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A randomized, double-blind, parallel group, international study to evaluate the safety and efficacy of ocrelizumab compared to placebo in patients with active rheumatoid arthritis who have an inadequate response to at least one anti-TNF-alpha therapy.

A randomized, double-blind, parallel group, international study to evaluate the safety and efficacy of ocrelizumab compared to placebo in patients with active rheumatoid arthritis who have an inadequate response to at least one anti-TNF-alpha therapy.

Status
Unknown
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2080220469
Enrollment
Unknown
Registered
2007-11-26
Start date
2007-11-26
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

Sponsors

Chugai Pharmaceutical Co., Ltd.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Inclusion criteria: - adult patients, >=20 years of age; - rheumatoid arthritis for >=3 months; - inadequate response to previous or current treatment with at least one anti-TNF-alpha agent; - receiving either leflunomide or methotrexate for >=12 weeks, with a stable dose for the last 4 weeks. Exclusion criteria: - rheumatic autoimmune disease or inflammatory joint disease, other than RA; - any surgical procedure in past 12 weeks, or planned within 48 weeks of baseline.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Percentage of patients with ACR20 response at week 24, and week 48—

Outcome results

None listed

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