Systemic Lupus ErythematosusPhase 2NCT00383513
Study of Epratuzumab in Systemic Lupus Erythematosus
A Phase 2 study testing Epratuzumab in people with Systemic Lupus Erythematosus, run by UCB Pharma at 10 sites in United States.
Trial summary
Epratuzumab is an investigational antibody designed to help treat Systemic Lupus Erythematosus (SLE). The purpose of the study is to obtain additional long-term information regarding the safety and efficacy of continued maintenance-cycle administrations of Epratuzumab. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Systemic Lupus Erythematosus
- What is being tested?
- Epratuzumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 10 sitesUnited States
- Study dates
- Jun 2006to Jan 2012
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must have participated in SL0003 or SL0004 and benefitted from participation in those studies
Who cannot join
- Development of toxicity to epratuzumab
- Significant protocol deviations during the SL0003 or SL0004 studies
- Evidence of significant infection
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Study site
Baltimore, Maryland
Study site
Birmingham, Alabama
Study site
Colorado Springs, Colorado
Study site
Denver, Colorado
Study site
Durham, North Carolina
Study site
Los Angeles, California
Study site
Tucson, Arizona
Study site
Tulsa, Oklahoma
Study site
Upland, California
Study site
Washington D.C., District of Columbia
About this study
Official title: An Open-Label Re-treatment Trial for Patients Previously Randomized Into the SL0003 and SL0004, Randomized, Double-blind, Placebo-controlled, Multi-center Studies of Epratuzumab in Patients With Systemic Lupus Erythematosus
Epratuzumab is an investigational antibody designed to help treat Systemic Lupus Erythematosus (SLE). The purpose of the study is to obtain additional long-term information regarding the safety and efficacy of continued maintenance-cycle administrations of Epratuzumab.
Read the detailed description
Due to the logistical considerations, UCB has decided to consolidate the Phase II and Phase III open-label extension trials. Subjects completing this study will be offered the option of continuing to receive epratuzumab through participation in Phase III open-label extension study SL0012 (NCT01408576).
- Conditions
- Systemic Lupus Erythematosus
- Being tested
- Epratuzumab
- Keywords
- Lupus, Antibody, B-Cell Immunotherapy
- 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.
EpratuzumabBiological
360 mg/m^2 four consecutive 12-week maintenance cycles beginning with 2 consecutive weekly administrations each lasting ≤ 1 hour
| Study group | Role | What they receive |
|---|---|---|
| Epratuzumab | Experimental | Not described Receives: Biological: Epratuzumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects reporting at least 1 serious adverse event (SAE) from entry Visit 1 through end of treatment (approximately 6 years)
Measured: From Entry Visit 1 through end of treatment (approximately 6 years)
Number of subjects prematurely discontinuing due to a treatment emergent adverse event (TEAE) from entry Visit 1 through end of treatment (approximately 6 years)
Measured: From Entry Visit 1 through end of treatment (approximately 6 years)
Secondary outcomes (19)
Time to treatment failure from First Visit through end of treatment (approximately 6 years)
Treatment failure is defined as initiation of a protocol specified prohibited medication.
Measured: From the first infusion of the first treatment cycle and continuing through end of treatment (approximately 6 years)
Epratuzumab plasma concentration levels at Week 0
Measured: Week 0
Epratuzumab plasma concentration levels at Week 48
Measured: Week 48
Epratuzumab plasma concentration levels at Week 96
Measured: Week 96
Epratuzumab plasma concentration levels at Week 144
Measured: Week 144
Epratuzumab plasma concentration levels at Week 192
Measured: Week 192
Epratuzumab plasma concentration levels at Week 240
Measured: Week 240
Subject Epratuzumab plasma concentration levels at Week 288
Measured: Week 288
Number of subjects with anti-epratuzumab antibody in plasma at Week 0
Measured: Week 0
Number of subjects with anti-epratuzumab antibody in plasma at Week 48
Measured: Week 48
Number of subjects with anti-epratuzumab antibody in plasma at Week 96
Measured: Week 96
Number of subjects with anti-epratuzumab antibody in plasma at Week 144
Measured: Week 144
Number of subjects with anti-epratuzumab antibody in plasma at Week 192
Measured: Week 192
Number of subjects with anti-epratuzumab antibody in plasma at Week 240
Measured: Week 240
Number of subjects with anti-epratuzumab antibody in plasma at Week 288
Measured: Week 288
Change From Baseline in Short Form 36-items Health Survey (SF-36) Physical Component Summary (PCS) Score
Measured: Baseline, Last Visit
Change from Baseline in Short Form 36-items Health Survey (SF-36) Mental Composite Summary (MCS) Score
Measured: Baseline, Last Visit
Change from Baseline in Patient's Global Assessment of Disease Activity (PtGADA)
Five point scale where 1 = very poor and 5 = very good.
Measured: Baseline, Last Visit
Change from Baseline in Physician's Global Assessment of Disease Activity (PGADA)
Five point scale where 1 = very poor and 5 = very good.
Measured: Baseline, Last Visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2006 (estimated)
- Study startJun 2006
- Primary completionJan 2012
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- UCB Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- UCB Clinical Trial Call Center, Study director, +1 877 822 9493 (UCB)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00383513
- Sponsor's protocol ID
- SL0006
- Other IDs
- EudraCT #: 2006-004496-36
- Status last verified
- Jul 2012
- First submitted
- 29 Sep 2006
- Last updated
- 12 Jul 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Re-treatment Trial for Patients Previously Randomized Into the SL0003 and SL0004, Randomized, Double-blind, Placebo-controlled, Multi-center Studies of Epratuzumab in Patients With Systemic Lupus Erythematosus
- ClinicalTrials.gov ID
- NCT00383513
- Acronym / sponsor ID
- SL0006
- Conditions
- Systemic Lupus Erythematosus
- Keywords
- Lupus, Antibody, B-Cell Immunotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- UCB PharmaIndustry (pharma, biotech, devices)
- Study start
- Jun 2006
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 3 Oct 2006 (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.
Epratuzumab is an investigational antibody designed to help treat Systemic Lupus Erythematosus (SLE). The purpose of the study is to obtain additional long-term information regarding the safety and efficacy of continued maintenance-cycle administrations of Epratuzumab.
Detailed description
Due to the logistical considerations, UCB has decided to consolidate the Phase II and Phase III open-label extension trials. Subjects completing this study will be offered the option of continuing to receive epratuzumab through participation in Phase III open-label extension study SL0012 (NCT01408576).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Epratuzumab | Experimental | Biological: Epratuzumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Must have participated in SL0003 or SL0004 and benefitted from participation in those studies
Key exclusion criteria (3 listed)
- Development of toxicity to epratuzumab
- Significant protocol deviations during the SL0003 or SL0004 studies
- Evidence of significant infection
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 |
|---|---|---|
| Epratuzumab360 mg/m^2 four consecutive 12-week maintenance cycles beginning with 2 consecutive weekly administrations each lasting ≤ 1 hour | Biological | Epratuzumab |
Primary outcome
Number of subjects reporting at least 1 serious adverse event (SAE) from entry Visit 1 through end of treatment (approximately 6 years)
Time frame: From Entry Visit 1 through end of treatment (approximately 6 years)
Number of subjects prematurely discontinuing due to a treatment emergent adverse event (TEAE) from entry Visit 1 through end of treatment (approximately 6 years)
Time frame: From Entry Visit 1 through end of treatment (approximately 6 years)
19 secondary outcomes
Time to treatment failure from First Visit through end of treatment (approximately 6 years)
Time frame: From the first infusion of the first treatment cycle and continuing through end of treatment (approximately 6 years)
Epratuzumab plasma concentration levels at Week 0
Time frame: Week 0
Epratuzumab plasma concentration levels at Week 48
Time frame: Week 48
Epratuzumab plasma concentration levels at Week 96
Time frame: Week 96
Epratuzumab plasma concentration levels at Week 144
Time frame: Week 144
Epratuzumab plasma concentration levels at Week 192
Time frame: Week 192
Epratuzumab plasma concentration levels at Week 240
Time frame: Week 240
Subject Epratuzumab plasma concentration levels at Week 288
Time frame: Week 288
Number of subjects with anti-epratuzumab antibody in plasma at Week 0
Time frame: Week 0
Number of subjects with anti-epratuzumab antibody in plasma at Week 48
Time frame: Week 48
Number of subjects with anti-epratuzumab antibody in plasma at Week 96
Time frame: Week 96
Number of subjects with anti-epratuzumab antibody in plasma at Week 144
Time frame: Week 144
Number of subjects with anti-epratuzumab antibody in plasma at Week 192
Time frame: Week 192
Number of subjects with anti-epratuzumab antibody in plasma at Week 240
Time frame: Week 240
Number of subjects with anti-epratuzumab antibody in plasma at Week 288
Time frame: Week 288
Change From Baseline in Short Form 36-items Health Survey (SF-36) Physical Component Summary (PCS) Score
Time frame: Baseline, Last Visit
Change from Baseline in Short Form 36-items Health Survey (SF-36) Mental Composite Summary (MCS) Score
Time frame: Baseline, Last Visit
Change from Baseline in Patient's Global Assessment of Disease Activity (PtGADA)
Time frame: Baseline, Last Visit
Change from Baseline in Physician's Global Assessment of Disease Activity (PGADA)
Time frame: Baseline, Last Visit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2012.
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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.
UCB Clinical Trial Call Center study director
+1 877 822 9493 (UCB)
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Epratuzumab in people with Systemic Lupus Erythematosus, run by UCB Pharma at 10 sites in United States.
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 1 inclusion and 3 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: finished, as of the sponsor's last update on 12 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of subjects reporting at least 1 serious adverse event (SAE) from entry Visit 1 through end of treatment (approximately 6 years) (time frame: From Entry Visit 1 through end of treatment (approximately 6 years)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Jul 2012.