Study of Epratuzumab in Serologically-Positive Systemic Lupus Erythematosus Patients With Active Disease - Full Text View

Sponsored by:	UCB
Information provided by:	UCB
ClinicalTrials.gov Identifier:	NCT00624351

Purpose

The primary objective of the study is to assess the dose response and the dose frequency of epratuzumab in patients with SLE.

Condition	Intervention	Phase
Systemic Lupus Erythematosus	Biological: Epratuzumab Other: Placebo	Phase II

MedlinePlus related topics: Lupus

Drug Information available for: Immunoglobulins Globulin, Immune Epratuzumab Yttrium Y 90 Epratuzumab

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy 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 Patients With Active Disease

Further study details as provided by UCB:

Primary Outcome Measures:

Efficacy as measured by the responder rate according to a combined response index evaluated at week 12 (visit 10) incorporating BILAG assessment, SLEDAI, a physician's global assessment and treatment failure status. [ Time Frame: Week 12 ]

Secondary Outcome Measures:

The combined response index analysis described for the primary endpoint. [ Time Frame: Weeks 4 and 8 ]
The combined response index including an additional criteria involving the SF-36 response. [ Time Frame: Weeks 4, 8 and 12 ]
Number and percent of patients with BILAG improvement. [ Time Frame: Weeks 4, 8, 12, and 24 ]
Change from baseline in total BILAG score. [ Time Frame: Week 12 ]
Change from baseline in SLEDAI. [ Time Frame: Weeks 2, 4, 8 and 12 ]
Change from baseline in physician and patient global assessments. [ Time Frame: Week 12 ]
Percentage of patients achieving SF-36 response. [ Time Frame: At various study weeks 2 - 12 ]
EQ-5D results at weeks 12. [ Time Frame: Week 12 ]
Time to first sustained BILAG response [ Time Frame: Various including study weeks 6, 8 and 12 ]
Time to enhanced BILAG response. [ Time Frame: Various including study weeks 6, 8 and 12 ]
Proportion of patients meeting treatment failure. [ Time Frame: Various including study weeks 6, 8 and 12 ]
Endpoints relating to use of steroids over treatment period. [ Time Frame: Various including study weeks 6, 8 and 12 ]
Safety outcome measures include adverse events (including infusion reactions), vital signs and clinical safety laboratory assessments. [ Time Frame: Various including study weeks 6, 8 and 12 ]
Immunogenicity as measured by human anti-human antibodies (HAHA) [ Time Frame: Various including study weeks 6, 8 and 12 ]
Assessment of changes from baseline in levels of circulating B and T cells [ Time Frame: Various including study weeks 6, 8 and 12 ]

Estimated Enrollment:	210
Study Start Date:	January 2008
Estimated Study Completion Date:	April 2009
Estimated Primary Completion Date:	April 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Placebo Comparator PBS infusions	Other: Placebo Placebo at study weeks 0, 1, 2, and 3
2: Experimental 600 mg Epratuzumab infusions at study weeks 0, 1, 2, and 3.	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. Dosage and frequency varies per arm (See above)
3: Experimental 100 mg Epratuzumab infusions at study weeks 0, and 2, and placebo at study weeks 1 and 3.	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. Dosage and frequency varies per arm (See above) Other: Placebo Placebo at study weeks 0, 1, 2, and 3
4: Experimental 400 mg Epratuzumab infusions at study weeks 0, and 2, and placebo at study weeks 1 and 3.	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. Dosage and frequency varies per arm (See above) Other: Placebo Placebo at study weeks 0, 1, 2, and 3
5: Experimental 1200 mg Epratuzumab infusions at study weeks 0, and 2, and placebo at study weeks 1 and 3.	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. Dosage and frequency varies per arm (See above) Other: Placebo Placebo at study weeks 0, 1, 2, and 3
6: Experimental 1800 mg Epratuzumab infusions at study weeks 0, and 2, and placebo at study weeks 1 and 3.	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. Dosage and frequency varies per arm (See above) Other: Placebo Placebo at study weeks 0, 1, 2, and 3

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Positive ANA result at visit 1 either via screening or confirmatory laboratory testing methodologies;
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 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.

Exclusion Criteria:

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 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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00624351

Contacts

Contact: UCB Clinical Trial Call Center

1 877 822 9493

Show 55 Study Locations

Sponsors and Collaborators

UCB

Investigators

Study Director:

UCB Clinical Trial Call Center

+1 877 822 9493 (UCB)

More Information

Responsible Party:	UCB ( Study Director )
Study ID Numbers:	SL0007, EudraCT Number: 2007-002566-35
Study First Received:	February 15, 2008
Last Updated:	December 17, 2008
ClinicalTrials.gov Identifier:	NCT00624351
Health Authority:	Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment; Brazil: National Health Surveillance Agency; Hong Kong: Department of Health; Hungary: National Institute of Pharmacy; India: Drugs Controller General of India; Lithuania: State Medicine Control Agency - Ministry of Health; Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products; Spain: Spanish Agency of Medicines; Ukraine: State Pharmacological Center - Ministry of Health; United Kingdom: Medicines and Healthcare Products Regulatory Agency; United States: Food and Drug Administration

Keywords provided by UCB:

Lupus
Monoclonal antibody
B-Cell immunotherapy

Study placed in the following topic categories:

Antibodies, Monoclonal
Antibodies
Autoimmune Diseases

Lupus Erythematosus, Systemic
Connective Tissue Diseases
Immunoglobulins

Additional relevant MeSH terms:

Immune System Diseases

ClinicalTrials.gov processed this record on January 16, 2009