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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
MOUNTAIN Trial 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
MOUNTAIN Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 5-years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5-years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Evaluating the role of novel quantitative imaging
Secondary outcome measures
Comparing peripheral blood telomere length (PB-TL)
Defining peripheral blood transcriptomic profiles
Exploring if a composite profile more accurately identifies progressive RA-ILD
MOUNTAIN 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.
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Who is running the clinical trial?
University of Colorado, DenverLead Sponsor
1,742 Previous Clinical Trials
2,152,309 Total Patients Enrolled
6 Trials studying Rheumatoid Arthritis
2,282 Patients Enrolled for Rheumatoid Arthritis
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,843 Previous Clinical Trials
47,816,658 Total Patients Enrolled
5 Trials studying Rheumatoid Arthritis
585 Patients Enrolled for Rheumatoid Arthritis
University of MichiganOTHER
1,800 Previous Clinical Trials
6,378,690 Total Patients Enrolled
3 Trials studying Rheumatoid Arthritis
170 Patients Enrolled for Rheumatoid Arthritis
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