A Study to Evaluate the Efficacy, Safety and Pharmacokinetics/Pharmacodynamics (PK/PD) of Ocrelizumab in Patients With Rheumatoid Arthritis
This study is ongoing, but not recruiting participants.
Sponsor:
Chugai Pharmaceutical
Information provided by (Responsible Party):
Chugai Pharmaceutical
ClinicalTrials.gov Identifier:
NCT00779220
First received: October 23, 2008
Last updated: July 31, 2012
Last verified: July 2012
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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 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
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 Study Completion Date: | March 2013 |
| Primary Completion Date: | February 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Placebo Comparator: 1 |
Drug: placebo
Intravenous repeating dose
Drug: methotrexate
Oral repeating dose
|
| Experimental: 2 |
Drug: methotrexate
Oral repeating dose
Drug: ocrelizumabu 50mg
Intravenous repeating dose (50mg)
|
| 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)
|
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
Locations
| Japan | |
| Chubu region | |
| Chubu, Japan | |
| Chugoku region | |
| Chugoku, Japan | |
| Hokkaido Region | |
| Hokkaido, Japan | |
| Kanto Region | |
| Kanto, Japan | |
| Kinki Region | |
| Kinki, Japan | |
| Kyusyu region | |
| Kyusyu, Japan | |
| Sikoku region | |
| Sikoku, Japan | |
Sponsors and Collaborators
Chugai Pharmaceutical
Investigators
| Study Chair: | Naritoshi Mochidome | Chugai Pharmaceutical |
More Information
No publications provided by Chugai Pharmaceutical
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Chugai Pharmaceutical |
| ClinicalTrials.gov Identifier: | NCT00779220 History of Changes |
| Other Study ID Numbers: | JA21963 |
| Study First Received: | October 23, 2008 |
| Last Updated: | July 31, 2012 |
| Health Authority: | Japan: Ministry of Health, Labor and Welfare |
Additional relevant MeSH terms:
|
Arthritis Arthritis, Rheumatoid Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Connective Tissue Diseases Autoimmune Diseases Immune System Diseases Methotrexate Abortifacient Agents, Nonsteroidal Abortifacient Agents Reproductive Control Agents Physiological Effects of Drugs |
Pharmacologic Actions Therapeutic Uses Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Dermatologic Agents Enzyme Inhibitors Folic Acid Antagonists Immunosuppressive Agents Immunologic Factors Antirheumatic Agents Nucleic Acid Synthesis Inhibitors |
ClinicalTrials.gov processed this record on May 16, 2013