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Sandimmun optoral (Cyclosporin A) is used for the musculoskeletal manifestations of Primary Sjögren Syndrome
NSAR are used currently for the treatment of musculoskeletal manifestations at Sjögren Syndrome for the symptomatic release of pain. For therapy-resistant cases drugs also used in Rheumatoid Arthritis are used. For these drugs there is no registration for the treatment of Sjögren Syndrome.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cyclosporine A | Other | All patients will receive Cyclosporine A in a dose of 2mg/kg/BW daily for 16 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cyclosporine A | Drug | Patients will receive Cyclosporine A in a dose of ca. 2mg/kg/BW daily for a 16 week period |
|
| Measure | Description | Time Frame |
|---|---|---|
| Examination of the therapeutic effects (improvement in number of tender, swolen joints, DAS 28) of low dose Cyclosporine A in patients with primary Sjögren Syndrome and articular involvement after a treatment-phase of 16 weeks. | 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of the safety (type and number of adverse events and serious adverse events) of low-dose Cyclosporine A in patients with primary Sjögren Syndrome | 28 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Study the general health changes and improvement of Sicca-symptoms | 16 weeks | |
| Documentation of improvement of articular manifestations by ultrasound examination | 16 weeks |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eugen Feist, Dr. med. | Charite University, Berlin, Germany | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Charite Universitätsklinikum Berlin Campus Mitte | Berlin | State of Berlin | 10117 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27470087 | Derived | Kedor C, Zernicke J, Hagemann A, Gamboa LM, Callhoff J, Burmester GR, Feist E. A phase II investigator-initiated pilot study with low-dose cyclosporine A for the treatment of articular involvement in primary Sjogren's syndrome. Clin Rheumatol. 2016 Sep;35(9):2203-10. doi: 10.1007/s10067-016-3360-4. Epub 2016 Jul 28. |
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| ID | Term |
|---|---|
| D016572 | Cyclosporine |
| ID | Term |
|---|---|
| D003524 | Cyclosporins |
| D010456 | Peptides, Cyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
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| D010455 |
| Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |