A Study to Evaluate the Tolerability, Safety and Effectiveness of Edratide in the Treatment of Lupus - Clinical Trial for Systemic Lupus Erythematosus | NCT00203151

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Primary Purpose

Status

Terminated

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

edratide

About this trial

This is an interventional treatment trial for Systemic Lupus Erythematosus

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

2

Arm Description

Outcomes

Primary Outcome Measures

Improvement of Disease Activity Score

Secondary Outcome Measures

Full Information

NCT ID

NCT00203151

First Posted

September 13, 2005

Last Updated

April 8, 2011

Sponsor

Teva Branded Pharmaceutical Products R&D, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT00203151

Brief Title

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

Acronym

PRELUDE

Official Title

A Multi-National, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose, Parallel Group Study to Assess the Efficacy, Tolerability and Safety of Edratide for Subcutaneous Injection in Systemic Lupus Erythematosus (SLE)

Study Type

Interventional

2. Study Status

Record Verification Date

April 2011

Overall Recruitment Status

Terminated

Why Stopped

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

Study Start Date

July 2005 (undefined)

Primary Completion Date

February 2007 (Actual)

Study Completion Date

February 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Teva Branded Pharmaceutical Products R&D, Inc.

4. Oversight

5. Study Description

Brief Summary

It is thought that Edratide may be able to reduce the symptoms of SLE.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Systemic Lupus Erythematosus

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

340 (Actual)

8. Arms, Groups, and Interventions

Arm Title

1

Arm Type

Experimental

Arm Title

2

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

edratide

Intervention Description

0.5 mg, 1.0 mg, 2.5 mg injection once weekly

Primary Outcome Measure Information:

Title

Improvement of Disease Activity Score

Time Frame

30 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

No

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Dan Goldsatub, Ph.D.

Organizational Affiliation

Teva Branded Pharmaceutical Products R&D, Inc.

Official's Role

Study Director

12. IPD Sharing Statement

Citations:

PubMed Identifier

26301100

Citation

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.

Results Reference

derived

A Study to Evaluate the Tolerability, Safety and Effectiveness of Edratide in the Treatment of Lupus (PRELUDE)

Systemic Lupus Erythematosus

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial