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A Study to Evaluate the Efficacy and Safety of Rontalizumab in Patients With Moderately to Severely Active Systemic Lupus Erythematosus (ROSE)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.
ClinicalTrials.gov Identifier:
NCT00962832
First received: August 19, 2009
Last updated: November 4, 2014
Last verified: November 2014
  Purpose

This is a Phase II, randomized, double-blind, placebo-controlled multicenter stu dy to evaluate the efficacy and safety of rontalizumab compared with placebo in patients with moderately to severely active systemic lupus erythematosus (SLE). The study will enroll approximately 210 patients at up to 100 sites in North Ame rica, Latin America, and Europe.


Condition Intervention Phase
Systemic Lupus Erythematosus
Drug: placebo
Drug: rontalizumab
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Genentech, Inc.:

Primary Outcome Measures:
  • Proportion of responders at Week 24 [ Time Frame: Until study discontinuation or up to 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time-adjusted area under the curve (AUC) of the BILAG index global score [ Time Frame: Until study discontinuation or up to 24 weeks ] [ Designated as safety issue: No ]
  • Treatment failure status [ Time Frame: Until study discontinuation or up to 24 weeks ] [ Designated as safety issue: No ]
  • Time to treatment failure [ Time Frame: Until study discontinuation or up to 24 weeks ] [ Designated as safety issue: No ]

Enrollment: 238
Study Start Date: September 2009
Study Completion Date: August 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: A Drug: placebo
Part 1: Intravenous (IV) repeating dose; Part 2: Subcutaneous repeating dose
Experimental: B Drug: rontalizumab
Part 1: IV repeating dose; Part 2: Subcutaneous repeating dose; Part 3: Open-label extension IV repeating dose

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 SLE (e.g., 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 (two or more hospitalizations or two or more courses of IV antibiotics) within 6 months prior to screening
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00962832

  Hide Study Locations
Locations
United States, Alabama
Anniston, Alabama, United States, 36207
Birmingham, Alabama, United States, 35294
United States, Arizona
Tucson, Arizona, United States, 85724
United States, California
La Jolla, California, United States, 92037
Long Beach, California, United States, 90806
Los Angeles, California, United States, 90048
Palo Alto, California, United States, 94304
San Leandro, California, United States, 94578
Upland, California, United States, 91786
United States, Florida
Aventura, Florida, United States, 33180
Clearwater, Florida, United States, 33765
Orlando, Florida, United States, 32806
United States, Georgia
Atlanta, Georgia, United States, 30303
United States, Idaho
Coeur D'alene, Idaho, United States, 83814
United States, Illinois
Chicago, Illinois, United States, 60637
Chicago, Illinois, United States, 60612
United States, Kansas
Kansas City, Kansas, United States, 66160
United States, Louisiana
Baton Rouge, Louisiana, United States, 70809
United States, Maryland
Cumberland, Maryland, United States, 21502
Hagerstown, Maryland, United States, 21740
United States, Massachusetts
Boston, Massachusetts, United States, 02114
United States, Michigan
Ann Arbor, Michigan, United States, 48109
United States, New York
Brooklyn, New York, United States, 11203
Great Neck, New York, United States, 11020
Manhasset, New York, United States, 11030
New York, New York, United States, 10021
New York, New York, United States, 10016
Rochester, New York, United States, 14618
Roslyn, New York, United States, 11576
United States, North Carolina
Chapel HIll, North Carolina, United States, 27599
Charlotte, North Carolina, United States, 28210
Greenville, North Carolina, United States, 27834
Winston-Salem, North Carolina, United States, 27157
United States, Ohio
Cleveland, Ohio, United States, 44109
United States, Oklahoma
Oklahoma City, Oklahoma, United States, 73104
Tulsa, Oklahoma, United States, 74104
United States, Pennsylvania
Bethlehem, Pennsylvania, United States, 18015
Philadelphia, Pennsylvania, United States, 19141
Pittsburgh, Pennsylvania, United States, 15213
United States, South Carolina
Charleston, South Carolina, United States, 29406
Charleston, South Carolina, United States, 29425
United States, Texas
Dallas, Texas, United States, 75390
Dallas, Texas, United States, 75231
Houston, Texas, United States, 77034
Houston, Texas, United States, 77074
Houston, Texas, United States, 77004
Sugar Land, Texas, United States, 77479
United States, Virginia
Arlington, Virginia, United States, 22205
United States, Washington
Spokane, Washington, United States, 99204
Argentina
Buenos Aires, Argentina, C1181ACH
Buenos Aires, Argentina, C1015ABO
Ciudad Autonoma Buenos A., Argentina, C1284AEB
Rosario, Argentina, S2000DSV
San Miguel de Tucuman, Argentina, T4000AXL
Colombia
Barranquilla, Colombia
Barranquilla-Atlantico, Colombia
Bogota D.C., Colombia
Bogotá, Colombia
Bucaramanga, Colombia
Medellin-Antioquia, Colombia
Mexico
Guadalajara, Mexico, 44280
Mexico, Mexico, 06726
Mexico Ctiy, Mexico, 07760
Mexico D.F., Mexico, 14000
Miexico City, Mexico, 06700
Morelia, Mexico, 58070
San Luis Potosi S.L.P., Mexico, 78240
Poland
Bydgoszcz, Poland, 85-168
Elblag, Poland, 82-300
Konskie, Poland, 26-200
Koscian, Poland, 64-000
Krakow, Poland, 30-510
Poznan, Poland, 60-218
Warszawa, Poland, 02-637
Russian Federation
Kazan, Russian Federation, 420064
Moscow, Russian Federation, 115522
Tomsk, Russian Federation, 634063
Yaroslavl, Russian Federation, 150030
Sponsors and Collaborators
Genentech, Inc.
Investigators
Study Director: William Kennedy, M.D. Genentech, Inc.
  More Information

No publications provided

Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT00962832     History of Changes
Other Study ID Numbers: IFN4575g, GA00806
Study First Received: August 19, 2009
Last Updated: November 4, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Genentech, Inc.:
rhuMAb IFNalpha
SLE

Additional relevant MeSH terms:
Lupus Erythematosus, Systemic
Autoimmune Diseases
Connective Tissue Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on November 25, 2014