An observational study in Rheumatoid Arthritis and Interstitial Lung Disease, sponsored by University of Colorado, Denver. Recruiting at 1 site in United States. Open to participants aged 45 Years to 90 Years. Per ClinicalTrials.gov, last updated 2026-05-01.
Sponsored by University of Colorado, Denver · Observational
Among 975 studies in Arthritis, Rheumatoid with a site in United States — 82 open to participants now, 122 under way, 7 of them phase 3. Arthritis, Rheumatoid · United States.
Among the 975 studies in Arthritis, Rheumatoid with a site in United States, this one is the 52nd largest by planned enrollment of the 199 observational ones, is one of 31 that started in 2017, is one of 201 observational ones, reaches primary completion later than 54 of the 121 other live ones, and was the 708th registered.
3,332 studies on the registry are indexed under Arthritis, Rheumatoid; 443 are open to participants now.
This study's planned enrollment of 750 is above the median of 176 across 1,016 observational studies indexed under Arthritis, Rheumatoid.
Browse Arthritis, Rheumatoid studies →82 of the 975 studies in Arthritis, Rheumatoid with a site in United States are open now, in 12 countries. Each count lists the studies.
Of the 293 Arthritis, Rheumatoid studies recruiting now, 150 (51%) set no upper age limit and 109 (37%) stop at 75 or younger; 15 take children under 18; 36 take healthy volunteers.
This study: 45 Years to 90 Years · all sexes · no healthy volunteers.
The full table on the hub →975 studies; the count open now beside each. This study's row is marked.
First in 1991; this study’s year is marked. 31 started in 2017.
Median enrollment 120 across the 771 interventional studies, 200 across the 199 observational. Of the 802 that completed or were terminated, 417 (52%) have results posted.
629 of 975 have an industry lead sponsor. The 10 most frequent:
University of Colorado, Denver is the lead sponsor of 1,543 studies on the registry; 317 are open to participants now.
Of its 147 completed or terminated interventional studies of FDA-regulated products, 92 (63%) have results posted.
University of Colorado, Denver has 5 studies filed under Arthritis, Rheumatoid — fewer than ten, so there is no comparison to draw.
38 of the studies in Arthritis, Rheumatoid with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06201416Sonoma Biotherapeutics, Inc.Study of Single Doses of SBT777101 in Subjects With Rheumatoid Arthritis | 2026-11 |
| NCT06628206LAPIX Therapeutics Inc.Safety and Pharmacokinetics of LPX-TI641 in Rheumatoid Arthritis and Psoriatic Arthritis | 2026-11-15 |
| NCT05961592Rise Therapeutics LLCR-2487 in Patients With Rheumatoid Arthritis | 2026-11-30 |
| NCT03409718Zimmer BiometDatabase Retrieval for the Comprehensive Shoulder | 2026-12 |
| NCT01480440Zimmer BiometOutcomes Study of the Trabecular Metal (TM) Reverse Shoulder System | 2026-12 |
Among the 975 studies in Arthritis, Rheumatoid with a site in United States, from their registry updates:
The overall goal of this study is to define the phenotype of Interstitial Lung Disease (ILD), and identify factors that predict radiologic progression in those with subclinical RA-ILD, in patients with rheumatoid arthritis (RA). The investigators hypothesize that there are common core elements (e.g. clinical features, genetic variants, and/or biologic markers) between other forms of ILD (e.g. idiopathic pulmonary fibrosis, IPF) and subclinical RA-ILD that places individuals at risk for the development of lung disease.
Subjects are selected for participation in the study because they have an active diagnosis of rheumatoid arthritis and are at risk for the development of lung disease.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Subjects will be followed annually until study closure. Assessments are as follows: 1. Clinical (Annual): Demographics, health-related behaviors, co-morbidities, medications, respiratory symptoms, rheumatologic assessment, quality of life 2. Physiologic (3-5 yrs FU): Lung function on Pulmonary Function Test (PFT) 3. Radiologic (3-5 yrs FU): HRCT scan of chest 4. Genetic (3-5 yrs FU): Blood sample collection for RNA 5. Biologic (3-5 yrs FU): Blood sample collection for other blood markers
Subjects will be followed annually until study closure. Assessments are as follows: 1. Clinical (Annual): Demographics, health-related behaviors, co-morbidities, medications, respiratory symptoms, rheumatologic assessment, quality of life 2. Physiologic (3-5 yrs FU): Lung function on Pulmonary Function Test (PFT) 3. Radiologic (3-5 yrs FU): HRCT scan of chest 4. Genetic (3-5 yrs FU): Blood sample collection for RNA 5. Biologic (3-5 yrs FU): Blood sample collection for other blood markers Note: Certain follow-up procedures may not occur for every subject and will be determined by the research team.
Presence of interstitial lung disease on high resolution CT (HRCT) chest imaging
HRCT scans of the chest will be interpreted by two radiologists and the presence or absence of interstitial lung abnormality will be recorded. When present, abnormalities will be categorized as absent, equivocal, non-fibrotic, or fibrotic, and the extent of any reticular abnormalities will be graded on an 11-point scale (0, 1-10%, 11-20%, etc.). Additionally, the presence or absence of airway disease, centrilobular thickening, mosaic attenuation, and air trapping will be recorded.
Time frame: 3-5 years
Progression of lung disease over time
Radiologic progression of lung disease will be determined through a comparison of baseline HRCT chest findings to follow-up HRCT chest findings at the 3-5 year follow-up benchmark. Similar to baseline, follow-up HRCT scans of the chest will be interpreted by 2 different radiologists. Quantitative radiologic progression will be defined as ≥ 10% increase in fibrotic changes from baseline to follow-up - additionally, the percent reticular change, percent honeycomb change, and percent traction bronchiectasis on the follow-up scan will be quantified and recorded. Radiologic findings of progression will be used in correlation with other clinical features to determine the clinical relevance of the change. The clinical features include - change in cough, change in dyspnea (as measured by UCSD shortness of breath questionnaire), change in FVC percent predicted value, the development of established RA-ILD, or respiratory-related death, over the same time period.
Time frame: 3-5 Years
Impact of subclinical RA-ILD on health-related quality of life in RA
The impact of subclinical RA-ILD on health-related quality of life will be measured using subjective patient questionnaires that will be completed at both baseline and follow-up. These questionnaires include - SF-36, St. George Respiratory Questionnaire, and Multi-Dimensional Health Assessment Questionnaire.
Time frame: 3-5 Years
Outcome of airways disease
Clinical outcomes will be measured through respiratory assessment (physical exam), changes is dyspnea (based on the University of California San Diego shortness of breath questionnaire), changes in FVC percent predicted values (based on pulmonary function testing), increase in cough (determined using a visual analog scale, where 10 is the worst cough and 0 is no cough), and development of RA-ILD requiring treatment.
Time frame: 3-5 Years
Plan to share: No
No publications or documents are linked to this record.
Started Jun 2017 (actual). Primary completion is estimated for Jun 2027, 120 months after the start.
Of 234 non-industry observational studies under Arthritis, Rheumatoid, half reached primary completion within 43 months of starting (the median), counting those still running; a quarter within 20 and three quarters within 145. This study's planned 120 months is above that.
Counting every sponsor, half of 389 studies reached it within 50 months; a quarter within 25 and three quarters within 113.
How these figures are worked out, and which studies are left out of them.
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University of Colorado, Denver →