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

• Register: ClinicalTrials.gov
• Last refreshed on: 22 August 2016
• Main ID: NCT00962832
• Date of registration: 19/08/2009
• Prospective Registration: Yes
• Primary sponsor: Genentech, Inc.
• Public title: A Study to Evaluate the Efficacy and Safety of Rontalizumab in Patients With Moderately to Severely Active Systemic Lupus Erythematosus
• Scientific 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
• Date of first enrolment: September 2009
• Target sample size: 238
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00962832
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

Argentina, Colombia, Mexico, Poland, Russian Federation, United Kingdom, United States

Contacts

• Name: William Kennedy, M.D.
• Affiliation: Genentech, Inc.

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 65 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Systemic Lupus Erythematosus

Intervention(s)

Drug: Placebo

Drug: Rontalizumab

Primary Outcome(s)

Proportion of responders at Week 24 [Time Frame: Until study discontinuation or up to 24 weeks]

Secondary Outcome(s)

Time-adjusted area under the curve (AUC) of the BILAG index global score [Time Frame: Until study discontinuation or up to 24 weeks]

Time to treatment failure [Time Frame: Until study discontinuation or up to 24 weeks]

Treatment failure status [Time Frame: Until study discontinuation or up to 24 weeks]

Secondary ID(s)

IFN4575g

GA00806

Source(s) of Monetary Support

Please refer to primary and secondary sponsors