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

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ClinicalTrials.gov Identifier: NCT00962832
Recruitment Status : Completed
First Posted : August 20, 2009
Last Update Posted : August 12, 2016
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.

Tracking Information
First Submitted Date  ICMJE August 19, 2009
First Posted Date  ICMJE August 20, 2009
Last Update Posted Date August 12, 2016
Study Start Date  ICMJE September 2009
Actual Primary Completion Date January 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 19, 2009)
Proportion of responders at Week 24 [ Time Frame: Until study discontinuation or up to 24 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00962832 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 19, 2009)
  • Time-adjusted area under the curve (AUC) of the BILAG index global score [ Time Frame: Until study discontinuation or up to 24 weeks ]
  • Treatment failure status [ Time Frame: Until study discontinuation or up to 24 weeks ]
  • Time to treatment failure [ Time Frame: Until study discontinuation or up to 24 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Evaluate the Efficacy and Safety of Rontalizumab in Patients With Moderately to Severely Active Systemic Lupus Erythematosus
Official Title  ICMJE 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
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).
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Systemic Lupus Erythematosus
Intervention  ICMJE
  • Drug: Placebo
    Placebo was supplied as a sterile liquid solution.
  • Drug: Rontalizumab
    Rontalizumab was supplied as a sterile liquid solution.
Study Arms  ICMJE
  • Placebo Comparator: Part 1 - Placebo intravenously
    Participants received placebo intravenously every 4 weeks for 24 weeks.
    Intervention: Drug: Placebo
  • Experimental: Part 1 - Rontalizumab 750 mg intravenously
    Participants received rontalizumab 750 mg intravenously every 4 weeks for 24 weeks.
    Intervention: Drug: Rontalizumab
  • Placebo Comparator: Part 2 - Placebo subcutaneously
    Participants received placebo subcutaneously every 2 weeks for 24 weeks.
    Intervention: Drug: Placebo
  • Experimental: Part 2 - Rontalizumab 300 mg subcutaneously
    Participants received rontalizumab 300 mg subcutaneously every 2 weeks for 24 weeks.
    Intervention: Drug: Rontalizumab
  • Experimental: Part 3 - Rontalizumab 750 mg intravenously
    Participants received rontalizumab 750 mg intravenously every 4 weeks for 120 weeks.
    Intervention: Drug: Rontalizumab
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 1, 2013)
238
Original Estimated Enrollment  ICMJE
 (submitted: August 19, 2009)
210
Actual Study Completion Date  ICMJE August 2013
Actual Primary Completion Date January 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Colombia,   Mexico,   Poland,   Russian Federation,   United States
Removed Location Countries United Kingdom
 
Administrative Information
NCT Number  ICMJE NCT00962832
Other Study ID Numbers  ICMJE IFN4575g
GA00806 ( Other Identifier: Hoffmann-La Roche )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Genentech, Inc.
Study Sponsor  ICMJE Genentech, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: William Kennedy, M.D. Genentech, Inc.
PRS Account Genentech, Inc.
Verification Date August 2016

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