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

Phase 2

Terminated

• Conditions: Rheumatoid Arthritis
• Interventions: Drug: placebo; Drug: ocrelizumab 500mg; Drug: ocrelizumabu 50mg; Drug: ocrelizumabu 200mg; Drug: methotrexate

• Registration Number: NCT00779220
• Lead Sponsor: Chugai Pharmaceutical

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.

Study Timeline

• Study Start: 2008-10
• Study First Submitted: 2008-10-23
• Study First Submitted QC: 2008-10-23
• Study First Posted: 2008-10-24
• Primary Completion: 2010-02
• Status Verified: 2015-03
• Study Completion: 2015-03
• Last Update Submitted: 2015-03-24
• Last Update Posted: 2015-03-25

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 152

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
4:	ocrelizumab 500mg	-
2	ocrelizumabu 50mg	-
3	ocrelizumabu 200mg	-
1	placebo	-
1	methotrexate	-
2	methotrexate	-
3	methotrexate	-
4:	methotrexate	-

Primary Outcome Measures

Name	Time	Method
Percentage of patients with ACR20 response.	week 24

Secondary Outcome Measures

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

Trial Locations

Locations (7)

Chugoku region; 🇯🇵 Chugoku, Japan

Sikoku region; 🇯🇵 Sikoku, Japan

Chubu region; 🇯🇵 Chubu, Japan

Hokkaido Region; 🇯🇵 Hokkaido, Japan

Kanto Region; 🇯🇵 Kanto, Japan

Kinki Region; 🇯🇵 Kinki, Japan

Kyusyu region; 🇯🇵 Kyusyu, Japan