A Study of Intravenous MabThera/Rituxan in Pediatric Patients With Severe Granulomatosis With Polyangiitis (Wegener's) or Microscopic Polyangiitis

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Hoffmann-La Roche
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01750697
First received: December 13, 2012
Last updated: July 7, 2014
Last verified: July 2014
  Purpose

This multicenter, open-label, uncontrolled study will evaluate the safety and ph armacokinetics of MabThera/Rituxan (rituximab) in pediatric patients with severe granulomatosis with polyangiitis (Wegener's) or microscopic polyangiitis. Patie nts will receive MabThera/Rituxan 375 mg/m2 intravenously on Days 1, 8, 15 and 2 2.


Condition Intervention Phase
Wegener's Granulomatosis, Microscopic Polyangiitis
Drug: rituximab [MabThera/Rituxan]
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A PHASE IIa, INTERNATIONAL, MULTICENTER, OPEN-LABEL, UNCONTROLLED STUDY TO EVALUATE THE SAFETY AND PHARMACOKINETICS OF 4 x 375 mg/m2 INTRAVENOUS RITUXIMAB IN PEDIATRIC PATIENTS WITH SEVERE GRANULOMATOSIS WITH POLYANGIITIS (WEGENER S) OR MICROSCOPIC POLYANGIITIS

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Safety: Incidence of adverse events [ Time Frame: approximately 3.5 years ] [ Designated as safety issue: No ]
  • Safety: Nature and severity of adverse events [ Time Frame: approximately 3.5 years ] [ Designated as safety issue: No ]
  • Pharmacokinetics: Clearance (CL) [ Time Frame: up to Day 22 and at Month 1, 2, 4 and 6 ] [ Designated as safety issue: No ]
  • Pharmacokinetics: Volume of distribution [ Time Frame: up to Day 22 and at Month 1, 2, 4 and 6 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pharmacokinetics: Area under the concentration-time curve (AUC) [ Time Frame: up to Day 22 and at Month 1, 2, 4 and 6 ] [ Designated as safety issue: No ]
  • Pharmacokinetics: Maximum concentration (Cmax) [ Time Frame: up to Day 22 and at Month 1, 2, 4 and 6 ] [ Designated as safety issue: No ]

Estimated Enrollment: 25
Study Start Date: May 2013
Estimated Study Completion Date: November 2016
Estimated Primary Completion Date: November 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MabThera/Rituxan Drug: rituximab [MabThera/Rituxan]
375 mg/m2 iv on Days 1, 8, 15 and 22

  Eligibility

Ages Eligible for Study:   2 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age at screening between >/= 2 and < 18 years
  • Diagnosis of granulomatosis with polyangiitis (EULAR/PRINTO/PRES 2008, Ankara criteria for childhood Wegener's granulomatosis) or diagnosis of microscopic polyangiitis (according to the Chapel Hill Consensus Conference)
  • Newly diagnosed patients or patients with relapsing disease according to the following definition:

The recurrence or new onset of potentially organ- or life-threatening disease (i.e. one or more major BVAS/WG items as listed in the protocol or disease severe enough to require treatment with cyclophosphamide)

  • For patients of reproductive potential (males and females), use of reliable means of contraception throughout the study participation
  • For all eligible patients, mandatory prophylactic treatment for Pneumocystis jirovecii infection

Exclusion Criteria:

  • Diagnosis of Churg-Strauss syndrome, as defined by the Chapel Hill consensus Conference (Jennette 1994)
  • Limited disease that would not normally be treated with cyclophosphamide
  • Severe disease requiring mechanical ventilation due to alveolar hemorrhage
  • Requirement for plasmapheresis or dialysis at screening
  • Pregnancy or breastfeeding
  • Evidence of other significant uncontrolled concomitant disease, or of disorder or condition that, in the investigator's opinion, would preclude or interfere with patient participation
  • Primary or secondary immunodeficiency (history of or currently active), including known history of human immunodeficiency virus (HIV) infection
  • Known active infection of any kind (excluding fungal infections of nail beds), or any major episode of infection requiring hospitalization with IV anti-infective agents within 4 weeks of baseline or completion of oral anti-infective agents within 2 weeks prior to baseline
  • History of deep space/tissue infection within 24 weeks prior to baseline
  • History of serious recurrent or chronic infection
  • History of cancer (except for basal cell and squamous cell carcinoma of the skin that have been excised and cured)
  • Currently active alcohol or drug abuse or history of alcohol or drug abuse
  • History of severe allergic or anaphylactic reaction to a biologic agent or known hypersensitivity to any component of rituximab or to murine proteins
  • Previous treatment with rituximab
  • Previous treatment with any cell-depleting therapies
  • Receipt of oral or IV cyclophosphamide within the previous 4 months prior to the baseline visit
  • Receipt of infliximab within 3 months, adalimumab within 2 months or etanercept within 1 month prior to the baseline visit
  • Treatment with any investigational agent within 28 days of baseline or 5 half-lives of the investigational drug (whichever is longer)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01750697

Contacts
Contact: Reference Study ID Number: WA25615 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) global.rochegenentechtrials@roche.com

Locations
United States, Kentucky
Recruiting
Louisville, Kentucky, United States, 40202
United States, New Jersey
Recruiting
Hackensack, New Jersey, United States, 07601
United States, New York
Not yet recruiting
New York, New York, United States, 10032
United States, Ohio
Recruiting
Cincinnati, Ohio, United States, 45229
Recruiting
Cleveland, Ohio, United States, 44195
United States, Utah
Recruiting
Salt Lake City, Utah, United States, 84109
France
Recruiting
Bron, France, 69677
Recruiting
Paris, France, 75743
Germany
Recruiting
Hamburg, Germany, 20246
Recruiting
Heidelberg, Germany, 69120
Italy
Recruiting
Roma, Lazio, Italy, 00165
Recruiting
Genova, Liguria, Italy, 16147
Not yet recruiting
Milano, Lombardia, Italy, 20122
Completed
Padova, Veneto, Italy, 35128
Turkey
Recruiting
Ankara, Turkey, 06100
Active, not recruiting
Istanbul, Turkey, 34098
United Kingdom
Active, not recruiting
Liverpool, United Kingdom, L12 2AP
Active, not recruiting
London, United Kingdom, WC1N 1EH
Active, not recruiting
Nottingham, United Kingdom, NG7 2UH
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01750697     History of Changes
Other Study ID Numbers: WA25615, 2012-002062-13
Study First Received: December 13, 2012
Last Updated: July 7, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Wegener Granulomatosis
Systemic Vasculitis
Microscopic Polyangiitis
Lung Diseases, Interstitial
Lung Diseases
Respiratory Tract Diseases
Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
Vasculitis
Vascular Diseases
Cardiovascular Diseases
Autoimmune Diseases
Immune System Diseases
Rituximab
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents

ClinicalTrials.gov processed this record on July 28, 2014