Actemra All-Patient, Long-Term Special Drug Use Surveillance

Actemra All-Patient, Long-Term Special Drug Use Surveillance - Actemra All-Patient, Long-Term Special Drug Use Surveillance

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000023071

Enrollment

2147483647

Registered

2016-07-08

Start date

2005-06-13

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

Castleman&#39

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: All Patients with CD without an indication for lymphadenectomy who have symptoms and laboratory findings for which tocilizumab were administrated.

Exclusion criteria

Exclusion criteria: No criteria

Design outcomes

Primary

Measure	Time frame
Safety: Adverse reaction incidence and infection Efficacy: Improvement in the clinical symptoms and laboratory findings of Castleman's disease Symptoms and findings including CRP, fibrinogen, ESR, hemoglobin, albumin, and PS. CRP, hemoglobin, PS are assessed biweekly for 3 years. Fibrinogen, ESR, albumin are assessed once a 4 week for 3 years.	—

Secondary

Measure	Time frame
Safety: -Incidence of ADRs and infections by patient baseline characteristics -Incidence of ADRs and infections in special patient populations -Incidence of serious adverse events -Incidence of ADRs and infections during long-term treatment (>=12 months) -Effects on infection -Effects on cardiac function Efficacy: -Evaluation of enlarged lymph nodes -Percent reduction in short axis x longest diameter of evaluable lesions (neck, chest, abdomen, pelvis, other site) -Effect on clinical and associated symptoms of Castleman's disease -Clinical symptoms, interstitial pneumonia, rash, hepatomegaly, splenomegaly, secondary amyloidosis, neurological symptoms -Actemra treatment status -Treatment status, reason for treatment discontinuation in patients with treatment discontinuation -Detailed information on treatment discontinuations due to death must be recorded in the adverse events section. -Time course of steroid dose	—

Measure

Time frame

Safety: -Incidence of ADRs and infections by patient baseline characteristics -Incidence of ADRs and infections in special patient populations -Incidence of serious adverse events -Incidence of ADRs and infections during long-term treatment (>=12 months) -Effects on infection -Effects on cardiac function Efficacy: -Evaluation of enlarged lymph nodes -Percent reduction in short axis x longest diameter of evaluable lesions (neck, chest, abdomen, pelvis, other site) -Effect on clinical and associated symptoms of Castleman's disease -Clinical symptoms, interstitial pneumonia, rash, hepatomegaly, splenomegaly, secondary amyloidosis, neurological symptoms -Actemra treatment status -Treatment status, reason for treatment discontinuation in patients with treatment discontinuation -Detailed information on treatment discontinuations due to death must be recorded in the adverse events section. -Time course of steroid dose

—

Countries

Japan

Contacts

Public ContactMakoto Nomura

Chugai Pharmaceutical Co. Ltd. Pharmacovigilance Dept.

nomuramkt@chugai-pharm.co.jp03-3273-0905

Outcome results