A randomized placebo-controlled, multicenter, blinded Phase I/II study of the safety of escalating single intravenous doses of ocrelizumab (Ro 496-4913, PRO70769, rhuMAb 2H7) in patients with moderate to severe rheumatoid arthritis receiving stable doses of concomitant methotrexate but with unsatisfactory clinical response. - N/A

F. Hoffmann-La Roche Limited0 sites160 target enrollmentMarch 11, 2005

ConditionsRheumatoid Arthritis

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Rheumatoid Arthritis
Sponsor: F. Hoffmann-La Roche Limited
Enrollment: 160
Status: Active, not recruiting
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

March 11, 2005

End Date

February 6, 2013

Last Updated

6 years ago

Study Type

Interventional clinical trial of medicinal product

Investigators

Sponsor

F. Hoffmann-La Roche Limited

Eligibility Criteria

Inclusion Criteria

•Patients must meet the following criteria to be eligible for study entry:
•Ability and willingness to provide written informed consent and to comply with the requirements of the protocol
•Aged 18–80 years inclusive
•Have active disease defined as:
•Diagnosis of RA for at least 6 months according to the revised 1987 ACR criteria for the classification of RA (see Study Procedures and Administrative Manual)
•Positive serum rheumatoid factor (\=20 IU/L)
•Current treatment for RA on an outpatient basis
•At screening: one of the following: C\-reactive protein (CRP) \=1\.0 mg/dL (10 mg/L)
•erythrocyte sedimentation rate (ESR) \=28 mm/hr or morning stiffness of \=45 minutes
•Swollen joint count of \=8 (66 joint count) and tender joint count of \=8 (68 joint count) at screening

Exclusion Criteria

•Patients who meet any of the following exclusion criteria related to rheumatoid arthritis are ineligible for study entry:
•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); patients with Sjogren’s syndrome with RA are eligible.
•Functional Class IV as defined by the ACR classification of functional status in RA (see Study Procedures and Administrative Manual)
•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).
•Exclusion Criteria Related to Medications
•Patients who meet the following criteria related to medications will be excluded:
•Concurrent treatment with any DMARD (except MTX) or any anti–TNF\-a therapy or other biologic therapy
•Treatment with any investigational agent within 4 weeks of screening or five half\-lives of the investigational drug (whichever is longer).
•Patients who have received previous treatment with natalizumab (Tysabri) in clinical trials are excluded, unless 12 weeks (5 half\-lives) has elapsed since the last treatment, and a baseline neurologic evaluation shows no abnormalities