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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00888745
Recruitment Status : Completed
First Posted : April 28, 2009
Last Update Posted : December 1, 2010
Information provided by:
Genentech, Inc.

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

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Drug: placebo Drug: PRO283698 Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 65 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : May 2009
Actual Primary Completion Date : June 2010

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 1 Drug: PRO283698
Intravenous and subcutaneous ascending dose

Placebo Comparator: 2 Drug: placebo
Intravenous and subcutaneous ascending dose

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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00888745

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
Investigational Site
Budapest, Hungary, 1027
Investigational Site
Debrecen, Hungary, 4043
Investigational Site
Szeged, Hungary, 6720
Sponsors and Collaborators
Genentech, Inc.
Study Director: June Lee, M.D. Genentech, Inc.

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Disclosures Group, Genentech, Inc. Identifier: NCT00888745     History of Changes
Other Study ID Numbers: []4623g
First Posted: April 28, 2009    Key Record Dates
Last Update Posted: December 1, 2010
Last Verified: November 2010

Keywords provided by Genentech, Inc.:

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