NCT03977415

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
76

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 27, 2018

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 26, 2018

Completed
11 months until next milestone

First Posted

Study publicly available on registry

June 6, 2019

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2020

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2021

Completed
Last Updated

June 6, 2019

Status Verified

June 1, 2019

Enrollment Period

1.9 years

First QC Date

July 26, 2018

Last Update Submit

June 5, 2019

Conditions

Rheumatoid ArthritisInterstitial Lung Disease

Keywords

Interstitial Lung DiseaseILDPulmonary FibrosisRheumatoid ArthritisRARheumatology

Outcome Measures

Primary Outcomes (6)

  • 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

Study Arms (2)

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

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • Age 18 - 90 years
  • 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)
  • Able to read, speak, and understand English
  • Able and willing to perform all study related tasks, including returning to NJH every 6 months for an 18 month period of time

You may not qualify if:

  • Pregnant women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Jewish Health

Denver, Colorado, 80206, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Serum biomarker and cell collection

MeSH Terms

Conditions

Arthritis, RheumatoidLung Diseases, InterstitialPulmonary Fibrosis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System DiseasesLung DiseasesRespiratory Tract DiseasesFibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Joshua Solomon, MD

    National Jewish Health

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Faduma Ahmed, MPH

CONTACT

303-398-1285ahmedf@NJHealth.org

Jami Henriksen

CONTACT

303-398-1996henriksenj@njhealth.org

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 26, 2018

First Posted

June 6, 2019

Study Start

March 27, 2018

Primary Completion

February 1, 2020

Study Completion

August 1, 2021

Last Updated

June 6, 2019

Record last verified: 2019-06

Locations

US(1)