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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03977415
Recruitment Status : Recruiting
First Posted : June 6, 2019
Last Update Posted : June 6, 2019
Sponsor:
Collaborator:
Boehringer Ingelheim
Information provided by (Responsible Party):
National Jewish Health

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.

Condition or disease
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.

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Study Type : Observational
Estimated Enrollment : 76 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Interstitial Lung Disease in Early Rheumatoid Arthritis
Actual Study Start Date : March 27, 2018
Estimated Primary Completion Date : February 1, 2020
Estimated Study Completion Date : August 1, 2021


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:

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

Biospecimen Retention:   Samples With DNA
Serum biomarker and cell collection


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03977415


Contacts
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Contact: Faduma Ahmed, MPH 303-398-1285 ahmedf@NJHealth.org
Contact: Jami Henriksen 303-398-1996 henriksenj@njhealth.org

Locations
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United States, Colorado
National Jewish Health Recruiting
Denver, Colorado, United States, 80206
Contact: Faduma Ahmed    303-398-1285    ahmedf@NJHealth.org   
Sub-Investigator: Kristen M Demoruelle, MD         
Sub-Investigator: Michael Mohning, MD         
Sponsors and Collaborators
National Jewish Health
Boehringer Ingelheim
Investigators
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Principal Investigator: Joshua Solomon, MD National Jewish Health
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Responsible Party: National Jewish Health
ClinicalTrials.gov Identifier: NCT03977415    
Other Study ID Numbers: HS-3140
First Posted: June 6, 2019    Key Record Dates
Last Update Posted: June 6, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by National Jewish Health:
Interstitial Lung Disease
ILD
Pulmonary Fibrosis
Rheumatoid Arthritis
RA
Rheumatology
Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Lung Diseases
Lung Diseases, Interstitial
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Respiratory Tract Diseases