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A Phase 2 Study to Evaluate the Safety, Tolerability, and Activity of Fontolizumab in Subjects With Active Rheumatoid Arthritis

NCT00281294 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2008-08-05

No results posted yet for this study

Summary

To evaluate the efficacy of fontolizumab in subjects with active rheumatoid arthritis as determined by a 50% improvement of an American College of Rheumatology criteria (ACR50) response at Week 14 (Stage A of study).

Conditions

  • Arthritis, Rheumatoid

Interventions

DRUG

Fontolizumab

Sponsors & Collaborators

  • PDL BioPharma, Inc.

    lead INDUSTRY

Principal Investigators

  • Mark C. Genovese, MD · Stanford University Medical Center-Div. of Rheumatology

  • Jerry Molitor, MD, PhD · Benaroya Research Institute at Virginia Mason

  • Michael H. Schiff, MD · Denver Arthritis Clinic

  • Alan Kivitz, MD · Altoona Center for Clinical Research

  • Craig Wiesenhutter, MD · Coeur d Alene Arthritis Clinic

  • Justus J. Fiechtner, MD · Justus Fiechtner MD PC

  • Daniel Wallace, MD · Wallace Rheumatic Study Center

  • Joel Kremer, MD · The Center for Rheumatology

  • Robert S. Katz, MD · Rheumatology Associates Clinical Research

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-12-31
Completion
2006-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00281294 on ClinicalTrials.gov