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The RITAI Cohort: An Observational Study on Rituximab Off-label Use for Auto-immune Disorders

2014-08-27 03:19:57 | BioPortfolio

Summary

The primary purpose of the study is to describe by a prospective observational study the serious adverse events occurring in patients treated off-label by rituximab for various auto-immune diseases.

Description

Every patient treated by rituximab off -label for auto-immune diseases in the public hospitals of the Midi-Pyrénées County (France) is eligible for the study, whatever the dose and the number of planned infusions. The enrollment is definitive at the time the first rituximab infusion begins. Follow-up visits are planned at months 1, 3, 6, 12 and 18 after the first infusion. At each visit, the investigators will record the adverse events that have occurred since the last visit. Serious or unexpected adverse events will be systematically monitored and declared to the Pharmacovigilance. Imputability will be quoted according to the French method. A biological collection will be constituted to allow pharmaco- immunological studies.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Conditions

Pemphigus

Intervention

Rituximab (MABTHERA® or RITUXAN®).

Location

Service de médecine interne, hôpital Purpan, place du Dr Baylac
Toulouse
France
31059

Status

Recruiting

Source

University Hospital, Toulouse

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:19:57-0400

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Medical and Biotech [MESH] Definitions

Separation of the prickle cells of the stratum spinosum of the epidermis, resulting in atrophy of the prickle cell layer. It is seen in diseases such as pemphigus vulgaris (see PEMPHIGUS) and DARIER DISEASE.

An autosomal dominantly inherited skin disorder characterized by recurrent eruptions of vesicles and BULLAE mainly on the neck, axillae, and groin. Mutations in the ATP2C1 gene (encoding the secretory pathway Ca2++/Mn2++ ATPase 1 (SPCA1)) cause this disease. It is clinically and histologically similar to DARIER DISEASE - both have abnormal, unstable DESMOSOMES between KERATINOCYTES and defective CALCIUM-TRANSPORTING ATPASES. It is unrelated to PEMPHIGUS VULGARIS though it closely resembles that disease.

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A desmosomal cadherin that is an autoantigen in the acquired skin disorder PEMPHIGUS VULGARIS.

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