Recruiting

Observational Study

Sponsor:

Hospital for Special Surgery, New York

Code:

NCT02234388

Conditions

Undifferentiated Connective Tissue Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Observation

Study Details

Brief summary:

This registry has been established to gain a better understanding of the clinical and emotional presentations of patients with undifferentiated connective tissue disease.

Conditions

Undifferentiated Connective Tissue Disease

Study ID

NCT02234388

Start date

Mar, 2012

Status verified date

Jan, 2026

Completion date

Mar 31, 2027

Anticipated

Primary completion date

Mar 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

100 participants

Anticipated

Interventions and Outcome Measures

Arms

Registry Participants

All patients who participate in the UCTD Registry will be put into this cohort and observed over approximately 3 years.

Interventions

Observation

There are no interventions associated with this registry as it is purely observational.

Primary outcome measure

  • Change in SF-36 Score [ Time Frame: 3 years ]
  • Change in Fatigue Severity Scale Score [ Time Frame: 3 years ]
  • Change in Beck Depression Inventory Score [ Time Frame: 3 years ]
  • Connective Tissue Disease Criteria [ Time Frame: 3 years ]

Central Contacts and Locations

Locations

Hospital for Special Surgery

Recruiting

New York, New York, United States, 10021

Contacts

Lucy Masto, BS

917-260-4968mastol@hss.edu

Amaya Smole, BA

212-774-2960smolea@hss.edu

Principal Investigator:

Lisa Sammaritano, MD

More Information

Sponsor

Hospital for Special Surgery, New York

Last update posted

Feb 12, 2026

Last verified

Jan, 2026

Keywords

  • connective tissue disease
  • registry
  • hospital for special surgery

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Hospital for Special Surgery, New York on 2026-02-12.