Interstitial Lung Disease in Early Rheumatoid Arthritis

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03977415

Acronym

ILD-Early RA

Enrollment

Registered

2019-06-06

Start date

2018-03-27

Completion date

2021-08-01

Last updated

2019-06-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Interstitial Lung Disease, Rheumatoid Arthritis

Keywords

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

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.

Detailed description

Participation involves 5 study visits over an 18 month timeframe. During each of these visits, a recent medical history and physical exam will take place, blood and phlegm will be collected, quality of life questionnaires will be administered, and a CT-scan of the chest and pulmonary function testing may be performed.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

Healthy volunteers

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

Design outcomes

Primary

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

Countries

United States

Contacts

Primary ContactFaduma Ahmed, MPH

ahmedf@NJHealth.org303-398-1285

Backup ContactJami Henriksen

henriksenj@njhealth.org303-398-1996

Outcome results