Sarcoidosis MedDRA version: 16.1 Level: HLGT Classification code 10003816 Term: Autoimmune disorders System Organ Class: 10021428 - Immune system disorders
Conditions
Interventions
Trade Name: Sandostatin LAR
Pharmaceutical Form: Powder and solvent for solution for injection
INN or Proposed INN: OCTREOTIDE
CAS Number: 83150-76-9
Current Sponsor code: SMS 201-995
Other descriptiv
Sponsors
Erasmus Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Age above 18 years with obtained written consent • Have biopsy-proven symptomatic, stable, chronic sarcoidosis for minimal three years. • Have a positive SRS • Involvement of skin, joint, lymph nodes or lung. Patients with pulmonary involvement have a diffusing capacity between 60 and 75 percent. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 20 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Corticosteroid use up to three months prior of trial • Chronic renal failure defined as a GFR below 50% • Liver disease • Have an indication for intensifying immunosuppressive therapy; threatening organ damage • Have received anti TNF-a therapy • Have an underlying cardiac disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate efficacy of SST looking at the change in uptake on SRS in a subset of chronically active patients in which intensification of corticosteroid therapy is not indicated.;Secondary Objective: To study 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.;Primary end point(s): To evaluate efficacy of SST in a subset of patients that are refractory/intolerant for corticosteroid therapy by a change in uptake on SRS. Change in uptake in SRS, defined as improved, no change, worse.;Timepoint(s) of evaluation of this end point: Before start of study and at month 9. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): To study the composite clinical score using the following parameters. Measurements of ESR, CRP, full blood count, lysozyme, ACE, 25-hydroxyvitamin D, 1,25-dihydroxyvitamin D3 sIL-2R. Quality of life score assessment with RAND-36 will be conducted. When applicable lung-function test with FVC and DLCO and skin evaluation will take place. ;Timepoint(s) of evaluation of this end point: Bloodtests, quality of life and skin assesment takes place before start of study and at 2 weeks and 3, 6, 9, 12 months. Lungfunction before trial and at 6 months. | — |
Countries
Netherlands
Contacts
Public ContactCoordinating investigator
Erasmus Medical Center
Outcome results
None listed