Pharmacokinetics Study of Epratuzumab in Systemic Lupus Erythematosus (SLE)

Lupus Erythematosus, Systemic Clinical Trial

Official title:

A Randomized Phase II Pharmacokinetics/Pharmacodynamics Study of Epratuzumab in Patients With Systemic Lupus Erythematosus

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00113971
• Other study ID #: SL0002 (IMMU-103-SLE-02)
• Status: Terminated
• Phase: Phase 2
• First received: June 10, 2005
• Last updated: March 30, 2012
• Start date: April 2005
• Est. completion date: June 2007

Study information

• Verified date: March 2012
• Source: UCB Pharma
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The goal of this study is to evaluate how epratuzumab is processed by the body (pharmacokinetics) and whether 2 dose levels of epratuzumab are safe and effective in patients with SLE.

Description:

This study is planned to provide information on how the body processes epratuzumab and how epratuzumab affects the body when epratuzumab is given once weekly for 4 weeks in a row at one of 2 different dose levels. Additional information will be obtained related to the natural variability of disease activity in SLE patients.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 20
• Est. completion date: June 2007
• Est. primary completion date: March 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Has SLE by American College of Rheumatology revised criteria (meets >/= 4 criteria)

• Has had SLE for at least 6 months prior to study entry

• Has at least one elevated autoantibody level at study entry

• Has moderately active SLE disease at study entry in any body/organ system (Full criteria not present here due to length of considerations. The protocols should be consulted regarding the complete list of entry criteria.)

Exclusion criteria:

• Active Severe Lupus as defined by BILAG Index Level A in any body system or organ

• Allergy to human antibodies or Murine

• Prior therapy with other anti-B cell antibodies

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lupus Erythematosus, Systemic

Intervention

Drug:
• epratuzumab

Locations

Country	Name	City	State
United States	Rheumatology Associates	Charleston	South Carolina
United States	Columbia Presbyterian Medical Center	New York	New York
United States	Lupus Center of Excellence	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
UCB Pharma

Country where clinical trial is conducted

United States, 

References & Publications (1)

Kaufmann J, Wegener WA, Horak ID, et al. Pilot clinical trial of epratuzumab (humanized anti-CD22 antibody) for immunotherapy in systemic lupus erythematosus (SLE) [abstract]. Ann Rheum Dis 2004; 63 (suppl I): Thu0443. (Published online at http://www.eular.org)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of pharmacokinetic samples for epratuzumab levels and evaluation of adverse events, infusion reactions and other safety parameters.
Secondary	Evaluation of pharmacokinetic samples to assess immunogenicity and evaluation of post-treatment BILAG scores for initial efficacy and disease variability.