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

Bristol-Myers Squibb (BMS) logo

Bristol-Myers Squibb (BMS)

Status and phase

Completed
Phase 2

Conditions

Systemic Lupus Erythematosus

Treatments

Drug: Abatacept
Drug: Prednisone
Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT00119678
IM101-042

Details and patient eligibility

About

The purpose of this clinical research study is to learn whether Abatacept can treat and prevent lupus flares; specifically, in patients with 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 (arthritis). All participants will receive prednisone or prednisone-equivalent treatment in combination with study medication. The safety of this treatment will also be studied.

Enrollment

183 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • participants 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 (arthritis)
  • Stable dose of prednisone (<30mg) for at least one month

Exclusion criteria

  • participants 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
  • participants with active viral or bacterial infections
  • participants with any other autoimmune disease as a main diagnosis
  • Prior treatment with rituximab

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

Double Blind

183 participants in 3 patient groups, including a placebo group

Abatacept + Prednisone
Active Comparator group
Description:
Double Blind Period
Treatment:
Drug: Abatacept
Drug: Prednisone
Drug: Abatacept
Placebo + Prednisone
Placebo Comparator group
Description:
Double Blind Period
Treatment:
Drug: Prednisone
Drug: Placebo
Abatacept
Experimental group
Description:
Open Label
Treatment:
Drug: Abatacept
Drug: Abatacept

Trial contacts and locations

52

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Data sourced from clinicaltrials.gov

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