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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Genentech, Inc.

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