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The use of the electronic nose in the diagnosis of patients with rheumatoid arthritis or psoriatic arthritis

Conditions
10003816
psoriatic arthritis
rheumatiod arthritis
10023213
Registration Number
NL-OMON36459
Lead Sponsor
Academisch Medisch Centrum
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Pending
Sex
Not specified
Target Recruitment
45
Inclusion Criteria

RA patients 18-75 years with:
RA according to the ACR criteria
DAS28 * 3.2
No medication, or methotrexaat / hydroxychloroquine / sulfasalazine / leflunomide and/or prednison stable use * 28 days;Psoriatic arthritis patients 18-75 years with:
PsA according to the CASPAR criteria
DAS28 * 3.2
No medication, or methotrexaat / sulfasalazine / leflunomide/ prednison stable use * 28 days;Controls
Non-smoking (< 5 pack-years, > 12 months)
Rheumatoid factor IgM and anti-CCP negative.

Exclusion Criteria

RA and PsA patients
Severe cardiovascular disease, history or present (Myocardial infarction, Coronary bypass surgery
CVA, Pulmonary embolism and deep venous thrombosis, Heart failure)
A history of diabetes mellitus
Systemic inflammatory disease other than RA or PsA
Active pulmonary disease, including extraarticular manifestation of RA, asthma, COPD, TBC, infection
Cancer diagnosed and treated within 5 years, or known incomplete remission if earlier
Presence or recent history (4 weeks) of paradontitis
History of upper or lower respiratory infection in the past 4 weeks
The use of inhalation medication in the past 4 weeks
The patient has an active infection or used antibiotics in the last 7 days
The patient has started * 28 days for inclusion with oral or systemic corticosteroids in a dosage of > 10 mg a day or has had intramuscular and intraarticular corticosteroids
The patient has stopped treatment with etanercept < 1 month, or adalimumab, infliximab, tocilizumab or abatacept < 3 months, or rituximab > 12 months
Eating (including chewing gum), drinking, brushing teeth < 2 hours before measurements
The patient smokes
Lack of comprehension of the study and measurements
Pregnancy
Unstable hyper- or hypothyroid function or change in the levothyroxine dosage * 28 days for inclusion
A history of renal insufficiency / liver insufficiency
The patient is not suited for participating in the study, according to the researcher;Controls
Severe cardiovascular disease, history or present (Myocardial infarction, Coronary bypass surgery, CVA, Pulmonary embolism and deep venous thrombosis, Heart failure)
A history of diabetes mellitus
Systemic inflammatory disease
Active pulmonary disease, including extraarticular manifestation of RA, asthma, COPD, TBC, infection.
Cancer diagnosed and treated within 5 years, or known incomplete remission if earlier
Presence or recent history (4 weeks) of paradontitis
History of upper or lower respiratory infection in the past 4 weeks
The use of inhalation medication in the past 4 weeks
The patient has an active infection or used antibiotics in the last 7 days
The patient has started * 28 days for inclusion with oral or systemic corticosteroids in a dosage of > 10 mg a day or has had intramuscular and intraarticular corticosteroids
Eating (including chewing gum), drinking, brushing teeth < 2 hours before measurements
Patient smokes
Lack of comprehension of the study and measurements
Pregnancy
Unstable hyper- or hypothyroid function or change in the levothyroxine dosage * 28 days for inclusion
A history of renal insufficiency / liver insufficiency
History of/or active artritis
The patient is not suited for participating in the study, according to the researcher

Study & Design

Study Type
Observational non invasive
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
<p>The primary outcome parameter is the smell-print provided by the electronic<br /><br>nose, together with the results of the on-board and offline statistical<br /><br>analysis.</p><br>
Secondary Outcome Measures
NameTimeMethod
<p>n.a.</p><br>
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