UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Efficacy of GMA in steroid naive patients with active ulcerative colitis. -a multicenter study -
Title of the study (Brief title)	To evaluate the efficacy of GMA in steroid naive patients with active ulcerative colitis.
Region	Japan

Condition
Condition	Ulcerative colitis
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy of GMA in steroid naive patients with active ulcerative colitis.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Remission rate
Key secondary outcomes	1.Improvement of endoscopic index. 2.The incidence of adverse events.

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	16 years-old <=
Age-upper limit	75 years-old >=
Gender	Male and Female
Key inclusion criteria	1. Steroid naive patients. 2. Patients refractory to high dose 5-ASA agents. 3. Antibiotics naive patients. 4. Patients with Mayo score 3 to 10.
Key exclusion criteria	1. Re-registered patients. 2. Patients whose granulocyte count below 2,000/mm3. 3. Patients with or suspected to have severe infection. 4. Patients with serious heart disease. 5. Patients with serious kidney disorder. 6. Patients with hypotension (mamimal blood pressure below 80mmHg). 7. Pregnant patients 8. Patients with serious dehydration, serious coagulation abnormality, or serious anemia (Hb below 8.0d/dL). 9. Patients with malignancy. 10. Patients who have artificial anus. 11. Patients who have undergone intestinal operation within 12 weeks. 12. Patients who have severe extraintestinal complications. 13. Patients who have received an initial dose or an increased dose of 5-ASA agents within 2 weeks before screening. 14. Patients who have received a dose of tacrolimus within 4 weeks before screening. 15. Patients who have received cytapheresis within 4 weeks before screening. 16. Patiens who have received an initial dose or an increased dose of immunomodulators within 8 weeks before screening. 17. Patients who are judged to be ineligible by an investigator.
Target sample size	200

Research contact person
Name of lead principal investigator	Kazuhide Higuchi
Organization	Osaka Medical College Hospital
Division name	2nd Department of Internal Medicine
Address	2-7, Daigaku-cho, Takatsuki-shi, Osaka, Japan
TEL	072-683-1221
Email	ninaika@art.osaka-med.ac.jp

Public contact
Name of contact person	Kazuki Kakimoto
Organization	Osaka Medical College Hospital
Division name	2nd Department of Internal Medicine
Address	2-7, Daigaku-cho, Takatsuki-shi, Osaka, Japan
TEL	072-683-1221
Homepage URL
Email	in2098@osaka-med.ac.jp

Sponsor
Institute	Osaka Medical College Hospital
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2014 Year 04 Month 13 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2013 Year 12 Month 12 Day
Anticipated trial start date	2014 Year 04 Month 21 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	None

Management information
Registered date	2014 Year 04 Month 13 Day
Last modified on	2018 Year 10 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015997