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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
UCB Pharma
ClinicalTrials.gov Identifier:
NCT00624351
First received: February 15, 2008
Last updated: September 2, 2011
Last verified: July 2011
  Purpose

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


Condition Intervention Phase
Systemic Lupus Erythematosus
Biological: Epratuzumab
Other: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by UCB Pharma:

Primary Outcome Measures:
  • Response at Week 12 according to a combined response index [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    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:
  • Response at Week 4 according to a combined response index [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
    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.

  • Response at Week 8 according to a combined response index [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
    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.

  • Response at Week 4 according to a combined response index involving Short Form-36 (SF-36) response [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
    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.

  • Response at Week 8 according to a combined response index involving Short Form-36 (SF-36) response [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
    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.

  • Response at Week 12 according to a combined response index involving Short Form-36 (SF-36) response [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    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.

  • Improvement (yes/no) in British Isles Lupus Assessment Group (BILAG) at Week 4 [ Time Frame: Baseline, Week 4 ] [ Designated as safety issue: No ]
  • Improvement (yes/no) in British Isles Lupus Assessment Group (BILAG) at Week 8 [ Time Frame: Baseline, Week 8 ] [ Designated as safety issue: No ]
  • Improvement (yes/no) in British Isles Lupus Assessment Group (BILAG) at Week 12 [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]
  • Improvement in British Isles Lupus Assessment Group (BILAG) at Week 24 [ Time Frame: Baseline, Week 24 ] [ Designated as safety issue: No ]
  • Change from baseline in total British Isles Lupus Assessment Group (BILAG) score at Week 12 [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]
  • Change from baseline in Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) at Week 2 [ Time Frame: Baseline, Week 2 ] [ Designated as safety issue: No ]
  • Change from baseline in Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) at Week 4 [ Time Frame: Baseline, Week 4 ] [ Designated as safety issue: No ]
  • Change from baseline in Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) at Week 8 [ Time Frame: Baseline, Week 8 ] [ Designated as safety issue: No ]
  • Change from baseline in Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) at Week 12 [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]
  • Change from baseline in physician global assessment at Week 12 [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]
  • Change from baseline in patient global assessment at Week 12 [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]
  • Short Form-36 (SF-36) response at Week 2 [ Time Frame: Baseline, Week 2 ] [ Designated as safety issue: No ]
    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.

  • Short Form-36 (SF-36) response at Week 4 [ Time Frame: Baseline, Week 4 ] [ Designated as safety issue: No ]
    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

  • Short Form-36 (SF-36) response at Week 8 [ Time Frame: Baseline, Week 8 ] [ Designated as safety issue: No ]
    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

  • Short Form-36 (SF-36) response at Week 12 [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]
    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

  • European Quality of Life-5 Dimensions (EQ-5D) score at Week 12 [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  • Time to first sustained British Isles Lupus Assessment Group (BILAG) response [ Time Frame: From Baseline to Week 12 ] [ Designated as safety issue: No ]
  • Time to enhanced British Isles Lupus Assessment Group (BILAG) response [ Time Frame: From Baseline to Week 12 ] [ Designated as safety issue: No ]
  • Treatment failure up to Week 12 [ Time Frame: From Baseline to Week 12 ] [ Designated as safety issue: No ]
    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.

  • Cumulative steroid dose at Week 12 [ Time Frame: From Baseline to Week 12 ] [ Designated as safety issue: No ]
  • Human anti-human antibodies (HAHA) levels at Week 12 [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  • Change from baseline in levels of circulating B cells at Week 12 [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]
  • Change from baseline in levels of circulating T cells at Week 12 [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]

Enrollment: 227
Study Start Date: January 2008
Study Completion Date: August 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00624351

  Show 53 Study Locations
Sponsors and Collaborators
UCB Pharma
Investigators
Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
  More Information

No publications provided by UCB Pharma

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: UCB Pharma
ClinicalTrials.gov Identifier: NCT00624351     History of Changes
Other Study ID Numbers: SL0007, 2007-002566-35
Study First Received: February 15, 2008
Last Updated: September 2, 2011
Health Authority: Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment
Brazil: National Health Surveillance Agency
Hong Kong: Department of Health
Hungary: National Institute of Pharmacy
India: Drugs Controller General of India
Lithuania: State Medicine Control Agency - Ministry of Health
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Spain: Spanish Agency of Medicines
Ukraine: State Pharmacological Center - Ministry of Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United States: Food and Drug Administration

Keywords provided by UCB Pharma:
Lupus
Monoclonal antibody
B-Cell immunotherapy

Additional relevant MeSH terms:
Lupus Erythematosus, Systemic
Autoimmune Diseases
Connective Tissue Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on October 22, 2014