Clinical trial NCT00888745: A Study of the Safety and Pharmacokinetics of PRO283698 in Patients With Rheumatoid Arthritis
Official title: A Phase I, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial of the Safety and Pharmacokinetics of PRO283698 in Patients With Rheumatoid Arthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Rheumatoid Arthritis
Keywords: RA
Lead sponsor: Genentech, Inc.
Sponsor class: INDUSTRY
First posted: 2009-04-28
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a Phase I multicenter study that will be conducted in the United States and Europe.


Eligibility criteria: Inclusion Criteria:

* RA diagnosed according to the American College of Rheumatology (ACR)

Exclusion Criteria:

* Female patients who are pregnant, plan to become pregnant during the study, or are breastfeeding
* 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

Primary outcomes:
measure: Safety and tolerability of PRO283698 assessed through the incidence of adverse events
timeFrame: Through study completion or early study discontinuation
Secondary outcomes:
measure: Pharmacokinetic parameters
timeFrame: Following study drug administration
Other outcomes:
Locations:
city: Anniston
country: United States
facility: Investigational Site
state: Alabama
city: Orlando
country: United States
facility: Investigational Site
state: Florida
city: Ormond Beach
country: United States
facility: Investigational Site
state: Florida
city: Palm Harbor
country: United States
facility: Investigational Site
state: Florida
city: Idaho Falls
country: United States
facility: Investigational Site
state: Idaho
city: Indianapolis
country: United States
facility: Investigational Site
state: Indiana
city: Frederick
country: United States
facility: Investigational Site
state: Maryland
city: Oklahoma City
country: United States
facility: Investigational Site
state: Oklahoma
city: Duncansville
country: United States
facility: Investigational Site
state: Pennsylvania
city: Budapest
country: Hungary
facility: Investigational Site
city: Debrecen
country: Hungary
facility: Investigational Site
city: Szeged
country: Hungary
facility: Investigational Site
Study officials:
affiliation: Genentech, Inc.
name: June Lee, M.D.
role: STUDY_DIRECTOR
References:
citation: 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.