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Study Evaluating the Pharmacokinetics and Safety of Epratuzumab in Japanese Systemic Lupus Erythematosus (SLE)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
UCB, Inc.
ClinicalTrials.gov Identifier:
NCT01449071
First received: October 3, 2011
Last updated: March 26, 2013
Last verified: March 2013
History of Changes

October 3, 2011
March 26, 2013
October 2011
March 2013   (final data collection date for primary outcome measure)
  • Area under the concentration time curve (AUC) [ Time Frame: From baseline to 12 weeks ] [ Designated as safety issue: No ]

    AUC is defined as the area under the plot of plasma concentration of Epratuzumab against time after administration per subject.

    All measurements taken in the study (at administration day [day 0, 7, 14, 21] and the next four days of each administration day and week-4, 6, 8, 10, 12) are used to calculate AUC

  • Half-life (t1/2) [ Time Frame: From baseline to 12 weeks ] [ Designated as safety issue: No ]

    Half-life is defined as the time taken for plasma concentrations of Epratuzumab to decline by one half per subject.

    All measurements taken in the study (at administration day [day 0, 7, 14, 21] and the next four days of each administration day and week-4, 6, 8, 10, 12) are used to calculate Half-life.

  • Maximum plasma Concentration (Cmax) [ Time Frame: From Baseline to 12 weeks ] [ Designated as safety issue: No ]
    Plasma concentration of Epratuzumab for each pharmacokinetics parameter is measured at administration day (day 0, 7, 14, 21) and the next four days of each administration day and week-4, 6, 8, 10, 12.
Same as current
Complete list of historical versions of study NCT01449071 on ClinicalTrials.gov Archive Site
Incidence of anti-epratuzumab in plasma during administration over 12 weeks [ Time Frame: Day 0 (initial administration day) and week 12 (end of the evaluation period) ] [ Designated as safety issue: No ]
Blood drawing for anti- epratuzumab is carried out at initial administration day (day 0) and end of the evaluation period (week 12).
Same as current
Not Provided
Not Provided
 
Study Evaluating the Pharmacokinetics and Safety of Epratuzumab in Japanese Systemic Lupus Erythematosus (SLE)
A Phase1/2, Randomized, Parallel-group, Double-Blind, Placebo-Controlled, Multicenter Study of the Safety and Pharmacokinetics of One 12 Week Treatment Cycle of Epratuzumab in Japanese Systemic Lupus Erythematosus (SLE) Subjects With Moderate to Severe Disease

The primary objective of the study is to evaluate the safety, tolerability and Pharmacokinetics (PK) of Epratuzumab in Japanese subjects with moderate to severe general SLE as add on to standard of care treatment during the trial.
Not Provided
Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Systemic Lupus Erythematosus
  • Biological: Placebo
    Placebo infusions at study weeks 0, 1, 2, and 3.
  • Biological: Epratuzumab 400 mg
    Epratuzumab 400 mg infusions at study weeks 0, and 2, and placebo infusion at study weeks 1 and 3.
  • Biological: Epratuzumab 1200 mg
    Epratuzumab 1200 mg infusions at study weeks 0, and 2, and placebo infusion at study weeks 1 and 3.
  • Biological: Epratuzumab 100 mg
    Epratuzumab 100 mg infusions at study weeks 0, and 2, and placebo infusion at study weeks 1 and 3.
  • Biological: Epratuzumab 600 mg
    Epratuzumab 600 mg infusions at study weeks 0, 1, 2, and 3.
  • Placebo Comparator: Placebo Group
    Intervention: Biological: Placebo
  • Experimental: Epratuzumab 600 mg Group
    Intervention: Biological: Epratuzumab 600 mg
  • Experimental: Epratuzumab 100 mg Group
    Intervention: Biological: Epratuzumab 100 mg
  • Experimental: Epratuzumab 400 mg Group
    Intervention: Biological: Epratuzumab 400 mg
  • Experimental: Epratuzumab 1200 mg Group
    Intervention: Biological: Epratuzumab 1200 mg
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
March 2013
March 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Positive Anti-nuclear Antibody (ANA) at Screening (Visit 1)
  • Current clinical diagnosis of Systemic Lupus Erythematosus (SLE) by American College of Rheumatology (ACR) criteria
  • Active moderate to severe SLE activity as demonstrated by British Isles Lupus Assessment Group Index (BILAG)
  • Active moderate to severe SLE disease as demonstrated by Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) total score on stable SLE treatment

Exclusion Criteria:

  • Subjects who are breastfeeding, pregnant, or plan to become pregnant
  • Subjects with active, severe SLE disease activity which involves the renal system and active, severe, neuropsychiatric SLE, defined as any neuropsychiatric element scoring BILAG level A
  • Serious infections
Both
18 Years to 64 Years
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT01449071
SL0026
No
UCB, Inc.
UCB, Inc.
Not Provided
Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
UCB, Inc.
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP