Systemic Lupus ErythematosusPhase 2NCT00624351
Study of Epratuzumab in Serologically-positive Systemic Lupus Erythematosus (SLE) Patients With Active Disease
A Phase 2 study testing Epratuzumab in people with Systemic Lupus Erythematosus, run by UCB Pharma at 53 sites in 11 countries.
Trial summary
The primary objective of the study is to assess the dose response and the dose frequency 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?
- Yes, some participants may receive a placebo
- How many people
- 227 participants
- Where
- 53 sitesin 11 countries
- Study dates
- Jan 2008to Aug 2009
- 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
- Positive ANA result at visit 1
- Current diagnosis of systemic lupus erythematosus (SLE) by American College of Rheumatology revised criteria such that at least 4 of the 11 criteria are met
- Active moderate or severe SLE disease activity as demonstrated by British Isles Lupus Assessment Group (BILAG) A level disease activity in at least one body/organ system or BILAG B level disease activity in at least two body/organ systems if no BILAG A level disease is present
- If on antimalarials, dose regimen must be stable for 4 weeks prior to study entry.
Who cannot join
- Patients receiving 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 central nervous system (CNS) (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 World Health Organization (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
53 sites in 11 countries.
53 sites in 11 countries
United States19 sites
Study site
Arlington, Virginia
Study site
Aventura, Florida
Study site
Baltimore, Maryland
Study site
Birmingham, Alabama
Study site
Brooklyn, New York
Study site
Chapel Hill, North Carolina
Study site
Charlotte, North Carolina
Study site
Dallas, Texas
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
Milwaukee, Wisconsin
Study site
Oklahoma City, Oklahoma
Study site
San Leandro, California
Study site
Tampa, Florida
Study site
Tucson, Arizona
Study site
Wilmington, North Carolina
Brazil6 sites
Study site
Curitiba
Study site
Goiânia
Study site
Porto Alegre
Study site
Rio de Janeiro
Study site
São Paulo
Study site
Sorocaba
India6 sites
Study site
Bangalore
Study site
Hyderabad
Study site
Ludhiana
Study site
Madurai
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
About this study
Official title: A Phase IIb Randomized, Double-blind, Placebo-controlled, Dose and Dose Regimen-ranging Study of the Safety and Efficacy of Epratuzumab in Serologically-positive Systemic Lupus Erythematosus (SLE) Patients With Active Disease
The primary objective of the study is to assess the dose response and the dose frequency of epratuzumab in patients with SLE.
- Conditions
- Systemic Lupus Erythematosus
- Being tested
- Epratuzumab, Placebo
- 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 Phosphate buffered Saline (PBS) as a vehicle/buffer for the infusion procedure.
PlaceboOther
Phosphate-buffered Saline (PBS) infusion.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Phosphate-buffered Saline (PBS) infusions at study weeks 0, 1, 2, and 3. Receives: Other: Placebo |
| EMAB 600mg | Experimental | 600 mg Epratuzumab infusions at study weeks 0, 1, 2, and 3. Receives: Biological: Epratuzumab |
| EMAB 100mg | Experimental | 100 mg Epratuzumab infusions at study weeks 0, and 2, and placebo at study weeks 1 and 3. Receives: Biological: Epratuzumab; Other: Placebo |
| EMAB 400mg | Experimental | 400 mg Epratuzumab infusions at study weeks 0, and 2, and placebo at study weeks 1 and 3. Receives: Biological: Epratuzumab; Other: Placebo |
| EMAB 1200mg | Experimental | 1200 mg Epratuzumab infusions at study weeks 0, and 2, and placebo at study weeks 1 and 3. Receives: Biological: Epratuzumab; Other: Placebo |
| EMAB 1800mg | Experimental | 1800 mg Epratuzumab infusions at study weeks 0, and 2, and placebo at study weeks 1 and 3. Receives: Biological: Epratuzumab; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response at Week 12 according to a combined response index
The combined response index incorporates the Bristish Isles Lupus Assessment Group (BILAG) assessment, the Systemic Lupus Eyrthematosus Disease Activity Index (SLEDAI), a physician's global assessment of disease activity, and treatment failure status.
Measured: Week 12
Secondary outcomes (28)
Response at Week 4 according to a combined response index
The combined response index incorporates the Bristish Isles Lupus Assessment Group (BILAG) assessment, the Systemic Lupus Eyrthematosus Disease Activity Index (SLEDAI), a physician's global assessment of disease activity, and treatment failure status.
Measured: Week 4
Response at Week 8 according to a combined response index
The combined response index incorporates the Bristish Isles Lupus Assessment Group (BILAG) assessment, the Systemic Lupus Eyrthematosus Disease Activity Index (SLEDAI), a physician's global assessment of disease activity, and treatment failure status.
Measured: Week 8
Response at Week 4 according to a combined response index involving Short Form-36 (SF-36) response
The combined response index incorporates the Bristish Isles Lupus Assessment Group (BILAG) assessment, the Systemic Lupus Eyrthematosus Disease Activity Index (SLEDAI), a physician's global assessment of disease activity, treatment failure status, and SF-36 response.
Measured: Week 4
Response at Week 8 according to a combined response index involving Short Form-36 (SF-36) response
The combined response index incorporates the Bristish Isles Lupus Assessment Group (BILAG) assessment, the Systemic Lupus Eyrthematosus Disease Activity Index (SLEDAI), a physician's global assessment of disease activity, treatment failure status, and SF-36 response.
Measured: Week 8
Response at Week 12 according to a combined response index involving Short Form-36 (SF-36) response
The combined response index incorporates the Bristish Isles Lupus Assessment Group (BILAG) assessment, the Systemic Lupus Eyrthematosus Disease Activity Index (SLEDAI), a physician's global assessment of disease activity, treatment failure status, and SF-36 response.
Measured: Week 12
Improvement (yes/no) in British Isles Lupus Assessment Group (BILAG) at Week 4
Measured: Baseline, Week 4
Improvement (yes/no) in British Isles Lupus Assessment Group (BILAG) at Week 8
Measured: Baseline, Week 8
Improvement (yes/no) in British Isles Lupus Assessment Group (BILAG) at Week 12
Measured: Baseline, Week 12
Improvement in British Isles Lupus Assessment Group (BILAG) at Week 24
Measured: Baseline, Week 24
Change from baseline in total British Isles Lupus Assessment Group (BILAG) score at Week 12
Measured: Baseline, Week 12
Change from baseline in Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) at Week 2
Measured: Baseline, Week 2
Change from baseline in Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) at Week 4
Measured: Baseline, Week 4
Change from baseline in Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) at Week 8
Measured: Baseline, Week 8
Change from baseline in Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) at Week 12
Measured: Baseline, Week 12
Change from baseline in physician global assessment at Week 12
Measured: Baseline, Week 12
Change from baseline in patient global assessment at Week 12
Measured: Baseline, Week 12
Short Form-36 (SF-36) response at Week 2
SF-36 response is defined as no changes from baseline more negative than -0.8 in PCS or > -2.5 changes in any of the 8 domain scores.
Measured: Baseline, Week 2
Short Form-36 (SF-36) response at Week 4
SF-36 response is defined as no changes from baseline more negative than -0.8 in PCS or > -2.5 changes in any of the 8 domain scores
Measured: Baseline, Week 4
Short Form-36 (SF-36) response at Week 8
SF-36 response is defined as no changes from baseline more negative than -0.8 in PCS or > -2.5 changes in any of the 8 domain scores
Measured: Baseline, Week 8
Short Form-36 (SF-36) response at Week 12
SF-36 response is defined as no changes from baseline more negative than -0.8 in PCS or > -2.5 changes in any of the 8 domain scores
Measured: Baseline, Week 12
European Quality of Life-5 Dimensions (EQ-5D) score at Week 12
Measured: Week 12
Time to first sustained British Isles Lupus Assessment Group (BILAG) response
Measured: From Baseline to Week 12
Time to enhanced British Isles Lupus Assessment Group (BILAG) response
Measured: From Baseline to Week 12
Treatment failure up to Week 12
Treatment failure is defined as increase in (or addition of a new) immunosuppressive agent over baseline treatment levels, or any increase in corticosteroid baseline treatment level, or any IV, IA, or IM injections of corticosteroids.
Measured: From Baseline to Week 12
Cumulative steroid dose at Week 12
Measured: From Baseline to Week 12
Human anti-human antibodies (HAHA) levels at Week 12
Measured: Week 12
Change from baseline in levels of circulating B cells at Week 12
Measured: Baseline, Week 12
Change from baseline in levels of circulating T cells at Week 12
Measured: Baseline, Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2008 (estimated)
- Study startJan 2008
- Primary completionAug 2009
- Study completionAug 2009
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 227 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
- NCT00624351
- Sponsor's protocol ID
- SL0007
- Other IDs
- 2007-002566-35
- Status last verified
- Jul 2011
- First submitted
- 15 Feb 2008
- Last updated
- 12 Sep 2011
- Results posted
- No
- Data monitoring committee
- Yes
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, Kalunian K, Petri MA, Strand V, Houssiau FA, Pike M, Kilgallen B, Bongardt S, Barry A, Kelley L, Gordon C. Efficacy and safety of epratuzumab in patients with moderate/severe active systemic lupus erythematosus: results from EMBLEM, a phase IIb, randomised, double-blind, placebo-controlled, multicentre study. Ann Rheum Dis. 2014 Jan;73(1):183-90. doi: 10.1136/annrheumdis-2012-202760. Epub 2013 Jan 12.
PubMed 23313811
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IIb Randomized, Double-blind, Placebo-controlled, Dose and Dose Regimen-ranging Study of the Safety and Efficacy of Epratuzumab in Serologically-positive Systemic Lupus Erythematosus (SLE) Patients With Active Disease
- ClinicalTrials.gov ID
- NCT00624351
- Acronym / sponsor ID
- SL0007
- Conditions
- Systemic Lupus Erythematosus
- Keywords
- Lupus, Monoclonal antibody, B-Cell immunotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 227 participants (actual)
- Lead sponsor
- UCB PharmaIndustry (pharma, biotech, devices)
- Study start
- Jan 2008
- Primary completion
- Aug 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 27 Feb 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 dose response and the dose frequency of epratuzumab in patients with SLE.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Other: PlaceboPhosphate-buffered Saline (PBS) infusions at study weeks 0, 1, 2, and 3. |
| EMAB 600mg | Experimental | Biological: Epratuzumab600 mg Epratuzumab infusions at study weeks 0, 1, 2, and 3. |
| EMAB 100mg | Experimental | Biological: Epratuzumab, Other: Placebo100 mg Epratuzumab infusions at study weeks 0, and 2, and placebo at study weeks 1 and 3. |
| EMAB 400mg | Experimental | Biological: Epratuzumab, Other: Placebo400 mg Epratuzumab infusions at study weeks 0, and 2, and placebo at study weeks 1 and 3. |
| EMAB 1200mg | Experimental | Biological: Epratuzumab, Other: Placebo1200 mg Epratuzumab infusions at study weeks 0, and 2, and placebo at study weeks 1 and 3. |
| EMAB 1800mg | Experimental | Biological: Epratuzumab, Other: Placebo1800 mg Epratuzumab infusions at study weeks 0, and 2, and placebo at study weeks 1 and 3. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Positive ANA result at visit 1
- Current diagnosis of systemic lupus erythematosus (SLE) by American College of Rheumatology revised criteria such that at least 4 of the 11 criteria are met
- Active moderate or severe SLE disease activity as demonstrated by British Isles Lupus Assessment Group (BILAG) A level disease activity in at least one body/organ system or BILAG B level disease activity in at least two body/organ systems if no BILAG A level disease is present
- If on antimalarials, dose regimen must be stable for 4 weeks prior to study entry.
Key exclusion criteria (5 listed)
- Patients receiving 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 central nervous system (CNS) (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 World Health Organization (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 Phosphate buffered Saline (PBS) as a vehicle/buffer for the infusion procedure. | Biological | EMAB 100mg, EMAB 1200mg, EMAB 1800mg, EMAB 400mg, EMAB 600mg |
| PlaceboPhosphate-buffered Saline (PBS) infusion. | Other | EMAB 100mg, EMAB 1200mg, EMAB 1800mg, EMAB 400mg, Placebo |
Primary outcome
Response at Week 12 according to a combined response index
Time frame: Week 12
The combined response index incorporates the Bristish Isles Lupus Assessment Group (BILAG) assessment, the Systemic Lupus Eyrthematosus Disease Activity Index (SLEDAI), a physician's global assessment of disease activity, and treatment failure status.
28 secondary outcomes
Response at Week 4 according to a combined response index
Time frame: Week 4
Response at Week 8 according to a combined response index
Time frame: Week 8
Response at Week 4 according to a combined response index involving Short Form-36 (SF-36) response
Time frame: Week 4
Response at Week 8 according to a combined response index involving Short Form-36 (SF-36) response
Time frame: Week 8
Response at Week 12 according to a combined response index involving Short Form-36 (SF-36) response
Time frame: Week 12
Improvement (yes/no) in British Isles Lupus Assessment Group (BILAG) at Week 4
Time frame: Baseline, Week 4
Improvement (yes/no) in British Isles Lupus Assessment Group (BILAG) at Week 8
Time frame: Baseline, Week 8
Improvement (yes/no) in British Isles Lupus Assessment Group (BILAG) at Week 12
Time frame: Baseline, Week 12
Improvement in British Isles Lupus Assessment Group (BILAG) at Week 24
Time frame: Baseline, Week 24
Change from baseline in total British Isles Lupus Assessment Group (BILAG) score at Week 12
Time frame: Baseline, Week 12
Change from baseline in Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) at Week 2
Time frame: Baseline, Week 2
Change from baseline in Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) at Week 4
Time frame: Baseline, Week 4
Change from baseline in Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) at Week 8
Time frame: Baseline, Week 8
Change from baseline in Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) at Week 12
Time frame: Baseline, Week 12
Change from baseline in physician global assessment at Week 12
Time frame: Baseline, Week 12
Change from baseline in patient global assessment at Week 12
Time frame: Baseline, Week 12
Short Form-36 (SF-36) response at Week 2
Time frame: Baseline, Week 2
Short Form-36 (SF-36) response at Week 4
Time frame: Baseline, Week 4
Short Form-36 (SF-36) response at Week 8
Time frame: Baseline, Week 8
Short Form-36 (SF-36) response at Week 12
Time frame: Baseline, Week 12
European Quality of Life-5 Dimensions (EQ-5D) score at Week 12
Time frame: Week 12
Time to first sustained British Isles Lupus Assessment Group (BILAG) response
Time frame: From Baseline to Week 12
Time to enhanced British Isles Lupus Assessment Group (BILAG) response
Time frame: From Baseline to Week 12
Treatment failure up to Week 12
Time frame: From Baseline to Week 12
Cumulative steroid dose at Week 12
Time frame: From Baseline to Week 12
Human anti-human antibodies (HAHA) levels at Week 12
Time frame: Week 12
Change from baseline in levels of circulating B cells at Week 12
Time frame: Baseline, Week 12
Change from baseline in levels of circulating T cells at Week 12
Time frame: Baseline, Week 12
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 Sep 2011.
- 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 23313811Wallace DJ, Kalunian K, Petri MA, Strand V, Houssiau FA, Pike M, Kilgallen B, Bongardt S, Barry A, Kelley L, Gordon C. Efficacy and safety of epratuzumab in patients with moderate/severe active systemic lupus erythematosus: results from EMBLEM, a phase IIb, randomised, double-blind, placebo-controlled, multicentre study. Ann Rheum Dis. 2014 Jan;73(1):183-90. doi: 10.1136/annrheumdis-2012-202760. Epub 2013 Jan 12.
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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)
53 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 53 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 4 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 Sep 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 53 sites in United States, Brazil, India, Poland, Ukraine 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. 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 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?
Response at Week 12 according to a combined response index (time frame: Week 12). 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 NCT00624351, 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 Sep 2011.