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

• Sponsor: Centre Hospitalier Universitaire de Saint Etienne (Other)
• Overall Status: Terminated
• CT.gov ID: NCT02474888
• Collaborator: Theradiag (Other)
• Enrollment: 28
• Locations: 4
• Actual Duration (Months): 56.9
• Patients Per Site: 7
• Patients Per Site Per Month: 0.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Granulomatosis, Wegener's; Microscopic Polyangiitis	Other: blood specimen

Study Design

• Study Type: Observational
• Actual Enrollment: 28 participants
• 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)
• Actual Study Start Date: Sep 15, 2015
• Actual Primary Completion Date: Jun 12, 2020
• Actual Study Completion Date: Jun 12, 2020

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

1. serum rituximab levels [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

1. serum rituximab levels [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

2. serum rituximab levels [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

3. serum anti-rituximab antibodies [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

4. serum anti-rituximab antibodies [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

5. serum anti-rituximab antibodies [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

6. Serum B lymphocytes (CD19+ cells) levels [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

7. Serum B lymphocytes (CD19+ cells) levels [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

8. Serum B lymphocytes (CD19+ cells) levels [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

9. patient number with adverse event [from start of induction rituximab regimen until six monthes after stop of induction regimen]

   frequency and nature of rituximab-attributed adverse events

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Hôpital Edouard Herriot	Lyon		France	69003
2	Hôpital de la Croix Rousse	Lyon		France	69317
3	CH Lyon Sud	Pierre-Bénite		France	69495
4	CHU Saint-Etienne	Saint-Etienne		France	42055

Sponsors and Collaborators

• Centre Hospitalier Universitaire de Saint Etienne
• Theradiag

Investigators

• Principal Investigator: Pascal CATHEBRAS, PHD, CHU Saint-Etienne

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Centre Hospitalier Universitaire de Saint Etienne
• ClinicalTrials.gov Identifier: NCT02474888
• Other Study ID Numbers: 1508058; 2015-001807-29
• First Posted: Jun 18, 2015
• Last Update Posted: Nov 16, 2020
• Last Verified: Nov 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Granulomatosis with Polyangiitis; Microscopic Polyangiitis; Vasculitis; Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis

Study Results

No Results Posted as of Nov 16, 2020