myositis, inflammation of muscles
Conditions
Interventions
 
Sponsors
Amsterdam UMC
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Adult patients (18-80 years) with idiopathic inflammatory myopathy (IIM), according to diagnostic criteria: • Dermatomyositis • Overlapmyositis • Antisynthethase syndrome - Informed consent
Exclusion criteria
Exclusion criteria: Exclusion criteria: - Patients who are not able to give informed consent - Pregnancy - Present or previous (< 2 year) treatment with any cell depleting therapies, including anti-B-cell therapy or other investigational agents (e.g., abetimus sodium, anti CD40L antibody, BG9588/ IDEC 131). - History of infection: • Currently on any suppressive therapy for a chronic infection (such as tuberculosis, pneumocystis, cytomegalovirus, herpes simplex virus, herpes zoster and atypical mycobacteria) • Hospitalization for treatment of infection within 60 days of Day 0. • Use of parenteral (IV or IM) antibiotics (anti-bacterial, antiviral, anti-fungal, or anti-parasitic agents) - History of malignancies neoplasm within the last 5 years except basal cell or squamous cell carcinoma of the skin treated with local resection only or carcinoma in situ of the uterine cervix treated locally and with no evidence of metastatic disease for 3 years - Have a history of a primary immunodeficiency, including significant IgG deficiency (IgG level < 400 mg/dL) or IgA deficiency (IgA level < 10 mg/dL) - Have current drug or alcohol abuse or dependence, or a history of drug or alcohol abuse or dependence within 365 days prior to Day 0 - Have a historically positive HIV test or test positive at screening for HIV - Have any other clinically significant abnormal laboratory value in the opinion of the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Identifying the cellular and molecular changes in immune system and functional characterisation of B cells, T cells, stromal cells and their signalling pathways in peripheral blood, lymph nodes and bone marrow as well as inflamed muscle tissue in IIM patients. | — |
Countries
Netherlands
Contacts
Public ContactM Kocyigit
Amsterdam UMC
Outcome results
None listed