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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00888745
• Date of registration: 27/04/2009
• Prospective Registration: Yes
• Primary sponsor: Genentech, Inc.
• Public title: A Study of the Safety and Pharmacokinetics of PRO283698 in Patients With Rheumatoid Arthritis
• Scientific title: A Phase I, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial of the Safety and Pharmacokinetics of PRO283698 in Patients With Rheumatoid Arthritis
• Date of first enrolment: May 2009
• Target sample size: 65
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00888745
• Study type: Interventional
• Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
• Phase: Phase 1

Countries of recruitment

Hungary, United Kingdom, United States

Contacts

• Name: June Lee, M.D.
• Affiliation: Genentech, Inc.

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 75 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Rheumatoid Arthritis

Intervention(s)

Drug: placebo

Drug: PRO283698

Primary Outcome(s)

Safety and tolerability of PRO283698 assessed through the incidence of adverse events [Time Frame: Through study completion or early study discontinuation]

Secondary Outcome(s)

Pharmacokinetic parameters [Time Frame: Following study drug administration]

Secondary ID(s)

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Source(s) of Monetary Support

Please refer to primary and secondary sponsors