Clinical trial NCT00779220: 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
Overall status: TERMINATED
Phase: PHASE2
Conditions: Rheumatoid Arthritis
Lead sponsor: Chugai Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2008-10-24
Enrollment: 152
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Percentage of patients with ACR20 response.
timeFrame: week 24
Secondary outcomes:
measure: Percentage of patients with ACR20, 50, and 70 response, and the components of this outcome.
timeFrame: very 4 Weeks, from Week 4 to Week 24
measure: EULAR response rate.
timeFrame: Every 4 Weeks, from Week 4 to Week 24
measure: DAS 28, HAQ-DI score.
timeFrame: Every 4 Weeks, from Week 4 to Week 24
measure: FACIT Fatigue Scale score
timeFrame: Weeks 4,12,and 24
measure: Weeks 4,12,and 24
timeFrame: Length of study
measure: Incidence of human anti-human(ocrelizumab) antibodies (HAHA)
timeFrame: Length of study
measure: Pharmacokinetics and Pharmacodynamics of ocrelizumab.
timeFrame: Length of study
Other outcomes:
Locations:
city: Chubu
country: Japan
facility: Chubu region
city: Chugoku
country: Japan
facility: Chugoku region
city: Hokkaido
country: Japan
facility: Hokkaido Region
city: Kanto
country: Japan
facility: Kanto Region
city: Kinki
country: Japan
facility: Kinki Region
city: Kyusyu
country: Japan
facility: Kyusyu region
city: Sikoku
country: Japan
facility: Sikoku region
Study officials:
affiliation: Chugai Pharmaceutical
name: Naritoshi Mochidome
role: STUDY_CHAIR
References:
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.