450 Participants Needed

Defining the Molecular and Radiologic Phenotype of Progressive RA Interstitial Lung Disease

(MOUNTAIN Trial)

Recruiting at 3 trial locations
HL
JS
Overseen ByJoyce S Lee
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Colorado, Denver
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

JS

Joyce S Lee

Principal Investigator

University of Colorado, Denver

Are You a Good Fit for This Trial?

Inclusion Criteria

My condition is RA-ILD diagnosed by a team of doctors.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Initial collection of blood samples, buccal swabs, questionnaires, and clinical tests including HRCT scans and pulmonary function tests if performed clinically

Year 0
1 visit (in-person)

Ongoing Monitoring

Every 4 months, blood samples and questionnaires are collected at clinic visits

Every 4 months
3 visits per year (in-person)

Annual Follow-up

Annual collection of blood samples, buccal swabs, questionnaires, and clinical tests including HRCT scans and pulmonary function tests if performed clinically

Year 1 and Year 2
1 visit per year (in-person)

Long-term Follow-up

Participants are monitored for disease progression and survival status through questionnaires and medical chart review

5 years

What Are the Treatments Tested in This Trial?

How Is the Trial Designed?
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 Clinic Near You

Who Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials
1,842
Recruited
3,028,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials
3,987
Recruited
47,860,000+

University of Michigan

Collaborator

Trials
1,891
Recruited
6,458,000+

University of California, San Francisco

Collaborator

Trials
2,636
Recruited
19,080,000+

University of Kansas

Collaborator

Trials
157
Recruited
332,000+
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