Sjögren´s SyndromePhase 2CYPRESSNCT01693393
Low Dose Cyclosporin A in Primary Sjögren Syndrome
A Phase 2 study testing Cyclosporine A in people with Sjögren´s Syndrome, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial summary
Sandimmun optoral (Cyclosporin A) is used for the musculoskeletal manifestations of Primary Sjögren Syndrome Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Sjögren´s Syndrome
- What is being tested?
- Cyclosporine A
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2010to Oct 2014
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
Charite Universitätsklinikum Berlin Campus Mitte
Berlin, State of Berlin, 10117
About this study
Official title: A Phase II Pilot-Study With Low-dose Sandimmun Optoral (Cyclosporin A) for the Treatment of Primary Sjögren Syndrome
Sandimmun optoral (Cyclosporin A) is used for the musculoskeletal manifestations of Primary Sjögren Syndrome
Read the detailed description
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.
- Conditions
- Sjögren´s Syndrome
- Being tested
- Cyclosporine A
- Keywords
- primary Sjogren´s Syndrome, Cyclosporine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cyclosporine ADrug
Also called Sandimmun optoral
Patients will receive Cyclosporine A in a dose of ca. 2mg/kg/BW daily for a 16 week period
| Study group | Role | What they receive |
|---|---|---|
| Cyclosporine A | Other | All patients will receive Cyclosporine A in a dose of 2mg/kg/BW daily for 16 weeks Receives: Drug: Cyclosporine A |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 28 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2012 (estimated)
- Study startMar 2010
- Primary completionOct 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sjögren´s SyndromeStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eugen Feist, Charite University, Berlin, Germany
- Investigators
- Eugen Feist, Dr. med., Principal investigator, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01693393
- Sponsor's protocol ID
- COLO400BDE02T
- Acronym
- CYPRESS
- Status last verified
- Jul 2015
- First submitted
- 14 Sep 2012
- Last updated
- 29 Jul 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 27470087
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Pilot-Study With Low-dose Sandimmun Optoral (Cyclosporin A) for the Treatment of Primary Sjögren Syndrome
- ClinicalTrials.gov ID
- NCT01693393
- Acronym / sponsor ID
- CYPRESS / COLO400BDE02T
- Conditions
- Sjögren´s Syndrome
- Keywords
- primary Sjogren´s Syndrome, Cyclosporine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 26 Sep 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Sandimmun optoral (Cyclosporin A) is used for the musculoskeletal manifestations of Primary Sjögren Syndrome
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cyclosporine A | Other | Drug: Cyclosporine AAll patients will receive Cyclosporine A in a dose of 2mg/kg/BW daily for 16 weeks |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- pre-treatment with Cyclosporine A
- Infection
- Neoplasia
- relevant cardiac, pulmonary, neurologic or psychiatric disease
- life-Vaccination within 4 weeks before begin with study medication
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cyclosporine AAlso: Sandimmun optoralPatients will receive Cyclosporine A in a dose of ca. 2mg/kg/BW daily for a 16 week period | Drug | Cyclosporine A |
Primary outcome
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.
Time frame: 16 weeks
1 secondary outcome
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
Time frame: 28 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2015.
- Derived from this study: PubMed 27470087Kedor 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eugen Feist, Dr. med. principal investigator
Charite University, Berlin, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cyclosporine A in people with Sjögren´s Syndrome, run by Charite University, Berlin, Germany at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01693393, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2015.