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Completed

NCT Number: NCT00624351

Study of Epratuzumab in Serologically-positive Systemic Lupus Erythematosus (SLE) Patients With Active Disease

The primary objective of the study is to assess the dose response and the dose frequency of epratuzumab in patients with SLE.

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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

Brussels, Belgium

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Positive ANA result at visit 1
  • Current diagnosis of systemic lupus erythematosus (SLE) by American College of Rheumatology revised criteria such that at least 4 of the 11 criteria are met
  • Active moderate or severe SLE disease activity as demonstrated by British Isles Lupus Assessment Group (BILAG) A level disease activity in at least one body/organ system or BILAG B level disease activity in at least two body/organ systems if no BILAG A level disease is present
  • If on antimalarials, dose regimen must be stable for 4 weeks prior to study entry.

Exclusion criteria

  • Patients receiving any live vaccination within 2 weeks prior to visit 1 or during the course of the study
  • Active severe SLE disease activity which involves the central nervous system (CNS) (defined by BILAG neurologic A level activity) including transverse myelitis, psychosis and seizures
  • Active severe SLE disease activity which involves the Renal system (defined by BILAG renal level A activity or Grade III or higher World Health Organization (WHO) nephritis) or serum creatinine >2.5mg/dL or clinically significant serum creatinine increase within the prior 4 weeks or proteinuria >3.5gm/day
  • Patients with a history of anti-phospholipid antibody syndrome AND use of oral anticoagulants or anti-platelet treatment
  • Patients with a history of chronic infection, recent significant infection, or any current sign of symptom that may indicate an infection

Treatment and study plan

epratuzumab

Biological

Epratuzumab at a concentration of 10 mg/mL prepared in 17.5 ml vials for slow intravenous infusion using only Phosphate buffered Saline (PBS) as a vehicle/buffer for the infusion procedure.

Placebo

Other

Phosphate-buffered Saline (PBS) infusion.

Primary outcomes

  1. Response at Week 12 according to a combined response index

    Time frame: Week 12

    The combined response index incorporates the Bristish Isles Lupus Assessment Group (BILAG) assessment, the Systemic Lupus Eyrthematosus Disease Activity Index (SLEDAI), a physician's global assessment of disease activity, and treatment failure status.

Secondary outcomes

  1. Response at Week 4 according to a combined response index

    Time frame: Week 4

    The combined response index incorporates the Bristish Isles Lupus Assessment Group (BILAG) assessment, the Systemic Lupus Eyrthematosus Disease Activity Index (SLEDAI), a physician's global assessment of disease activity, and treatment failure status.

  2. Response at Week 8 according to a combined response index

    Time frame: Week 8

    The combined response index incorporates the Bristish Isles Lupus Assessment Group (BILAG) assessment, the Systemic Lupus Eyrthematosus Disease Activity Index (SLEDAI), a physician's global assessment of disease activity, and treatment failure status.

  3. Response at Week 4 according to a combined response index involving Short Form-36 (SF-36) response

    Time frame: Week 4

    The combined response index incorporates the Bristish Isles Lupus Assessment Group (BILAG) assessment, the Systemic Lupus Eyrthematosus Disease Activity Index (SLEDAI), a physician's global assessment of disease activity, treatment failure status, and SF-36 response.

  4. Response at Week 8 according to a combined response index involving Short Form-36 (SF-36) response

    Time frame: Week 8

    The combined response index incorporates the Bristish Isles Lupus Assessment Group (BILAG) assessment, the Systemic Lupus Eyrthematosus Disease Activity Index (SLEDAI), a physician's global assessment of disease activity, treatment failure status, and SF-36 response.

  5. Response at Week 12 according to a combined response index involving Short Form-36 (SF-36) response

    Time frame: Week 12

    The combined response index incorporates the Bristish Isles Lupus Assessment Group (BILAG) assessment, the Systemic Lupus Eyrthematosus Disease Activity Index (SLEDAI), a physician's global assessment of disease activity, treatment failure status, and SF-36 response.

  6. Improvement (yes/no) in British Isles Lupus Assessment Group (BILAG) at Week 4

    Time frame: Baseline, Week 4

  7. Improvement (yes/no) in British Isles Lupus Assessment Group (BILAG) at Week 8

    Time frame: Baseline, Week 8

  8. Improvement (yes/no) in British Isles Lupus Assessment Group (BILAG) at Week 12

    Time frame: Baseline, Week 12

  9. Improvement in British Isles Lupus Assessment Group (BILAG) at Week 24

    Time frame: Baseline, Week 24

  10. Change from baseline in total British Isles Lupus Assessment Group (BILAG) score at Week 12

    Time frame: Baseline, Week 12

  11. Change from baseline in Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) at Week 2

    Time frame: Baseline, Week 2

  12. Change from baseline in Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) at Week 4

    Time frame: Baseline, Week 4

  13. Change from baseline in Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) at Week 8

    Time frame: Baseline, Week 8

  14. Change from baseline in Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) at Week 12

    Time frame: Baseline, Week 12

  15. Change from baseline in physician global assessment at Week 12

    Time frame: Baseline, Week 12

  16. Change from baseline in patient global assessment at Week 12

    Time frame: Baseline, Week 12

  17. Short Form-36 (SF-36) response at Week 2

    Time frame: Baseline, Week 2

    SF-36 response is defined as no changes from baseline more negative than -0.8 in PCS or > -2.5 changes in any of the 8 domain scores.

  18. Short Form-36 (SF-36) response at Week 4

    Time frame: Baseline, Week 4

    SF-36 response is defined as no changes from baseline more negative than -0.8 in PCS or > -2.5 changes in any of the 8 domain scores

  19. Short Form-36 (SF-36) response at Week 8

    Time frame: Baseline, Week 8

    SF-36 response is defined as no changes from baseline more negative than -0.8 in PCS or > -2.5 changes in any of the 8 domain scores

  20. Short Form-36 (SF-36) response at Week 12

    Time frame: Baseline, Week 12

    SF-36 response is defined as no changes from baseline more negative than -0.8 in PCS or > -2.5 changes in any of the 8 domain scores

  21. European Quality of Life-5 Dimensions (EQ-5D) score at Week 12

    Time frame: Week 12

  22. Time to first sustained British Isles Lupus Assessment Group (BILAG) response

    Time frame: From Baseline to Week 12

  23. Time to enhanced British Isles Lupus Assessment Group (BILAG) response

    Time frame: From Baseline to Week 12

  24. Treatment failure up to Week 12

    Time frame: From Baseline to Week 12

    Treatment failure is defined as increase in (or addition of a new) immunosuppressive agent over baseline treatment levels, or any increase in corticosteroid baseline treatment level, or any IV, IA, or IM injections of corticosteroids.

  25. Cumulative steroid dose at Week 12

    Time frame: From Baseline to Week 12

  26. Human anti-human antibodies (HAHA) levels at Week 12

    Time frame: Week 12

  27. Change from baseline in levels of circulating B cells at Week 12

    Time frame: Baseline, Week 12

  28. Change from baseline in levels of circulating T cells at Week 12

    Time frame: Baseline, Week 12

Sponsors and collaborators

Lead sponsor

UCB Pharma

Industry

Registry information

Official study title

A Phase IIb Randomized, Double-blind, Placebo-controlled, Dose and Dose Regimen-ranging Study of the Safety and Efficacy of Epratuzumab in Serologically-positive Systemic Lupus Erythematosus (SLE) Patients With Active Disease

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Feb 27, 2008
Registry last updated
Sep 12, 2011

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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