Special drug use survey of Stelara for Crohn's disease

Special drug use survey of Stelara for Crohn's disease - STL2L

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000026966

Enrollment

300

Registered

2017-05-31

Start date

2017-05-24

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&#39

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients who initiate Stelara Intravenous Infusion 130 mg Vial for moderate to severe active Crohn's disease (Only patients who have failed or were intolerant to previous treatment)

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Variables related to safety a.Data on adverse reactions/infection b.Data on serious adverse events c.Data on adverse reactions of primary survey items d.Factors possibly affecting the safety e.Investigation of the safety in specific patient populations (the elderly, pregnant/nursing women, patients with renal impairment, patients with hepatic function disorder) f.Data on adverse reactions of malignancy after long term of administration Variables related to efficacy a.Change in CDAI b.Change in CRP c.Result of endoscopy d.Physician's Global Assessment e.Effectiveness of changing administration interval f.Factors possibly affecting the effectiveness g.Investigation of the effectiveness in specific patient populations (the elderly, pregnant/nursing women, patients with renal impairment, patients with hepatic function disorder)	—

Measure

Time frame

Variables related to safety a.Data on adverse reactions/infection b.Data on serious adverse events c.Data on adverse reactions of primary survey items d.Factors possibly affecting the safety e.Investigation of the safety in specific patient populations (the elderly, pregnant/nursing women, patients with renal impairment, patients with hepatic function disorder) f.Data on adverse reactions of malignancy after long term of administration Variables related to efficacy a.Change in CDAI b.Change in CRP c.Result of endoscopy d.Physician's Global Assessment e.Effectiveness of changing administration interval f.Factors possibly affecting the effectiveness g.Investigation of the effectiveness in specific patient populations (the elderly, pregnant/nursing women, patients with renal impairment, patients with hepatic function disorder)

—

Countries

Japan

Contacts

Public ContactMasayuki Talagishi

Janssen Pharmaceutical K.K. Safety risk management dept

mtakagis@its.jnj.com03-4411-5464

Outcome results