Open-labeled prospective randomized study between weekly and intensive(twice a week) treatment of GMA(granulocyte and monocyte absorption apheresis) for crohn disease

Open-labeled prospective randomized study between weekly and intensive(twice a week) treatment of GMA(granulocyte and monocyte absorption apheresis) for crohn disease - Open-labeled prospective randomized study between weekly and intensive(twice a week) treatment of GMA(granulocyte and monocyte absorption apheresis) for crohn disease

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000003666

Enrollment

200

Registered

2010-05-26

Start date

2010-05-01

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 disease

Interventions

Patiens in weekly GMA receive one treatment per week.The maximum number of treatments allowed is ten. Patiens in intensive GMA receive two treatment per week. The maximum number of treatments allowed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Moderately and Severe active disease defined as a CDAI 200-449 Adequate peripheral venous access to allow for completion of the aphereis treatment Able to provide informed consent Insufficient or resistant to conventional therapies, and not applicable to conventional therapies

Exclusion criteria

Exclusion criteria: Granulocyte count is equal to or less than 2,000/mm3 Serious infectious disease Serious heart disease Serious kidney disease Hypotonicity (less than maximum blood pressure 80mmHg) Pregnancy Serious exsiccation /Serious coagulation, Serious anemia (under haemoglobin 8g/dl) Malignancy Short-bowel syndrome Permanent ostomy External fistula and poor control anal fistula Total colectomy Intestinal stenosis to cause intestinal obstruction Serious parenteral complication Introduce or increase the dosage of Steroids (Intravenous infusion,oral,enema,suppository) within the last 1 weeks Introduce or increase the dosage of Use of Adalimumab with in last 2 weeks Introduce or increase the dosage of Use of total Infliximab with in last 6 weeks Operation (including strictureplasty) for bowel within 12 weeks Treated in clinical trials and other treatment not covered by insurance

Design outcomes

Primary

Measure	Time frame
The primary measure of response was clinical remission at the end of the study (weekly GMA:11week,intensive GMA:6week).Clinical remission is defined as CDAI<150	—

Secondary

Measure	Time frame
Clinical remission at 6week Clinical response at 6week Clinical response is defined as 70points reduction in their CDAI Reduction in CDAI Reduction in CRP Induction time to remission Safety assessment	—

Countries

Japan

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026