Interstitial Lung Disease in Early Rheumatoid Arthritis (ILD-Early RA)

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.

Study Overview

• Status: Unknown
• Conditions: Rheumatoid Arthritis; Interstitial Lung Disease

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.

• Study Type: Observational
• Enrollment (Anticipated): 76

Contacts and Locations

• Study Contact: Name: Faduma Ahmed, MPH; Phone Number: 303-398-1285; Email: ahmedf@NJHealth.org
• Study Contact Backup: Name: Jami Henriksen; Phone Number: 303-398-1996; Email: henriksenj@njhealth.org

Study Locations

• United States
  • Colorado
    • Denver, Colorado, United States, 80206
      • Recruiting
      • National Jewish Health
      • Sub-Investigator: Kristen M Demoruelle, MD
      • Sub-Investigator: Michael Mohning, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Subjects are selected for participation in the study because they have an active diagnosis of rheumatoid arthritis and are at risk fro the development of lung disease.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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: Medical history and Physical exams; Quality of Life Questionnaires; Collection of Sputum and Blood; Radiology (HRCT); 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: Medical history and Physical exams; Quality of Life Questionnaires; Collection of Sputum and Blood; Radiology (HRCT); Lung Function Test; Spirometry

What is the study measuring?

Primary Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: National Jewish Health
• Collaborators: Boehringer Ingelheim
• Investigators: Principal Investigator: Joshua Solomon, MD, National Jewish Health

Study record dates

Study Major Dates

• Study Start (Actual): March 27, 2018
• Primary Completion (Anticipated): February 1, 2020
• Study Completion (Anticipated): August 1, 2021

Study Registration Dates

• First Submitted: July 26, 2018
• First Submitted That Met QC Criteria: June 5, 2019
• First Posted (Actual): June 6, 2019

Study Record Updates

• Last Update Posted (Actual): June 6, 2019
• Last Update Submitted That Met QC Criteria: June 5, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Keywords: Rheumatoid Arthritis; RA; Rheumatology; ILD; Pulmonary Fibrosis; Interstitial Lung Disease
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Arthritis, Rheumatoid; Lung Diseases; Lung Diseases, Interstitial
• Other Study ID Numbers: HS-3140

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No