GMA (Granulocyte and Monocyte Adsorption) early combined with azathioprine vs Infliximab plus azathioprine for induction of remission in active Crohn's disease : an open randomized trial

• Register: JPRN
• Last refreshed on: 17 October 2023
• Main ID: JPRN-UMIN000005689
• Date of registration: 31/05/2011
• Prospective Registration: Yes
• Primary sponsor: Department of Gastroenterology and Hepatology, Kyoto University Hospital
• Public title: GMA (Granulocyte and Monocyte Adsorption) early combined with azathioprine vs Infliximab plus azathioprine for induction of remission in active Crohn's disease : an open randomized trial
• Scientific title: GMA (Granulocyte and Monocyte Adsorption) early combined with azathioprine vs Infliximab plus azathioprine for induction of remission in active Crohn's disease : an open randomized trial - Effect of GMA early combined with azathioprine on induction of remission in active Crohn's disease
• Date of first enrolment: 2011/09/01
• Target sample size: 60
• Recruitment status: Complete: follow-up complete
• URL: https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006728
• Study type: Interventional
• Study design: Parallel Randomized
• Phase: Not applicable

Countries of recruitment

Japan

Contacts

• Name: Minoru Matsuura
• Affiliation: Kyoto University Hospital Department of Gastroenterology and Hepatology

• Name: Hiroshi Nakase
• Affiliation: Kyoto University Hospital Division of Endoscopic Medicine

Key inclusion & exclusion criteria

Inclusion criteria:
Exclusion criteria: 1) Patients with granulocyte count of equal to or less than 2,000/mm3 2) Patients with serious infectious disease 3) Patients with serious heart disease 4) Patients with serious kidney disease 5) Patients with hypotension (less than maximum blood pressure 80mmHg) 6) Patients who are pregnant or have the possibility of pregnancy 7) Patients with serious dehydration, hypercoagulability, serious anemia (under haemoglobin 8g/dl) 8) Patients with malignancy 9) Patients with Short-bowel syndrome 10) Patients with permanent ostomy 11) Patients with external fistula, including poor control of anal fistula 12) Patients with total colectomy and subtotal colectomy 13) Patients with intestinal stenosis to cause intestinal obstruction 14) Patients with serious extraintestinal complication 15) Patients who had undergone previous immunosuppressive therapies 16) Patients who had undergone previous biologic therapies 17) Patients who had introduced or increased the dosage of Steroids (intravenous Infusion, oral, enema, suppository) within the last 2 weeks 18) Patients who had introduced or increased the dosage of Metronidazole within the last 2 weeks 19) Patients who had introduced or increased the dosage of Mesalazine sulfasalazine (oral, enema, suppository) within the last 4 weeks 20) Patients who had introduced or increased the dosage of elemental diet within the last 4 weeks 21) Patients who had undergone the operation (except replace of Seton) for anal fistula within 4 weeks 22) Patients who had undergone total parental nutrition with in last 4 weeks 23) Patients who had undergone the operation, including strictureplasty, for bowel within the last 12 weeks

Age minimum: 12years-old
Age maximum: 75years-old
Gender: Male and Female

Health Condition(s) or Problem(s) studied

Crohn's disease

Intervention(s)

Patients in the combination therapy of GMA with azathioprine receive intensive GMA (twice per week, total 10 sessions) and oral azathioprine.
Patients in the combination therapy of Infliximab and azathioprine receive infusion of IFX (at week 0, 2, 6) and oral azathioprine.

Primary Outcome(s)

Remission (CDAI<150) rate at the end of the study (intensive GMA plus azathioprine: at week 7, Infliximab plus azathioprine: at week 8)

Secondary Outcome(s)

1) Clinical response (70 points reduction in their CDAI) 2) Reduction in CRP 3) Cytokine profile in CD4 positive T cell 4) Cumulative non-relapse rate 5) Safety assessment

Source(s) of Monetary Support

JIMRO Co.,Ltd.

Ethics review

Status: YES
Approval date:
Contact:

Results

• Results available: Yes
• Date Completed: 31/05/2013