Interstitial Lung Disease in Early Rheumatoid Arthritis

Rheumatoid Arthritis Clinical Trial

— ILD-Early RA  

Official title:

Interstitial Lung Disease in Early Rheumatoid Arthritis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03977415
• Other study ID #: HS-3140
• Status: Recruiting
• Start date: March 27, 2018
• Est. completion date: August 1, 2021

Study information

• Verified date: June 2019
• Source: National Jewish Health
• Contact: Faduma Ahmed, MPH
• Phone: 303-398-1285
• Email: ahmedf[@]NJHealth.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 76
• Est. completion date: August 1, 2021
• Est. primary completion date: February 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Interstitial Lung Disease
• Lung Diseases
• Lung Diseases, Interstitial
• Rheumatoid Arthritis

Locations

Country	Name	City	State
United States	National Jewish Health	Denver	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
National Jewish Health	Boehringer Ingelheim

Country where clinical trial is conducted

United States, 

Outcome

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