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

Rheumatoid Arthritis Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00779220
• Other study ID #: JA21963
• Status: Terminated
• Phase: Phase 2
• First received: October 23, 2008
• Last updated: March 24, 2015
• Start date: October 2008
• Est. completion date: March 2015

Study information

• Verified date: March 2015
• Source: Chugai Pharmaceutical
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 152
• Est. completion date: March 2015
• Est. primary completion date: February 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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 ? 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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• placebo
Intravenous repeating dose
• methotrexate
Oral repeating dose
• ocrelizumabu 50mg
Intravenous repeating dose (50mg)
• ocrelizumabu 200mg
Intravenous repeating dose (200mg)
• ocrelizumab 500mg
Intravenous repeating dose (500mg)

Locations

Country	Name	City	State
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

Sponsors (1)

Lead Sponsor	Collaborator
Chugai Pharmaceutical

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of patients with ACR20 response.		week 24	No
Secondary	Percentage of patients with ACR20, 50, and 70 response, and the components of this outcome.		very 4 Weeks, from Week 4 to Week 24	No
Secondary	EULAR response rate.		Every 4 Weeks, from Week 4 to Week 24	No
Secondary	DAS 28, HAQ-DI score.		Every 4 Weeks, from Week 4 to Week 24	No
Secondary	FACIT Fatigue Scale score		Weeks 4,12,and 24	No
Secondary	Weeks 4,12,and 24		Length of study	No
Secondary	Incidence of human anti-human(ocrelizumab) antibodies (HAHA)		Length of study	No
Secondary	Pharmacokinetics and Pharmacodynamics of ocrelizumab.		Length of study	No