Undifferentiated Connective Tissue DiseaseUCTD RegistryNCT02234388
Undifferentiated Connective Tissue Disease Registry
An observational study of Undifferentiated Connective Tissue Disease, run by Hospital for Special Surgery, New York at 1 site in United States.
Trial summary
This registry has been established to gain a better understanding of the clinical and emotional presentations of patients with undifferentiated connective tissue disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Undifferentiated Connective Tissue Disease
- What is being tested?
- Observation
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2012to 31 Mar 2027
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients under the care of any HSS rheumatologist that have been diagnosed with undifferentiated connective tissue disease.
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Hospital for Special Surgery
New York, New York, 10021
Lucy Masto, BS, 917-260-4968, mastol@hss.edu
Amaya Smole, BA, 212-774-2960, smolea@hss.edu
About this study
This registry has been established to gain a better understanding of the clinical and emotional presentations of patients with undifferentiated connective tissue disease.
Read the detailed description
The purpose of this research registry is to gather information about clinical symptoms and laboratory test results in patients with undifferentiated connective tissue disease (UCTD). Analysis of this information may help to better predict the prognosis for patients with this form of autoimmune disease, and may identify risk factors for progression to more specific connective tissue diseases such as systemic lupus. This is done by collecting information from your medical records including clinical history, physical examination, and lab test results, and by asking you questions about specific symptoms you may have such as joint pain, rashes, and other common symptoms of UCTD. This information will be stored in a database, and used at a later time for research studies. All future research studies using information in this registry will be subject to oversight by HSS's Institutional Review Board (which is responsible for oversight of research at HSS involving human subjects). All patients who seek or receive medical care at HSS for undifferentiated connective tissue disease will be invited to participate in this registry.
Most future research studies involving this registry will only use the information in this registry, and therefore will not require the further involvement or additional informed consent of participants in the registry. But the information in this registry may also be used to identify patients who may be eligible to participate in certain future research studies conducted by HSS that relate to their particular disease, condition, or treatment and for which information is needed that is not in the registry. If you are identified (based on information about you in the registry) as being potentially eligible for a future research study that relates to your particular disease, condition, or treatment, you may be contacted to find out if you would be interested in participating in the research study. If you are interested, the research study would be fully explained to you, and you would have to give your informed consent before you could participate. If you participate in this registry, you will not be required to participate in any future research study that HSS contacts you about.
By participating in this registry, you will not be asked to do anything that would not ordinarily be done as a matter of routine care at HSS including clinical assessments, laboratory tests and radiology procedures. During your routine visits we will be recording all of the information about you that relates to your disease, condition, or treatment and will include that information in the registry. Your participation will involve a minimum of one yearly visit at the time of your visit to your own rheumatologist. Most study visits are expected to last 10 - 15 minutes.
- Being tested
- Observation
- Keywords
- connective tissue disease, registry, hospital for special surgery
- Medical subject headings
- Undifferentiated Connective Tissue Diseases, Connective Tissue Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationOther
There are no interventions associated with this registry as it is purely observational.
| Study group | Role | What they receive |
|---|---|---|
| Registry Participants | All patients who participate in the UCTD Registry will be put into this cohort and observed over approximately 3 years. Receives: Other: Observation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in SF-36 Score
Patient questionnaire that measures health-related quality of life.
Measured: 3 years
Change in Fatigue Severity Scale Score
Evaluates the impact of fatigue on the patient.
Measured: 3 years
Change in Beck Depression Inventory Score
Self-reported depression severity questionnaire
Measured: 3 years
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.
Measured: 3 years
Secondary outcomes (4)
CBC
Patients may have this clinical lab test ordered to monitor their hemoglobin, hematocrit, and platlet counts.
Measured: 3 years
Comprehensive Metabolic Panel
Patients may have this clinical laboratory test ordered to monitor their electrolytes, creatinine, glucose levels, phosphates, and blood protein levels.
Measured: 3 years
Cholesterol Profile
Patients may have this clinical laboratory test ordered to monitor their blood cholesterol levels.
Measured: 3 years
Urinalysis
Patients may have this clinical laboratory test ordered to monitor their health and the presence of any infections.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2014 (estimated)
- Study startMar 2012
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Undifferentiated Connective Tissue DiseaseStudies of the same condition, open and under way.
- More trials run by Hospital for Special Surgery, New YorkThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Hospital for Special Surgery, New York
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02234388
- Sponsor's protocol ID
- 2014-311
- Other IDs
- Robin J. Sillau Fund
- Acronym
- UCTD Registry
- Status last verified
- Jan 2026
- First submitted
- 3 Sep 2014
- Last updated
- 12 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Undifferentiated Connective Tissue Disease Registry
- ClinicalTrials.gov ID
- NCT02234388
- Acronym / sponsor ID
- UCTD Registry / 2014-311
- Keywords
- connective tissue disease, registry, hospital for special surgery
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Hospital for Special Surgery, New YorkUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 9 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This registry has been established to gain a better understanding of the clinical and emotional presentations of patients with undifferentiated connective tissue disease.
Detailed description
The purpose of this research registry is to gather information about clinical symptoms and laboratory test results in patients with undifferentiated connective tissue disease (UCTD). Analysis of this information may help to better predict the prognosis for patients with this form of autoimmune disease, and may identify risk factors for progression to more specific connective tissue diseases such as systemic lupus. This is done by collecting information from your medical records including clinical history, physical examination, and lab test results, and by asking you questions about specific symptoms you may have such as joint pain, rashes, and other common symptoms of UCTD. This information will be stored in a database, and used at a later time for research studies. All future research studies using information in this registry will be subject to oversight by HSS's Institutional Review Board (which is responsible for oversight of research at HSS involving human subjects). All patients who seek or receive medical care at HSS for undifferentiated connective tissue disease will be invited to participate in this registry.
Most future research studies involving this registry will only use the information in this registry, and therefore will not require the further involvement or additional informed consent of participants in the registry. But the information in this registry may also be used to identify patients who may be eligible to participate in certain future research studies conducted by HSS that relate to their particular disease, condition, or treatment and for which information is needed that is not in the registry. If you are identified (based on information about you in the registry) as being potentially eligible for a future research study that relates to your particular disease, condition, or treatment, you may be contacted to find out if you would be interested in participating in the research study. If you are interested, the research study would be fully explained to you, and you would have to give your informed consent before you could participate. If you participate in this registry, you will not be required to participate in any future research study that HSS contacts you about.
By participating in this registry, you will not be asked to do anything that would not ordinarily be done as a matter of routine care at HSS including clinical assessments, laboratory tests and radiology procedures. During your routine visits we will be recording all of the information about you that relates to your disease, condition, or treatment and will include that information in the registry. Your participation will involve a minimum of one yearly visit at the time of your visit to your own rheumatologist. Most study visits are expected to last 10 - 15 minutes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Registry Participants | – | Other: ObservationAll patients who participate in the UCTD Registry will be put into this cohort and observed over approximately 3 years. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients under the care of any HSS rheumatologist that have been diagnosed with undifferentiated connective tissue disease.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ObservationThere are no interventions associated with this registry as it is purely observational. | Other | Registry Participants |
Primary outcome
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.
4 secondary outcomes
CBC
Time frame: 3 years
Comprehensive Metabolic Panel
Time frame: 3 years
Cholesterol Profile
Time frame: 3 years
Urinalysis
Time frame: 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Undifferentiated Connective Tissue Disease, run by Hospital for Special Surgery, New York at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in SF-36 Score (time frame: 3 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2026.