Patients with rheumatoid arthritis or seronegative spondylarthropathy with at least one inflamed finger joint (MCP, PIP, DIP) referred for RSO with with Erbium [169Er]citrate MedDRA version: 8.1 Level: HLT Classification code 10039075 Term: Rheumatoid arthritis and associated conditions
Conditions
Interventions
Trade Name: ERMM-1
Pharmaceutical Form: Solution for injection
INN or Proposed INN: erbium citrate
Concentration unit: MBq/ml megabecquerel(s)/millilitre
Concentration type: equal
Concentration number
Sponsors
CIS bio international
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Age: at least 20 years (2) Diagnosis of rheumatoid arthritis or seronegative spondylarthropathy by a physician with experience in rheumatologic/joint diseases (e.g., rheumatologist, orthopedist) (3) Has at least one inflamed finger joint (MCP, PIP, DIP) (4) Referred to RSO with Erbium [169Er] citrate of 1 finger joint (MCP, PIP, DIP) for clinical reasons (5) Willingness to comply with the study procedures (e.g., follow-up visit at 45-50 days after RSO, having laboratory blood tests performed) (6) Has personally provided written informed consent 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: (1) No written informed consent (2) Age below 20 years (3) Women of child-bearing potential not using a reliable means of contraception (4) Women, being pregnant or breast-feeding (5) RSO of more than 1 joint planned (6) Septic arthritis of the joint to be treated (7) Local infection and disease of the skin in the vicinity of the injection site (8) Intraarticular fracture (9) Massive hemarthrosis (10) Surgery of the joint to be treated within 50 days before or planned within 50 days after RSO (11) Level of joint destruction higher than Steinbrocker radiological stage 3 (12) History of radiotherapy within 50 days before RSO or planned radiotherapy within 50 days after RSO (13) History of chemotherapy within 50 days before RSO or planned chemotherapy within 50 days after RSO (14) CT or x-ray fluoroscopy within 50 days before or after RSO (exception: fluoroscopy during the RSO procedure) (15) Planned change of any immunosuppressive therapy within 50 days before or after RSO (16) Any scintigraphy performed within 10 physical half-lives of the respective radionuclide before RSO or planned within 50 days after RSO (17) Any radionuclide therapy started within 10 physical half-lives of the respective radionuclide before RSO or planned to be started within 50 days after RSO (18) Already included in this or any other clinical study (19) Uncooperative, in the investigator’s opinion (20) Patients who are unable to give their informed consent personally
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the radiation exposure after radiation synovectomy (RSO) of phalangeal joints using the technique of biological dosimetry (assessment of chromosomal aberrations of blood lymphocytes before and after RSO);Secondary Objective: not applicable;Primary end point(s): Number of dicentric chromosomes in the blood samples before and after RSO | — |
Countries
Germany
Outcome results
None listed