Back to resultsA Study to Evaluate the Efficacy and Safety of Rontalizumab in Patients With Moderately to Severely Active Systemic Lupus Erythematosus
Primary Purpose
Systemic Lupus Erythematosus
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Placebo
Rontalizumab
Sponsored by
About this trial
This is an interventional treatment trial for Systemic Lupus Erythematosus focused on measuring rhuMAb IFNalpha, SLE
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Placebo Comparator
Experimental
Placebo Comparator
Experimental
Experimental
Arm Label
Part 1 - Placebo intravenously
Part 1 - Rontalizumab 750 mg intravenously
Part 2 - Placebo subcutaneously
Part 2 - Rontalizumab 300 mg subcutaneously
Part 3 - Rontalizumab 750 mg intravenously
Arm Description
Participants received placebo intravenously every 4 weeks for 24 weeks.
Participants received rontalizumab 750 mg intravenously every 4 weeks for 24 weeks.
Participants received placebo subcutaneously every 2 weeks for 24 weeks.
Participants received rontalizumab 300 mg subcutaneously every 2 weeks for 24 weeks.
Participants received rontalizumab 750 mg intravenously every 4 weeks for 120 weeks.
Outcomes
Primary Outcome Measures
Proportion of responders at Week 24
Secondary Outcome Measures
Time-adjusted area under the curve (AUC) of the BILAG index global score
Treatment failure status
Time to treatment failure
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00962832
Brief Title
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
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
August 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Genentech, Inc.
4. Oversight
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Systemic Lupus Erythematosus
Keywords
rhuMAb IFNalpha, SLE
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
238 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Part 1 - Placebo intravenously
Arm Type
Placebo Comparator
Arm Description
Participants received placebo intravenously every 4 weeks for 24 weeks.
Arm Title
Part 1 - Rontalizumab 750 mg intravenously
Arm Type
Experimental
Arm Description
Participants received rontalizumab 750 mg intravenously every 4 weeks for 24 weeks.
Arm Title
Part 2 - Placebo subcutaneously
Arm Type
Placebo Comparator
Arm Description
Participants received placebo subcutaneously every 2 weeks for 24 weeks.
Arm Title
Part 2 - Rontalizumab 300 mg subcutaneously
Arm Type
Experimental
Arm Description
Participants received rontalizumab 300 mg subcutaneously every 2 weeks for 24 weeks.
Arm Title
Part 3 - Rontalizumab 750 mg intravenously
Arm Type
Experimental
Arm Description
Participants received rontalizumab 750 mg intravenously every 4 weeks for 120 weeks.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo was supplied as a sterile liquid solution.
Intervention Type
Drug
Intervention Name(s)
Rontalizumab
Intervention Description
Rontalizumab was supplied as a sterile liquid solution.
Primary Outcome Measure Information:
Title
Proportion of responders at Week 24
Time Frame
Until study discontinuation or up to 24 weeks
Secondary Outcome Measure Information:
Title
Time-adjusted area under the curve (AUC) of the BILAG index global score
Time Frame
Until study discontinuation or up to 24 weeks
Title
Treatment failure status
Time Frame
Until study discontinuation or up to 24 weeks
Title
Time to treatment failure
Time Frame
Until study discontinuation or up to 24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William Kennedy, M.D.
Organizational Affiliation
Genentech, Inc.
Official's Role
Study Director
Facility Information:
City
Anniston
State/Province
Alabama
ZIP/Postal Code
36207
Country
United States
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
City
San Leandro
State/Province
California
ZIP/Postal Code
94578
Country
United States
City
Upland
State/Province
California
ZIP/Postal Code
91786
Country
United States
City
Aventura
State/Province
Florida
ZIP/Postal Code
33180
Country
United States
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33765
Country
United States
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30303
Country
United States
City
Coeur D'alene
State/Province
Idaho
ZIP/Postal Code
83814
Country
United States
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70809
Country
United States
City
Cumberland
State/Province
Maryland
ZIP/Postal Code
21502
Country
United States
City
Hagerstown
State/Province
Maryland
ZIP/Postal Code
21740
Country
United States
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11203
Country
United States
City
Great Neck
State/Province
New York
ZIP/Postal Code
11020
Country
United States
City
Manhasset
State/Province
New York
ZIP/Postal Code
11030
Country
United States
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
City
Rochester
State/Province
New York
ZIP/Postal Code
14618
Country
United States
City
Roslyn
State/Province
New York
ZIP/Postal Code
11576
Country
United States
City
Chapel HIll
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28210
Country
United States
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27834
Country
United States
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44109
Country
United States
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74104
Country
United States
City
Bethlehem
State/Province
Pennsylvania
ZIP/Postal Code
18015
Country
United States
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19141
Country
United States
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29406
Country
United States
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
City
Houston
State/Province
Texas
ZIP/Postal Code
77004
Country
United States
City
Houston
State/Province
Texas
ZIP/Postal Code
77034
Country
United States
City
Houston
State/Province
Texas
ZIP/Postal Code
77074
Country
United States
City
Sugar Land
State/Province
Texas
ZIP/Postal Code
77479
Country
United States
City
Arlington
State/Province
Virginia
ZIP/Postal Code
22205
Country
United States
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States
City
Buenos Aires
ZIP/Postal Code
C1015ABO
Country
Argentina
City
Buenos Aires
ZIP/Postal Code
C1181ACH
Country
Argentina
City
Ciudad Autonoma Buenos A.
ZIP/Postal Code
C1284AEB
Country
Argentina
City
Rosario
ZIP/Postal Code
S2000DSV
Country
Argentina
City
San Miguel de Tucuman
ZIP/Postal Code
T4000AXL
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
ZIP/Postal Code
44280
Country
Mexico
City
Mexico Ctiy
ZIP/Postal Code
07760
Country
Mexico
City
Mexico D.F.
ZIP/Postal Code
14000
Country
Mexico
City
Mexico
ZIP/Postal Code
06726
Country
Mexico
City
Miexico City
ZIP/Postal Code
06700
Country
Mexico
City
Morelia
ZIP/Postal Code
58070
Country
Mexico
City
San Luis Potosi S.L.P.
ZIP/Postal Code
78240
Country
Mexico
City
Bydgoszcz
ZIP/Postal Code
85-168
Country
Poland
City
Elblag
ZIP/Postal Code
82-300
Country
Poland
City
Konskie
ZIP/Postal Code
26-200
Country
Poland
City
Koscian
ZIP/Postal Code
64-000
Country
Poland
City
Krakow
ZIP/Postal Code
30-510
Country
Poland
City
Poznan
ZIP/Postal Code
60-218
Country
Poland
City
Warszawa
ZIP/Postal Code
02-637
Country
Poland
City
Kazan
ZIP/Postal Code
420064
Country
Russian Federation
City
Moscow
ZIP/Postal Code
115522
Country
Russian Federation
City
Tomsk
ZIP/Postal Code
634063
Country
Russian Federation
City
Yaroslavl
ZIP/Postal Code
150030
Country
Russian Federation
12. IPD Sharing Statement
Citations:
PubMed Identifier
26038091
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.
Results Reference
derived
PubMed Identifier
25861459
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.
Results Reference
derived
Learn more about this trial
A Study to Evaluate the Efficacy and Safety of Rontalizumab in Patients With Moderately to Severely Active Systemic Lupus Erythematosus
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