A Study to Evaluate the Tolerability, Safety and Effectiv... | NCT00203151

Studies
A Study to Evaluate the Tolerability, Safety and Effectiveness of Edratide in the Treatment of Lupus

NCT00203151

Sponsor

Teva Branded Pharmaceutical Products R&D, Inc.

Status

Terminated

Last Update Posted

Apr 12, 2011Estimated

Enrollment

340Actual

Phase

Phase 2

Conditions

Systemic Lupus Erythematosus

Interventions

edratide

Countries

Not provided

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

Apr 2011

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

TV-4710/201 did not meet its primary endpoints in patients with SLE

Expanded Access Info

Yes

Start Date

Jul 2005

Primary Completion Date

Feb 2007Actual

Completion Date

Feb 2007Actual

First Submitted Date

Sep 13, 2005

First Submission Date that Met QC Criteria

Sep 13, 2005

First Posted Date

Sep 20, 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

Apr 8, 2011

Last Update Posted Date

Apr 12, 2011Estimated

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

340Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental		Drug: edratide
2	Placebo Comparator		Drug: edratide

Interventions

Name	Type	Description	Arm Group Labels	Other Names
edratide	Drug	0.5 mg, 1.0 mg, 2.5 mg injection once weekly	1 2

Measure	Description	Time Frame
Improvement of Disease Activity Score		30 weeks

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Willing and able to give written informed consent
Between the ages of 18 and 65 years (inclusive)
Fulfilled at least 4 ACR classification criteria
SLE patients with moderate, active disease
Subjects on stable dose of SLE medications for at least 4 weeks before randomization.
Women of child-bearing potential must practice a medically acceptable method of contraception..
Must understand the requirements of the study and agree to comply with the study protocol.

Exclusion Criteria:

Any condition which the investigator feels may interfere with participation in the study.
Subjects having a history of chronic infection
Subjects with a history of immunodeficiency syndrome or malignancy,
Subjects who received any investigational medication (including DHEA) within 3 months prior to randomization,
Subjects treated with any cytotoxic agents in the 3 months prior to randomization.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Dan Goldsatub, Ph.D.	Teva Branded Pharmaceutical Products R&D, Inc.	Study Director

Locations

Not provided

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
26301100	Derived	Urowitz MB, Isenberg DA, Wallace DJ. Safety and efficacy of hCDR1 (Edratide) in patients with active systemic lupus erythematosus: results of phase II study. Lupus Sci Med. 2015 Aug 11;2(1):e000104. doi: 10.1136/lupus-2015-000104. eCollection 2015.

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