sarcoidosis
Conditions
Sponsors
Rigshospitalet
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: A person may participate in this trial if he/she fulfils the following criteria: - Patients (>= 18 years) with verified biopsy of sarcoidosis according to The Joint Statement of the American Thoracic Society (ATS), the European Respiratory Society (ERS) and the World Association of Sarcoidosis (WASOG) criteria. - Clinically and/or biochemical disease activity in one or more organ systems defined as decreased lung function (FEV1 =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: A person may not participate in this trial, if he/she fulfils one or more of the following criteria: - Positive serology for Hepatitis B or C indicating active infection. - Medical history with positive HIV status. - Medical history with tuberculosis, histoplasmosis or listeriosis. - Persons with latent TB (positive Mantoux skin-test, positive Quantiferon-Gold test, positive inoculation of mycobacterium in tissue samples and/or chest x-ray indicating TB) or other risk factors for activating latent TB. - Active or recurrent infections or severe infections requiring hospitalization or treatment with i.v. antibiotics within the last 30 days or oral antibiotics within the last 14 days prior to inclusion. - Previous cancer or lymph proliferative disease except from completely well treated squamous cell carcinoma, basal cell carcinoma or cervix dysplasia. - Diabetes, unstable ischemic heart disease, heart insufficiency (NYHA III-IV), active chronic inflammatory intestinal disease, recent cerebral apoplexia (within 3 months), chronic leg ulcus or any other condition (e.g. catheter à demeure) imposing an increased risk to the subject, if he/she participates in the protocol, as judged by Investigator. - Pregnancy or breast-feeding. - Clinically significant drug or alcohol abuse during the last year. - Previous diagnosis or signs of demyelinized disease in the CNS system (e.g. optic neuritis, visual disorder, difficulty in walking/ataxia, facial paresis, apraxia). - No pathological increased FDG PET imaging at first FDG PET scan.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate sarcoidosis activity by FDG-PET scan and chest x-ray in treatment refractory patients, in whom treatment with adalimumab (Humira®) is initiated.;Secondary Objective: Changes in lung function including FEV1, FVC, VCexp, VCinsp, TLC and DLCO from baseline to weeks 4, 8, 12, 16, 20, and 24. Changes in Short Form-36 health status survey (SF-36) from baseline to weeks 12 and 24. Changes in biochemistry markers for disease activity including B-haemoglobin, B-platelets, B-leukocytes, B-leukocyte count, B-CD4 lymphocytes, B-CD8 lymphocytes, P-IgG, P-IgA, P-IgM, P-IgE, S-angiotensin converting enzyme (SACE), S-soluble-interleukin-2-receptor (S-sIL-2R), S-YKL-40, P-creatinine, P-aspartate aminotransferase, P-alkaline phosphatase, P-bilirubin, INR, P-ionized calcium, P-total calcium, P-albumin from baseline to weeks 4, 8, 12, 16, 20, and 24. To demonstrate the safety of adalimumab treatment of patients with sarcoidosis by registering the number and severity of adverse events reported during this trial. ;Primary end point(s): FDG-PET: FDG-PET positive foci will be determined both qualitatively and semi-quantitatively. Qualitatively: Pathological foci will be described from visual determination indicating anatomic localisation by means of fusion of FDG-PET with low dose CT (organ/lymph node region). Metabolism of any of the most substantial focus in the lungs, mediastinum and extra pulmonary will be determined quantitatively by calculation of Standardized Uptake Value (SUV) which states the imaging in focus compared to the mean whole body imaging. Finally, the patient’s two scans (blinded) will be compared (are they similar or which scan shows the most pronounced activity) with the purpose of assessing whether the changes have worsened, improved or are unchanged. The percentage of change between the first and second examination will be determined by the SUV values. Lung function: The lung function parameters will be stated in absolute values and | — |
Countries
Denmark
Outcome results
None listed