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

Overview

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

Full Title of Study: “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 Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: August 2009

Interventions

  • 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.

Arms, Groups and Cohorts

  • Placebo Comparator: Placebo
    • Phosphate-buffered Saline (PBS) infusions at study weeks 0, 1, 2, and 3.
  • Experimental: EMAB 600mg
    • 600 mg Epratuzumab infusions at study weeks 0, 1, 2, and 3.
  • Experimental: EMAB 100mg
    • 100 mg Epratuzumab infusions at study weeks 0, and 2, and placebo at study weeks 1 and 3.
  • Experimental: EMAB 400mg
    • 400 mg Epratuzumab infusions at study weeks 0, and 2, and placebo at study weeks 1 and 3.
  • Experimental: EMAB 1200mg
    • 1200 mg Epratuzumab infusions at study weeks 0, and 2, and placebo at study weeks 1 and 3.
  • Experimental: EMAB 1800mg
    • 1800 mg Epratuzumab infusions at study weeks 0, and 2, and placebo at study weeks 1 and 3.

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • Improvement (yes/no) in British Isles Lupus Assessment Group (BILAG) at Week 4
    • Time Frame: Baseline, Week 4
  • Improvement (yes/no) in British Isles Lupus Assessment Group (BILAG) at Week 8
    • Time Frame: Baseline, Week 8
  • Improvement (yes/no) in British Isles Lupus Assessment Group (BILAG) at Week 12
    • Time Frame: Baseline, Week 12
  • Improvement in British Isles Lupus Assessment Group (BILAG) at Week 24
    • Time Frame: Baseline, Week 24
  • Change from baseline in total British Isles Lupus Assessment Group (BILAG) score at Week 12
    • Time Frame: Baseline, Week 12
  • Change from baseline in Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) at Week 2
    • Time Frame: Baseline, Week 2
  • Change from baseline in Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) at Week 4
    • Time Frame: Baseline, Week 4
  • Change from baseline in Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) at Week 8
    • Time Frame: Baseline, Week 8
  • Change from baseline in Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) at Week 12
    • Time Frame: Baseline, Week 12
  • Change from baseline in physician global assessment at Week 12
    • Time Frame: Baseline, Week 12
  • Change from baseline in patient global assessment at Week 12
    • Time Frame: Baseline, Week 12
  • 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.
  • 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
  • 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
  • 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
  • European Quality of Life-5 Dimensions (EQ-5D) score at Week 12
    • Time Frame: Week 12
  • Time to first sustained British Isles Lupus Assessment Group (BILAG) response
    • Time Frame: From Baseline to Week 12
  • Time to enhanced British Isles Lupus Assessment Group (BILAG) response
    • Time Frame: From Baseline to Week 12
  • 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.
  • Cumulative steroid dose at Week 12
    • Time Frame: From Baseline to Week 12
  • Human anti-human antibodies (HAHA) levels at Week 12
    • Time Frame: Week 12
  • Change from baseline in levels of circulating B cells at Week 12
    • Time Frame: Baseline, Week 12
  • Change from baseline in levels of circulating T cells at Week 12
    • Time Frame: Baseline, Week 12

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • UCB Pharma
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • UCB Clinical Trial Call Center, Study Director, +1 877 822 9493 (UCB)

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.