Systemic Lupus ErythematosusPhase 2PRELUDENCT00203151
A Study to Evaluate the Tolerability, Safety and Effectiveness of Edratide in the Treatment of Lupus
A Phase 2 study testing edratide in people with Systemic Lupus Erythematosus, run by Teva Branded Pharmaceutical Products R&D, Inc..
Trial summary
It is thought that Edratide may be able to reduce the symptoms of SLE. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Systemic Lupus Erythematosus
- What is being tested?
- edratide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 340 participants
- Where
- No sites listed yet
- Study dates
- Jul 2005to Feb 2007
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
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)
It is thought that Edratide may be able to reduce the symptoms of SLE.
- Conditions
- Systemic Lupus Erythematosus
- Being tested
- edratide
- Medical subject headings
- Lupus Erythematosus, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
edratideDrug
0.5 mg, 1.0 mg, 2.5 mg injection once weekly
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: edratide |
| 2 | Placebo comparator | Not described Receives: Drug: edratide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of Disease Activity Score
Measured: 30 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startJul 2005
- Primary completionFeb 2007
- Study completionFeb 2007
Why it stopped: TV-4710/201 did not meet its primary endpoints in patients with SLE
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Systemic Lupus ErythematosusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 340 participants (actual)
Sponsor and investigators
- Lead sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Dan Goldsatub, Ph.D., Study director, Teva Branded Pharmaceutical Products R&D, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00203151
- Sponsor's protocol ID
- TV-4710/201
- Acronym
- PRELUDE
- Status last verified
- Apr 2011
- First submitted
- 13 Sep 2005
- Last updated
- 12 Apr 2011
- Results posted
- No
- Expanded access
- Available
Publications
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.
PubMed 26301100
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT00203151
- Acronym / sponsor ID
- PRELUDE / TV-4710/201
- Conditions
- Systemic Lupus Erythematosus
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: TV-4710/201 did not meet its primary endpoints in patients with SLE
- Enrolment
- 340 participants (actual)
- Lead sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2005
- Primary completion
- Feb 2007 (actual)
- Study completion
- Feb 2007 (actual)
- First posted
- 20 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
It is thought that Edratide may be able to reduce the symptoms of SLE.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: edratide |
| 2 | Placebo comparator | Drug: edratide |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| edratide0.5 mg, 1.0 mg, 2.5 mg injection once weekly | Drug | 1, 2 |
Primary outcome
Improvement of Disease Activity Score
Time frame: 30 weeks
Results and safety
The study was stopped early (reason given: TV-4710/201 did not meet its primary endpoints in patients with SLE). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2011.
- Derived from this study: PubMed 26301100Urowitz 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dan Goldsatub, Ph.D. study director
Teva Branded Pharmaceutical Products R&D, Inc.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing edratide in people with Systemic Lupus Erythematosus, run by Teva Branded Pharmaceutical Products R&D, Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 12 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: TV-4710/201 did not meet its primary endpoints in patients with SLE). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement of Disease Activity Score (time frame: 30 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00203151, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2011; AzTrials last refreshed its copy on 2 Nov 2026.