|- candidate number||18206|
|- NTR Number||NTR4655|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||26-jun-2014|
|- Secondary IDs||MACS2757 Novartis|
|- Public Title||Sandostatin therapy in sarcoidosis|
|- Scientific Title||Sandostatin therapy in sarcoidosis|
|- ACRONYM||SST in SA|
|- hypothesis||Sarcoidosis (SA) is a rare systemic disease that is characterized by the formation of granulomas. It can affect any organ in the body. Somatostatin is a peptide hormone that regulates neuroendocrine processes but it also is an intersystem signalling molecule on the immune system and is implicated in the pathogenesis of SA. Sandostatin (SST), octreotide is the stable and synthetic analogue of the natural somatostatin. Octreotide has an inhibitory effect of the immune system. Affected locations in SA show octreotide uptake on SRS. As corticosteroids, with all the additional disadvantages, are first-line treatment in sarcoidosis, SST is studied as an alternative treatment for SA.|
|- Healt Condition(s) or Problem(s) studied||Sarcoidosis|
|- Inclusion criteria||1. Age above 18 years with obtained written consent |
2. Have biopsy-proven symptomatic, stable, chronic sarcoidosis for minimal three years.
3. Have a positive SRS
4. Involvement of skin, joint, lymph nodes or lung. Patients with pulmonary involvement have a diffusing capacity between 60 and 75 percent.
|- Exclusion criteria||1. Corticosteroid use up to three months prior of trial|
2. Chronic renal failure defined as a GFR below 50%
3. Liver disease
4. Have an indication for intensifying immunosuppressive therapy; threatening organ damage
5. Have failed on earlier anti TNF-alfa therapy
6. Have an underlying cardiac disease
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||Single arm|
|- planned startdate ||1-jul-2014|
|- planned closingdate||1-jul-2016|
|- Target number of participants||20|
|- Interventions||Patients will receive 20 mg of sandostatin injection intramuscular IM every month for six months. |
|- Primary outcome||The main endpoint is the change in uptake on somatostatin receptor scan.|
|- Secondary outcome||The secondary endpoint is the composite clinical score using the following parameters: blood test (ESR, CRP, full blood count, lysozyme, ACE, 25-hydroxyvitamin D, 1,25-dihydroxyvitamin D, sIL-2R), quality of life (RAND-36) and when applicable lung function test (FVC, DLCO) and skin evaluation.|
|- Timepoints||Duration of intervention is six months. Primary endpoint (somatostatin receptor scan) after nine months after initiation therapy. Total folluw up is 12 months.|
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||MD. PhD. P.L.A. Daele, van|
|- CONTACT for SCIENTIFIC QUERIES||MD. PhD. S.J.C.M.M. Neggers|
|- Sponsor/Initiator ||Erasmus Medical Center, Department of Internal Medicine |
(Source(s) of Monetary or Material Support)
|- Brief summary||Design:nonrandomized, open label, proof of principal investigator initiated trial.
Subjects:patients with chronic, symptomatic and stable sarcoidosis that show inflammatory activity on somatostatin receptor scan and previously received treatment with corticosteroids.
Study medication:Monthly injections with sandostatin for six months.
Objective: To evaluate efficacy of sandostatin in a subset of patients that are refractory/intolerant to corticosteroid therapy.
Primary endpoint:change in uptake on somatostatin receptor scan.
Secondary enpoints: bloodtests, quality of life score, pulmonary function and skin evaluation.
|- Main changes (audit trail)|
|- RECORD||26-jun-2014 - 6-aug-2014|