Abatacept in the Treatment and Prevention of Active Systemic Lupus Erythematosus (SLE) Flares in Combination With Prednisone - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields

Brief Title ^†

Abatacept in the Treatment and Prevention of Active Systemic Lupus Erythematosus (SLE) Flares in Combination With Prednisone

Official Title ^†

A Phase IIB, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Abatacept vs Placebo on a Background of Oral Glucocorticosteroids in the Treatment of Subjects With Systemic Lupus Erythematosus and the Prevention of Subsequent Lupus Flares

Brief Summary

The purpose of this clinical research study is to learn whether Abatacept can treat and prevent lupus flares; specifically, active lupus flares in at least one of three organ systems: skin (discoid lesions), inflammation of the lining of the heart (pericarditis), or inflammation of the lining of the lung (pleuritis/pleurisy); or inflammation of more than 4 joints. All subjects will receive prednisone or prednisone-equivalent treatment in combination with study medication. The safety of this treatment will also be studied.

Detailed Description

Study Phase

Phase II

Study Type ^†

Interventional

Study Design ^†

Prevention, Randomized, Double Blind (Subject, Investigator), Placebo Control, Single Group Assignment, Safety/Efficacy Study

Primary Outcome Measure ^†

The primary objective of this study will be to assess the proportion of subjects with new clinical flare of SLE (BILAG "A" or "B") [ Time Frame: during the 1 year double-blind treatment period ] [ Designated as safety issue: No ]

Secondary Outcome Measure ^†

Assess proportion of subjects with a new clinical flare of SLE (BILAG A or B) [ Time Frame: within the initial 6 months of the double-blind treatment period ] [ Designated as safety issue: No ]
Evaluate the proportion of subjects who experienced a BILAG A or B flare. [ Time Frame: during the study ] [ Designated as safety issue: No ]

Condition ^†

Systemic Lupus Erythematosus

Intervention ^†

Drug: Abatacept+Prednisone
Drug: Placebo + Prednisone

MEDLINE PMIDs

Links

BMS Clinical Trials Disclosure This link exits the ClinicalTrials.gov site

For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm This link exits the ClinicalTrials.gov site

Recruitment Information Fields

Recruitment Status ^†

Completed

Enrollment ^†

180

Start Date ^†

September 2005

Completion Date

November 2007

Eligibility Criteria ^†

Inclusion Criteria:

Subjects must be diagnosed with SLE and be experiencing an active lupus flare in at least one of three organ systems: skin (discoid lesions), inflammation of the lining of the heart (pericarditis), or inflammation of the lining of the lung (pleuritis/pleurisy); or inflammation of more than 4 joints within 14 days of a screening visit.
Stable dose of prednisone (<30mg) for at least one month.

Exclusion Criteria:

Subjects experiencing an active lupus flare in the kidney or central nervous systems.
Treatment with a stable dose of azathioprine, mycophenolate mofetil, hydroxychloroquine, chloroquine, or methotrexate for less than three months prior to the study.
Subjects with active viral or bacterial infections.
Subjects with any other autoimmune disease as a main diagnosis.
Prior treatment with rituximab.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

United States, Australia, Austria, Belgium, Brazil, Canada, France, Germany, Italy, Korea, Republic of, Mexico, Puerto Rico, South Africa, Taiwan, United Kingdom

Administrative Information Fields

NCT ID ^†

NCT00119678

Organization ID

IM101-042

Secondary IDs ^††

Study Sponsor ^†

Bristol-Myers Squibb

Collaborators ^††

Investigators ^†

Study Director:

Bristol-Myers Squibb

Information Provided By

Bristol-Myers Squibb

Verification Date

August 2008

First Received Date ^†

June 30, 2005

Last Updated Date

August 1, 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.