Pharmacokinetic Study of Rituximab Induction Regimen in ANCA-associated Vasculitis

NCT02474888 | Terminated

• 2 other identifiers: 15080582015-001807-29
• Study Type: observational
• Target: 28
• Locations: 1 country
• Sites: 4

Brief Summary

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.

Conditions

Granulomatosis, Wegener's; Microscopic Polyangiitis

Outcome Measures

Primary Outcomes (1)

• serum rituximab levels

  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

  1 month after stop of rituximab induction regimen

Secondary Outcomes (9)

• serum rituximab levels

  3 months after stop of rituximab induction regimen

• serum rituximab levels

  6 months after stop of rituximab induction regimen

• serum anti-rituximab antibodies

  1 month after stop of rituximab induction regimen

• serum anti-rituximab antibodies

  3 months after stop of rituximab induction regimen

• serum anti-rituximab antibodies

  6 months after stop of rituximab induction regimen

Study Arms (1)

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

Interventions

blood specimen OTHER

blood specimen for serum rituximab level and serum anti-rituximab level at M1 and M3 after stop of induction rituximab treatment

Rituximab

Eligibility Criteria

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

Study Population

Granulomatosis with polyangiitis or microscopic polyangiitis (according to Chapel Hill criterions), with or without detectable ANCA

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead
• Theradiag: collaborator

Study Sites (4)

Hôpital Edouard Herriot

Lyon, 69003, France

Location

Hôpital de la Croix Rousse

Lyon, 69317, France

Location

CH Lyon Sud

Pierre-Bénite, 69495, France

Location

CHU Saint-Etienne

Saint-Etienne, 42055, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood specimen for serum rituximab level and serum anti-rituximab level

MeSH Terms

Conditions

Granulomatosis with Polyangiitis; Microscopic Polyangiitis

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases; Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis; Systemic Vasculitis; Vasculitis; Vascular Diseases; Cardiovascular Diseases; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Cerebral Small Vessel Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Pascal CATHEBRAS, PHD

  CHU SAINT-ETIENNE

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2015
• First Posted: June 18, 2015
• Study Start: September 15, 2015
• Primary Completion: June 12, 2020
• Study Completion: June 12, 2020
• Last Updated: November 16, 2020

Record last verified: 2020-11

Locations

FR (4)