Undifferentiated Connective Tissue Disease Registry
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorHospital for Special Surgery, New York
About this trial
This registry has been established to gain a better understanding of the clinical and emotional presentations of patients with undifferentiated connective tissue disease.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Any patient under the care of an HSS rheumatologist
Positive ANA or a positive anti-ds DNA, anti-Ro/SS-A or other autoantibody on 2 or more occasions at least 12 weeks apart
One or more signs or symptoms of connective tissue disease, including but not limited to arthralgia, arthritis, myalgia, rash, sicca symptoms, pericarditis, pleuritis, pulmonary symptoms, peripheral neuropathy, photosensitivity, alopecia, oral or nasal ulcers, leucopenia, anemia, and abnormal nailfold capillaroscopy
Disqualifiers
Patients who meet criteria for well defined CTD including SLE, rheumatoid arthritis, polymyositis or dermatomyositis, systemic sclerosis, or antiphospholipid syndrome
Patients who are less than 18
Those unable to give informed consent in English
Trial population
Patients under the care of any HSS rheumatologist that have been diagnosed with undifferentiated connective tissue disease.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Observation
Other interventionThere are no interventions associated with this registry as it is purely observational.
Treatment groups
100 Participants
are divided into 1 treatment groupGroup A: Registry Participants1 intervention
Trial outcomes
Primary outcomes
1
Change in SF-36 Score
Patient questionnaire that measures health-related quality of life.
Time frame
3 years2
Change in Fatigue Severity Scale Score
Evaluates the impact of fatigue on the patient.
Time frame
3 years3
Change in Beck Depression Inventory Score
Self-reported depression severity questionnaire
Time frame
3 years4
Connective Tissue Disease Criteria
The physician will monitor which characteristics from each connective tissue disease the patient presents with. This will show how UCTD progresses and what the most prominent characteristics of the disease are.
Time frame
3 yearsSecondary outcomes
1
CBC
Patients may have this clinical lab test ordered to monitor their hemoglobin, hematocrit, and platlet counts.
Time frame
3 years2
Comprehensive Metabolic Panel
Patients may have this clinical laboratory test ordered to monitor their electrolytes, creatinine, glucose levels, phosphates, and blood protein levels.
Time frame
3 years3
Cholesterol Profile
Patients may have this clinical laboratory test ordered to monitor their blood cholesterol levels.
Time frame
3 years4
Urinalysis
Patients may have this clinical laboratory test ordered to monitor their health and the presence of any infections.
Time frame
3 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov