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

Sponsor:	Genentech
Information provided by:	Genentech
ClinicalTrials.gov Identifier:	NCT00962832

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 Primary Completion Date:	September 2012 (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:	Disclosures Group, Genentech, Inc.
ClinicalTrials.gov Identifier:	NCT00962832 History of Changes
Other Study ID Numbers:	IFN4575g
Study First Received:	August 19, 2009
Last Updated:	July 5, 2011
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 23, 2012