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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

152 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-10-31

Study Completion Date

2015-03-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Rheumatoid Arthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

Intravenous repeating dose

methotrexate

Intervention Type DRUG

Oral repeating dose

2

Group Type EXPERIMENTAL

methotrexate

Intervention Type DRUG

Oral repeating dose

ocrelizumabu 50mg

Intervention Type DRUG

Intravenous repeating dose (50mg)

3

Group Type EXPERIMENTAL

methotrexate

Intervention Type DRUG

Oral repeating dose

ocrelizumabu 200mg

Intervention Type DRUG

Intravenous repeating dose (200mg)

4:

Group Type EXPERIMENTAL

methotrexate

Intervention Type DRUG

Oral repeating dose

ocrelizumab 500mg

Intervention Type DRUG

Intravenous repeating dose (500mg)

Interventions

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placebo

Intravenous repeating dose

Intervention Type DRUG

methotrexate

Oral repeating dose

Intervention Type DRUG

ocrelizumabu 50mg

Intravenous repeating dose (50mg)

Intervention Type DRUG

ocrelizumabu 200mg

Intravenous repeating dose (200mg)

Intervention Type DRUG

ocrelizumab 500mg

Intravenous repeating dose (500mg)

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No