Interstitial Lung Disease in Early Rheumatoid Arthritis

NCT ID: NCT03977415

Last Updated: 2019-06-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

76 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-03-27

Study Completion Date

2021-08-01

Brief Summary

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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

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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.

Conditions

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Rheumatoid Arthritis Interstitial Lung Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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

No interventions assigned to this group

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

No interventions assigned to this group

Eligibility Criteria

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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

2. Pregnant women
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boehringer Ingelheim

INDUSTRY

Sponsor Role collaborator

National Jewish Health

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Joshua Solomon, MD

Role: PRINCIPAL_INVESTIGATOR

National Jewish Health

Locations

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National Jewish Health

Denver, Colorado, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Faduma Ahmed, MPH

Role: CONTACT

303-398-1285

Jami Henriksen

Role: CONTACT

303-398-1996

Facility Contacts

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Faduma Ahmed

Role: primary

303-398-1285

Other Identifiers

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HS-3140

Identifier Type: -

Identifier Source: org_study_id

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