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

March 24, 2015 updated by: Chugai Pharmaceutical

A Randomized, Double-blind, Parallel-group, Study to Evaluate the Efficacy, Safety and PK/PD of Ocrelizumab in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate Therapy

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

152

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Chubu, Japan
        • Chubu Region
      • Chugoku, Japan
        • Chugoku region
      • Hokkaido, Japan
        • Hokkaido region
      • Kanto, Japan
        • Kanto region
      • Kinki, Japan
        • Kinki region
      • Kyusyu, Japan
        • Kyusyu region
      • Sikoku, Japan
        • Sikoku region

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 2
Drug: methotrexate
Oral repeating dose
Drug: ocrelizumabu 50mg
Intravenous repeating dose (50mg)
Placebo Comparator: 1
Drug: placebo
Intravenous repeating dose
Drug: methotrexate
Oral repeating dose
Experimental: 3
Drug: methotrexate
Oral repeating dose
Drug: ocrelizumabu 200mg
Intravenous repeating dose (200mg)
Experimental: 4:
Drug: methotrexate
Oral repeating dose
Drug: ocrelizumab 500mg
Intravenous repeating dose (500mg)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of patients with ACR20 response.
Time Frame: week 24
week 24

Secondary Outcome Measures

Outcome Measure
Time Frame
Percentage of patients with ACR20, 50, and 70 response, and the components of this outcome.
Time Frame: very 4 Weeks, from Week 4 to Week 24
very 4 Weeks, from Week 4 to Week 24
EULAR response rate.
Time Frame: Every 4 Weeks, from Week 4 to Week 24
Every 4 Weeks, from Week 4 to Week 24
DAS 28, HAQ-DI score.
Time Frame: Every 4 Weeks, from Week 4 to Week 24
Every 4 Weeks, from Week 4 to Week 24
FACIT Fatigue Scale score
Time Frame: Weeks 4,12,and 24
Weeks 4,12,and 24
Weeks 4,12,and 24
Time Frame: Length of study
Length of study
Incidence of human anti-human(ocrelizumab) antibodies (HAHA)
Time Frame: Length of study
Length of study
Pharmacokinetics and Pharmacodynamics of ocrelizumab.
Time Frame: Length of study
Length of study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chugai Pharmaceutical

Investigators

  • Study Chair: Naritoshi Mochidome, Chugai Pharmaceutical

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2008

Primary Completion (Actual)

February 1, 2010

Study Completion (Actual)

March 1, 2015

Study Registration Dates

First Submitted

October 23, 2008

First Submitted That Met QC Criteria

October 23, 2008

First Posted (Estimate)

October 24, 2008

Study Record Updates

Last Update Posted (Estimate)

March 25, 2015

Last Update Submitted That Met QC Criteria

March 24, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JA21963

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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