The study of the combination effect of granulocyte/monocyte adsorptive apheresis in Crohn's disease patients who lose response to Infliximab therapy

The study of the combination effect of granulocyte/monocyte adsorptive apheresis in Crohn's disease patients who lose response to Infliximab therapy - The study of the combination effect of GMA in Crohn's disease patients who lose response to Infliximab therapy

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000035185

Enrollment

Registered

2019-04-01

Start date

2018-04-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Crohn&#39

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) Crohn's disease patients with maintenance IFX therapy (2) Patients with CDAI score of 220 to 450 points or serum CRP of more than 0.3mg/dl (3) Patients considered being capable for venous catheter insertion

Exclusion criteria

Exclusion criteria: (1) Adacolumn contraindication (2) Other patients judged as inappropriate by the physician

Design outcomes

Primary

Measure	Time frame
The rate of clinical response (improvement of CDAI score more than 70 points) at week 16	—

Secondary

Measure	Time frame
(1) Remission (CDAI<150) rate at week 16 (2) Change of blood lebel of IFX (3) Change of antibody to infliximab(ATI) (4) Change in CRP (5) Safety assessment	—

Countries

Japan

Contacts

Public ContactJunji Yokoyama

Niigata University Medical and Dental Hospital Division of endoscopy

yokoyaj@med.niigata-u.ac.jp025-227-2207

Outcome results