Long-Term Treatment Study of Ocrelizumab for Rheumatoid Arthritis

Status

Unknown

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080220736

Enrollment

200

Registered

2009-05-26

Start date

2009-05-26

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

investigational material(s) Generic name etc : Ocrelizumab INN of investigational material : Therapeutic category code : 399 Agents affecting metabolism, n.e.c. Dosage and Administration for Investig

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: -Subjects who have completed the week 24 visit in the previous study -Treatment with methotrexate (MTX) 6-8mg/week (administered orally) has continued from the previous study.

Exclusion criteria

Exclusion criteria: -Functional Class 4 as defined by the ACR Classification of Functional Status in rheumatoid arthritis. -Cardiac or pulmonary function worsens markedly from the week 24 visit in the previous study to enrolment in this study. -Primary or secondary immunodeficiency, including HIV infection occurs from the week 24 visit in the previous study to enrolment in this study. -Hepatitis B, hepatitis C or tuberculosis infection occurs from the week 24 visit in the previous study to enrolment in this study. -Malignancy occurs from the week 24 visit in the previous study to enrolment in this study.

Design outcomes

Primary

Measure	Time frame
Efficacy (the frequency of achievement of 20%, 50% and 70% in terms of the ACR criteria, DAS28, EULAR response rate, HAQ-DI score, FACIT-Fatigue scale, persistence rate), Safety (incidence of adverse events) Changes of endpoints from the beginning of the treatment in the previous study	—

Outcome results

None listed

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