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
  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

  Show 78 Study Locations
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: October 6, 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 October 23, 2014