Evaluation of Concomitant Adalimumab and Cytapheresis in Patients who lose Response to Adalimumab Therapy

Phase 4

• Conditions: Crohn' s disease

• Registration Number: JPRN-UMIN000006882
• Lead Sponsor: Department of Lower Gastroenterology, Hyogo College of Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-01-01
• Study Completion: 2014-01-01
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Not provided

Exclusion Criteria

(1) Cases that are contraindicated for GMA Granulocyte count below 2000/mm3 Complication by infection present or suspected (2) Patients with small intestine type Crohn's disease (no large bowel lesion) (3) Patients with colostomy (4) Patients younger than 15 (5) Patients who do not submit informed consent (6) Patients with malignant tumor (7) Patients within 3 months of post intestinal surgery (8) Patients with short bowel syndrome (9) Other patients judged as inappropriate by the physician

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Remission rate in week12 (remission:CDAI<150)

Secondary Outcome Measures

Name	Time	Method
Time course of CDAI during each observation period Time course of CRP during each observation period Mucosal healing rate at 12 weeks Incidence of adverse events etc.