CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 20 enrolled
Drug / intervention
Abataceptdrug
Likely dose
Abatacept 500 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00468208
NCT00468208Phase 2Completed
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A Multi-Center, Open-label Pilot Study of Abatacept (CTLA4-Ig) in the Treatment of Mild Relapsing Wegener's Granulomatosis

University of Pennsylvania·interventional·Posted May 2, 2007·Updated Jan 18, 2016

In Brief

A Phase 2 clinical trial evaluating Abatacept for Wegener's Granulomatosis. Completed, enrolled 20 participants across 4 sites.

Detailed Summary

Wegener's granulomatosis (WG) is a rare disease that causes inflammation of blood vessels, or vasculitis. It may involve many different parts of the body, but typically affects the upper and lower respiratory tract and kidneys. The purpose of this study is to determine the safety and effectiveness of the medication abatacept in treating adults with mild relapsing WG.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsWegener's Granulomatosis
CountriesUnited States
CollaboratorsOffice of Rare Diseases (ORD), National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), Rare Diseases Clinical Research Network

Timeline

Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 2, 2007
Enrollment StartFeb 1, 2008
Primary CompletionAug 1, 2011
TodayJul 2, 2026
Enrollment to primary: 3.5 yearsPosted 19.2 years ago

Interventions

Abataceptdrug

A participant's abatacept dose depended on body weight and will remain the same throughout the study: * 500 mg of abatacept for body weight less than 60 kg * 750 mg of abatacept for body weight between 60 and 100 kg * 1000 mg of abatacept for body weight greater than 100 kg Abatacept is administered in a 30-minute intravenous infusion.