NCT02234388

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
11mo left

Started Mar 2012

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress94%
Mar 2012Mar 2027

Study Start

First participant enrolled

March 1, 2012

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

September 3, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 9, 2014

Completed
12.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2027

Last Updated

February 12, 2026

Status Verified

January 1, 2026

Enrollment Period

15.1 years

First QC Date

September 3, 2014

Last Update Submit

February 11, 2026

Conditions

Keywords

connective tissue diseaseregistryhospital for special surgery

Outcome Measures

Primary Outcomes (4)

  • Change in SF-36 Score

    Patient questionnaire that measures health-related quality of life.

    3 years

  • Change in Fatigue Severity Scale Score

    Evaluates the impact of fatigue on the patient.

    3 years

  • Change in Beck Depression Inventory Score

    Self-reported depression severity questionnaire

    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.

    3 years

Secondary Outcomes (4)

  • CBC

    3 years

  • Comprehensive Metabolic Panel

    3 years

  • Cholesterol Profile

    3 years

  • Urinalysis

    3 years

Study Arms (1)

Registry Participants

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

Other: Observation

Interventions

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

Registry Participants

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients under the care of any HSS rheumatologist that have been diagnosed with undifferentiated connective tissue disease.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital for Special Surgery

New York, New York, 10021, United States

RECRUITING

MeSH Terms

Conditions

Undifferentiated Connective Tissue DiseasesConnective Tissue Diseases

Interventions

Observation

Condition Hierarchy (Ancestors)

Skin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
3 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 3, 2014

First Posted

September 9, 2014

Study Start

March 1, 2012

Primary Completion (Estimated)

March 31, 2027

Study Completion (Estimated)

March 31, 2027

Last Updated

February 12, 2026

Record last verified: 2026-01

Locations