Rheumatoid Arthritis
Conditions
Keywords
RA
Brief summary
This is a Phase I multicenter study that will be conducted in the United States and Europe.
Interventions
DRUGplacebo
Intravenous and subcutaneous ascending dose
DRUGPRO283698
Intravenous and subcutaneous ascending dose
Sponsors
Genentech, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and tolerability of PRO283698 assessed through the incidence of adverse events | Through study completion or early study discontinuation |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetic parameters | Following study drug administration |
Countries
Hungary, United States
Outcome results
None listed