Fatigue Clinical Trial
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
Verified date | March 2017 |
Source | University of Copenhagen |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 21 |
Est. completion date | August 2010 |
Est. primary completion date | June 2010 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 70 Years |
Eligibility |
Inclusion Criteria: - Female patients fulfilling the current American-European consensus classification criteria. - Fertile-age female patients must use safe anticonceptional methods such as pills, mini-pills, or intrauterine spiral. - The fertile-age females included in the study must not get pregnant in at least 12 months after the last treatment with Rituximab. Exclusion Criteria: - Pregnancy and lactation. - Fertile-age females who do not use safe anticonceptional methods. - Patients in systemic treatment with cytostatics. - Patients who previously have been treated with Rituximab. - Patient with an active infection that requires antibiotic treatment. |
Country | Name | City | State |
---|---|---|---|
Denmark | Institute of Odontology, Faculty of Health Sciences, University of Copenhagen | Copenhagen |
Lead Sponsor | Collaborator |
---|---|
University of Copenhagen | Rigshospitalet, Denmark |
Denmark,
Ring T, Kallenbach M, Praetorius J, Nielsen S, Melgaard B. Successful treatment of a patient with primary Sjögren's syndrome with Rituximab. Clin Rheumatol. 2006 Nov;25(6):891-4. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To investigate the effect of Rituximab on subjective disease symptoms including oral dryness, ocular dryness, myoartralgia and fatigue. | Baseline, Day 22 after second treatment, 1 month, 3 months and 6 months after treatment. | ||
Secondary | To study the effect of Rituximab: on the structural changes (focal lymphocytic infiltrates) in the labial salivary gland tissue, including changes in the T- and B-cell ratio in the infiltrates as well as in the expression of M3-receptors | Baseline and 6 months after treatment | ||
Secondary | On the salivary gland function, incl. the production and composition of whole saliva and parotid saliva, the cellular signalling mechanisms and also the distribution of M3-receptors (M3R), the expression of aquaporins, | Baseline, 1 month, 3 months and 6 months after treatment | ||
Secondary | On the circulating serum autoantibodies (anti-SSA/-SSB, rheumatoid factors) and on antibodies against the M3R and a-fodrin and on the IgG level. | Baseline, 1 month, 3 months and 6 months after treatment | ||
Secondary | On the phenotype of circulating T- and B-cells as well as cytokines and immunoregulators, especially BLyS/BAFF. | Baseline, 1 month, 3 months and 6 months after treatment | ||
Secondary | On the function of the tear glandula, including the quantity and quality of tear as well as the extent of corneal changes. | Baseline, 1 month, 3 months and 6 months after treatment | ||
Secondary | To evaluate the side-effects in relation to the use of Rituximab-/placebo treatment. | After first and second treatment and after 1 month |
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