A Study to Evaluate the Safety of Escalating Doses of Ocrelizumab in Subjects With Rheumatoid Arthritis

A Randomized, Placebo-Controlled, Multicenter, Blinded Phase I/II Study of the Safety of Escalating Doses of Ocrelizumab (PRO70769) in Subjects With Moderate to Severe Rheumatoid Arthritis Receiving Stable Doses of Concomitant Methotrexate

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00077870

Enrollment

237

Registered

2004-02-16

Start date

2004-02-29

Completion date

2006-12-31

Last updated

2009-09-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid Arthritis

Keywords

Moderate to severe rheumatoid arthritis

Brief summary

This is a randomized, placebo-controlled, multicenter, blinded Phase I/II, investigator and subject-blinded study of the safety of escalating doses of ocrelizumab in combination with MTX in subjects with moderate to severe RA

Interventions

DRUGocrelizumab

Study design

Primary purpose

TREATMENT

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Inclusion criteria

* Ability and willingness to provide written informed consent and to comply with the requirements of the protocol * Diagnosis of RA for at least 6 months according to the revised 1987 ACR criteria for the classification of RA * Positive serum RF * Current treatment for RA on an outpatient basis * Contact your local site that is listed for more inclusion criteria

Exclusion criteria

* Bone or joint surgery (including joint fusion) within 8 weeks prior to screening or joint surgery planned within 24 weeks after randomization * Rheumatic autoimmune disease other than RA or significant systemic involvement secondary to RA (e.g., vasculitis, pulmonary fibrosis, or Felty�s syndrome) * Functional Class IV as defined by the ACR classification of functional status in RA * History of or current inflammatory joint disease other than RA (e.g., gout, reactive arthritis, psoriatic arthritis, seronegative spondyloarthropathy, Lyme disease) or other systemic rheumatic disorders (e.g., systemic lupus erythematosus, inflammatory bowel disease, scleroderma, inflammatory myopathy, overlap syndrome) * Contact your local site that is listed for more

Design outcomes

Primary

Measure	Time frame
Safety and tolerability of ocrelizumab in subjects with moderate to severe RA	—

Secondary

Measure	Time frame
Pharmacokinetics of ocrelizumab	—
Pharmacodynamics of ocrelizumab	—
Percentage of subjects with clinical responses according to American College of Rheumatology (ACR) criteria	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026