A Study to Evaluate the Efficacy, Safety and Pharmacokinetics/Pharmacodynamics (PK/PD) of Ocrelizumab in Patients With Rheumatoid Arthritis

Chugai Pharmaceutical

Status and phase: Terminated; Phase 2

Conditions: Rheumatoid Arthritis

Treatments: Drug: methotrexate; Drug: ocrelizumabu 50mg; Drug: ocrelizumab 500mg; Drug: ocrelizumabu 200mg; Drug: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00779220

JA21963

Details and patient eligibility

About

This study will evaluate the efficacy, safety and PK/PD of ocrelizumab at each dose in combination with methotrexate（MTX）in patients with active rheumatoid arthritis (RA). The data from this study will also be compared with those from a clinical study of ocrelizumab in patients with active RA that was conducted in the U.S.

Full description

This study will evaluate the efficacy, safety and PK/PD of ocrelizumab at each dose in combination with MTX in patients with active RA. The data from this study will also be compared with those from a clinical study of ocrelizumab in patients with active RA that was conducted in the U.S.

Enrollment: 152 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of RA for ≧6 months according to the revised 1987 ACR criteria for the classification of RA.
• Adult patients, ≧20 years of age.
• Receiving methotrexate at a dose of 6 to 8mg/week（oral）for ≧12 weeks, with a stable dose for the last 4 weeks before treatment.
• Positive serum RF.

Exclusion criteria

• Rheumatic autoimmune disease other than RA, or Significant systemic involvement secondary to RA (including but not limited to vasculitis, pulmonary fibrosis, or Felty's syndrome).Patients with secondary Sjögren's syndrome or secondary limited cutaneous vasculitis with RA are eligible.
• 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 autoimmune disorder (e.g., systemic lupus erythematosus, inflammatory bowel disease, scleroderma, inflammatory myopathy, mixed connective tissue disease or other overlap syndrome).
• Any surgical procedure (except for minor surgeries requiring local or no anaesthesia and without any complications or sequelae) within 12 weeks prior to or planned within 24 weeks after baseline.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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152 participants in 4 patient groups, including a placebo group

1

Placebo Comparator group

Treatment:

Drug: placebo

Drug: methotrexate

2

Experimental group

Treatment:

Drug: ocrelizumabu 50mg

Drug: methotrexate

3

Experimental group

Treatment:

Drug: ocrelizumabu 200mg

Drug: methotrexate

4:

Experimental group

Treatment:

Drug: ocrelizumab 500mg

Drug: methotrexate