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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.
ClinicalTrials.gov Identifier:
NCT00962832
First received: August 19, 2009
Last updated: August 10, 2016
Last verified: August 2016

August 19, 2009
August 10, 2016
September 2009
January 2012   (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
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 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 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).
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Systemic Lupus Erythematosus
  • Drug: Placebo
    Placebo was supplied as a sterile liquid solution.
  • Drug: Rontalizumab
    Rontalizumab was supplied as a sterile liquid solution.
  • 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
Kalunian KC, Merrill JT, Maciuca R, McBride JM, Townsend MJ, Wei X, Davis JC Jr, Kennedy WP. A Phase II study of the efficacy and safety of rontalizumab (rhuMAb interferon-α) in patients with systemic lupus erythematosus (ROSE). Ann Rheum Dis. 2016 Jan;75(1):196-202. doi: 10.1136/annrheumdis-2014-206090.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
238
August 2013
January 2012   (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 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
Both
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States,   Argentina,   Colombia,   Mexico,   Poland,   Russian Federation
United Kingdom
 
NCT00962832
IFN4575g, GA00806
Not Provided
Not Provided
Not Provided
Genentech, Inc.
Genentech, Inc.
Not Provided
Study Director: William Kennedy, M.D. Genentech, Inc.
Genentech, Inc.
August 2016

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