Recruiting

Observational Study

Sponsor:

National Jewish Health

Code:

NCT03977415

Conditions

Rheumatoid Arthritis

Interstitial Lung Disease

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

The purpose of this study is to determine how interstitial lung disease can be predicted over time in early rheumatoid arthritis. The investigators will study blood and phlegm samples from participants, along with quality of life questionnaires to determine if and how the presence of ILD may impact the participants quality of life over time.

Conditions

Rheumatoid Arthritis

Interstitial Lung Disease

Study ID

NCT03977415

Start date

Mar 27, 2018

Status verified date

Jun, 2019

Completion date

Aug 1, 2021

Anticipated

Primary completion date

Feb 1, 2020

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Age 18 - 90 years
2. Diagnosis of "early RA" with or without ILD as defined by ACR/EULAR 2010 criteria and confirmed by a member of the ILD or Rheumatology programs at National Jewish Health (NJH)
3. Able to read, speak, and understand English
4. Able and willing to perform all study related tasks, including returning to NJH every 6 months for an 18 month period of time

Exclusion Criteria:

1. Subjects who do not meet all inclusion criteria
2. Pregnant women

Study Design

Enrollment

76 participants

Anticipated

Interventions and Outcome Measures

Arms

RA with no ILD

Subjects diagnosed with RA less then 2 years and without a diagnosis of ILD, will complete 5 in-person study visits. Visits will be performed every 6 months for 18 months.

Study Assessments Include:

1. Medical history and Physical exams
2. Quality of Life Questionnaires
3. Collection of Sputum and Blood
4. Radiology (HRCT)
5. Lung Function Test

RA with ILD

Patients diagnosed with RA less than 2 years, and clinically diagnosed with interstitial lung disease (ILD), will complete 5 in-person study visits. Visits will be performed every 6 months for 18 months.

Study Assessments Include:

1. Medical history and Physical exams
2. Quality of Life Questionnaires
3. Collection of Sputum and Blood
4. Radiology (HRCT)
5. Lung Function Test
6. Spirometry

Primary outcome measure

  • Change in anti-CCP antibody test to identify the presence or development of RA in patients with or without ILD [ Time Frame: 18 months ]
  • Change in lung antigen targets in RA-ILD using induced sputum [ Time Frame: 18 months ]
  • Change from baseline for Leicester Cough questionnaire-Acute (LCQ_Acute) [ Time Frame: 18 months ]
  • Change from baseline for Short Form (SF_36) questionnaire [ Time Frame: 18 months ]
  • Change from baseline for UCSD Medical Center Pulmonary Rehabilitations Program Shortness-of-Breath questionnaire [ Time Frame: 18 months ]
  • Change from baseline for Multi-Dimensional Health Assessment questionnaire (MDHAQ) [ Time Frame: 18 months ]

Central Contacts and Locations

Central contacts

Faduma Ahmed, MPH

303-398-1285ahmedf@NJHealth.org

Jami Henriksen

303-398-1996henriksenj@njhealth.org

Locations

National Jewish Health

Recruiting

Denver, Colorado, United States, 80206

Contacts

Faduma Ahmed

303-398-1285ahmedf@NJHealth.org

More Information

Sponsor

National Jewish Health

Last update posted

Jun 6, 2019

Last verified

Jun, 2019

Keywords

  • Interstitial Lung Disease
  • ILD
  • Pulmonary Fibrosis
  • Rheumatoid Arthritis
  • RA
  • Rheumatology

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by National Jewish Health on 2019-06-06.