Rheumatoid ArthritisILD-Early RANCT03977415
Interstitial Lung Disease in Early Rheumatoid Arthritis
An observational study of Rheumatoid Arthritis and Interstitial Lung Disease, run by National Jewish Health at 1 site in United States.
Trial summary
The purpose of this study is to determine how interstitial lung disease can be predicted over time in early rheumatoid arthritis. The investigators will study blood and phlegm samples from participants, along with quality of life questionnaires to determine if and how the presence of ILD may impact the participants… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Rheumatoid Arthritis, Interstitial Lung Disease
- How many people
- 76 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Mar 2018to 1 Aug 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects are selected for participation in the study because they have an active diagnosis of rheumatoid arthritis and are at risk fro the development of lung disease.
Who may be able to join
- Age 18 - 90 years
- Diagnosis of "early RA" with or without ILD as defined by ACR/EULAR 2010 criteria and confirmed by a member of the ILD or Rheumatology programs at National Jewish Health (NJH)
- Able to read, speak, and understand English
- Able and willing to perform all study related tasks, including returning to NJH every 6 months for an 18 month period of time
Who cannot join
- Subjects who do not meet all inclusion criteria
- Pregnant women
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
National Jewish Health
Denver, Colorado, 80206
Faduma Ahmed, 303-398-1285, ahmedf@NJHealth.org
Kristen M Demoruelle, MD
About this study
The purpose of this study is to determine how interstitial lung disease can be predicted over time in early rheumatoid arthritis. The investigators will study blood and phlegm samples from participants, along with quality of life questionnaires to determine if and how the presence of ILD may impact the participants quality of life over time.
Read the detailed description
Participation involves 5 study visits over an 18 month timeframe. During each of these visits, a recent medical history and physical exam will take place, blood and phlegm will be collected, quality of life questionnaires will be administered, and a CT-scan of the chest and pulmonary function testing may be performed.
- Conditions
- Rheumatoid Arthritis, Interstitial Lung Disease
- Keywords
- Interstitial Lung Disease, ILD, Pulmonary Fibrosis, Rheumatoid Arthritis, RA, Rheumatology
- Medical subject headings
- Arthritis, Rheumatoid, Lung Diseases, Interstitial, Pulmonary Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| RA with no ILD | Subjects diagnosed with RA less then 2 years and without a diagnosis of ILD, will complete 5 in-person study visits. Visits will be performed every 6 months for 18 months. Study Assessments Include: 1. Medical history and Physical exams 2. Quality of Life Questionnaires 3. Collection of Sputum and Blood 4. Radiology (HRCT) 5. Lung Function Test | |
| RA with ILD | Patients diagnosed with RA less than 2 years, and clinically diagnosed with interstitial lung disease (ILD), will complete 5 in-person study visits. Visits will be performed every 6 months for 18 months. Study Assessments Include: 1. Medical history and Physical exams 2. Quality of Life Questionnaires 3. Collection of Sputum and Blood 4. Radiology (HRCT) 5. Lung Function Test 6. Spirometry |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in anti-CCP antibody test to identify the presence or development of RA in patients with or without ILD
Measured: 18 months
Change in lung antigen targets in RA-ILD using induced sputum
Measured: 18 months
Change from baseline for Leicester Cough questionnaire-Acute (LCQ_Acute)
Measured: 18 months
Change from baseline for Short Form (SF_36) questionnaire
Measured: 18 months
Change from baseline for UCSD Medical Center Pulmonary Rehabilitations Program Shortness-of-Breath questionnaire
Measured: 18 months
Change from baseline for Multi-Dimensional Health Assessment questionnaire (MDHAQ)
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2019
- Study start27 Mar 2018
- Primary completion1 Feb 2020 (estimated)
- Study completion1 Aug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Jewish Health
- Sponsor type
- University, hospital or other
- Collaborators
- Boehringer Ingelheim
- Responsible party
- Sponsor
- Investigators
- Joshua Solomon, MD, Principal investigator, National Jewish Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03977415
- Sponsor's protocol ID
- HS-3140
- Acronym
- ILD-Early RA
- Status last verified
- Jun 2019
- First submitted
- 26 Jul 2018
- Last updated
- 6 Jun 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interstitial Lung Disease in Early Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT03977415
- Acronym / sponsor ID
- ILD-Early RA / HS-3140
- Conditions
- Rheumatoid Arthritis, Interstitial Lung Disease
- Keywords
- Interstitial Lung Disease, ILD, Pulmonary Fibrosis, Rheumatoid Arthritis, RA, Rheumatology
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- National Jewish HealthUniversity, hospital or other
- Collaborators
- Boehringer Ingelheim
- Study start
- 27 Mar 2018 (actual)
- Primary completion
- 1 Feb 2020 (estimated)
- Study completion
- 1 Aug 2021 (estimated)
- First posted
- 6 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine how interstitial lung disease can be predicted over time in early rheumatoid arthritis. The investigators will study blood and phlegm samples from participants, along with quality of life questionnaires to determine if and how the presence of ILD may impact the participants quality of life over time.
Detailed description
Participation involves 5 study visits over an 18 month timeframe. During each of these visits, a recent medical history and physical exam will take place, blood and phlegm will be collected, quality of life questionnaires will be administered, and a CT-scan of the chest and pulmonary function testing may be performed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RA with no ILD | – | –Subjects diagnosed with RA less then 2 years and without a diagnosis of ILD, will complete 5 in-person study visits. Visits will be performed every 6 months for 18 months. Study Assessments Include: 1. Medical history and Physical exams 2. Quality of Life Questionnaires 3. Collection of Sputum and Blood 4. Radiology (HRCT) 5. Lung Function Test |
| RA with ILD | – | –Patients diagnosed with RA less than 2 years, and clinically diagnosed with interstitial lung disease (ILD), will complete 5 in-person study visits. Visits will be performed every 6 months for 18 months. Study Assessments Include: 1. Medical history and Physical exams 2. Quality of Life Questionnaires 3. Collection of Sputum and Blood 4. Radiology (HRCT) 5. Lung Function Test 6. Spirometry |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects are selected for participation in the study because they have an active diagnosis of rheumatoid arthritis and are at risk fro the development of lung disease.
Key inclusion criteria (4 listed)
- Age 18 - 90 years
- Diagnosis of "early RA" with or without ILD as defined by ACR/EULAR 2010 criteria and confirmed by a member of the ILD or Rheumatology programs at National Jewish Health (NJH)
- Able to read, speak, and understand English
- Able and willing to perform all study related tasks, including returning to NJH every 6 months for an 18 month period of time
Key exclusion criteria (2 listed)
- Subjects who do not meet all inclusion criteria
- Pregnant women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in anti-CCP antibody test to identify the presence or development of RA in patients with or without ILD
Time frame: 18 months
Change in lung antigen targets in RA-ILD using induced sputum
Time frame: 18 months
Change from baseline for Leicester Cough questionnaire-Acute (LCQ_Acute)
Time frame: 18 months
Change from baseline for Short Form (SF_36) questionnaire
Time frame: 18 months
Change from baseline for UCSD Medical Center Pulmonary Rehabilitations Program Shortness-of-Breath questionnaire
Time frame: 18 months
Change from baseline for Multi-Dimensional Health Assessment questionnaire (MDHAQ)
Time frame: 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joshua Solomon, MD principal investigator
National Jewish Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rheumatoid Arthritis and Interstitial Lung Disease, run by National Jewish Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Faduma Ahmed, MPH (303-398-1285, ahmedf@NJHealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in anti-CCP antibody test to identify the presence or development of RA in patients with or without ILD (time frame: 18 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2019.