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

NCT00779220 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 152

Last updated 2015-03-25

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

placebo

Intravenous repeating dose

DRUG

methotrexate

Oral repeating dose

DRUG

ocrelizumabu 50mg

Intravenous repeating dose (50mg)

DRUG

ocrelizumabu 200mg

Intravenous repeating dose (200mg)

DRUG

ocrelizumab 500mg

Intravenous repeating dose (500mg)

Sponsors & Collaborators

  • Chugai Pharmaceutical

    lead INDUSTRY

Principal Investigators

  • Naritoshi Mochidome · Chugai Pharmaceutical

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-10-31
Primary Completion
2010-02-28
Completion
2015-03-31

Countries

  • Japan

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00779220 on ClinicalTrials.gov