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A Study to Evaluate the Safety of Escalating Doses of Ocrelizumab in Subjects With Rheumatoid Arthritis

Primary Purpose

Rheumatoid Arthritis

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
ocrelizumab
Sponsored by
Genentech, Inc.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring Moderate to severe rheumatoid arthritis

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Ability and willingness to provide written informed consent and to comply with the requirements of the protocol Diagnosis of RA for at least 6 months according to the revised 1987 ACR criteria for the classification of RA Positive serum RF Current treatment for RA on an outpatient basis Contact your local site that is listed for more inclusion criteria Exclusion Criteria: Bone or joint surgery (including joint fusion) within 8 weeks prior to screening or joint surgery planned within 24 weeks after randomization Rheumatic autoimmune disease other than RA or significant systemic involvement secondary to RA (e.g., vasculitis, pulmonary fibrosis, or Felty�s syndrome) 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 rheumatic disorders (e.g., systemic lupus erythematosus, inflammatory bowel disease, scleroderma, inflammatory myopathy, overlap syndrome) Contact your local site that is listed for more exclusion criteria

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Safety and tolerability of ocrelizumab in subjects with moderate to severe RA

    Secondary Outcome Measures

    Pharmacokinetics of ocrelizumab
    Pharmacodynamics of ocrelizumab
    Percentage of subjects with clinical responses according to American College of Rheumatology (ACR) criteria

    Full Information

    First Posted
    February 12, 2004
    Last Updated
    September 1, 2009
    Sponsor
    Genentech, Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00077870
    Brief Title
    A Study to Evaluate the Safety of Escalating Doses of Ocrelizumab in Subjects With Rheumatoid Arthritis
    Official Title
    A Randomized, Placebo-Controlled, Multicenter, Blinded Phase I/II Study of the Safety of Escalating Doses of Ocrelizumab (PRO70769) in Subjects With Moderate to Severe Rheumatoid Arthritis Receiving Stable Doses of Concomitant Methotrexate
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2009
    Overall Recruitment Status
    Completed
    Study Start Date
    February 2004 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    December 2006 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Genentech, Inc.

    4. Oversight

    5. Study Description

    Brief Summary
    This is a randomized, placebo-controlled, multicenter, blinded Phase I/II, investigator and subject-blinded study of the safety of escalating doses of ocrelizumab in combination with MTX in subjects with moderate to severe RA

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Rheumatoid Arthritis
    Keywords
    Moderate to severe rheumatoid arthritis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1, Phase 2
    Enrollment
    237 (false)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    ocrelizumab
    Primary Outcome Measure Information:
    Title
    Safety and tolerability of ocrelizumab in subjects with moderate to severe RA
    Secondary Outcome Measure Information:
    Title
    Pharmacokinetics of ocrelizumab
    Title
    Pharmacodynamics of ocrelizumab
    Title
    Percentage of subjects with clinical responses according to American College of Rheumatology (ACR) criteria

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Ability and willingness to provide written informed consent and to comply with the requirements of the protocol Diagnosis of RA for at least 6 months according to the revised 1987 ACR criteria for the classification of RA Positive serum RF Current treatment for RA on an outpatient basis Contact your local site that is listed for more inclusion criteria Exclusion Criteria: Bone or joint surgery (including joint fusion) within 8 weeks prior to screening or joint surgery planned within 24 weeks after randomization Rheumatic autoimmune disease other than RA or significant systemic involvement secondary to RA (e.g., vasculitis, pulmonary fibrosis, or Felty�s syndrome) 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 rheumatic disorders (e.g., systemic lupus erythematosus, inflammatory bowel disease, scleroderma, inflammatory myopathy, overlap syndrome) Contact your local site that is listed for more exclusion criteria
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Wolfgang Dummer, M.D.
    Organizational Affiliation
    Genentech, Inc.
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    18759293
    Citation
    Genovese MC, Kaine JL, Lowenstein MB, Del Giudice J, Baldassare A, Schechtman J, Fudman E, Kohen M, Gujrathi S, Trapp RG, Sweiss NJ, Spaniolo G, Dummer W; ACTION Study Group. Ocrelizumab, a humanized anti-CD20 monoclonal antibody, in the treatment of patients with rheumatoid arthritis: a phase I/II randomized, blinded, placebo-controlled, dose-ranging study. Arthritis Rheum. 2008 Sep;58(9):2652-61. doi: 10.1002/art.23732.
    Results Reference
    result

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    A Study to Evaluate the Safety of Escalating Doses of Ocrelizumab in Subjects With Rheumatoid Arthritis

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