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: October 6, 2014
Last verified: October 2014

August 19, 2009
October 6, 2014
September 2009
August 2013   (final data collection date for primary outcome measure)
Proportion of responders at Week 24 [ Time Frame: Until study discontinuation or up to 24 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00962832 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
A Study to Evaluate the Efficacy and Safety of Rontalizumab in Patients With Moderately to Severely Active Systemic Lupus Erythematosus (ROSE)
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

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Systemic Lupus Erythematosus
  • Drug: placebo
    Part 1: Intravenous (IV) repeating dose; Part 2: Subcutaneous repeating dose
  • Drug: rontalizumab
    Part 1: IV repeating dose; Part 2: Subcutaneous repeating dose; Part 3: Open-label extension IV repeating dose
  • Placebo Comparator: A
    Intervention: Drug: placebo
  • Experimental: B
    Intervention: Drug: rontalizumab
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
238
August 2013
August 2013   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Russian Federation,   Argentina,   Colombia,   Mexico,   Poland
 
NCT00962832
IFN4575g, GA00806
Not Provided
Genentech, Inc.
Genentech, Inc.
Not Provided
Study Director: William Kennedy, M.D. Genentech, Inc.
Genentech, Inc.
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP