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Patients with RA-ILD for Rheumatoid Arthritis (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 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
3,922 Previous Clinical Trials
47,760,288 Total Patients Enrolled
5 Trials studying Rheumatoid Arthritis
585 Patients Enrolled for Rheumatoid Arthritis
University of MichiganOTHER
1,849 Previous Clinical Trials
6,431,034 Total Patients Enrolled
3 Trials studying Rheumatoid Arthritis
170 Patients Enrolled for Rheumatoid Arthritis
University of Colorado, DenverLead Sponsor
1,802 Previous Clinical Trials
2,821,662 Total Patients Enrolled
6 Trials studying Rheumatoid Arthritis
2,282 Patients Enrolled for Rheumatoid Arthritis
~300 spots leftby Jan 2029