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Trial record 14 of 46 for:    "Microscopic polyangiitis"

Pharmacokinetic Study of Rituximab Induction Regimen in ANCA-associated Vasculitis (MONITUX)

This study is currently recruiting participants.
Verified October 2017 by Centre Hospitalier Universitaire de Saint Etienne
Sponsor:
ClinicalTrials.gov Identifier:
NCT02474888
First Posted: June 18, 2015
Last Update Posted: October 18, 2017
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
theradiag
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Saint Etienne
  Purpose

The aim of the investigators' study is to evaluate whether monitoring serum rituximab levels could be an interesting tool in the follow-up of ANCA-associated vasculitis patients.

All consecutive patients, hospitalized for a new diagnosis of ANCA-associated vasculitis or the relapse of a known ANCA-associated vasculitis, in which the decision to start an induction regimen with rituximab has been taken, will be included.

Serum rituximab levels (along with serum anti-rituximab antibodies levels) will be determined (at M+1 and M+3) and the correlation with clinical outcome at M+6 will be analyzed.


Condition Intervention
Granulomatosis, Wegener's Microscopic Polyangiitis Other: blood specimen

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pharmacokinetic Study of Rituximab Induction Regimen in ANCA-associated Vasculitis : a Predictive Factor of Clinical Outcome? (MONITUX)

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire de Saint Etienne:

Primary Outcome Measures:
  • serum rituximab levels [ Time Frame: 1 month after stop of rituximab induction regimen ]
    rituximab level comparison between number of non-responders and number of responders after rituximab induction regimen. The number of non-responders is defined by a Birmingham Vascularitis Activity score > 0, 6 months after stop of induction regimen


Secondary Outcome Measures:
  • serum rituximab levels [ Time Frame: 3 months after stop of rituximab induction regimen ]
    rituximab level comparison between number of non-responders and number of responders after rituximab induction regimen. The number of non-responders is defined by a Birmingham Vascularitis Activity score > 0 six months after stop of induction regimen

  • serum rituximab levels [ Time Frame: 6 months after stop of rituximab induction regimen ]
    rituximab level comparison between number of non-responders and number of responders after rituximab induction regimen. The number of non-responders is defined by a Birmingham Vascularitis Activity score > 0 six months after stop of induction regimen

  • serum anti-rituximab antibodies [ Time Frame: 1 month after stop of rituximab induction regimen ]
    serum anti-rituximab antibodies level comparison between number of non-responders and number of responders after rituximab induction regimen. The number of non-responders is defined by a Birmingham Vascularitis Activity score > 0 six months after stop of induction regimen

  • serum anti-rituximab antibodies [ Time Frame: 3 months after stop of rituximab induction regimen ]
    serum anti-rituximab antibodies level comparison between number of non-responders and number of responders after rituximab induction regimen. The number of non-responders is defined by a Birmingham Vascularitis Activity score > 0 six months after stop of induction regimen

  • serum anti-rituximab antibodies [ Time Frame: 6 months after stop of rituximab induction regimen ]
    serum anti-rituximab antibodies level comparison between number of non-responders and number of responders after rituximab induction regimen. The number of non-responders is defined by a Birmingham Vascularitis Activity score > 0 six months after stop of induction regimen

  • Serum B lymphocytes (CD19+ cells) levels [ Time Frame: 1 month after stop of rituximab induction regimen ]
    Serum B lymphocytes (CD19+ cells) levels comparison between number of non-responders and number of responders after rituximab induction regimen. The number of non-responders is defined by a Birmingham Vascularitis Activity score > 0 six months after stop of induction regimen

  • Serum B lymphocytes (CD19+ cells) levels [ Time Frame: 3 months after stop of rituximab induction regimen ]
    Serum B lymphocytes (CD19+ cells) levels comparison between number of non-responders and number of responders after rituximab induction regimen. The number of non-responders is defined by a Birmingham Vascularitis Activity score > 0 six months after stop of induction regimen

  • Serum B lymphocytes (CD19+ cells) levels [ Time Frame: 6 months after stop of rituximab induction regimen ]
    Serum B lymphocytes (CD19+ cells) levels comparison between number of non-responders and number of responders after rituximab induction regimen. The number of non-responders is defined by a Birmingham Vascularitis Activity score > 0 six months after stop of induction regimen

  • patient number with adverse event [ Time Frame: from start of induction rituximab regimen until six monthes after stop of induction regimen ]
    frequency and nature of rituximab-attributed adverse events


Biospecimen Retention:   Samples Without DNA
blood specimen for serum rituximab level and serum anti-rituximab level

Estimated Enrollment: 50
Actual Study Start Date: October 2015
Estimated Study Completion Date: November 2018
Estimated Primary Completion Date: May 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Rituximab
a classical induction regimen with rituximab (decision taken before inclusion), implying an infusion of 375mg/m² per week, for 4 consecutive weeks (from week -3 until week 0) with blood specimen.
Other: blood specimen
blood specimen for serum rituximab level and serum anti-rituximab level at M1 and M3 after stop of induction rituximab treatment

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Granulomatosis with polyangiitis or microscopic polyangiitis (according to Chapel Hill criterions), with or without detectable ANCA
Criteria

Inclusion Criteria:

  • Age > 18 years
  • Granulomatosis with polyangiitis or microscopic polyangiitis (according to Chapel Hill criterions), with or without detectable ANCA
  • Decision taken to start an induction regimen with rituximab
  • Informed and having signed the study consent form
  • If of child-bearing potential, female patients will have use an effective method of contraception during RTX (rituximab) treatment and in the 12 months following RTX treatment stop
  • no-breast-feeding during RTX treatment and in the 12 months following RTX treatment stop

Exclusion Criteria:

  • Other primary or secondary systemic vasculitis
  • Incapacity or refusal to sign the informed consent form
  • Incapacity or refusal to adhere to treatment or perform the follow-up examinations required by the study
  • Allergy, documented hypersensitivity or contraindication to the medications used in the present study (corticosteroids, rituximab)
  • severe active infection
  • Patient with severe heart failure (stage NYHA IV) or any other unstable heart disease Pregnancy, except for cases where the expected benefit oj treatment seems to surpass the potential risks
  • Patients with active hepatitis B
  • Any live vaccine within four weeks prior to the first infusion of RTX
  Contacts and Locations
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): NCT02474888


Contacts
Contact: Pascal Cathebras, PHD (0)477828342 ext +33 pascal.cathebras@chu-st-etienne.fr
Contact: Martin Killian martin.killian7@yahoo.fr

Locations
France
Hôpital Edouard Herriot Not yet recruiting
Lyon, France, 69003
Contact: Arnaud Hot, PHD         
Principal Investigator: Arnaud HOT, PHD         
Sub-Investigator: Laurent PERARD, MD         
Sub-Investigator: Cécile-Audrey DUREL, MD         
Hôpital de la Croix Rousse Not yet recruiting
Lyon, France, 69317
Contact: Pascal Seve, PHD         
Principal Investigator: Pascal SEVE, PHD         
Sub-Investigator: Claire BERNARD, MD         
Sub-Investigator: Mathieu GERFAUD-VALENTIN, MD         
Sub-Investigator: Yvan JAMILLOUX, MD         
CH Lyon Sud Not yet recruiting
Pierre-Bénite, France, 69495
Contact: Jean-Christophe LEGA, MD         
Principal Investigator: Jean-Christophe LEGA, MD         
Sub-Investigator: Quitterie Reynaud, MD         
CHU Saint-Etienne Recruiting
Saint-Etienne, France, 42055
Contact: Pascal CATHEBRAS, PHD    (0)477828342    pascal.cathebras@chu-st-etienne.fr   
Contact: Martin KILLIAN       martin.killian7@yahoo.fr   
Principal Investigator: Pascal CATHEBRAS, PHD         
Sub-Investigator: Christophe MARIAT, PHD         
Sub-Investigator: Ingrid MASSON, MD         
Sub-Investigator: Jean-Baptiste GAULTIER, MD         
Sub-Investigator: Isabelle GUICHARD, MD         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Saint Etienne
theradiag
Investigators
Principal Investigator: Pascal CATHEBRAS, PHD CHU Saint-Etienne
  More Information

Responsible Party: Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier: NCT02474888     History of Changes
Other Study ID Numbers: 1508058
First Submitted: June 10, 2015
First Posted: June 18, 2015
Last Update Posted: October 18, 2017
Last Verified: October 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Microscopic Polyangiitis
Vasculitis
Systemic Vasculitis
Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
Granulomatosis with Polyangiitis
Vascular Diseases
Cardiovascular Diseases
Autoimmune Diseases
Immune System Diseases
Cerebral Small Vessel Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Lung Diseases, Interstitial
Lung Diseases
Respiratory Tract Diseases
Rituximab
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents