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

This study has been completed.
Sponsor:
Information provided by:
Genentech
ClinicalTrials.gov Identifier:
NCT00888745
First received: April 27, 2009
Last updated: November 29, 2010
Last verified: November 2010
History of Changes
  Purpose

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


Condition Intervention Phase
Rheumatoid Arthritis
 Drug: placebo
Drug: PRO283698
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Phase I, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial of the Safety and Pharmacokinetics of PRO283698 in Patients With Rheumatoid Arthritis

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Genentech:

Primary Outcome Measures:
  • Safety and tolerability of PRO283698 assessed through the incidence of adverse events [ Time Frame: Through study completion or early study discontinuation ]

Secondary Outcome Measures:
  • Pharmacokinetic parameters [ Time Frame: Following study drug administration ]

Enrollment: 65
Study Start Date: May 2009
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: PRO283698
Intravenous and subcutaneous ascending dose
Placebo Comparator: 2 Drug: placebo
Intravenous and subcutaneous ascending dose

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00888745

Locations
United States, Alabama
Investigational Site
Anniston, Alabama, United States, 36207
United States, Florida
Investigational Site
Orlando, Florida, United States, 32804
Investigational Site
Ormond Beach, Florida, United States, 32174
Investigational Site
Palm Harbor, Florida, United States, 34684
United States, Idaho
Investigational Site
Idaho Falls, Idaho, United States, 83404
United States, Indiana
Investigational Site
Indianapolis, Indiana, United States, 46227
United States, Maryland
Investigational Site
Frederick, Maryland, United States, 21702
United States, Oklahoma
Investigational Site
Oklahoma City, Oklahoma, United States, 73103
United States, Pennsylvania
Investigational Site
Duncansville, Pennsylvania, United States, 16635
Hungary
Investigational Site
Budapest, Hungary, 1027
Investigational Site
Debrecen, Hungary, 4043
Investigational Site
Szeged, Hungary, 6720
Sponsors and Collaborators
Genentech
Investigators
Study Director: June Lee, M.D. Genentech
  More Information

No publications provided by Genentech

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Disclosures Group, Genentech, Inc.
ClinicalTrials.gov Identifier: NCT00888745     History of Changes
Other Study ID Numbers: []4623g
Study First Received: April 27, 2009
Last Updated: November 29, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Genentech:
RA

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
 Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on June 18, 2013