MedPath

Sandostatin therapy in sarcoidosis

Phase 2
Completed
Conditions
Sarcoidosis
10003816
Registration Number
NL-OMON40194
Lead Sponsor
Erasmus MC, Universitair Medisch Centrum Rotterdam
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
20
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.

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 failed on earlier anti TNF-* therapy
* Have an underlying cardiac disease

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
<p>To evaluate efficacy of SST in a subset of patients that are<br /><br>refractory/intolerant for corticosteroid therapy by a change in uptake on SRS.<br /><br>Change in uptake in SRS, defined as improved, no change, worse.</p><br>
Secondary Outcome Measures
NameTimeMethod
<p>To study the composite clinical score using the following parameters.<br /><br>Measurements of ESR, CRP, full blood count, lysozyme, ACE, 25-hydroxyvitamin<br /><br>D, 1,25-dihydroxyvitamin D3 sIL-2R. Quality of life score assessment with<br /><br>RAND-36 will be conducted. When applicable lung-function test with FVC and DLCO<br /><br>and skin evaluation will take place. </p><br>
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