Rheumatoid Arthritis Clinical Trial
Official title:
A Phase I, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial of the Safety and Pharmacokinetics of PRO283698 in Patients With Rheumatoid Arthritis
NCT number | NCT00888745 |
Other study ID # | []4623g |
Secondary ID | |
Status | Completed |
Phase | Phase 1 |
First received | April 27, 2009 |
Last updated | November 29, 2010 |
Start date | May 2009 |
Verified date | November 2010 |
Source | Genentech, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
This is a Phase I multicenter study that will be conducted in the United States and Europe.
Status | Completed |
Enrollment | 65 |
Est. completion date | |
Est. primary completion date | June 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 75 Years |
Eligibility |
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 |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Hungary | Investigational Site | Budapest | |
Hungary | Investigational Site | Debrecen | |
Hungary | Investigational Site | Szeged | |
United States | Investigational Site | Anniston | Alabama |
United States | Investigational Site | Duncansville | Pennsylvania |
United States | Investigational Site | Frederick | Maryland |
United States | Investigational Site | Idaho Falls | Idaho |
United States | Investigational Site | Indianapolis | Indiana |
United States | Investigational Site | Oklahoma City | Oklahoma |
United States | Investigational Site | Orlando | Florida |
United States | Investigational Site | Ormond Beach | Florida |
United States | Investigational Site | Palm Harbor | Florida |
Lead Sponsor | Collaborator |
---|---|
Genentech, Inc. |
United States, Hungary,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Safety and tolerability of PRO283698 assessed through the incidence of adverse events | Through study completion or early study discontinuation | ||
Secondary | Pharmacokinetic parameters | Following study drug administration |
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