NCT00888745

Brief Summary

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

Trial Health

85
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
65

participants targeted

Target at P75+ for phase_1 rheumatoid-arthritis

Geographic Reach
2 countries

12 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 27, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 28, 2009

Completed
3 days until next milestone

Study Start

First participant enrolled

May 1, 2009

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
Last Updated

December 1, 2010

Status Verified

November 1, 2010

Enrollment Period

1.1 years

First QC Date

April 27, 2009

Last Update Submit

November 29, 2010

Conditions

Rheumatoid Arthritis

Keywords

RA

Outcome Measures

Primary Outcomes (1)

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

    Through study completion or early study discontinuation

Secondary Outcomes (1)

  • Pharmacokinetic parameters

    Following study drug administration

Study Arms (2)

1

EXPERIMENTAL
Drug: PRO283698

2

PLACEBO COMPARATOR
Drug: placebo

Interventions

placeboDRUG

Intravenous and subcutaneous ascending dose

2
PRO283698DRUG

Intravenous and subcutaneous ascending dose

1

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Investigational Site

Anniston, Alabama, 36207, United States

Location

Investigational Site

Orlando, Florida, 32804, United States

Location

Investigational Site

Ormond Beach, Florida, 32174, United States

Location

Investigational Site

Palm Harbor, Florida, 34684, United States

Location

Investigational Site

Idaho Falls, Idaho, 83404, United States

Location

Investigational Site

Indianapolis, Indiana, 46227, United States

Location

Investigational Site

Frederick, Maryland, 21702, United States

Location

Investigational Site

Oklahoma City, Oklahoma, 73103, United States

Location

Investigational Site

Duncansville, Pennsylvania, 16635, United States

Location

Investigational Site

Budapest, 1027, Hungary

Location

Investigational Site

Debrecen, 4043, Hungary

Location

Investigational Site

Szeged, 6720, Hungary

Location

Related Publications (1)

  • 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.

    PMID: 22225620DERIVED

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

pateclizumab

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • June Lee, M.D.

    Genentech, Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

April 27, 2009

First Posted

April 28, 2009

Study Start

May 1, 2009

Primary Completion

June 1, 2010

Last Updated

December 1, 2010

Record last verified: 2010-11

Locations

US(9)HU(3)