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

• Register: JPRN
• Last refreshed on: 17 October 2023
• Main ID: JPRN-UMIN000006882
• Date of registration: 01/01/2012
• Prospective Registration: Yes
• Primary sponsor: Department of Lower Gastroenterology, Hyogo College of Medicine
• Public title: Evaluation of Concomitant Adalimumab and Cytapheresis in Patients who lose Response to Adalimumab Therapy
• Scientific title: Evaluation of Concomitant Adalimumab and Cytapheresis in Patients who lose Response to Adalimumab Therapy - Supplement cytapheresis improve response of adalimumab; SAPPHIRE study
• Date of first enrolment: 2012/02/01
• Target sample size: 20
• Recruitment status: Complete: follow-up complete
• URL: https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008130
• Study type: Interventional
• Study design: Single arm Non-randomized
• Phase: Phase IV

Countries of recruitment

Japan

Contacts

• Name: Fukunaga, Ken
• Affiliation: Hyogo College of Medicine Department of Lower Gastroenterology

• Name: Shiro Nakamura
• Affiliation: Hyogo College of Medicine Department of Lower Gastroenterology

Key inclusion & exclusion criteria

Inclusion criteria:
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

Age minimum: 15years-old
Age maximum: Not applicable
Gender: Male and Female

Health Condition(s) or Problem(s) studied

Crohn's disease

Intervention(s)

Adalimumab therapy (40 mg/dose, every other week) combined with Granulocyte/ Monocyte Apheresis (GMA), once weekly for 5 comsecutive weeks. If responses are noted, GMA is applied for another 5 sessions (once weekly).

Primary Outcome(s)

Remission rate in week12 (remission:CDAI<150)

Secondary Outcome(s)

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.

Source(s) of Monetary Support

Department of Lower Gastroenterology, Hyogo College of Medicine

Secondary Sponsor(s)

Hyogo College of Medicine (Hyogo, Japan), Osaka City Univ. (Osaka, Japan), Osaka Medical College (Osaka, Japan), Kyoto Univ. (Kyoto, Japan), Shiga University of Medical Science (Shiga, Japan)

Ethics review

Status: YES
Approval date:
Contact:

Results

• Results available: Yes
• Date Completed: 01/01/2014