Tocilizumab LTE study in patients with SSc

A PHASE III, MULTICENTER, OPEN-LABEL, SINGLE-ARM STUDY TO ASSESS THE LONG-TERM SAFETY AND EFFICACY OF TOCILIZUMAB IN PATIENTS WITH SYSTEMIC SCLEROSIS

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080223704

Enrollment

Registered

2017-11-07

Start date

2017-11-10

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

Systemic sclerosis

Interventions

investigational material(s) Generic name etc : tocilizumab INN of investigational material : tocilizumab Therapeutic category code : 639 Other biological preparations Dosage and Administration for Inv

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) Patients who participated in WA29767 study and finished assessments scheduled at Week 96

Exclusion criteria

Exclusion criteria: (1) Evidence of moderately severe pulmonary (e.g., asthma and emphysema), cardiovascular, hepatic, nervous system, renal, endocrine, or gastrointestinal disease not related to SSc as determined by the investigator at study entry (2) Known active current bacterial, viral, fungal, mycobacterial, or other recurrent infections (e.g., atopical mycobacterial disease, hepatitis B or C, herpes zoster, infected digital ulcers, and osteomyelitis) at study entry

Design outcomes

Primary

Measure	Time frame
safety efficacy pharmacodynamics Safety: adverse event, laboratory value, vital sign Efficacy: change in mRSS, FVC, J-HAQ Pharmacodynamics: change in PD biomarker concentration (IL-6, sIL-6R, CRP, ESR)	—

Countries

Japan

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026