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A Study of the Safety and Pharmacokinetics of PRO283698 in Patients With Rheumatoid Arthritis

Primary Purpose

Rheumatoid Arthritis

Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
placebo
PRO283698
Sponsored by
Genentech, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring RA

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Investigational Site
  • Investigational Site
  • Investigational Site
  • Investigational Site
  • Investigational Site
  • Investigational Site
  • Investigational Site
  • Investigational Site
  • Investigational Site
  • Investigational Site
  • Investigational Site
  • Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

2

Arm Description

Outcomes

Primary Outcome Measures

Safety and tolerability of PRO283698 assessed through the incidence of adverse events

Secondary Outcome Measures

Pharmacokinetic parameters

Full Information

First Posted
April 27, 2009
Last Updated
November 29, 2010
Sponsor
Genentech, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00888745
Brief Title
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

2. Study Status

Record Verification Date
November 2010
Overall Recruitment Status
Completed
Study Start Date
May 2009 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Genentech, Inc.

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
Keywords
RA

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
65 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
Intravenous and subcutaneous ascending dose
Intervention Type
Drug
Intervention Name(s)
PRO283698
Intervention Description
Intravenous and subcutaneous ascending dose
Primary Outcome Measure Information:
Title
Safety and tolerability of PRO283698 assessed through the incidence of adverse events
Time Frame
Through study completion or early study discontinuation
Secondary Outcome Measure Information:
Title
Pharmacokinetic parameters
Time Frame
Following study drug administration

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
June Lee, M.D.
Organizational Affiliation
Genentech, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Investigational Site
City
Anniston
State/Province
Alabama
ZIP/Postal Code
36207
Country
United States
Facility Name
Investigational Site
City
Orlando
State/Province
Florida
ZIP/Postal Code
32804
Country
United States
Facility Name
Investigational Site
City
Ormond Beach
State/Province
Florida
ZIP/Postal Code
32174
Country
United States
Facility Name
Investigational Site
City
Palm Harbor
State/Province
Florida
ZIP/Postal Code
34684
Country
United States
Facility Name
Investigational Site
City
Idaho Falls
State/Province
Idaho
ZIP/Postal Code
83404
Country
United States
Facility Name
Investigational Site
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46227
Country
United States
Facility Name
Investigational Site
City
Frederick
State/Province
Maryland
ZIP/Postal Code
21702
Country
United States
Facility Name
Investigational Site
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73103
Country
United States
Facility Name
Investigational Site
City
Duncansville
State/Province
Pennsylvania
ZIP/Postal Code
16635
Country
United States
Facility Name
Investigational Site
City
Budapest
ZIP/Postal Code
1027
Country
Hungary
Facility Name
Investigational Site
City
Debrecen
ZIP/Postal Code
4043
Country
Hungary
Facility Name
Investigational Site
City
Szeged
ZIP/Postal Code
6720
Country
Hungary

12. IPD Sharing Statement

Citations:
PubMed Identifier
22225620
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.
Results Reference
derived

Learn more about this trial

A Study of the Safety and Pharmacokinetics of PRO283698 in Patients With Rheumatoid Arthritis

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