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Patients with RA-ILD for 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
  • Interstitial Lung Disease
  • Rheumatoid Arthritis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5-years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5-years for reporting.

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
3,916 Previous Clinical Trials
47,757,745 Total Patients Enrolled
University of MichiganOTHER
1,844 Previous Clinical Trials
6,429,307 Total Patients Enrolled
University of Colorado, DenverLead Sponsor
1,798 Previous Clinical Trials
2,796,655 Total Patients Enrolled
~300 spots leftby Jan 2029
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