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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 is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Genentech
ClinicalTrials.gov Identifier:
NCT00962832
First received: August 19, 2009
Last updated: January 28, 2013
Last verified: January 2013
History of Changes
  Purpose

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). The study will enroll approximately 210 patients at up to 100 sites in North America, 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:

MedlinePlus related topics: Lupus
U.S. FDA Resources

Further study details as provided by Genentech:

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: 237
Study Start Date: August 2009
Estimated Study Completion Date: August 2013
Estimated 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00962832

  Show 62 Study Locations
Sponsors and Collaborators
Genentech
Investigators
Study Director: William Kennedy, M.D. Genentech
  More Information

No publications provided

Responsible Party: Genentech
ClinicalTrials.gov Identifier: NCT00962832     History of Changes
Other Study ID Numbers: IFN4575g
Study First Received: August 19, 2009
Last Updated: January 28, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Genentech:
rhuMAb IFNalpha
SLE

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

ClinicalTrials.gov processed this record on May 22, 2013