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

Completed · Phase 1 · Has a placebo group

Conditions studied: Rheumatoid Arthritis

In brief

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

Key facts

Study ID

NCT00888745

Run by

Genentech, Inc.

People needed

65

Starts

2009-05-01

Last updated by the study team

2010-12-01

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

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

Full record on ClinicalTrials.gov

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