NCT02234388 · Hospital for Special Surgery, New York
Undifferentiated Connective Tissue Disease Registry
(UCTD Registry)
What this study is about
This registry has been established to gain a better understanding of the clinical and emotional presentations of patients with undifferentiated connective tissue disease.
View original scientific description
This registry has been established to gain a better understanding of the clinical and emotional presentations of patients with undifferentiated connective tissue disease.
Interventions
OTHER
Observation
There are no interventions associated with this registry as it is purely observational.
Primary outcome measures
Change in SF-36 Score
Time frame: 3 years
Patient questionnaire that measures health-related quality of life.
Change in Fatigue Severity Scale Score
Time frame: 3 years
Evaluates the impact of fatigue on the patient.
Change in Beck Depression Inventory Score
Time frame: 3 years
Self-reported depression severity questionnaire
Connective Tissue Disease Criteria
Time frame: 3 years
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
Exclusion criteria
- 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
Where
- New York, New York
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 12, 2026 · Source of record for eligibility and locations