Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:29 AM
Ignite Modification Date:
2025-12-25 @ 4:29 AM
NCT ID:
NCT02096120
Eligibility Criteria:
Inclusion Criteria:
* Written informed consent
* Age 18 years or older
* Diagnosis of rheumatoid arthritis according to the ACR/EULAR 2010 classification criteria plus both serological, high titer (\>3x ULN) rheumatoid factor and CCP antibody titer
* Severe chronic periodontitis (clinical attachment loss \>/= 5mm at two separate locations)
* DAS 28 \> 4.2 at screening and inclusion (within 28 days after screening) and 1 out of two additional disease activity criteria:
1. Synovial hyperplasia \>22/66 points on basis of 22 joints, or at least 1/3 of the maximum score when analyzes in at least selected 5 joints of interest OR
2. Serum CRP \> 10 mg/l at screening and at inclusion
* Stable doses for \>=3 months, if currently under synthetic or recombinant disease modifying anti-rheumatic drugs. If under anti-CD20 treatment: last rituximab infusion \>90 days before inclusion.
* Systemic corticosteroids \<= 10 mg and stable for at least 14 days
* Nonsteroidal-antirheumatic drugs and peripheral analgesics at stable doses for at least 14 days
Exclusion Criteria:
* Intolerance to amoxicillin und azithromycin (EBV infection, lymphatic leukemia, exanthema), general hypersensitivity to any beta-lactam antibiotics, intolerance to metronidazole or local anaesthesia
* Current intake of allopurinol or probenicid, oral anticoagulation, disulfiram, phenobarbital phenytoin, lithium or ciclosporin
* Seizures
* Severe cardial electric conduction blockade
* Recent myocardial infraction or instable coronary vessel disease, non-compensated myocardial insufficiency or heart failure
* Non-compensated arterial hypertension
* Genetic cholinesterase deficiency
* General hemorrhagic diathesis or intake of oral anticoagulants
* Intake of monoaminooxidase inhibitors or tricyclic antidepressants
* Liver insufficiency
* Renal failure (eGFR \< 30 ml/min)
* Hemoglobin \<10 g/dl
* Leukocytes \< 3/nl
* Neutrophils \< 1/nl
* Platelets \< 100/nl
* ALAT oder ASAT \> 3x ULN
* Pregnancy or breastfeeding
* Psychiatric or any other condition which could, to the opinion of the investigator, interfere with the compliance of this protocol
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02096120
Study Brief:
Protocol Section:
NCT02096120