NCT00203151

Brief Summary

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

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
340

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jul 2005

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2005

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 20, 2005

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2007

Completed
Last Updated

April 12, 2011

Status Verified

April 1, 2011

Enrollment Period

1.6 years

First QC Date

September 13, 2005

Last Update Submit

April 8, 2011

Conditions

Systemic Lupus Erythematosus

Outcome Measures

Primary Outcomes (1)

  • Improvement of Disease Activity Score

    30 weeks

Study Arms (2)

1

EXPERIMENTAL
Drug: edratide

2

PLACEBO COMPARATOR
Drug: edratide

Interventions

edratideDRUG

0.5 mg, 1.0 mg, 2.5 mg injection once weekly

12

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 26301100DERIVED

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Interventions

edratide

Condition Hierarchy (Ancestors)

Connective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Dan Goldsatub, Ph.D.

    Teva Branded Pharmaceutical Products R&D, Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Expanded Access
Yes

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 20, 2005

Study Start

July 1, 2005

Primary Completion

February 1, 2007

Study Completion

February 1, 2007

Last Updated

April 12, 2011

Record last verified: 2011-04