Multicenter, open-label parallel-groups study comparing tocilizumab versus conventional treatment in rheumatoid arthritis with the complication of AA amyloidosis

Multicenter, open-label parallel-groups study comparing tocilizumab versus conventional treatment in rheumatoid arthritis with the complication of AA amyloidosis - Comparative study of tocilizumab therapy versus conventional therapy for the treatment of rheumatoid arthritis complicating AA amyloidosis

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000002421

Enrollment

Registered

2009-09-04

Start date

2008-07-01

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

rheumatoid arthritis

Interventions

tocilizumab Conventional DMARDs and immune suppressive drugs and biologics except for tocilizumab

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Diagnosis of rheumatoid arthritis using the American College of Rheumatology classification criteria (1987) 2. Confirmation of the amyloid deposition by the tissue biopsy or diagnosis of "rheumatoid arthritis complicating AA amylidosis" in own institution 3. Patients who have the observational periods for about six months before starting the study 4. Patients must sign the informed consent

Exclusion criteria

Exclusion criteria: 1. Pregnancy, lactation or planning pregnancy 2. Complicating severe infection 3. History of hypersensitivity to the treatment drug 4. Patients who are judged to be inappropriate by investigator

Design outcomes

Primary

Measure	Time frame
Change of the amyloid deposition in the gastric biopsy specimen	—

Secondary

Measure	Time frame
Change of renal function Serum creatinine, urinary protein, urinary creatinine, estimated creatinine clearance, cystatin C Change of serum SAA Change of diarrhea frequency Change of DAS28-ESR	—

Countries

Japan

Contacts

Public ContactKazuyuki Yoshizaki

Osaka University Immuno-Medical Science Division of Applied Chemistry, Graduate School of Engineering

kyoshi@chem.eng.osaka-u.ac.jp06-6879-4738

Outcome results

None listed

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