Special drug use results surveillance for the use of SIMPONI in ulcerative colitis

Special drug use results surveillance for the use of SIMPONI in ulcerative colitis - SMP4L

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000027542

Enrollment

300

Registered

2017-06-01

Start date

2017-06-15

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

ulcerative colitis

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

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)".

Exclusion criteria

Exclusion criteria: Patients with a history of use of Golimumab (active ingredient of this product)

Design outcomes

Primary

Measure	Time frame
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)	—

Measure

Time frame

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)

—

Countries

Japan

Contacts

Public ContactAkiko Yamamoto

Janssen Pharmaceutical K.K. Safety Risk Management Dept.

ayamamot@its.jnj.com03-4411-5173

Outcome results