NCT00888745

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

Completed Phase 1 Last updated 29 November 2010

What this trial tests

Phase 1 trial testing placebo in Rheumatoid Arthritis in 65 participants. Completed.

Timeline

1 May 2009

Primary endpoint
1 June 2010

Quick facts

Lead sponsor	Genentech, Inc.
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	65
Start date	1 May 2009
Primary completion	1 June 2010
Sites	12 locations across United States, Hungary

Drugs / interventions tested

• placebo
• PRO283698 — full drug profile →

Conditions studied

• Rheumatoid Arthritis — all drugs for Rheumatoid Arthritis →

Sponsor

Genentech, Inc. — full company profile →

Who can join

Adults 18 to 75, any sex, with Rheumatoid Arthritis. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Safety and tolerability of PRO283698 assessed through the incidence of adverse events
  Time frame: Through study completion or early study discontinuation

Sponsor's own description

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

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Safety, pharmacokinetics, and biologic activity of pateclizumab, a novel monoclonal antibody targeting lymphotoxin α: results of a phase I randomized, placebo-controlled trial.
   Emu B, Luca D, Offutt C, Grogan JL, et al · · 2012 · cited 26× · PMID 22225620 · DOI 10.1186/ar3554