Clinical trial NCT00624351: Study of Epratuzumab in Serologically-positive Systemic Lupus Erythematosus (SLE) Patients With Active Disease
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
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: 2008-02-27
Enrollment: 227
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: Inclusion Criteria:

* 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.

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 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

Primary outcomes:
measure: Response at Week 12 according to a combined response index
timeFrame: Week 12
Secondary outcomes:
measure: Response at Week 4 according to a combined response index
timeFrame: Week 4
measure: Response at Week 8 according to a combined response index
timeFrame: Week 8
measure: Response at Week 4 according to a combined response index involving Short Form-36 (SF-36) response
timeFrame: Week 4
measure: Response at Week 8 according to a combined response index involving Short Form-36 (SF-36) response
timeFrame: Week 8
measure: Response at Week 12 according to a combined response index involving Short Form-36 (SF-36) response
timeFrame: Week 12
measure: Improvement (yes/no) in British Isles Lupus Assessment Group (BILAG) at Week 4
timeFrame: Baseline, Week 4
measure: Improvement (yes/no) in British Isles Lupus Assessment Group (BILAG) at Week 8
timeFrame: Baseline, Week 8
measure: Improvement (yes/no) in British Isles Lupus Assessment Group (BILAG) at Week 12
timeFrame: Baseline, Week 12
measure: Improvement in British Isles Lupus Assessment Group (BILAG) at Week 24
timeFrame: Baseline, Week 24
measure: Change from baseline in total British Isles Lupus Assessment Group (BILAG) score at Week 12
timeFrame: Baseline, Week 12
measure: Change from baseline in Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) at Week 2
timeFrame: Baseline, Week 2
measure: Change from baseline in Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) at Week 4
timeFrame: Baseline, Week 4
measure: Change from baseline in Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) at Week 8
timeFrame: Baseline, Week 8
measure: Change from baseline in Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) at Week 12
timeFrame: Baseline, Week 12
measure: Change from baseline in physician global assessment at Week 12
timeFrame: Baseline, Week 12
measure: Change from baseline in patient global assessment at Week 12
timeFrame: Baseline, Week 12
measure: Short Form-36 (SF-36) response at Week 2
timeFrame: Baseline, Week 2
measure: Short Form-36 (SF-36) response at Week 4
timeFrame: Baseline, Week 4
measure: Short Form-36 (SF-36) response at Week 8
timeFrame: Baseline, Week 8
measure: Short Form-36 (SF-36) response at Week 12
timeFrame: Baseline, Week 12
measure: European Quality of Life-5 Dimensions (EQ-5D) score at Week 12
timeFrame: Week 12
measure: Time to first sustained British Isles Lupus Assessment Group (BILAG) response
timeFrame: From Baseline to Week 12
measure: Time to enhanced British Isles Lupus Assessment Group (BILAG) response
timeFrame: From Baseline to Week 12
measure: Treatment failure up to Week 12
timeFrame: From Baseline to Week 12
measure: Cumulative steroid dose at Week 12
timeFrame: From Baseline to Week 12
measure: Human anti-human antibodies (HAHA) levels at Week 12
timeFrame: Week 12
measure: Change from baseline in levels of circulating B cells at Week 12
timeFrame: Baseline, Week 12
measure: Change from baseline in levels of circulating T cells at Week 12
timeFrame: Baseline, Week 12
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: Aventura
country: United States
state: Florida
city: Tampa
country: United States
state: Florida
city: Baltimore
country: United States
state: Maryland
city: Brooklyn
country: United States
state: New York
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: Dallas
country: United States
state: Texas
city: Arlington
country: United States
state: Virginia
city: Milwaukee
country: United States
state: Wisconsin
city: Brussels
country: Belgium
city: Leuven
country: Belgium
city: Curitiba
country: Brazil
city: Goiania
country: Brazil
city: Porto Alegre
country: Brazil
city: Rio de Janeiro
country: Brazil
city: Sao Paulo
country: Brazil
city: Sorocaba
country: Brazil
city: Chai Wan
country: Hong Kong
city: Shatin
country: Hong Kong
city: Debrecen
country: Hungary
city: Zalaegerszeg
country: Hungary
city: Bangalore
country: India
city: Hyderabad
country: India
city: Ludhiana
country: India
city: Madurai
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: Poznań
country: Poland
city: Torun
country: Poland
city: Barcelona
country: Spain
city: Santander
country: Spain
city: Valencia
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, 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.