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

Genentech

Status and phase

Completed

Phase 1

Conditions

Rheumatoid Arthritis

Treatments

Drug: placebo

Drug: PRO283698

Study type

Interventional

Funder types

Industry

Identifiers

[]4623g

Details and patient eligibility

About

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

Enrollment

65 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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