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

Primary Purpose

Rheumatoid Arthritis

Status

Terminated

Phase

Phase 2

Locations

Japan

Study Type

Interventional

Intervention

placebo

methotrexate

ocrelizumabu 50mg

ocrelizumabu 200mg

ocrelizumab 500mg

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Chubu region
Chugoku region
Hokkaido Region
Kanto Region
Kinki Region
Kyusyu region
Sikoku region

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Experimental

Arm Label

Arm Description

Outcomes

Primary Outcome Measures

Percentage of patients with ACR20 response.

Secondary Outcome Measures

Percentage of patients with ACR20, 50, and 70 response, and the components of this outcome.

EULAR response rate.

DAS 28, HAQ-DI score.

FACIT Fatigue Scale score

Weeks 4,12,and 24

Incidence of human anti-human(ocrelizumab) antibodies (HAHA)

Pharmacokinetics and Pharmacodynamics of ocrelizumab.

Full Information

NCT ID

NCT00779220

First Posted

October 23, 2008

Last Updated

March 24, 2015

Sponsor

Chugai Pharmaceutical

1. Study Identification

Unique Protocol Identification Number

NCT00779220

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2015

Overall Recruitment Status

Terminated

Study Start Date

October 2008 (undefined)

Primary Completion Date

February 2010 (Actual)

Study Completion Date

March 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Chugai Pharmaceutical

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Rheumatoid Arthritis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

152 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Placebo Comparator

Arm Title

Arm Type

Experimental

Arm Title

Arm Type

Experimental

Arm Title

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

placebo

Intervention Description

Intravenous repeating dose

Intervention Type

Drug

Intervention Name(s)

methotrexate

Intervention Description

Oral repeating dose

Intervention Type

Drug

Intervention Name(s)

ocrelizumabu 50mg

Intervention Description

Intravenous repeating dose (50mg)

Intervention Type

Drug

Intervention Name(s)

ocrelizumabu 200mg

Intervention Description

Intravenous repeating dose (200mg)

Intervention Type

Drug

Intervention Name(s)

ocrelizumab 500mg

Intervention Description

Intravenous repeating dose (500mg)

Primary Outcome Measure Information:

Title

Percentage of patients with ACR20 response.

Time Frame

week 24

Secondary Outcome Measure Information:

Title

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

Title

EULAR response rate.

Time Frame

Every 4 Weeks, from Week 4 to Week 24

Title

DAS 28, HAQ-DI score.

Time Frame

Every 4 Weeks, from Week 4 to Week 24

Title

FACIT Fatigue Scale score

Time Frame

Weeks 4,12,and 24

Title

Weeks 4,12,and 24

Time Frame

Length of study

Title

Incidence of human anti-human(ocrelizumab) antibodies (HAHA)

Time Frame

Length of study

Title

Pharmacokinetics and Pharmacodynamics of ocrelizumab.

Time Frame

Length of study

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Naritoshi Mochidome

Organizational Affiliation

Chugai Pharmaceutical

Official's Role

Study Chair

Facility Information:

Facility Name

Chubu region

City

Chubu

Country

Japan

Facility Name

Chugoku region

City

Chugoku

Country

Japan

Facility Name

Hokkaido Region

City

Hokkaido

Country

Japan

Facility Name

Kanto Region

City

Kanto

Country

Japan

Facility Name

Kinki Region

City

Kinki

Country

Japan

Facility Name

Kyusyu region

City

Kyusyu

Country

Japan

Facility Name

Sikoku region

City

Sikoku

Country

Japan

12. IPD Sharing Statement

Citations:

PubMed Identifier

22247354

Citation

Harigai M, Tanaka Y, Maisawa S; JA21963 Study Group. Safety and efficacy of various dosages of ocrelizumab in Japanese patients with rheumatoid arthritis with an inadequate response to methotrexate therapy: a placebo-controlled double-blind parallel-group study. J Rheumatol. 2012 Mar;39(3):486-95. doi: 10.3899/jrheum.110994. Epub 2012 Jan 15.

Results Reference

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

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