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

Purpose

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.

Condition	Intervention	Phase
Systemic Lupus Erythematosus	Drug: Abatacept+Prednisone Drug: Placebo + Prednisone	Phase II

MedlinePlus related topics:

Lupus

Drug Information available for:

Prednisone Abatacept

U.S. FDA Resources

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

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

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:

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 Measures:

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 ]

Estimated Enrollment:	180
Study Start Date:	September 2005
Study Completion Date:	November 2007
Primary Completion Date:	November 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A1: Active Comparator	Drug: Abatacept+Prednisone Injectable + tablets, intravenous + oral, abatacept 10mg/kg prednisone 30mg, abatacept every 28 days prednisone daily for 28 days then taper, 12 months.
A2: Placebo Comparator	Drug: Placebo + Prednisone Injectable + tablets, intravenous + oral, placebo & prednisone 30mg, placebo every 28 days prednisone daily for 28 days then taper, 12 months.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00119678

Show 52 Study Locations

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators


Study Director:	Bristol-Myers Squibb	Bristol-Myers Squibb

More Information

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

Responsible Party:	Bristol-Myers Squibb ( Study Director )
Study ID Numbers:	IM101-042
First Received:	June 30, 2005
Last Updated:	August 1, 2008
ClinicalTrials.gov Identifier:	NCT00119678
Health Authority:	United States: Food and Drug Administration

Keywords provided by Bristol-Myers Squibb:

SLE

Study placed in the following topic categories:

Prednisone

Abatacept

Autoimmune Diseases

Lupus Erythematosus, Systemic

Connective Tissue Diseases

Additional relevant MeSH terms:

Anti-Inflammatory Agents

Immune System Diseases

Antineoplastic Agents, Hormonal

Immunologic Factors

Antineoplastic Agents

Physiological Effects of Drugs

Hormones, Hormone Substitutes, and Hormone Antagonists

Glucocorticoids

Hormones

Immunosuppressive Agents

Pharmacologic Actions

Therapeutic Uses

Antirheumatic Agents

ClinicalTrials.gov processed this record on November 19, 2008

Sponsored by:	Bristol-Myers Squibb
Information provided by:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00119678