PsA Treatment With hOKT3γ1 (Ala-Ala)

NCT00239720 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 4

Last updated 2017-04-27

Study results available
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Summary

hOKT3gamma1 (Ala-Ala) is a man-made antibody that is commonly used to prevent organ rejection. The purpose of this study is to determine whether hOKT3gamma1 (Ala-Ala) is safe and effective in psoriatic arthritis patients who are unable to control their arthritis with methotrexate or azathioprine.

Conditions

  • Arthritis, Psoriatic

Interventions

DRUG

hOKT3gamma1(Ala-Ala)

Escalating dose given IV over 5 days (1mg, 2mg, 4mg on days 3-5) of each 28 day cycle

DRUG

Placebo

Intravenous dose of placebo given over 5 days of each 28 day cycle

Sponsors & Collaborators

  • Immune Tolerance Network (ITN)

    collaborator NETWORK
  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Marcus Clark, MD · University of Chicago

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-03-16
Primary Completion
2006-12-31
Completion
2008-06-25

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT00239720 on ClinicalTrials.gov