Status:
COMPLETED
A Study of the Safety and Pharmacokinetics of PRO283698 in Patients With Rheumatoid Arthritis
Lead Sponsor:
Genentech, Inc.
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief Summary
This is a Phase I multicenter study that will be conducted in the United States and Europe.
Eligibility Criteria
Inclusion
- RA diagnosed according to the American College of Rheumatology (ACR)
Exclusion
- 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
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
65 Patients enrolled
Trial Details
Trial ID
NCT00888745
Start Date
May 1 2009
Last Update
December 1 2010
Active Locations (12)
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1
Investigational Site
Anniston, Alabama, United States, 36207
2
Investigational Site
Orlando, Florida, United States, 32804
3
Investigational Site
Ormond Beach, Florida, United States, 32174
4
Investigational Site
Palm Harbor, Florida, United States, 34684