CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 118 enrolled
Drug / intervention
Sifalimumabdrug
Likely dose
Sifalimumab 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/NCT00979654
NCT00979654Phase 2Completed
CompareCT.gov

A Phase 2 Open-label Study to Evaluate the Long-term Safety of Sifalimumab in Adult Subjects With Systemic Lupus Erythematosus or Myositis

MedImmune LLC·interventional·Posted Sep 18, 2009·Updated Oct 27, 2016

In Brief

A Phase 2 clinical trial evaluating Sifalimumab for Systemic Lupus Erythematosus. Completed, enrolled 118 participants across 28 sites in 4 countries.

Detailed Summary

The objective of this study is to assess the safety and tolerability of sifalimumab in adult participants with active systemic lupus erythematosus (SLE) or active dermatomyositis (DM) or polymyositis (PM) who participated in the following clinical studies: MI-CP151, MI-CP152, or MI-CP179.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSystemic Lupus Erythematosus
CountriesBrazil, Canada, Chile, United States
CollaboratorsPPD Development, LP

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedSep 18, 2009
Enrollment StartAug 1, 2010
Primary CompletionMar 1, 2015
TodayJul 2, 2026
Enrollment to primary: 4.6 yearsPosted 16.8 years ago

Interventions

Sifalimumabdrug

All participants will receive intravenous (IV) sifalimumab as fixed dose of 500 mg every 2 weeks (Q2W) on Day 1, Week 2, and Week 4, then every 4 weeks (Q4W) thereafter for a total of 156 weeks. The initial fixed dose of 500 mg is increased to 600 mg with subsequent protocol amendment.