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Completed

NCT Number: NCT00888745

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

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

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Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Investigational Site, Budapest, Hungary

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placebo

Drug

Intravenous and subcutaneous ascending dose

PRO283698

Drug

Intravenous and subcutaneous ascending dose

Primary outcomes

  1. Safety and tolerability of PRO283698 assessed through the incidence of adverse events

    Time frame: Through study completion or early study discontinuation

Secondary outcomes

  1. Pharmacokinetic parameters

    Time frame: Following study drug administration

Sponsors and collaborators

Lead sponsor

Genentech, Inc.

Industry

Registry information

Official study title

A Phase I, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial of the Safety and Pharmacokinetics of PRO283698 in Patients With Rheumatoid Arthritis

Important dates

Study start
2009
Primary completion
2010
First posted
Apr 28, 2009
Registry last updated
Dec 1, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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