Open-label Study of Epratuzumab in Serologically-positive Systemic Lupus Erythematosus Patients With Active Disease

• ClinicalTrials.gov Identifier: NCT00660881
• Recruitment Status: Completed
• First Posted: April 17, 2008
• Last Update Posted: July 12, 2012
• Sponsor: UCB Pharma
• Information provided by (Responsible Party): UCB Pharma

Study Description

Brief Summary:

The primary objective of the study is to assess the safety of epratuzumab in patients with SLE.

Condition or disease	Intervention/treatment	Phase
Systemic Lupus Erythematosus	Biological: Epratuzumab	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 210 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Study Start Date: May 2008
• Actual Primary Completion Date: December 2011
• Actual Study Completion Date: December 2011

Arms and Interventions

Arm	Intervention/treatment
Experimental: EMAB; 1200 mg epratuzumab given in 2 doses every other week in 12 week treatment cycles.	Biological: Epratuzumab; 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.

Outcome Measures

Primary Outcome Measures :

1. 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 ]

Secondary Outcome Measures :

1. 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 ]
2. The combined response index including an additional criteria involving the SF-36 response [ Time Frame: Every 12 weeks ]
3. BILAG score assessment [ Time Frame: Every 4 weeks through week 48, then every 12 weeks through completion ]
4. SLEDAI scores assessment [ Time Frame: Every 4 weeks through week 48, then every 12 weeks through completion ]
5. Patient and physician VAS [ Time Frame: Every 4 weeks through week 48, then every 12 weeks through completion ]
6. Percentage of patients achieving SF-36 stabilization or improvement as compared to baseline [ Time Frame: Every 12 weeks ]
7. SF-36 PCS, MCS [ Time Frame: Every 12 weeks ]
8. EQ-5D results [ Time Frame: Every 12 weeks ]
9. Proportion of patients meeting treatment failure [ Time Frame: Every 12 weeks ]
10. Total daily steroid dose [ Time Frame: Every 4 weeks for the first 48 weeks and then every 12 weeks ]
11. 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 ]
12. SLEDAI responder [ Time Frame: Every 4 weeks for the first 48 weeks and then every 12 weeks ]
13. Time to sustained response for patients entering SL0008 with flare as defined by the BILAG. [ Time Frame: over the entire course of the trial ]
14. Immunogenicity as measured by human anti-human antibodies [ Time Frame: at each dosing visit and 4 weeks post first dose of each treatment cycle ]
15. 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 ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Contacts and Locations

Locations

United States, Alabama

Birmingham, Alabama, United States

United States, Arizona

Tucson, Arizona, United States

United States, California

La Jolla, California, United States

Los Angeles, California, United States

San Leandro, California, United States

United States, Colorado

Denver, Colorado, United States

United States, Connecticut

Farmington, Connecticut, United States

United States, Florida

Tampa, Florida, United States

United States, North Carolina

Chapel Hill, North Carolina, United States

Charlotte, North Carolina, United States

Durham, North Carolina, United States

Wilmington, North Carolina, United States

United States, Oklahoma

Oklahoma City, Oklahoma, United States

United States, Virginia

Arlington, Virginia, United States

Belgium

Brussels, Belgium

Leuven, Belgium

Brazil

Goiania, GO, Brazil

Porto Alegre, Brazil

Sao Paulo, Brazil

Hong Kong

Shatin, Hong Kong

Hungary

Debrecen, Hungary

Zalaegerszeg, Hungary

India

Madurai, Tamilnadu, India

Bangalore, India

Hyderabad, India

Manipal, India

Nagpur, India

Lithuania

Kaunas, Lithuania

Klaipeda, Lithuania

Vilnius, Lithuania

Poland

Elblag, Poland

Konskie, Poland

Lublin, Poland

Poznan, Poland

Torun, Poland

Spain

Barcelona, Spain

Santander, Spain

Ukraine

Donetsk, Ukraine

Ivano-Frankivsk, Ukraine

Kiev, Ukraine

Lviv, Ukraine

United Kingdom

Birmingham, United Kingdom

Sponsors and Collaborators

UCB Pharma

Investigators

• Study Director: UCB Clinical Trial Call Center; +1 877 822 9493 (UCB)

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

Wallace 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.

• Responsible Party: UCB Pharma
• ClinicalTrials.gov Identifier: NCT00660881
• Other Study ID Numbers: SL0008; EudraCT Number: 2007-002589-37
• First Posted: April 17, 2008
• Last Update Posted: July 12, 2012
• Last Verified: July 2012

Keywords provided by UCB Pharma:

Lupus; Monoclonal antibody; B-Cell immunotherapy

Additional relevant MeSH terms:

Lupus Erythematosus, Systemic; Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Epratuzumab; Antineoplastic Agents, Immunological; Antineoplastic Agents