Systemic Sclerosis Sjögren's Syndrome Cutaneous Lupus Erythematodus
Conditions
Interventions
Product Name: [89Zr]Zr-Df-crefmirlimab berdoxam
Product Code: IND 127861
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: [89Zr]Zr-Df-crefmirlimab berdoxam
Other descriptive name: Minib
Sponsors
radboudumc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: General inclusion criteria are age > 50 years for patients undergoing a [89Zr] anti-CD8 PET scan because of the necessary radioactive dose for this scan. Inclusion criteria for SSj patients are: diagnosis of primary SSj according to the European American consensus group criteria (15) and presence of anti-nuclear (ANA), anti-SSA and/or anti-SSB antibodies. Inclusion criteria for CLE patients are: diagnosis of subacute cutaneous lupus erythematosus (SCLE) or SLE with cutaneous lupus according to the Düsseldorf classification criteria (22). Presence of anti-nuclear (ANA), anti-SSA and/or anti-SSB antibodies. Active skin disease as assessed by the treating physician. Inclusion criteria for the SSc patients are: diagnosis of early diffuse cutaneous SSc, according to the VEDOSS criteria defined as having a diffuse skin involvement, presence of anti-nuclear antibodies (ANA), a disease duration (from first non-Raynaud symptom) of 10 points or > 25% in the past year. Patients will be selected with skin involvement of the legs, which allows the analysis of an inguinal lymph node as locoregional lymph node. 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 15 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 15
Exclusion criteria
Exclusion criteria: Exclusion criteria for SSj, CLE and SSc patients are presence of active concurrent inflammatory or infectious condition, current or previous use of biologic treatment, previous other systemic autoimmune disease diagnosis or positive serology for hepatitis C or Human Immunodeficiëncy Virus. SSj, CLE and SSc patients will be asked for separate consent for collection of a lymph node tissue biopsy. Analysis of lymph node biopsies in patients with allow the direct comparison of autoreactive B and T cell expansions, controlling for tissue specific regulatory mechanisms.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Objective: Investigate patients with CLE, SSj and SSc to: 1.Comparatively analyze the B and T cell repertoire in locoregional lymph node versus blood and involved skin (CLE, SSc) and salivary gland (SSj) for shared clonal expansions, somatic hypermutation, preferential gene usage and ontogenetic relations. 2.analyze lineage commitment and expression of activation and regulatory factors of activated and expanded T cell clones in the locoregional lymph node. 3.Analyze the subset origin of expanded B cell clones by comparative analysis of FACS sorted B cells from peripheral blood. 4.Compare [18F]FLT and [89Zr] Df-IAB22M2C anti-CD8 PET imaging as a tool to select involved lymph nodes for biopsy. ;Secondary Objective: Not applicable ;Primary end point(s): The difference between CLE, SSj and SSc in differentiation, activation and regulation of expanded B and T cell clones, shared between locoregional lymph node versus involved skin and salivary gland;Timepoint(s) of evaluation of this end point: LVLS | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Not applicable ;Timepoint(s) of evaluation of this end point: LVLS | — |
Countries
Netherlands
Contacts
Public Contactdepartment of rheumatology
Radboudumc
Outcome results
None listed