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Defining the Molecular and Radiologic Phenotype of Progressive RA Interstitial Lung Disease (MOUNTAIN Trial)
N/A
Recruiting
Led By Joyce S Lee
Research Sponsored by University of Colorado, Denver
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5-years
Awards & highlights
No Placebo-Only Group
Summary
A study to identify patients with Rheumatoid Arthritis - Associated Interstitial Lung Disease (RA-ILD) that are at the highest risk for progression. The goal of the investigators is to recruit a group of patients with RA-ILD and collect information to help us understand more about disease progression. The investigators will do this using a combination of clinical, radiologic, and biologic features.
Eligible Conditions
- Rheumatoid Arthritis
- Interstitial Lung Disease
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 5-years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5-years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Evaluating the role of novel quantitative imaging
Secondary study objectives
Comparing peripheral blood telomere length (PB-TL)
Defining peripheral blood transcriptomic profiles
Exploring if a composite profile more accurately identifies progressive RA-ILD
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Patients with RA-ILDExperimental Treatment3 Interventions
Assessments include:
* Clinical: height, weight, oxygen saturation at rest, and 6-minute walk test.
* Rheumatological: study Rheumatologist will document rheumatoid arthritis symptoms and clinical findings at baseline and follow-up.
* Pulmonary Function Testing: data will be collected from clinically performed spirometry and diffusing capacity for carbon monoxide.
* High-resolution computed tomography (HRCT) imaging: HRCT scans will be collected at baseline and 12 months in line with standard of care for treatment of RA-ILD.
* Lab specimens: peripheral blood will be obtained for DNA, RNA, serum, and plasma at baseline and at 12 months for all sites or every 3-4 months in Colorado. Buccal swabs (cheek) will also be collected once each year.
* Information collected: will include demographics, co-morbidities, disease history, medication history, pulmonary function, radiographic imaging, and transplant/survival status through questionnaires and medical chart review.
Find a Location
Who is running the clinical trial?
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,938 Previous Clinical Trials
47,791,848 Total Patients Enrolled
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585 Patients Enrolled for Rheumatoid Arthritis
University of MichiganOTHER
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3 Trials studying Rheumatoid Arthritis
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University of Colorado, DenverLead Sponsor
1,809 Previous Clinical Trials
2,821,849 Total Patients Enrolled
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2,282 Patients Enrolled for Rheumatoid Arthritis
University of California, San FranciscoOTHER
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University of KansasOTHER
153 Previous Clinical Trials
331,291 Total Patients Enrolled
Joyce S LeePrincipal InvestigatorUniversity of Colorado, Denver