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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00624351
Recruitment Status : Completed
First Posted : February 27, 2008
Last Update Posted : September 12, 2011
Sponsor:
Information provided by (Responsible Party):
UCB Pharma

Study Description
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Brief Summary:
The primary objective of the study is to assess the dose response and the dose frequency of epratuzumab in patients with SLE.

Condition or disease Intervention/treatment Phase
Systemic Lupus Erythematosus Biological: Epratuzumab Other: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 227 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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
Study Start Date : January 2008
Actual Primary Completion Date : August 2009
Actual Study Completion Date : August 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lupus

Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: Placebo
Phosphate-buffered Saline (PBS) infusions at study weeks 0, 1, 2, and 3.
 Other: Placebo
Phosphate-buffered Saline (PBS) infusion.
Experimental: EMAB 600mg
600 mg Epratuzumab infusions at study weeks 0, 1, 2, and 3.
 Biological: Epratuzumab
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.
Experimental: EMAB 100mg
100 mg Epratuzumab infusions at study weeks 0, and 2, and placebo at study weeks 1 and 3.
 Biological: Epratuzumab
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.

Other: Placebo
Phosphate-buffered Saline (PBS) infusion.
Experimental: EMAB 400mg
400 mg Epratuzumab infusions at study weeks 0, and 2, and placebo at study weeks 1 and 3.
 Biological: Epratuzumab
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.

Other: Placebo
Phosphate-buffered Saline (PBS) infusion.
Experimental: EMAB 1200mg
1200 mg Epratuzumab infusions at study weeks 0, and 2, and placebo at study weeks 1 and 3.
 Biological: Epratuzumab
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.

Other: Placebo
Phosphate-buffered Saline (PBS) infusion.
Experimental: EMAB 1800mg
1800 mg Epratuzumab infusions at study weeks 0, and 2, and placebo at study weeks 1 and 3.
 Biological: Epratuzumab
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.

Other: Placebo
Phosphate-buffered Saline (PBS) infusion.


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Eligibility Criteria
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Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00624351


Locations
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Sponsors and Collaborators
UCB Pharma
Investigators
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Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: UCB Pharma
ClinicalTrials.gov Identifier: NCT00624351    
Other Study ID Numbers: SL0007
2007-002566-35 ( EudraCT Number )
First Posted: February 27, 2008    Key Record Dates
Last Update Posted: September 12, 2011
Last Verified: July 2011
Keywords provided by UCB Pharma:
Lupus
Monoclonal antibody
B-Cell immunotherapy
Additional relevant MeSH terms:
Layout table for MeSH terms
Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
 Epratuzumab
Antineoplastic Agents, Immunological
Antineoplastic Agents