CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 183 enrolled
Drug / intervention
Abatacept +3 moredrug
Likely dose
Abatacept 10 mg/kg intravenously every 28 days for 12 monthsAI-extracted
Key inclusion· 2
  • ✓Diagnosed with SLE and experiencing an active lupus flare in at least one of three organ systems: skin (discoid lesions), pericarditis, or pleuritis; or inflammation of more than 4 joints within 14 days of screening
  • ✓Stable prednisone dose <30 mg/day for at least one month prior to study entry
Key exclusion· 5
  • ✕Active lupus flare involving the kidney or central nervous system
  • ✕Treatment with azathioprine, mycophenolate mofetil, hydroxychloroquine, chloroquine, or methotrexate for less than three months prior to study
  • ✕Active viral or bacterial infections
  • ✕Any other autoimmune disease as a main diagnosis

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

Search/NCT00119678
NCT00119678Phase 2Completed
CompareCT.gov

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

Bristol-Myers Squibb·interventional·Posted Jul 14, 2005·Updated Sep 22, 2014

In Brief

A Phase 2 clinical trial evaluating Abatacept, Placebo, and 1 other intervention for Systemic Lupus Erythematosus. Completed, enrolled 183 participants across 52 sites in 15 countries.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSystemic Lupus Erythematosus
CountriesAustralia, Austria, Belgium, Brazil, Canada, France, Germany, Italy, Mexico, Puerto Rico, South Africa, South Korea, Taiwan, United Kingdom, United States
Collaborators--

Timeline

Phase 2CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 14, 2005
Enrollment StartSep 1, 2005
Primary CompletionNov 1, 2008
TodayJul 2, 2026
Enrollment to primary: 3.2 yearsPosted 21.0 years ago

Interventions

Abataceptdrug

Injectable, intravenous, 10 mg/kg, abatacept every 28 days, 12 months

Placebodrug

Injectable, intravenous, 0 mg, every 28 days, 12 months

Prednisonedrug

Tablets, oral, 30 mg, daily for 28 days then taper off, 12 months

Abataceptdrug

Injectable, intravenous, 10 mg/kg, every 28 days