Impact of Capillaroscopy on the Management of Undifferentiated Connective Tissue Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCHU de Quebec-Universite Laval
About this trial
Connective tissue diseases (CTD) are a group of diseases with diverse manifestations, most often multisystemic, which share an autoimmune etiology. They include Systemic lupus erythematosus (SLE), Systemic sclerosis (SSc), Sjögren's syndrome (SS), Inflammatory myopathies (IM) and Mixed connective tissue disease (MCTD).
Many patients in rheumatology present signs and symptoms of CTD, but without meeting all the classification criteria for one of these diseases. These patients will generally receive a diagnosis of undifferentiated connective tissue disease (UCTD). It is increasingly suggested that there are two subgroups of patients with UCTD: one which will eventually evolve into a better characterized CTD (approximately 30% of patients at 5 years) and another with a more benign prognosis. The optimal management of patients with UCTD is not clearly established.
Capillaroscopy is a diagnostic test used in the investigation of patients with CTD. It is a low-cost, non-invasive, rapid and specific test in the evaluation of this class of diseases. Its role is now well established in the diagnosis of SSc and in the investigation of Raynaud's phenomenon. In addition, capillaroscopy helps to identify patients suffering from CTD more quickly.
Knowledge about the role of capillaroscopy in UCTD is more limited. It is established that a significant proportion of patients with UCTD present abnormalities on UCTD present non-specific abnormalities and 11% present a scleroderma pattern. In these patients, abnormal capillaroscopy seems to increase the risk of progressing to a better characterized CTD, notably SSc.
However, although capillaroscopy is increasingly used in rheumatology in patients with CTD, more research is needed to clarify the role of this examination in UCTD. First, it is not established whether capillaroscopy should be performed in all patients with UCTD, nor when exactly it should be performed. There also remain questions about the impact of capillaroscopy on the prognosis and management of patients with this disease. To our knowledge, there is no prospective study that has addressed this question. The investigators hypothesize that in patients with UCTD, capillaroscopy compared to usual care makes it possible to increase the proportion of patients obtaining a diagnosis of better characterized CTD in the first six months of follow-up.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Be aged 18 and over;
Have been diagnosed with undifferentiated connective tissue disease by a rheumatologist;
Meet the preliminary classification criteria for undifferentiated connective tissue disease: present signs and symptoms suggestive of connective tissue disease, but do not meet the criteria for a connective tissue disease and have a positive antinuclear antibody on at least 2 occasions;
Have developed the first signs and symptoms of the disease less than 10 years before recruitment.
Disqualifiers
In the opinion of the clinician, have a health condition that does not allow a delay of six months before carrying out the capillaroscopy;
Have been diagnosed and/or meet the classification criteria for another connective tissue disease (for example, systemic lupus, etc.);
Have already performed a capillaroscopy in the past, regardless of the time or the reason;
Be unable to consent or respond to questionnaires.
Trial design
Design model
Parallel
Treatments tested in this trial
Nail capillaroscopy
Diagnostic testThe intervention studied as part of the project is capillaroscopy. This examination consists of visualizing the capillaries located at the base of the nail using a device called a capillaroscope. This device magnifies the image of the capillaries to clearly visualize them. Capillaries are the smallest blood vessels, which allow the passage of only one red blood cell at a time. At the nail bed, they form a network of loops and are aligned next to each other. This alignment allows them to be viewed over their entire length. Researchers have described abnormalities in capillaries that are associated with certain diseases involving microvascular damage. The results of capillaroscopy will be reported qualitatively, for all eight long fingers examined.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: CapillaroscopyActive comparator 1 intervention
Group B: ControlOther 1 intervention
Trial outcomes
Primary outcomes
1
Proportion of participants who transitioned from a diagnosis of undifferentiated connective tissue disease to a diagnosis of better characterized connective tissue disease
The primary endpoint of the study will be the proportion of participants who transitioned from a diagnosis of undifferentiated connective tissue disease to a diagnosis of better characterized connective tissue disease at 6 months.
Time frame
6 monthsSecondary outcomes
1
Proportion of participants who went from a diagnosis of undifferentiated connective tissue disease to a diagnosis of better characterized connective tissue disease
The proportion of participants who went from a diagnosis of undifferentiated connective tissue disease to a diagnosis of better characterized connective tissue disease at 12 months;
Time frame
12 months2
Proportion of participants with a medication change from the baseline visit
The proportion of participants with a medication change from the baseline visit (defined as the addition, discontinuation, or dosage change of nonbiologic disease-modifying drugs, biologic disease-modifying drugs, Raynaud's medications, and corticosteroids) at 6 and 12 months
Time frame
6 and 12 months3
Average number of rheumatology medical visits per participant
The average number of rheumatology medical visits per participant at 6 and 12 months (continuous value);
Time frame
6 and 12 months4
Average number of medical visits in specialties other than rheumatology per participant
The average number of medical visits in specialties other than rheumatology per participant at 6 and 12 months (continuous value);
Time frame
6 and 12 monthsOther outcomes
1
Questionnaire of acceptability of capillaroscopy
The investigators will determine the acceptability of capillaroscopy by a questionnaire consisting in 4 questions (duration of capillaroscopy, absence of pain and discomfort, acceptability of capillaroscopy to investigate the participant condition, recommendation of capillaroscopy to somebody else) to be answered by the use of 5-point Likert scale (from totally agree to totally disagree).
Time frame
6 and 12 months2
Questionnaire of satisfaction about study questionnaires
The investigators will evaluate the satisfaction of participants about study questionnaires by a questionnaire consisting in two questions (easiness to understand questionnaires, adequateness of time to complete questionnaires) to be answered by the use of 5-point Likert scale (from totally agree to totally disagree).
Time frame
6 and 12 months3
Number of individuals screened, eligible and recruited.
The investigators will measure the number of individuals screened, eligible and finally recruited in the study.
Time frame
6 and 12 monthsSponsors and contacts
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Source ClinicalTrials.gov