks before screening. 17. Patients who are judged to be ineligible by an investigator.

Study & Design

• Study Type: Observational
• Study Design: Not specified