Research Testing for Rheumatoid Arthritis-Associated Interstitial Lung Disease

(MOUNTAIN Trial)

Recruiting at 3 trial locations

Overseen By Joyce S Lee

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Colorado, Denver

Disqualifiers: Prior RA-ILD treatment, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

450 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand the progression of Rheumatoid Arthritis-Associated Interstitial Lung Disease (RA-ILD) in patients. Researchers will gather detailed information on the disease through scans, blood tests, and breathing tests. They seek to identify which patients are more likely to experience worsening conditions. Individuals with RA-ILD who have not received specific treatment for it may be suitable candidates for this study. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could enhance future treatments for RA-ILD.

Why are researchers excited about this trial?

Researchers are excited about this trial because it aims to better understand the molecular and radiologic characteristics of progressive rheumatoid arthritis-associated interstitial lung disease (RA-ILD). Unlike traditional treatments focusing primarily on symptom management, this study digs deeper into the disease's underlying mechanisms. By gathering detailed clinical, rheumatological, and pulmonary data, along with advanced imaging and genetic analysis, researchers hope to uncover new insights that could lead to more targeted and effective treatment strategies in the future. This comprehensive approach could revolutionize how RA-ILD is diagnosed and managed.

Who Is on the Research Team?

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?

Group I: Patients with RA-ILD Experimental Treatment 3 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.

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+