Low Dose Cyclosporin A in Primary Sjögren Syndrome
CYPRESS
A Phase II Pilot-Study With Low-dose Sandimmun Optoral (Cyclosporin A) for the Treatment of Primary Sjögren Syndrome
1 other identifier
interventional
30
1 country
1
Brief Summary
Sandimmun optoral (Cyclosporin A) is used for the musculoskeletal manifestations of Primary Sjögren Syndrome
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Mar 2010
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2010
CompletedFirst Submitted
Initial submission to the registry
September 14, 2012
CompletedFirst Posted
Study publicly available on registry
September 26, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2014
CompletedJuly 29, 2015
July 1, 2015
4.6 years
September 14, 2012
July 27, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (1)
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
Other Outcomes (2)
Study the general health changes and improvement of Sicca-symptoms
16 weeks
Documentation of improvement of articular manifestations by ultrasound examination
16 weeks
Study Arms (1)
Cyclosporine A
OTHERAll patients will receive Cyclosporine A in a dose of 2mg/kg/BW daily for 16 weeks
Interventions
Patients will receive Cyclosporine A in a dose of ca. 2mg/kg/BW daily for a 16 week period
Eligibility Criteria
You may qualify if:
- Diagnosis of a primary Sjögren´s Syndrome
- Liver values above 1,5 ULN
- uncontrolled arterial hypertension
- intraarticular or systemic use of Glucocorticoids in the last 4 weeks before
- begin with Study medication
You may not qualify if:
- pre-treatment with Cyclosporine A
- Infection
- Neoplasia
- relevant cardiac, pulmonary, neurologic or psychiatric disease
- life-Vaccination within 4 weeks before begin with study medication
- pregnant or breast-feeding
- weight under 45kg or more than 110kg
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Charite Universitätsklinikum Berlin Campus Mitte
Berlin, State of Berlin, 10117, Germany
Related Publications (1)
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.
PMID: 27470087DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Eugen Feist, Dr. med.
Charite University, Berlin, Germany
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PD. Dr. med. Eugen Feist
Study Record Dates
First Submitted
September 14, 2012
First Posted
September 26, 2012
Study Start
March 1, 2010
Primary Completion
October 1, 2014
Study Completion
October 1, 2014
Last Updated
July 29, 2015
Record last verified: 2015-07