A Study to Evaluate the Efficacy and Safety of Rontalizumab in Patients With Moderately to Severely Active Systemic Lupus Erythematosus
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
2 other identifiers
interventional
238
6 countries
79
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Sep 2009
Typical duration for phase_2
79 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 19, 2009
CompletedFirst Posted
Study publicly available on registry
August 20, 2009
CompletedStudy Start
First participant enrolled
September 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2013
CompletedAugust 12, 2016
August 1, 2016
2.3 years
August 19, 2009
August 10, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Proportion of responders at Week 24
Until study discontinuation or up to 24 weeks
Secondary Outcomes (3)
Time-adjusted area under the curve (AUC) of the BILAG index global score
Until study discontinuation or up to 24 weeks
Treatment failure status
Until study discontinuation or up to 24 weeks
Time to treatment failure
Until study discontinuation or up to 24 weeks
Study Arms (5)
Part 1 - Placebo intravenously
PLACEBO COMPARATORParticipants received placebo intravenously every 4 weeks for 24 weeks.
Part 1 - Rontalizumab 750 mg intravenously
EXPERIMENTALParticipants received rontalizumab 750 mg intravenously every 4 weeks for 24 weeks.
Part 2 - Placebo subcutaneously
PLACEBO COMPARATORParticipants received placebo subcutaneously every 2 weeks for 24 weeks.
Part 2 - Rontalizumab 300 mg subcutaneously
EXPERIMENTALParticipants received rontalizumab 300 mg subcutaneously every 2 weeks for 24 weeks.
Part 3 - Rontalizumab 750 mg intravenously
EXPERIMENTALParticipants received rontalizumab 750 mg intravenously every 4 weeks for 120 weeks.
Interventions
Placebo was supplied as a sterile liquid solution.
Rontalizumab was supplied as a sterile liquid solution.
Eligibility Criteria
You may qualify if:
- Diagnosis of SLE.
- Active disease at the time of screening.
- Agreement to use an effective form of contraception for the duration of the study.
You may not qualify if:
- 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.
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Genentech, Inc.lead
Study Sites (79)
Unknown Facility
Anniston, Alabama, 36207, United States
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Birmingham, Alabama, 35294, United States
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Tucson, Arizona, 85724, United States
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La Jolla, California, 92037, United States
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Long Beach, California, 90806, United States
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Los Angeles, California, 90048, United States
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Palo Alto, California, 94304, United States
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San Leandro, California, 94578, United States
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Upland, California, 91786, United States
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Aventura, Florida, 33180, United States
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Clearwater, Florida, 33765, United States
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Orlando, Florida, 32806, United States
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Atlanta, Georgia, 30303, United States
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Coeur d'Alene, Idaho, 83814, United States
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Chicago, Illinois, 60612, United States
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Chicago, Illinois, 60637, United States
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Kansas City, Kansas, 66160, United States
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Baton Rouge, Louisiana, 70809, United States
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Cumberland, Maryland, 21502, United States
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Hagerstown, Maryland, 21740, United States
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Boston, Massachusetts, 02114, United States
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Ann Arbor, Michigan, 48109, United States
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Brooklyn, New York, 11203, United States
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Great Neck, New York, 11020, United States
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Manhasset, New York, 11030, United States
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New York, New York, 10016, United States
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New York, New York, 10021, United States
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Rochester, New York, 14618, United States
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Roslyn, New York, 11576, United States
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Chapel Hill, North Carolina, 27599, United States
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Charlotte, North Carolina, 28210, United States
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Greenville, North Carolina, 27834, United States
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Winston-Salem, North Carolina, 27157, United States
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Cleveland, Ohio, 44109, United States
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Oklahoma City, Oklahoma, 73104, United States
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Tulsa, Oklahoma, 74104, United States
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Bethlehem, Pennsylvania, 18015, United States
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Philadelphia, Pennsylvania, 19141, United States
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Pittsburgh, Pennsylvania, 15213, United States
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Charleston, South Carolina, 29406, United States
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Charleston, South Carolina, 29425, United States
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Dallas, Texas, 75231, United States
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Dallas, Texas, 75390, United States
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Houston, Texas, 77004, United States
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Houston, Texas, 77034, United States
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Houston, Texas, 77074, United States
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Sugar Land, Texas, 77479, United States
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Arlington, Virginia, 22205, United States
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Spokane, Washington, 99204, United States
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Buenos Aires, C1015ABO, Argentina
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Buenos Aires, C1181ACH, Argentina
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Ciudad Autonoma Buenos A., C1284AEB, Argentina
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Rosario, S2000DSV, Argentina
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San Miguel de Tucumán, T4000AXL, Argentina
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Barranquilla, Colombia
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Barranquilla-Atlantico, Colombia
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Bogota D.C., Colombia
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Bogotá, Colombia
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Bucaramanga, Colombia
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Chia-Cundinamarca, Colombia
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Medellin-Antioquia, Colombia
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Guadalajara, 44280, Mexico
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Mexico City, 14000, Mexico
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Mexico Ctiy, 07760, Mexico
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México, 06726, Mexico
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Miexico City, 06700, Mexico
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Morelia, 58070, Mexico
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San Luis Potosi S.l.p., 78240, Mexico
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Bydgoszcz, 85-168, Poland
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Elblag, 82-300, Poland
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Gmina Końskie, 26-200, Poland
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Kościan, 64-000, Poland
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Krakow, 30-510, Poland
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Poznan, 60-218, Poland
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Warsaw, 02-637, Poland
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Kazan', 420064, Russia
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Moscow, 115522, Russia
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Tomsk, 634063, Russia
Unknown Facility
Yaroslavl, 150030, Russia
Related Publications (2)
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.
PMID: 26038091DERIVEDKennedy 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.
PMID: 25861459DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
William Kennedy, M.D.
Genentech, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 19, 2009
First Posted
August 20, 2009
Study Start
September 1, 2009
Primary Completion
January 1, 2012
Study Completion
August 1, 2013
Last Updated
August 12, 2016
Record last verified: 2016-08