Impact of Capillaroscopy on the Management of Undifferentiated Connective Tissue Disease

NCT06399822 | Recruiting

• 1 other identifier: 2024-7303
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Undifferentiated Connective Tissue Diseases

Keywords

undifferentiated connective tissue disease; capillaroscopy; randomized pilot clinical study

Outcome Measures

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.

  6 months

Secondary Outcomes (19)

• Proportion of participants who went from a diagnosis of undifferentiated connective tissue disease to a diagnosis of better characterized connective tissue disease

  12 months

• Proportion of participants with a medication change from the baseline visit

  6 and 12 months

• Average number of rheumatology medical visits per participant

  6 and 12 months

• Average number of medical visits in specialties other than rheumatology per participant

  6 and 12 months

• Average number of hospitalizations per participant

  6 and 12 months

Other Outcomes (3)

• Questionnaire of acceptability of capillaroscopy

  6 and 12 months

• Questionnaire of satisfaction about study questionnaires

  6 and 12 months

• Number of individuals screened, eligible and recruited.

  6 and 12 months

Study Arms (2)

Capillaroscopy

ACTIVE COMPARATOR

In the capillaroscopy group, the capillaroscopy will be performed in the month following recruitment.

Diagnostic Test: Nail capillaroscopy

Control

OTHER

In the control group, the capillaroscopy will be performed six months (+/- 2 weeks) after recruitment.

Diagnostic Test: Nail capillaroscopy

Interventions

Nail capillaroscopy DIAGNOSTIC_TEST

The 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.

Capillaroscopy; Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• CHU de Quebec-Universite Laval: lead

Study Sites (1)

CHU de Quebec-Université Laval

Québec, Quebec, G1V4G2, Canada

RECRUITING

Related Links

• The established and evolving role of nailfold capillaroscopy in connective-tissue disease

MeSH Terms

Conditions

Undifferentiated Connective Tissue Diseases

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Laetitia Michou, MD PhD

  CHU de Quebec (Université Laval)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Laetitia Michou, MD PhD

CONTACT

418-525-4444; laetitia.michou@crchudequebec.ulaval.ca

William Berthelot, MD

CONTACT

418-654-2242; william.berthelot.1@ulaval.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2024
• First Posted: May 6, 2024
• Study Start: May 22, 2024
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: March 17, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)