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Sponsors and Collaborators: |
University of Copenhagen Rigshospitalet, Denmark |
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Information provided by: | University of Copenhagen |
ClinicalTrials.gov Identifier: | NCT00426543 |
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 Sjögren´s 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 Sjögren´s syndrome.
Condition | Intervention | Phase |
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Primary Sjögren's Syndrome Xerostomia Hyposalivation Keratoconjunctivitis Sicca Fatigue |
Drug: MabThera (rituximab) Drug: Rituximab, Mabthera |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Phase 1 Study of B-Cell Depletion With Rituximab on Oral, Ocular and General Disease Manifestations in Patients With Primary Sjögren's Syndrome |
Estimated Enrollment: | 22 |
Study Start Date: | January 2007 |
Estimated Study Completion Date: | March 2010 |
Estimated Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
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 Sjögren's 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 patients.The 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 Sjögren's 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 Sjögren's 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 A/S provide investigational medicine, but the study was initiated and is entirely controlled by the investigators.
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Anne Marie Lynge Pedersen, PhD, DDS | +45 35 32 67 00 | amp@odont.ku.dk |
Contact: Soren Jacobsen, MD, DMSci | +45 35 45 75 60 | sj@dadlnet.dk |
Denmark | |
Institute of Odontology, Faculty of Health Sciences, University of Copenhagen | Recruiting |
Copenhagen, Denmark, 2200 | |
Contact: Anne Marie Lynge Pedersen, PhD, DDS +45 35 32 67 29 amp@odont.ku.dk | |
Contact: Soren Jacobsen, MD, DMSci +45 35 45 75 60 sj@dadlnet.dk | |
Principal Investigator: Anne Marie Lynge Pedersen, PhD, DDS |
Principal Investigator: | Anne Marie Lynge Pedersen, PhD, DDS | Institute of Odontology, Faculty of Health Sciences, University of Copenhagen |
Responsible Party: | University of Copenhagen and Rigshospitalet ( Anne Marie Lynge Pedersen ) |
Study ID Numbers: | KF 02 282294, EudractCT-no. 2005-004740-31 |
Study First Received: | January 23, 2007 |
Last Updated: | August 12, 2008 |
ClinicalTrials.gov Identifier: | NCT00426543 |
Health Authority: | Denmark: Danish Dataprotection Agency; Denmark: Danish Medicines Agency; Denmark: Ethics Committee |
Clinical trial Intervention study Double-blind randomised controlled study |
Mouth Diseases Arthritis, Rheumatoid Lacrimal Apparatus Diseases Dry Eye Syndromes Musculoskeletal Diseases Arthritis Connective Tissue Diseases Salivary Gland Diseases Keratoconjunctivitis Sicca Corneal Diseases Fatigue Autoimmune Diseases Keratoconjunctivitis sicca |
Rituximab Eye Diseases Joint Diseases Conjunctivitis Rheumatic Diseases Keratoconjunctivitis Conjunctival Diseases Xerostomia Xerophthalmia Keratitis Sjogren's Syndrome Stomatognathic Diseases |
Pathologic Processes Disease Immunologic Factors Immune System Diseases Antineoplastic Agents |
Therapeutic Uses Syndrome Physiological Effects of Drugs Antirheumatic Agents Pharmacologic Actions |