E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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 |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 8.1 |
E.1.2 | Level | HLT |
E.1.2 | Classification code | 10039075 |
E.1.2 | Term | Rheumatoid arthritis and associated conditions |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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) |
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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 |
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E.4 | Principal 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 |
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E.5 End points |
E.5.1 | Primary end point(s) |
Number of dicentric chromosomes in the blood samples before and after RSO |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Information not present in EudraCT |
E.6.2 | Prophylaxis | Information not present in EudraCT |
E.6.3 | Therapy | Information not present in EudraCT |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Information not present in EudraCT |
E.6.6 | Pharmacokinetic | Information not present in EudraCT |
E.6.7 | Pharmacodynamic | Information not present in EudraCT |
E.6.8 | Bioequivalence | Information not present in EudraCT |
E.6.9 | Dose response | Information not present in EudraCT |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | Information not present in EudraCT |
E.6.12 | Pharmacoeconomic | Information not present in EudraCT |
E.6.13 | Others | Information not present in EudraCT |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | Information not present in EudraCT |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Yes |
E.7.1.3.1 | Other trial type description |
Safety, required by BfArM |
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E.7.2 | Therapeutic exploratory (Phase II) | Information not present in EudraCT |
E.7.3 | Therapeutic confirmatory (Phase III) | Information not present in EudraCT |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | Information not present in EudraCT |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
E.8.5 | The trial involves multiple Member States | No |
E.8.5.1 | Number of sites anticipated in the EEA | 1 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 5 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 5 |