A Study of the Safety and Pharmacokinetics of PRO283698 in Patients With Rheumatoid Arthritis
NCT ID: NCT00888745
Last Updated: 2010-12-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
65 participants
INTERVENTIONAL
2009-05-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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1
PRO283698
Intravenous and subcutaneous ascending dose
2
placebo
Intravenous and subcutaneous ascending dose
Interventions
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placebo
Intravenous and subcutaneous ascending dose
PRO283698
Intravenous and subcutaneous ascending dose
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Clinically significant abnormal ECG
* History of anaphylactic reactions
* Positive hepatitis C antibody or hepatitis B surface antigen
* Positive serology for human immunodeficiency virus (HIV) by quantitative polymerase chain reaction
* A history of an autoimmune disease other than RA (other than secondary Sjogren syndrome)
* Significant systemic involvement of RA, including vasculitis, pulmonary fibrosis, or Felty syndrome
* Malignancy, or prior malignancy, other than non-melanoma skin cancer, or cervical carcinoma in situ that has been resected
* Recent administration of a live, attenuated vaccine, or anticipation that such a live attenuated vaccine will be required during the study or within 60 days after the last dose
* Concomitant therapy with a biologic agent
* Recent exposure to any investigational agent
* Any current or recent signs or symptoms of infection requiring parenteral antibiotic administration
* Hospitalization for a clinically relevant event within the 4 weeks prior to screening
18 Years
75 Years
ALL
No
Sponsors
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Genentech, Inc.
INDUSTRY
Responsible Party
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Genentech, Inc.
Principal Investigators
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June Lee, M.D.
Role: STUDY_DIRECTOR
Genentech, Inc.
Locations
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Investigational Site
Anniston, Alabama, United States
Investigational Site
Orlando, Florida, United States
Investigational Site
Ormond Beach, Florida, United States
Investigational Site
Palm Harbor, Florida, United States
Investigational Site
Idaho Falls, Idaho, United States
Investigational Site
Indianapolis, Indiana, United States
Investigational Site
Frederick, Maryland, United States
Investigational Site
Oklahoma City, Oklahoma, United States
Investigational Site
Duncansville, Pennsylvania, United States
Investigational Site
Budapest, , Hungary
Investigational Site
Debrecen, , Hungary
Investigational Site
Szeged, , Hungary
Countries
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References
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Emu B, Luca D, Offutt C, Grogan JL, Rojkovich B, Williams MB, Tang MT, Xiao J, Lee JH, Davis JC. Safety, pharmacokinetics, and biologic activity of pateclizumab, a novel monoclonal antibody targeting lymphotoxin alpha: results of a phase I randomized, placebo-controlled trial. Arthritis Res Ther. 2012 Jan 8;14(1):R6. doi: 10.1186/ar3554.
Other Identifiers
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[]4623g
Identifier Type: -
Identifier Source: org_study_id