Clinical trial NCT00962832: A Study to Evaluate the Efficacy and Safety of Rontalizumab in Patients With Moderately to Severely Active Systemic Lupus Erythematosus
Official title: A Phase II, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Rontalizumab (rhuMAb IFNalpha) in Patients With Moderately to Severely Active Systemic Lupus Erythematosus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Systemic Lupus Erythematosus
Keywords: rhuMAb IFNalpha
SLE
Lead sponsor: Genentech, Inc.
Sponsor class: INDUSTRY
First posted: 2009-08-20
Enrollment: 238
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a Phase II, randomized, double-blind, placebo-controlled multicenter study to evaluate the efficacy and safety of rontalizumab compared with placebo in patients with moderately to severely active systemic lupus erythematosus (SLE).

Detailed description: The study will be conducted in 3 parts. Parts 1 and 2 of the study will include a double-blind treatment period of 24 weeks and a safety follow-up period of 48 weeks for participants who do not continue onto Part 3. Patients meeting the eligibility criteria for enrollment in Part 3, will enter Part 3 after completion of the Week 24 visit but prior to completion of the Week 72 visit. In Part 1, participants will be randomized in a 2:1 ratio (active drug:placebo) to receive either rontalizumab 750 mg or matching placebo intravenously every 4 weeks for 24 weeks. Part 2 was will be initiated upon the completion of recruitment for Part 1. In Part 2, participants will be randomized in a 2:1 ratio (active drug:placebo) to receive either rontalizumab 300 mg or matching placebo subcutaneously every 2 weeks for 24 weeks. After Week 24, patients will enter a 48-week safety follow-up period, or, after the open label extension became available via protocol amendment, will have the option of entering Part 3 of the study, if eligible. In Part 3, all participants will receive rontalizumab 750 mg intravenously every 4 weeks for 120 weeks (up to 144 weeks total).

Eligibility criteria: Inclusion Criteria:

* Diagnosis of SLE.
* Active disease at the time of screening.
* Agreement to use an effective form of contraception for the duration of the study.

Exclusion Criteria:

* Acutely life- or organ-threatening manifestations of systemic lupus erythematosus (SLE) (eg, proliferative nephritis, unstable neuropsychiatric disease).
* Pregnancy or breastfeeding.
* History of severe allergic or anaphylactic reactions to monoclonal antibodies or intravenous (IV) immunoglobulin.
* Significant, uncontrolled medical disease in any organ system not related to SLE that in the investigator's opinion would preclude patient participation.
* Concomitant conditions that required systemic corticosteroid use within 1 year prior to screening. Use of topical, intraarticular, or inhaled corticosteroids is not exclusionary.
* History of cancer within 5 years of screening.
* Any current or recent (within 4 weeks of screening) signs or symptoms of infection, except for minor infections, fungal infections of the nail beds, or oral or vaginal candidiasis.
* History of severe systemic bacterial, fungal, viral, or parasitic infections (2 or more hospitalizations or 2 or more courses of IV antibiotics) within 6 months prior to screening

Primary outcomes:
measure: Proportion of responders at Week 24
timeFrame: Until study discontinuation or up to 24 weeks
Secondary outcomes:
measure: Time-adjusted area under the curve (AUC) of the BILAG index global score
timeFrame: Until study discontinuation or up to 24 weeks
measure: Treatment failure status
timeFrame: Until study discontinuation or up to 24 weeks
measure: Time to treatment failure
timeFrame: Until study discontinuation or up to 24 weeks
Other outcomes:
Locations:
city: Anniston
country: United States
state: Alabama
city: Birmingham
country: United States
state: Alabama
city: Tucson
country: United States
state: Arizona
city: La Jolla
country: United States
state: California
city: Long Beach
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Palo Alto
country: United States
state: California
city: San Leandro
country: United States
state: California
city: Upland
country: United States
state: California
city: Aventura
country: United States
state: Florida
city: Clearwater
country: United States
state: Florida
city: Orlando
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Coeur D'alene
country: United States
state: Idaho
city: Chicago
country: United States
state: Illinois
city: Chicago
country: United States
state: Illinois
city: Kansas City
country: United States
state: Kansas
city: Baton Rouge
country: United States
state: Louisiana
city: Cumberland
country: United States
state: Maryland
city: Hagerstown
country: United States
state: Maryland
city: Boston
country: United States
state: Massachusetts
city: Ann Arbor
country: United States
state: Michigan
city: Brooklyn
country: United States
state: New York
city: Great Neck
country: United States
state: New York
city: Manhasset
country: United States
state: New York
city: New York
country: United States
state: New York
city: New York
country: United States
state: New York
city: Rochester
country: United States
state: New York
city: Roslyn
country: United States
state: New York
city: Chapel HIll
country: United States
state: North Carolina
city: Charlotte
country: United States
state: North Carolina
city: Greenville
country: United States
state: North Carolina
city: Winston-Salem
country: United States
state: North Carolina
city: Cleveland
country: United States
state: Ohio
city: Oklahoma City
country: United States
state: Oklahoma
city: Tulsa
country: United States
state: Oklahoma
city: Bethlehem
country: United States
state: Pennsylvania
city: Philadelphia
country: United States
state: Pennsylvania
city: Pittsburgh
country: United States
state: Pennsylvania
city: Charleston
country: United States
state: South Carolina
city: Charleston
country: United States
state: South Carolina
city: Dallas
country: United States
state: Texas
city: Dallas
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Sugar Land
country: United States
state: Texas
city: Arlington
country: United States
state: Virginia
city: Spokane
country: United States
state: Washington
city: Buenos Aires
country: Argentina
city: Buenos Aires
country: Argentina
city: Ciudad Autonoma Buenos A.
country: Argentina
city: Rosario
country: Argentina
city: San Miguel de Tucuman
country: Argentina
city: Barranquilla-Atlantico
country: Colombia
city: Barranquilla
country: Colombia
city: Bogota D.C.
country: Colombia
city: Bogotá
country: Colombia
city: Bucaramanga
country: Colombia
city: Chia-Cundinamarca
country: Colombia
city: Medellin-Antioquia
country: Colombia
city: Guadalajara
country: Mexico
city: Mexico Ctiy
country: Mexico
city: Mexico D.F.
country: Mexico
city: Mexico
country: Mexico
city: Miexico City
country: Mexico
city: Morelia
country: Mexico
city: San Luis Potosi S.L.P.
country: Mexico
city: Bydgoszcz
country: Poland
city: Elblag
country: Poland
city: Konskie
country: Poland
city: Koscian
country: Poland
city: Krakow
country: Poland
city: Poznan
country: Poland
city: Warszawa
country: Poland
city: Kazan
country: Russian Federation
city: Moscow
country: Russian Federation
city: Tomsk
country: Russian Federation
city: Yaroslavl
country: Russian Federation
Study officials:
affiliation: Genentech, Inc.
name: William Kennedy, M.D.
role: STUDY_DIRECTOR
References:
citation: Kalunian KC, Merrill JT, Maciuca R, McBride JM, Townsend MJ, Wei X, Davis JC Jr, Kennedy WP. A Phase II study of the efficacy and safety of rontalizumab (rhuMAb interferon-alpha) in patients with systemic lupus erythematosus (ROSE). Ann Rheum Dis. 2016 Jan;75(1):196-202. doi: 10.1136/annrheumdis-2014-206090. Epub 2015 Jun 2.
citation: Kennedy WP, Maciuca R, Wolslegel K, Tew W, Abbas AR, Chaivorapol C, Morimoto A, McBride JM, Brunetta P, Richardson BC, Davis JC Jr, Behrens TW, Townsend MJ. Association of the interferon signature metric with serological disease manifestations but not global activity scores in multiple cohorts of patients with SLE. Lupus Sci Med. 2015 Mar 28;2(1):e000080. doi: 10.1136/lupus-2014-000080. eCollection 2015.