An open-label continuation trial of tocilizumab for familial Mediterranean fever with colchicine ineffective or intolerance

An open-label continuation trial of tocilizumab for familial Mediterranean fever with colchicine ineffective or intolerance - An open-label continuation trial of tocilizumab for familial Mediterranean fever

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000032557

Enrollment

Registered

2018-05-30

Start date

2018-09-01

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

familial Mediterranean fever

Interventions

Tocilizumab

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) Patients who completed the 24-week study drug administration period of the preceding trial. (2) Patients who got adequate explanation about the contents of explanatory documents and other matters concerning clinical trials, understand the contents thereof, and obtain written consent based on free will about participation in this trial.

Exclusion criteria

Exclusion criteria: Patients applicable to even one of the following are excluded from the subject (1) Women who are breast-feeding, pregnant, or may become pregnant (2) Patients with a history of hypersensitivity to the components of tocilizumab (3) Patients whose corticosteroids are routinely used (excluding topical treatments such as external preparations) due to diseases other than familial Mediterranean fever and which are judged inappropriate by investigators or clinical trial doctors (4) Patients who have interstitial pneumonia and who are judged inappropriate by investigators or clinical trial doctors (5) Patients who have complicated serious diseases and who are judged inappropriate by investigators or clinical trial doctors as clinical trials (6) Patients whose investigator or clinical trial doctor judged that the condition in the preceding study is inappropriate for continued administration (7) Patients judged inappropriate by investigators or clinical trial doctors

Design outcomes

Primary

Measure	Time frame
Safety Adverse event	—

Secondary

Measure	Time frame
Efficacy Number of fever attacks	—

Countries

Japan

Contacts

Public ContactTomohiro Koga

Nagasaki University Graduate School of Biomedical Sciences Department of Immunology and Rheumatology, Division of Advanced Preventive Medical Sciences

tkoga@nagasaki-u.ac.jp095-819-7260

Outcome results

None listed

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