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OpenTrials
Completed

NCT Number: NCT00660881

Open-label Study of Epratuzumab in Serologically-positive Systemic Lupus Erythematosus Patients With Active Disease

The primary objective of the study is to assess the safety 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

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • SL0007 patients who completed through week 12 of the study or who early terminated at week 8 or later due to treatment failure
  • Patients must have maintained eligibility requirements throughout their participation in SL0007
  • Written informed consent signed prior to initiation of any study-specific assessments at visit 1

Exclusion criteria

  • Patients may not receive 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 CNS system (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 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 PBS as a vehicle/buffer for the infusion procedure.

Primary outcomes

  1. Continue to assess safety of epratuzumab by assessing adverse events (including infusion reactions), vital signs and clinical safety laboratory assessments (Timeframe: All visits)

    Time frame: 12 Week treatment cycles

Secondary outcomes

  1. The combined response index analysis evaluating BILAG, SLEDAI, and a physician's global assessment and treatment failure status

    Time frame: Every 4 weeks through week 48, then every 12 weeks through completion

  2. The combined response index including an additional criteria involving the SF-36 response

    Time frame: Every 12 weeks

  3. BILAG score assessment

    Time frame: Every 4 weeks through week 48, then every 12 weeks through completion

  4. SLEDAI scores assessment

    Time frame: Every 4 weeks through week 48, then every 12 weeks through completion

  5. Patient and physician VAS

    Time frame: Every 4 weeks through week 48, then every 12 weeks through completion

  6. Percentage of patients achieving SF-36 stabilization or improvement as compared to baseline

    Time frame: Every 12 weeks

  7. SF-36 PCS, MCS

    Time frame: Every 12 weeks

  8. EQ-5D results

    Time frame: Every 12 weeks

  9. Proportion of patients meeting treatment failure

    Time frame: Every 12 weeks

  10. Total daily steroid dose

    Time frame: Every 4 weeks for the first 48 weeks and then every 12 weeks

  11. Time to flare for patients who entered the study without flare as defined by the BILAG

    Time frame: over the entire course of the trial

  12. SLEDAI responder

    Time frame: Every 4 weeks for the first 48 weeks and then every 12 weeks

  13. Time to sustained response for patients entering SL0008 with flare as defined by the BILAG.

    Time frame: over the entire course of the trial

  14. Immunogenicity as measured by human anti-human antibodies

    Time frame: at each dosing visit and 4 weeks post first dose of each treatment cycle

  15. Assessment of changes in baseline in levels of circulating B and T cells

    Time frame: The first dosing visit of each treatment cycle and at 4 weeks post first dose of each treatment cycle

Sponsors and collaborators

Lead sponsor

UCB Pharma

Industry

Registry information

Official study title

A Phase IIb Multi-Center, Open-label, Follow-up Study to Assess Safety and Efficacy of Epratuzumab in Serologically-positive Systemic Lupus Erythematosus Patients With Active Disease Who Participated in Study SL0007

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Apr 17, 2008
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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