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Sandostatin therapy in sarcoidosis

Sandostatin therapy in sarcoidosis

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON25865
Enrollment
20
Registered
2014-06-26
Start date
2014-07-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sarcoidosis, sandostatin Sarcoïdose, sandostatine

Interventions

Patients will receive 20 mg of sandostatin injection intramuscular IM every month for six months.

Sponsors

Erasmus Medical Center, Department of Internal Medicine.
Lead Sponsor

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
The main endpoint is the change in uptake on somatostatin receptor scan.

Secondary

MeasureTime frame
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.

Contacts

Public ContactP.L.A. Daele, van

Erasmus Medical Center Dept. Internal Medicine D-419

p.l.a.vandaele@erasmusmc.nl+31 (0)10 7035954

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)