Sandostatin therapy in sarcoidosis

• Register: EUCTR
• Last refreshed on: 14 March 2016
• Main ID: EUCTR2013-005376-17-NL
• Date of registration: 27/02/2014
• Prospective Registration: Yes
• Primary sponsor: Erasmus Medical Center
• Public title: Sandostatin therapy in sarcoidosis
• Scientific title: Sandostatin therapy in sarcoidosis - SST in SA
• Date of first enrolment: 20/06/2014
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2013-005376-17
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: no Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no

Countries of recruitment

Netherlands

Contacts

• Name: Coordinating investigator
• Affiliation: Erasmus Medical Center

• Name: Coordinating investigator
• Affiliation: Erasmus Medical Center

Key inclusion & exclusion 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:
• 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



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Sarcoidosis
MedDRA version: 16.1 Level: HLGT Classification code 10003816 Term: Autoimmune disorders System Organ Class: 10021428 - Immune system disorders

Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Intervention(s)

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 descriptive name: octreotide LAR / Sandostatin LAR (LAR=long acting release)
Concentration unit: mg milligram(s)
Concentration type: range
Concentration number: 20-30

Primary Outcome(s)

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.

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.

Secondary Outcome(s)

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.

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.

Secondary ID(s)

201401

Source(s) of Monetary Support

Novartis Pharma