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

Sponsored by:	Chugai Pharmaceutical
Information provided by:	Chugai Pharmaceutical
ClinicalTrials.gov Identifier:	NCT00779220

Purpose

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.

Condition	Intervention	Phase
Rheumatoid Arthritis	Drug: placebo Drug: methotrexate Drug: ocrelizumabu 50mg Drug: ocrelizumabu 200mg Drug: ocrelizumab 500mg	Phase II

MedlinePlus related topics: Rheumatoid Arthritis

Drug Information available for: Methotrexate Ocrelizumab

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by Chugai Pharmaceutical:

Primary Outcome Measures:

Percentage of patients with ACR20 response. [ Time Frame: week 24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: No ]
EULAR response rate. [ Time Frame: Every 4 Weeks, from Week 4 to Week 24 ] [ Designated as safety issue: No ]
DAS 28, HAQ-DI score. [ Time Frame: Every 4 Weeks, from Week 4 to Week 24 ] [ Designated as safety issue: No ]
FACIT Fatigue Scale score [ Time Frame: Weeks 4,12,and 24 ] [ Designated as safety issue: No ]
Weeks 4,12,and 24 [ Time Frame: Length of study ] [ Designated as safety issue: No ]
Incidence of human anti-human(ocrelizumab) antibodies (HAHA) [ Time Frame: Length of study ] [ Designated as safety issue: No ]
Pharmacokinetics and Pharmacodynamics of ocrelizumab. [ Time Frame: Length of study ] [ Designated as safety issue: No ]

Estimated Enrollment:	200
Study Start Date:	October 2008
Estimated Primary Completion Date:	November 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Placebo Comparator	Drug: placebo Intravenous repeating dose Drug: methotrexate Oral repeating dose
2: Experimental	Drug: methotrexate Oral repeating dose Drug: ocrelizumabu 50mg Intravenous repeating dose (50mg)
3: Experimental	Drug: methotrexate Oral repeating dose Drug: ocrelizumabu 200mg Intravenous repeating dose (200mg)
4:: Experimental	Drug: methotrexate Oral repeating dose Drug: ocrelizumab 500mg Intravenous repeating dose (500mg)

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.

Eligibility

Ages Eligible for Study:	20 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00779220

Contacts

Contact: Naritoshi Mochidome

clinical-trials@chugai-pharm.co.jp

Locations

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

Sponsors and Collaborators

Chugai Pharmaceutical

Investigators

Study Chair:

Naritoshi Mochidome

Chugai Pharmaceutical

More Information

Responsible Party:	Chugai Pharmaceutical Co., Ltd. ( Naritoshi Mochidome )
Study ID Numbers:	JA21963
Study First Received:	October 23, 2008
Last Updated:	October 23, 2008
ClinicalTrials.gov Identifier:	NCT00779220
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Study placed in the following topic categories:

Folic Acid
Autoimmune Diseases
Musculoskeletal Diseases
Joint Diseases
Arthritis

Connective Tissue Diseases
Arthritis, Rheumatoid
Methotrexate
Rheumatic Diseases

Additional relevant MeSH terms:

Antimetabolites
Antimetabolites, Antineoplastic
Immunologic Factors
Immune System Diseases
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Enzyme Inhibitors
Reproductive Control Agents

Folic Acid Antagonists
Abortifacient Agents, Nonsteroidal
Immunosuppressive Agents
Pharmacologic Actions
Therapeutic Uses
Abortifacient Agents
Antirheumatic Agents
Dermatologic Agents
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on January 14, 2009