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

Rheumatoid Arthritis Clinical Trial

Official title:

A Phase I, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial of the Safety and Pharmacokinetics of PRO283698 in Patients With Rheumatoid Arthritis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00888745
• Other study ID #: []4623g
• Status: Completed
• Phase: Phase 1
• First received: April 27, 2009
• Last updated: November 29, 2010
• Start date: May 2009

Study information

• Verified date: November 2010
• Source: Genentech, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• placebo
Intravenous and subcutaneous ascending dose
• PRO283698
Intravenous and subcutaneous ascending dose

Locations

Country	Name	City	State
Hungary	Investigational Site	Budapest
Hungary	Investigational Site	Debrecen
Hungary	Investigational Site	Szeged
United States	Investigational Site	Anniston	Alabama
United States	Investigational Site	Duncansville	Pennsylvania
United States	Investigational Site	Frederick	Maryland
United States	Investigational Site	Idaho Falls	Idaho
United States	Investigational Site	Indianapolis	Indiana
United States	Investigational Site	Oklahoma City	Oklahoma
United States	Investigational Site	Orlando	Florida
United States	Investigational Site	Ormond Beach	Florida
United States	Investigational Site	Palm Harbor	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Genentech, Inc.

Countries where clinical trial is conducted

United States,  Hungary, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and tolerability of PRO283698 assessed through the incidence of adverse events		Through study completion or early study discontinuation
Secondary	Pharmacokinetic parameters		Following study drug administration