Systemic Lupus ErythematosusPhase 2NCT00660881
Open-label Study of Epratuzumab in Serologically-positive Systemic Lupus Erythematosus Patients With Active Disease
A Phase 2 study testing Epratuzumab in people with Systemic Lupus Erythematosus, run by UCB Pharma at 42 sites in 11 countries.
Trial summary
The primary objective of the study is to assess the safety of epratuzumab in patients with SLE. 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
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 42 sitesin 11 countries
- Study dates
- May 2008to Dec 2011
- 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
- SL0007 patients who completed through week 12 of the study or who early terminated at week 8 or later due to treatment failure
- Patients must have maintained eligibility requirements throughout their participation in SL0007
- Written informed consent signed prior to initiation of any study-specific assessments at visit 1
Who cannot join
- Patients may not receive any live vaccination within 2 weeks prior to visit 1 or during the course of the study
- Active severe SLE disease activity which involves the CNS system (defined by BILAG neurologic A level activity) including transverse myelitis, psychosis and seizures
- Active severe SLE disease activity which involves the Renal system (defined by BILAG renal level A activity or Grade III or higher WHO nephritis) or serum creatinine >2.5mg/dL or clinically significant serum creatinine increase within the prior 4 weeks or proteinuria >3.5gm/day
- Patients with a history of anti-phospholipid antibody syndrome AND Use of oral anticoagulants or anti-platelet treatment
- Patients with a history of chronic infection, recent significant infection, or any current sign of symptom that may indicate an infection.
Trial locations and contacts
42 sites in 11 countries.
42 sites in 11 countries
United States14 sites
Study site
Arlington, Virginia
Study site
Birmingham, Alabama
Study site
Chapel Hill, North Carolina
Study site
Charlotte, North Carolina
Study site
Denver, Colorado
Study site
Durham, North Carolina
Study site
Farmington, Connecticut
Study site
La Jolla, California
Study site
Los Angeles, California
Study site
Oklahoma City, Oklahoma
Study site
San Leandro, California
Study site
Tampa, Florida
Study site
Tucson, Arizona
Study site
Wilmington, North Carolina
India5 sites
Study site
Bangalore
Study site
Hyderabad
Study site
Madurai, Tamil Nadu
Study site
Manipal
Study site
Nagpur
Poland5 sites
Study site
Elblag
Study site
Gmina Końskie
Study site
Lublin
Study site
Poznan
Study site
Torun
Ukraine4 sites
Study site
Donetsk
Study site
Ivano-Frankivsk
Study site
Kiev
Study site
Lviv
Brazil3 sites
Study site
Goiânia, Goiás
Study site
Porto Alegre
Study site
São Paulo
About this study
Official title: A Phase IIb Multi-Center, Open-label, Follow-up Study to Assess Safety and Efficacy of Epratuzumab in Serologically-positive Systemic Lupus Erythematosus Patients With Active Disease Who Participated in Study SL0007
The primary objective of the study is to assess the safety of epratuzumab in patients with SLE.
- Conditions
- Systemic Lupus Erythematosus
- Being tested
- Epratuzumab
- Keywords
- Lupus, Monoclonal 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
Epratuzumab at a concentration of 10 mg/mL prepared in 17.5 ml vials for slow intravenous infusion using only PBS as a vehicle/buffer for the infusion procedure.
| Study group | Role | What they receive |
|---|---|---|
| EMAB | Experimental | 1200 mg epratuzumab given in 2 doses every other week in 12 week treatment cycles. Receives: Biological: Epratuzumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Continue to assess safety of epratuzumab by assessing adverse events (including infusion reactions), vital signs and clinical safety laboratory assessments (Timeframe: All visits)
Measured: 12 Week treatment cycles
Secondary outcomes (15)
The combined response index analysis evaluating BILAG, SLEDAI, and a physician's global assessment and treatment failure status
Measured: Every 4 weeks through week 48, then every 12 weeks through completion
The combined response index including an additional criteria involving the SF-36 response
Measured: Every 12 weeks
BILAG score assessment
Measured: Every 4 weeks through week 48, then every 12 weeks through completion
SLEDAI scores assessment
Measured: Every 4 weeks through week 48, then every 12 weeks through completion
Patient and physician VAS
Measured: Every 4 weeks through week 48, then every 12 weeks through completion
Percentage of patients achieving SF-36 stabilization or improvement as compared to baseline
Measured: Every 12 weeks
SF-36 PCS, MCS
Measured: Every 12 weeks
EQ-5D results
Measured: Every 12 weeks
Proportion of patients meeting treatment failure
Measured: Every 12 weeks
Total daily steroid dose
Measured: Every 4 weeks for the first 48 weeks and then every 12 weeks
Time to flare for patients who entered the study without flare as defined by the BILAG
Measured: over the entire course of the trial
SLEDAI responder
Measured: Every 4 weeks for the first 48 weeks and then every 12 weeks
Time to sustained response for patients entering SL0008 with flare as defined by the BILAG.
Measured: over the entire course of the trial
Immunogenicity as measured by human anti-human antibodies
Measured: at each dosing visit and 4 weeks post first dose of each treatment cycle
Assessment of changes in baseline in levels of circulating B and T cells
Measured: The first dosing visit of each treatment cycle and at 4 weeks post first dose of each treatment cycle
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2008 (estimated)
- Study startMay 2008
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 210 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
- NCT00660881
- Sponsor's protocol ID
- SL0008
- Other IDs
- EudraCT Number: 2007-002589-37
- Status last verified
- Jul 2012
- First submitted
- 15 Apr 2008
- Last updated
- 12 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Hannon CW, McCourt C, Lima HC, Chen S, Bennett C. Interventions for cutaneous disease in systemic lupus erythematosus. Cochrane Database Syst Rev. 2021 Mar 9;3(3):CD007478. doi: 10.1002/14651858.CD007478.pub2.
PubMed 33687069Wallace DJ, Hobbs K, Clowse ME, Petri M, Strand V, Pike M, Merrill JT, Leszczynski P, Neuwelt CM, Jeka S, Houssiau F, Keiserman M, Ordi-Ros J, Bongardt S, Kilgallen B, Galateanu C, Kalunian K, Furie R, Gordon C. Long-Term Safety and Efficacy of Epratuzumab in the Treatment of Moderate-to- Severe Systemic Lupus Erythematosus: Results From an Open-Label Extension Study. Arthritis Care Res (Hoboken). 2016 Apr;68(4):534-43. doi: 10.1002/acr.22694.
PubMed 26316325
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
- A Phase IIb Multi-Center, Open-label, Follow-up Study to Assess Safety and Efficacy of Epratuzumab in Serologically-positive Systemic Lupus Erythematosus Patients With Active Disease Who Participated in Study SL0007
- ClinicalTrials.gov ID
- NCT00660881
- Acronym / sponsor ID
- SL0008
- Conditions
- Systemic Lupus Erythematosus
- Keywords
- Lupus, Monoclonal antibody, B-Cell immunotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 210 participants (actual)
- Lead sponsor
- UCB PharmaIndustry (pharma, biotech, devices)
- Study start
- May 2008
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 17 Apr 2008 (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.
The primary objective of the study is to assess the safety of epratuzumab in patients with SLE.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EMAB | Experimental | Biological: Epratuzumab1200 mg epratuzumab given in 2 doses every other week in 12 week treatment cycles. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- SL0007 patients who completed through week 12 of the study or who early terminated at week 8 or later due to treatment failure
- Patients must have maintained eligibility requirements throughout their participation in SL0007
- Written informed consent signed prior to initiation of any study-specific assessments at visit 1
Key exclusion criteria (5 listed)
- Patients may not receive any live vaccination within 2 weeks prior to visit 1 or during the course of the study
- Active severe SLE disease activity which involves the CNS system (defined by BILAG neurologic A level activity) including transverse myelitis, psychosis and seizures
- Active severe SLE disease activity which involves the Renal system (defined by BILAG renal level A activity or Grade III or higher WHO nephritis) or serum creatinine >2.5mg/dL or clinically significant serum creatinine increase within the prior 4 weeks or proteinuria >3.5gm/day
- Patients with a history of anti-phospholipid antibody syndrome AND Use of oral anticoagulants or anti-platelet treatment
- Patients with a history of chronic infection, recent significant infection, or any current sign of symptom that may indicate an 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 |
|---|---|---|
| EpratuzumabEpratuzumab at a concentration of 10 mg/mL prepared in 17.5 ml vials for slow intravenous infusion using only PBS as a vehicle/buffer for the infusion procedure. | Biological | EMAB |
Primary outcome
Continue to assess safety of epratuzumab by assessing adverse events (including infusion reactions), vital signs and clinical safety laboratory assessments (Timeframe: All visits)
Time frame: 12 Week treatment cycles
15 secondary outcomes
The combined response index analysis evaluating BILAG, SLEDAI, and a physician's global assessment and treatment failure status
Time frame: Every 4 weeks through week 48, then every 12 weeks through completion
The combined response index including an additional criteria involving the SF-36 response
Time frame: Every 12 weeks
BILAG score assessment
Time frame: Every 4 weeks through week 48, then every 12 weeks through completion
SLEDAI scores assessment
Time frame: Every 4 weeks through week 48, then every 12 weeks through completion
Patient and physician VAS
Time frame: Every 4 weeks through week 48, then every 12 weeks through completion
Percentage of patients achieving SF-36 stabilization or improvement as compared to baseline
Time frame: Every 12 weeks
SF-36 PCS, MCS
Time frame: Every 12 weeks
EQ-5D results
Time frame: Every 12 weeks
Proportion of patients meeting treatment failure
Time frame: Every 12 weeks
Total daily steroid dose
Time frame: Every 4 weeks for the first 48 weeks and then every 12 weeks
Time to flare for patients who entered the study without flare as defined by the BILAG
Time frame: over the entire course of the trial
SLEDAI responder
Time frame: Every 4 weeks for the first 48 weeks and then every 12 weeks
Time to sustained response for patients entering SL0008 with flare as defined by the BILAG.
Time frame: over the entire course of the trial
Immunogenicity as measured by human anti-human antibodies
Time frame: at each dosing visit and 4 weeks post first dose of each treatment cycle
Assessment of changes in baseline in levels of circulating B and T cells
Time frame: The first dosing visit of each treatment cycle and at 4 weeks post first dose of each treatment cycle
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.
- Derived from this study: PubMed 33687069Hannon CW, McCourt C, Lima HC, Chen S, Bennett C. Interventions for cutaneous disease in systemic lupus erythematosus. Cochrane Database Syst Rev. 2021 Mar 9;3(3):CD007478. doi: 10.1002/14651858.CD007478.pub2.
- Derived from this study: PubMed 26316325Wallace DJ, Hobbs K, Clowse ME, Petri M, Strand V, Pike M, Merrill JT, Leszczynski P, Neuwelt CM, Jeka S, Houssiau F, Keiserman M, Ordi-Ros J, Bongardt S, Kilgallen B, Galateanu C, Kalunian K, Furie R, Gordon C. Long-Term Safety and Efficacy of Epratuzumab in the Treatment of Moderate-to- Severe Systemic Lupus Erythematosus: Results From an Open-Label Extension Study. Arthritis Care Res (Hoboken). 2016 Apr;68(4):534-43. doi: 10.1002/acr.22694.
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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)
42 sites in 11 countries: 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 42 sites in 11 countries.
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 3 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: 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 42 sites in United States, India, Poland, Ukraine, Brazil and 6 more countries. 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?
Continue to assess safety of epratuzumab by assessing adverse events (including infusion reactions), vital signs and clinical safety laboratory assessments (Timeframe: All visits) (time frame: 12 Week treatment cycles). 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 NCT00660881, which also lists 2 linked publications.
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.