UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Special drug use results surveillance for the use of SIMPONI in ulcerative colitis
Title of the study (Brief title)	SMP4L
Region	Japan

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

Objectives
Narrative objectives1	To investigate safety and effectiveness of SIMPONI Subcutaneous Injection 50 mg Syringe (hereinafter, "SIMPONI") in long-term use for ulcerative colitis (hereinafter, "this Survey"). In addition, follow up the patient for 3 years after administration of SIMPONI to investigate the incidence of malignancy.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Safety analysis a. Onset status of adverse drug reactions including infectious events b. Onset status of serious adverse events c. Influencing factors d. Onset status of safety concerns and special interests e. Investigations on special populations (pediatric, elderly, pregnant/delivering/nursing women, patients with renal dysfunction, patients with hepatic dysfunction) Efficacy analysis a. Rate of responders b. Change in partial Mayo score c. Rate of clinical response d. Influencing factors e. Investigations on special populations (pediatric, elderly, pregnant/delivering/nursing women, patients with renal dysfunction, patients with hepatic dysfunction)
Key secondary outcomes

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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients who received SIMPONI for the first time for its indication "inducing clinical response and maintenance therapy in patients with moderate to severe active ulcerative colitis (only patients who have had an adequate response to conventional therapy)".
Key exclusion criteria	Patients with a history of use of Golimumab (active ingredient of this product)
Target sample size	300

Research contact person
Name of lead principal investigator	Toshiya Kato
Organization	Janssen Pharmaceutical K.K
Division name	Safety Risk Management Dept.
Address	5-2, Nishi-Kanda 3-chome, Chiyoda-ku, Tokyo
TEL	03-4411-5478
Email	tkato1@its.jnj.com

Public contact
Name of contact person	Akiko Yamamoto
Organization	Janssen Pharmaceutical K.K.
Division name	Safety Risk Management Dept.
Address	5-2, Nishi-Kanda 3-chome, Chiyoda-ku, Tokyo
TEL	03-4411-5173
Homepage URL
Email	ayamamot@its.jnj.com

Sponsor
Institute	Janssen Pharmaceutical K.K.
Institute
Department

Funding Source
Organization	Janssen Pharmaceutical K.K.
Organization
Division
Category of Funding Organization	Profit organization
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	2017 Year 06 Month 01 Day

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2017 Year 05 Month 15 Day
Anticipated trial start date	2017 Year 06 Month 15 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	Special drug use results surveillance

Management information
Registered date	2017 Year 05 Month 30 Day
Last modified on	2019 Year 03 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031576