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NCT02474888: MONITUX
Pharmacokinetic Study of Rituximab Induction Regimen in ANCA-associated Vasculitis
trial testing blood specimen in Granulomatosis, Wegener's in 28 participants. Terminated before completion.
12 June 2020
Quick facts
| Lead sponsor | Centre Hospitalier Universitaire de Saint Etienne |
|---|---|
| Status | Terminated |
| Study type | OBSERVATIONAL |
| Enrollment | 28 |
| Start date | 15 September 2015 |
| Primary completion | 12 June 2020 |
| Estimated completion | 12 June 2020 |
| Sites | 4 locations across France |
Drugs / interventions tested
- blood specimen — full drug profile →
Conditions studied
- Granulomatosis, Wegener's — all drugs for Granulomatosis, Wegener's →
- Microscopic Polyangiitis — all drugs for Microscopic Polyangiitis →
Sponsor
Centre Hospitalier Universitaire de Saint Etienne
Who can join
18 and older, any sex, with Granulomatosis, Wegener's or Microscopic Polyangiitis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT02474888
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Other Centre Hospitalier Universitaire de Saint Etienne trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT02474888 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Centre Hospitalier Universitaire de Saint Etienne
- Last refreshed: 16 November 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02474888.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing