Clinical trial NCT00660881: Open-label Study of Epratuzumab in Serologically-positive Systemic Lupus Erythematosus Patients With Active Disease
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Systemic Lupus Erythematosus
Keywords: Lupus
Monoclonal antibody
B-Cell immunotherapy
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2008-04-17
Enrollment: 210
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility 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.

Primary outcomes:
measure: Continue to assess safety of epratuzumab by assessing adverse events (including infusion reactions), vital signs and clinical safety laboratory assessments (Timeframe: All visits)
timeFrame: 12 Week treatment cycles
Secondary outcomes:
measure: The combined response index analysis evaluating BILAG, SLEDAI, and a physician's global assessment and treatment failure status
timeFrame: Every 4 weeks through week 48, then every 12 weeks through completion
measure: The combined response index including an additional criteria involving the SF-36 response
timeFrame: Every 12 weeks
measure: BILAG score assessment
timeFrame: Every 4 weeks through week 48, then every 12 weeks through completion
measure: SLEDAI scores assessment
timeFrame: Every 4 weeks through week 48, then every 12 weeks through completion
measure: Patient and physician VAS
timeFrame: Every 4 weeks through week 48, then every 12 weeks through completion
measure: Percentage of patients achieving SF-36 stabilization or improvement as compared to baseline
timeFrame: Every 12 weeks
measure: SF-36 PCS, MCS
timeFrame: Every 12 weeks
measure: EQ-5D results
timeFrame: Every 12 weeks
measure: Proportion of patients meeting treatment failure
timeFrame: Every 12 weeks
measure: Total daily steroid dose
timeFrame: Every 4 weeks for the first 48 weeks and then every 12 weeks
measure: Time to flare for patients who entered the study without flare as defined by the BILAG
timeFrame: over the entire course of the trial
measure: SLEDAI responder
timeFrame: Every 4 weeks for the first 48 weeks and then every 12 weeks
measure: Time to sustained response for patients entering SL0008 with flare as defined by the BILAG.
timeFrame: over the entire course of the trial
measure: Immunogenicity as measured by human anti-human antibodies
timeFrame: at each dosing visit and 4 weeks post first dose of each treatment cycle
measure: Assessment of changes in baseline in levels of circulating B and T cells
timeFrame: The first dosing visit of each treatment cycle and at 4 weeks post first dose of each treatment cycle
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Tucson
country: United States
state: Arizona
city: La Jolla
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: San Leandro
country: United States
state: California
city: Denver
country: United States
state: Colorado
city: Farmington
country: United States
state: Connecticut
city: Tampa
country: United States
state: Florida
city: Chapel Hill
country: United States
state: North Carolina
city: Charlotte
country: United States
state: North Carolina
city: Durham
country: United States
state: North Carolina
city: Wilmington
country: United States
state: North Carolina
city: Oklahoma City
country: United States
state: Oklahoma
city: Arlington
country: United States
state: Virginia
city: Brussels
country: Belgium
city: Leuven
country: Belgium
city: Goiania
country: Brazil
state: GO
city: Porto Alegre
country: Brazil
city: Sao Paulo
country: Brazil
city: Shatin
country: Hong Kong
city: Debrecen
country: Hungary
city: Zalaegerszeg
country: Hungary
city: Madurai
country: India
state: Tamilnadu
city: Bangalore
country: India
city: Hyderabad
country: India
city: Manipal
country: India
city: Nagpur
country: India
city: Kaunas
country: Lithuania
city: Klaipeda
country: Lithuania
city: Vilnius
country: Lithuania
city: Elblag
country: Poland
city: Konskie
country: Poland
city: Lublin
country: Poland
city: Poznan
country: Poland
city: Torun
country: Poland
city: Barcelona
country: Spain
city: Santander
country: Spain
city: Donetsk
country: Ukraine
city: Ivano-Frankivsk
country: Ukraine
city: Kiev
country: Ukraine
city: Lviv
country: Ukraine
city: Birmingham
country: United Kingdom
Study officials:
affiliation: +1 877 822 9493 (UCB)
name: UCB Clinical Trial Call Center
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.