Pharmacokinetics Study of Epratuzumab in Systemic Lupus E... | NCT00113971

Studies
Pharmacokinetics Study of Epratuzumab in Systemic Lupus Erythematosus (SLE)

NCT00113971

Sponsor

UCB Pharma

Status

Terminated

Last Update Posted

Apr 3, 2012Estimated

Enrollment

Phase

Phase 2

Conditions

Lupus Erythematosus, Systemic

Interventions

epratuzumab

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2012

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2005

Primary Completion Date

Mar 2007Actual

Completion Date

Jun 2007Actual

First Submitted Date

Jun 10, 2005

First Submission Date that Met QC Criteria

Jun 10, 2005

First Posted Date

Jun 13, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 30, 2012

Last Update Posted Date

Apr 3, 2012Estimated

Description Module

Brief 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.

Detailed 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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Name	Type	Description	Arm Group Labels	Other Names
epratuzumab	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Evaluation of pharmacokinetic samples for epratuzumab levels and evaluation of adverse events, infusion reactions and other safety parameters.

Secondary Outcomes

Measure	Description	Time Frame
Evaluation of pharmacokinetic samples to assess immunogenicity and evaluation of post-treatment BILAG scores for initial efficacy and disease variability.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Anna Barry	UCB Pharma	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Columbia Presbyterian Medical Center		New York	New York	10032	United States
Lupus Center of Excellence

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
	Background	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)

ID	Term
D003240	Connective Tissue Diseases
D017437	Skin and Connective Tissue Diseases
D001327	Autoimmune Diseases
D007154	Immune System Diseases