Ignite Creation Date:
2024-05-05 @ 5:18 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00426543
Status:
COMPLETED
Last Update Posted:
2017-03-14
First Post:
2007-01-23
Brief Title:
Effect of B-cell Depletion in Patients With Primary Sjögrens Syndrome
Sponsor:
University of Copenhagen
Organization:
University of Copenhagen
Study Overview
Official Title:
Phase 1 Study of B-cell Depletion With Rituximab on Oral Ocular and General Disease Manifestations in Patients With Primary Sjögrens Syndrome
Status:
COMPLETED
Status Verified Date:
2017-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The primary purpose of the study is to determine whether B-cell depletion with Rituximab has an effect on the oral ocular and general disease manifestations in patients with primary Sjögrens syndrome that is an effect on the symptoms of oral and ocular dryness improvement of the glandular function and a beneficial effect on the general symptoms such as fatigue The secondary purpose of the study is the investigate the underlying autoimmune and pathophysiological mechanisms in Sjögrens syndrome
Detailed Description:
The trial is designed as a double-blind parallel comparison between 2 infusions of 1 g Rituximab and solvent saline given two weeks apart in 22 patients with the diagnosis of primary Sjögrens syndrome as based on the current American-European consensus classification criteria The patients will be followed at the Department of Oral Medicine Clinical Oral Physiology Oral Pathology Anatomy University of Copenhagen the Department of Rheumatology Rigshospitalet and at the Department of Ophthalmology Rigshospitalet
The primary endpoints are clinical and a response has been delineated as at least 50 improvement in score With the provision that this occurs for any item in at least 60 of the treated patients as compared to 1 in the control patients a power of over 80 at doubled sided significance level of 5 is found with 20 patientsThe patients will be followed within this study for 6 months after Rituximab
The study will allow the first real dynamic appraisal of the immunologic pathophysiology in Sjögrens syndrome Hence attempts will be made to determine at the best possible level if and how Rituximab influences and possibly resets the autoimmunity both at the whole body and particularly at the local level in the salivary glands Also the basal transport mechanism in salivary secretion which must necessarily be perturbed in Sjögrens syndrome will be scrutinized employing the best available of techniques Every possible effort to envisage a priory and then monitor the decisive mechanisms has been made
In particular this includes repetitive biopsies from the parotid glands which will allow combining functional and structural data to reduce as much as possible random variability of crucial quantities Also this will allow for the first time to assess the relative and combined utility of obtaining biopsies from both the parotid and labial salivary glands
Roche AS provide investigational medicine but the study was initiated and is entirely controlled by the investigators
The primary endpoints are clinical and a response has been delineated as at least 50 improvement in score With the provision that this occurs for any item in at least 60 of the treated patients as compared to 1 in the control patients a power of over 80 at doubled sided significance level of 5 is found with 20 patientsThe patients will be followed within this study for 6 months after Rituximab
The study will allow the first real dynamic appraisal of the immunologic pathophysiology in Sjögrens syndrome Hence attempts will be made to determine at the best possible level if and how Rituximab influences and possibly resets the autoimmunity both at the whole body and particularly at the local level in the salivary glands Also the basal transport mechanism in salivary secretion which must necessarily be perturbed in Sjögrens syndrome will be scrutinized employing the best available of techniques Every possible effort to envisage a priory and then monitor the decisive mechanisms has been made
In particular this includes repetitive biopsies from the parotid glands which will allow combining functional and structural data to reduce as much as possible random variability of crucial quantities Also this will allow for the first time to assess the relative and combined utility of obtaining biopsies from both the parotid and labial salivary glands
Roche AS provide investigational medicine but the study was initiated and is entirely controlled by the investigators
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| EudractCT-no 2005-004740-31 | None | None | None |