A Study of rhuMAb IFNalpha in Adults With Systemic Lupus Erythematosus

NCT00541749 | Completed Phase 1

• 1 other identifier: IFN3958g
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a Phase I, randomized, placebo-controlled, double-blind, dose-escalation study of single and repeat doses of rhuMAb IFNalpha, administered through the SC or IV route, in adults with Systemic Lupus Erythematosus.

Conditions

Systemic Lupus Erythematosus

Keywords

SLE

Outcome Measures

Primary Outcomes (2)

• The incidence and nature of laboratory abnormalities

  Length of study

• The incidence, nature, and severity of adverse events

  Length of study

Secondary Outcomes (2)

• The PK profile of rhuMAb IFNalpha

  Length of study

• The incidence of antibodies directed against rhuMAb IFNalpha

  Length of study

Interventions

rhuMAb IFNalpha DRUG

Intravenous repeating dose

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• For patients with reproductive potential (males and females), use of a reliable means of contraception (e.g., hormonal contraceptive, patch, vaginal ring, intrauterine device, physical barrier) throughout their participation in the study
• Diagnosis of SLE according to current American College of Rheumatology (ACR) criteria
• Disease duration of ≥ 1 year (after first diagnosis by a physician)
• Current immunity to measles, mumps, rubella, and varicella, as evidenced by positive IgG titers at the time of screening
• Current vaccination against influenza unless contraindicated in the investigator's judgment
• Normal Pap smear within the applicable time interval recommended by current American Cancer Society guidelines

You may not qualify if:

• Presence of active lupus nephritis
• Presence of active central nervous system (CNS) disease requiring treatment with high-dose corticosteroids or immunosuppressive agents
• Presence of active vasculitis requiring treatment
• History of arterial or venous thromboses within 12 months of screening
• Moderate to severe anemia, thrombocytopenia, or neutropenia
• Any manifestation likely to require, in the investigator's judgment, treatment with high-dose corticosteroids or the addition of an immunosuppressive regimen during the course of the trial
• Pregnancy or lactation
• Lack of peripheral venous access
• History of alcohol or substance abuse within 6 months of screening
• History of severe allergic or anaphylactic reactions to antibodies or fusion proteins
• Evidence of significant uncontrolled concomitant diseases
• Significant laboratory or electrocardiogram (ECG) abnormalities
• Evidence of any clinically significant abnormality on a chest X-ray
• Severly impaired renal function
• Impaired hepatic function

Sponsors & Collaborators

• Genentech, Inc.: lead

Related Publications (1)

• McBride JM, Jiang J, Abbas AR, Morimoto A, Li J, Maciuca R, Townsend M, Wallace DJ, Kennedy WP, Drappa J. Safety and pharmacodynamics of rontalizumab in patients with systemic lupus erythematosus: results of a phase I, placebo-controlled, double-blind, dose-escalation study. Arthritis Rheum. 2012 Nov;64(11):3666-76. doi: 10.1002/art.34632.

  PMID: 22833362 DERIVED

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Interventions

rontalizumab

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Jorn Drappa, M.D.

  Genentech, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2007
• First Posted: October 10, 2007
• Study Start: February 1, 2007
• Last Updated: September 22, 2011

Record last verified: 2011-09