Evaluation of Concomitant Infliximab and Granulocyte/ Monocyte Adsorption Apheresis in Crohn's disease Patients who lose Response to 5mg/kg/dose Infliximab Therapy

Phase 4

• Conditions: Crohn' s disease

• Registration Number: JPRN-UMIN000006889
• 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: 2013-07-01
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Not provided

Exclusion Criteria

(1) Cases that granulocyte count below 2000/mm3 (2) Cases that complication by infection present or suspected (3) Patients with severe heart disease (4) Patients with severe kidney disease (5) Patients with hypotension (Systolic blood pressure less than 80mmHg) (6) Patients willing or being pregnant (or lactation). (7) Patient with severe dehydration and/or hyper-viscosity. Patients with severe anemia (Hb <8g/dL) (8) Patients with malignant tumor (9) Patients with colostomy (10) Patients with uncontrollable external-fistulas. (11) Patients with intestinal stenosis. (12) Patients with severe extra-intestinal complications. (13) Patients with short bowel syndrome. (14) Patients after total colectomy. (15) Patients who have been treated with corticosteroids (iv, po, or topical) within 2 weeks. (16) Patients who have treated with intravenous hyperalimentation (IVH) within 4 weeks. (17) Patients who have been given more than 1,200kcal of elemental nutrition within 4 weeks. (18) Patients who have episode of starting or increasing dosage of thioprine within 8 weeks. (19) Patients who do not submit informed consent (20) Patients who have been treating with non-approval therapy and/or enrolling other clinical trials. (21) Other patients judged as inappropriate by the physician

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in CDAI at 24 weeks relative to the base-line

Secondary Outcome Measures

Name	Time	Method
(1) CDAI scores at each observation period (2) The CDAI 50 points improvement ratio (CR50) at each observation period (3) Remission (CDAI<150) induction rate at each observation period (4) Change in CDAI at each observation period relative to the base-line. (5) The CRP values at each observation period (6) Change in CRP and ESR at each observation period relative to the base-line. (7) Change in secretions of the various peripheral cytokine at each observation period relative to the base-line. (8) Endoscopic and/or barium enema evaluation comparing between pre- (-8 to 0 week) and post- (24 to 28 weeks) allocation (9) Incidence of adverse events etc.