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

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ClinicalTrials.gov Identifier: NCT00779220
Recruitment Status : Terminated
First Posted : October 24, 2008
Last Update Posted : March 25, 2015
Sponsor:
Information provided by (Responsible Party):
Chugai Pharmaceutical

October 23, 2008
October 24, 2008
March 25, 2015
October 2008
February 2010   (Final data collection date for primary outcome measure)
Percentage of patients with ACR20 response. [ Time Frame: week 24 ]
Same as current
Complete list of historical versions of study NCT00779220 on ClinicalTrials.gov Archive Site
  • 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 ]
  • EULAR response rate. [ Time Frame: Every 4 Weeks, from Week 4 to Week 24 ]
  • DAS 28, HAQ-DI score. [ Time Frame: Every 4 Weeks, from Week 4 to Week 24 ]
  • FACIT Fatigue Scale score [ Time Frame: Weeks 4,12,and 24 ]
  • Weeks 4,12,and 24 [ Time Frame: Length of study ]
  • Incidence of human anti-human(ocrelizumab) antibodies (HAHA) [ Time Frame: Length of study ]
  • Pharmacokinetics and Pharmacodynamics of ocrelizumab. [ Time Frame: Length of study ]
Same as current
Not Provided
Not Provided
 
A Study to Evaluate the Efficacy, Safety and Pharmacokinetics/Pharmacodynamics (PK/PD) of Ocrelizumab in Patients With Rheumatoid Arthritis
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
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.
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.
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Rheumatoid Arthritis
  • Drug: placebo
    Intravenous repeating dose
  • Drug: methotrexate
    Oral repeating dose
  • Drug: ocrelizumabu 50mg
    Intravenous repeating dose (50mg)
  • Drug: ocrelizumabu 200mg
    Intravenous repeating dose (200mg)
  • Drug: ocrelizumab 500mg
    Intravenous repeating dose (500mg)
  • Placebo Comparator: 1
    Interventions:
    • Drug: placebo
    • Drug: methotrexate
  • Experimental: 2
    Interventions:
    • Drug: methotrexate
    • Drug: ocrelizumabu 50mg
  • Experimental: 3
    Interventions:
    • Drug: methotrexate
    • Drug: ocrelizumabu 200mg
  • Experimental: 4:
    Interventions:
    • Drug: methotrexate
    • Drug: ocrelizumab 500mg
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
152
200
March 2015
February 2010   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
20 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
 
NCT00779220
JA21963
No
Not Provided
Not Provided
Chugai Pharmaceutical
Chugai Pharmaceutical
Not Provided
Study Chair: Naritoshi Mochidome Chugai Pharmaceutical
Chugai Pharmaceutical
March 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP