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NCT Number: NCT00383513

Study of Epratuzumab in Systemic Lupus Erythematosus

Epratuzumab is an investigational antibody designed to help treat Systemic Lupus Erythematosus (SLE). The purpose of the study is to obtain additional long-term information regarding the safety and efficacy of continued maintenance-cycle administrations of Epratuzumab.

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Key information

Conditions

Systemic Lupus Erythematosus Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Lupus Erythematosus, Systemic Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Birmingham, Alabama, United States

Loading trial locations.

About this study

Due to the logistical considerations, UCB has decided to consolidate the Phase II and Phase III open-label extension trials. Subjects completing this study will be offered the option of continuing to receive epratuzumab through participation in Phase III open-label extension study SL0012 (NCT01408576).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Must have participated in SL0003 or SL0004 and benefitted from participation in those studies

Exclusion criteria

  • Development of toxicity to epratuzumab
  • Significant protocol deviations during the SL0003 or SL0004 studies
  • Evidence of significant infection

Treatment and study plan

epratuzumab

Biological

360 mg/m^2 four consecutive 12-week maintenance cycles beginning with 2 consecutive weekly administrations each lasting ≤ 1 hour

Primary outcomes

  1. Number of subjects reporting at least 1 serious adverse event (SAE) from entry Visit 1 through end of treatment (approximately 6 years)

    Time frame: From Entry Visit 1 through end of treatment (approximately 6 years)

  2. Number of subjects prematurely discontinuing due to a treatment emergent adverse event (TEAE) from entry Visit 1 through end of treatment (approximately 6 years)

    Time frame: From Entry Visit 1 through end of treatment (approximately 6 years)

Secondary outcomes

  1. Time to treatment failure from First Visit through end of treatment (approximately 6 years)

    Time frame: From the first infusion of the first treatment cycle and continuing through end of treatment (approximately 6 years)

    Treatment failure is defined as initiation of a protocol specified prohibited medication.

  2. Epratuzumab plasma concentration levels at Week 0

    Time frame: Week 0

  3. Epratuzumab plasma concentration levels at Week 48

    Time frame: Week 48

  4. Epratuzumab plasma concentration levels at Week 96

    Time frame: Week 96

  5. Epratuzumab plasma concentration levels at Week 144

    Time frame: Week 144

  6. Epratuzumab plasma concentration levels at Week 192

    Time frame: Week 192

  7. Epratuzumab plasma concentration levels at Week 240

    Time frame: Week 240

  8. Subject Epratuzumab plasma concentration levels at Week 288

    Time frame: Week 288

  9. Number of subjects with anti-epratuzumab antibody in plasma at Week 0

    Time frame: Week 0

  10. Number of subjects with anti-epratuzumab antibody in plasma at Week 48

    Time frame: Week 48

  11. Number of subjects with anti-epratuzumab antibody in plasma at Week 96

    Time frame: Week 96

  12. Number of subjects with anti-epratuzumab antibody in plasma at Week 144

    Time frame: Week 144

  13. Number of subjects with anti-epratuzumab antibody in plasma at Week 192

    Time frame: Week 192

  14. Number of subjects with anti-epratuzumab antibody in plasma at Week 240

    Time frame: Week 240

  15. Number of subjects with anti-epratuzumab antibody in plasma at Week 288

    Time frame: Week 288

  16. Change From Baseline in Short Form 36-items Health Survey (SF-36) Physical Component Summary (PCS) Score

    Time frame: Baseline, Last Visit

  17. Change from Baseline in Short Form 36-items Health Survey (SF-36) Mental Composite Summary (MCS) Score

    Time frame: Baseline, Last Visit

  18. Change from Baseline in Patient's Global Assessment of Disease Activity (PtGADA)

    Time frame: Baseline, Last Visit

    Five point scale where 1 = very poor and 5 = very good.

  19. Change from Baseline in Physician's Global Assessment of Disease Activity (PGADA)

    Time frame: Baseline, Last Visit

    Five point scale where 1 = very poor and 5 = very good.

Sponsors and collaborators

Lead sponsor

UCB Pharma

Industry

Registry information

Official study title

An Open-Label Re-treatment Trial for Patients Previously Randomized Into the SL0003 and SL0004, Randomized, Double-blind, Placebo-controlled, Multi-center Studies of Epratuzumab in Patients With Systemic Lupus Erythematosus

Important dates

Study start
2006
Primary completion
2012
Study completion
2012
First posted
Oct 3, 2006
Registry last updated
Jul 12, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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