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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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.

Study Description
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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).

Condition or disease Intervention/treatment Phase
Systemic Lupus Erythematosus Drug: Placebo Drug: Rontalizumab Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 238 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
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
Study Start Date : September 2009
Actual Primary Completion Date : January 2012
Actual Study Completion Date : August 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lupus

Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: Part 1 - Placebo intravenously
Participants received placebo intravenously every 4 weeks for 24 weeks.
 Drug: Placebo
Placebo was supplied as a sterile liquid solution.
Experimental: Part 1 - Rontalizumab 750 mg intravenously
Participants received rontalizumab 750 mg intravenously every 4 weeks for 24 weeks.
 Drug: Rontalizumab
Rontalizumab was supplied as a sterile liquid solution.
Placebo Comparator: Part 2 - Placebo subcutaneously
Participants received placebo subcutaneously every 2 weeks for 24 weeks.
 Drug: Placebo
Placebo was supplied as a sterile liquid solution.
Experimental: Part 2 - Rontalizumab 300 mg subcutaneously
Participants received rontalizumab 300 mg subcutaneously every 2 weeks for 24 weeks.
 Drug: Rontalizumab
Rontalizumab was supplied as a sterile liquid solution.
Experimental: Part 3 - Rontalizumab 750 mg intravenously
Participants received rontalizumab 750 mg intravenously every 4 weeks for 120 weeks.
 Drug: Rontalizumab
Rontalizumab was supplied as a sterile liquid solution.


Outcome Measures
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Primary Outcome Measures :
  1. Proportion of responders at Week 24 [ Time Frame: Until study discontinuation or up to 24 weeks ]

Secondary Outcome Measures :
  1. Time-adjusted area under the curve (AUC) of the BILAG index global score [ Time Frame: Until study discontinuation or up to 24 weeks ]
  2. Treatment failure status [ Time Frame: Until study discontinuation or up to 24 weeks ]
  3. Time to treatment failure [ Time Frame: Until study discontinuation or up to 24 weeks ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00962832


Locations
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Sponsors and Collaborators
Genentech, Inc.
Investigators
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Study Director: William Kennedy, M.D. Genentech, Inc.
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT00962832    
Other Study ID Numbers: IFN4575g
GA00806 ( Other Identifier: Hoffmann-La Roche )
First Posted: August 20, 2009    Key Record Dates
Last Update Posted: August 12, 2016
Last Verified: August 2016
Keywords provided by Genentech, Inc.:
rhuMAb IFNalpha
SLE
Additional relevant MeSH terms:
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Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases