Rheumatoid ArthritisNCT05627089
Rheumatoid Arthritis and Myositis Cohort
An observational study of Rheumatoid Arthritis and Myositis, run by Attune Health Research, Inc..
Trial summary
The primary objective of this research is to establish a well characterized clinical and longitudinal cohort for individuals with Rheumatoid Arthritis (RA) and Myositis to create a place to maintain blood, urine, stool specimens, excess tissue from procedures, and clinical data, which may be accessed for future… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis, Myositis
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2023to 1 Jan 2035
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients seen with Rheumatoid Arthritis or Myositis who are at least 18 years of age will be eligible for the study.
Who may be able to join
- Subjects must be 18 years or older
- Diagnosed RA by a rheumatologist determined by the 2010 ACR/EULAR Classification Criteria.
- Diagnosed Myositis by a rheumatologist determined by the 2017 American College of Rheumatology Classification Criteria for Adult and Juvenile Idiopathic Inflammatory Myopathies
- Able to read and write in English or Spanish
Who cannot join
- Subject is less than 18 years old
About this study
The primary objective of this research is to establish a well characterized clinical and longitudinal cohort for individuals with Rheumatoid Arthritis (RA) and Myositis to create a place to maintain blood, urine, stool specimens, excess tissue from procedures, and clinical data, which may be accessed for future research purposes.
Specific research objectives of this cohort include:
- Observe the response that immunosuppressive medications have on the immune cell population and cytokines in individuals with RA or Myositis.
- Observe the role that the intestinal microbiome has on the immune cell population and cytokines in individuals with RA or Myositis.
- Observe the connection between intestinal inflammation has on the immune cell population and cytokines in individuals with RA or Myositis.
Read the detailed description
Autoimmune diseases are together the third most common type of disease that affect individuals in the United States. In 2005 the National Institute of Health estimated that 23.5 million people have an autoimmune condition. Previously considered to be rare, epidemiological studies have shown that there are nearly 100 different autoimmune diseases. Examples include organ specific autoimmune disease such as Primary Biliary Cirrhosis (PBC), or Systematic Lupus Erythematosus, which reflects immunological dysfunction involving multiple organs. As the prevalence and incidence of autoimmune diseases continue to rise, it creates a burden on individuals, their families, and society. The burden is noticeable through medical costs, diminished quality of life, and loss of productivity. The burden of this disease demands a comprehensive treatment that includes overall wellness.
The human gastrointestinal tract is home to trillions of microorganisms including bacteria, viruses, fungi, and protozoa, which together are referred to as the gut microbiome. Research in recent years has underlined that the microorganisms can influence varying physiological aspects such as the immune system, metabolism, and behavior. The microbiome has further been implicated in the pathogenesis of autoimmune diseases. In Systematic Lupus Erythematosus for example, modifications in the intestinal flora have been documented while changes in gut commensal and periodontal diseases have been brought forth as factors for consideration in the development of Rheumatoid Arthritis. Similarly, autoimmune diseases such as Systematic Sclerosis, Sjogren's Syndrome, and Anti-phospholipid Syndrome have been noted to share alterations in the gut microbiome.
Emerging research on the gut microbiome has demonstrated that diet plays a critical role in the make-up of gut microbiome and several experiments have shown that dietary modifications can prompt significant changes in the gut microbial composition. However, little is presently understood about the precise mechanisms and unique interactions between the gut microbiome, diet, and the pathogenesis of autoimmune diseases.
To investigate the triangular link between a patient's diet, their microbiome, and their disease activity, the investigators are seeking to establish a registry to track patients with autoimmune disease diagnoses. Furthermore, the investigators are looking to track the changes in the microbiome, diet, and disease progression as patients are introduced and sustained on medication.
- Conditions
- Rheumatoid Arthritis, Myositis
- Keywords
- Intestinal Microbiome, Immune cells, Cytokines, Rheumatoid Arthritis, Myositis, Autoimmune disease, Immunosuppressive medication, Diet, Disease Activity
- Medical subject headings
- Arthritis, Rheumatoid, Myositis, Autoimmune Diseases
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 |
|---|---|---|
| Patients with Rheumatoid Arthritis and/or Myositis | All patients 18 years or older who have been diagnosed with Rheumatoid Arthritis according to the 2010 ACR/EULAR Classification Criteria. All patients 18 years or older who have been diagnosed with Myositis according to the 2017 European League Against Rheumatism/American College of Rheumatology Classification Criteria for Adult and Juvenile Idiopathic Inflammatory Myopathies Classification Criteria. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in IL-1, IL-6, CXCL10 and Immune Cell Population due to Immunosuppressive Medication
Observe the response that immunosuppressive medications have on the immune cell population and cytokines in individuals with RA or Myositis.
Measured: 1 year
Change in IL-1, IL-6, CXCL10 and Immune Cell Population in response to Intestinal Microbiome
Observe the role that the intestinal microbiome has on the immune cell population and cytokines in individuals with RA or Myositis.
Measured: 1 year
Change in IL-1, IL-6, CXCL10 and Immune Cell Population in response to Intestinal Inflammation
Observe the connection between intestinal inflammation has on the immune cell population and cytokines in individuals with RA or Myositis.
Measured: 1 year
Secondary outcomes (3)
Change in IL-1, IL-6, CXCL10 and Immune Cell Population due to Immunosuppressive Medication
Observe the response that immunosuppressive medications have on the immune cell population and cytokines in individuals with RA or Myositis.
Measured: 10 years
Change in IL-1, IL-6, CXCL10 and Immune Cell Population due to changes in the intestinal microbiome
Observe the response that immunosuppressive medications have on the immune cell population and cytokines in individuals with RA or Myositis.
Measured: 10 years
Change in IL-1, IL-6, CXCL10 and Immune Cell Population due to Intestinal Inflammation
Observe the connection between intestinal inflammation has on the immune cell population and cytokines in individuals with RA or Myositis.
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2022
- Study start1 Jul 2023 (estimated)
- Primary completion1 Jan 2033 (estimated)
- Study completion1 Jan 2035 (estimated)
Why it stopped: Decided not to move forward
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Attune Health Research, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- ONCOtracker Inc
- Responsible party
- Principal investigator, Swamy Venuturupalli, Attune Health Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05627089
- Sponsor's protocol ID
- RAMC2022
- Status last verified
- Jan 2024
- First submitted
- 9 Nov 2022
- Last updated
- 30 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Bethesda. National Institutes of Health Autoimmune Disease Coordinating Committee Report. The Institutes, 2002.
Services USDoHaH. Progress in Autoimmune Diseases and Research. National Institutes of Health: The autoimmune Diseases Coordinating Committee, 2005:1-126.
Wang L, Wang FS, Gershwin ME. Human autoimmune diseases: a comprehensive update. J Intern Med. 2015 Oct;278(4):369-95. doi: 10.1111/joim.12395. Epub 2015 Jul 25.
PubMed 26212387Xu J, Yang Y. Gut microbiome and its meta-omics perspectives: profound implications for cardiovascular diseases. Gut Microbes. 2021 Jan-Dec;13(1):1936379. doi: 10.1080/19490976.2021.1936379.
PubMed 34170211De Luca F, Shoenfeld Y. The microbiome in autoimmune diseases. Clin Exp Immunol. 2019 Jan;195(1):74-85. doi: 10.1111/cei.13158.
PubMed 29920643Singh RK, Chang HW, Yan D, Lee KM, Ucmak D, Wong K, Abrouk M, Farahnik B, Nakamura M, Zhu TH, Bhutani T, Liao W. Influence of diet on the gut microbiome and implications for human health. J Transl Med. 2017 Apr 8;15(1):73. doi: 10.1186/s12967-017-1175-y.
PubMed 28388917Vieira SM, Pagovich OE, Kriegel MA. Diet, microbiota and autoimmune diseases. Lupus. 2014 May;23(6):518-26. doi: 10.1177/0961203313501401.
PubMed 24763536Anderson J, Caplan L, Yazdany J, Robbins ML, Neogi T, Michaud K, Saag KG, O'Dell JR, Kazi S. Rheumatoid arthritis disease activity measures: American College of Rheumatology recommendations for use in clinical practice. Arthritis Care Res (Hoboken). 2012 May;64(5):640-7. doi: 10.1002/acr.21649.
PubMed 22473918Fransen J, van Riel PL. The Disease Activity Score and the EULAR response criteria. Rheum Dis Clin North Am. 2009 Nov;35(4):745-57, vii-viii. doi: 10.1016/j.rdc.2009.10.001.
PubMed 19962619Rider LG, Aggarwal R, Machado PM, Hogrel JY, Reed AM, Christopher-Stine L, Ruperto N. Update on outcome assessment in myositis. Nat Rev Rheumatol. 2018 May;14(5):303-318. doi: 10.1038/nrrheum.2018.33. Epub 2018 Apr 12.
PubMed 29651119Instruments available for use in Assessment Center . Secondary Instruments available for use in Assessment Center. https://www.assessmentcenter.net/documents/InstrumentLibrary.pdf.
Deyo RA, Katrina Ramsey, Buckley DI, Michaels L, Kobus A, Eckstrom E, Forro V, Morris C. Performance of a Patient Reported Outcomes Measurement Information System (PROMIS) Short Form in Older Adults with Chronic Musculoskeletal Pain. Pain Med. 2016 Feb;17(2):314-24. doi: 10.1093/pm/pnv046.
PubMed 26814279Bigaard J, Frederiksen K, Tjonneland A, Thomsen BL, Overvad K, Heitmann BL, Sorensen TI. Waist circumference and body composition in relation to all-cause mortality in middle-aged men and women. Int J Obes (Lond). 2005 Jul;29(7):778-84. doi: 10.1038/sj.ijo.0802976.
PubMed 15917857Konijn NP, van Tuyl LH, Bultink IE, Lems WF, Earthman CP, van Bokhorst-de van der Schueren MA. Making the invisible visible: bioelectrical impedance analysis demonstrates unfavourable body composition in rheumatoid arthritis patients in clinical practice. Scand J Rheumatol. 2014;43(4):273-8. doi: 10.3109/03009742.2013.852239. Epub 2014 Feb 7.
PubMed 24797672Chen YM, Chen HH, Hsieh CW, Hsieh TY, Lan JL, Chen DY. A close association of body cell mass loss with disease activity and disability in Chinese patients with rheumatoid arthritis. Clinics (Sao Paulo). 2011;66(7):1217-22. doi: 10.1590/s1807-59322011000700016.
PubMed 21876977
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rheumatoid Arthritis and Myositis Cohort
- ClinicalTrials.gov ID
- NCT05627089
- Acronym / sponsor ID
- RAMC2022
- Conditions
- Rheumatoid Arthritis, Myositis
- Keywords
- Intestinal Microbiome, Immune cells, Cytokines, Rheumatoid Arthritis, Myositis, Autoimmune disease, Immunosuppressive medication, Diet
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Decided not to move forward
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Attune Health Research, Inc.Industry (pharma, biotech, devices)
- Collaborators
- ONCOtracker Inc
- Study start
- 1 Jul 2023 (estimated)
- Primary completion
- 1 Jan 2033 (estimated)
- Study completion
- 1 Jan 2035 (estimated)
- First posted
- 25 Nov 2022 (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 primary objective of this research is to establish a well characterized clinical and longitudinal cohort for individuals with Rheumatoid Arthritis (RA) and Myositis to create a place to maintain blood, urine, stool specimens, excess tissue from procedures, and clinical data, which may be accessed for future research purposes.
Specific research objectives of this cohort include:
- Observe the response that immunosuppressive medications have on the immune cell population and cytokines in individuals with RA or Myositis.
- Observe the role that the intestinal microbiome has on the immune cell population and cytokines in individuals with RA or Myositis.
- Observe the connection between intestinal inflammation has on the immune cell population and cytokines in individuals with RA or Myositis.
Detailed description
Autoimmune diseases are together the third most common type of disease that affect individuals in the United States. In 2005 the National Institute of Health estimated that 23.5 million people have an autoimmune condition. Previously considered to be rare, epidemiological studies have shown that there are nearly 100 different autoimmune diseases. Examples include organ specific autoimmune disease such as Primary Biliary Cirrhosis (PBC), or Systematic Lupus Erythematosus, which reflects immunological dysfunction involving multiple organs. As the prevalence and incidence of autoimmune diseases continue to rise, it creates a burden on individuals, their families, and society. The burden is noticeable through medical costs, diminished quality of life, and loss of productivity. The burden of this disease demands a comprehensive treatment that includes overall wellness.
The human gastrointestinal tract is home to trillions of microorganisms including bacteria, viruses, fungi, and protozoa, which together are referred to as the gut microbiome. Research in recent years has underlined that the microorganisms can influence varying physiological aspects such as the immune system, metabolism, and behavior. The microbiome has further been implicated in the pathogenesis of autoimmune diseases. In Systematic Lupus Erythematosus for example, modifications in the intestinal flora have been documented while changes in gut commensal and periodontal diseases have been brought forth as factors for consideration in the development of Rheumatoid Arthritis. Similarly, autoimmune diseases such as Systematic Sclerosis, Sjogren's Syndrome, and Anti-phospholipid Syndrome have been noted to share alterations in the gut microbiome.
Emerging research on the gut microbiome has demonstrated that diet plays a critical role in the make-up of gut microbiome and several experiments have shown that dietary modifications can prompt significant changes in the gut microbial composition. However, little is presently understood about the precise mechanisms and unique interactions between the gut microbiome, diet, and the pathogenesis of autoimmune diseases.
To investigate the triangular link between a patient's diet, their microbiome, and their disease activity, the investigators are seeking to establish a registry to track patients with autoimmune disease diagnoses. Furthermore, the investigators are looking to track the changes in the microbiome, diet, and disease progression as patients are introduced and sustained on medication.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with Rheumatoid Arthritis and/or Myositis | – | –All patients 18 years or older who have been diagnosed with Rheumatoid Arthritis according to the 2010 ACR/EULAR Classification Criteria. All patients 18 years or older who have been diagnosed with Myositis according to the 2017 European League Against Rheumatism/American College of Rheumatology Classification Criteria for Adult and Juvenile Idiopathic Inflammatory Myopathies Classification Criteria. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients seen with Rheumatoid Arthritis or Myositis who are at least 18 years of age will be eligible for the study.
Key inclusion criteria (4 listed)
- Subjects must be 18 years or older
- Diagnosed RA by a rheumatologist determined by the 2010 ACR/EULAR Classification Criteria.
- Diagnosed Myositis by a rheumatologist determined by the 2017 American College of Rheumatology Classification Criteria for Adult and Juvenile Idiopathic Inflammatory Myopathies
- Able to read and write in English or Spanish
Key exclusion criteria (1 listed)
- Subject is less than 18 years old
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 IL-1, IL-6, CXCL10 and Immune Cell Population due to Immunosuppressive Medication
Time frame: 1 year
Observe the response that immunosuppressive medications have on the immune cell population and cytokines in individuals with RA or Myositis.
Change in IL-1, IL-6, CXCL10 and Immune Cell Population in response to Intestinal Microbiome
Time frame: 1 year
Observe the role that the intestinal microbiome has on the immune cell population and cytokines in individuals with RA or Myositis.
Change in IL-1, IL-6, CXCL10 and Immune Cell Population in response to Intestinal Inflammation
Time frame: 1 year
Observe the connection between intestinal inflammation has on the immune cell population and cytokines in individuals with RA or Myositis.
3 secondary outcomes
Change in IL-1, IL-6, CXCL10 and Immune Cell Population due to Immunosuppressive Medication
Time frame: 10 years
Change in IL-1, IL-6, CXCL10 and Immune Cell Population due to changes in the intestinal microbiome
Time frame: 10 years
Change in IL-1, IL-6, CXCL10 and Immune Cell Population due to Intestinal Inflammation
Time frame: 10 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2024.
- BackgroundBethesda. National Institutes of Health Autoimmune Disease Coordinating Committee Report. The Institutes, 2002.
- BackgroundServices USDoHaH. Progress in Autoimmune Diseases and Research. National Institutes of Health: The autoimmune Diseases Coordinating Committee, 2005:1-126.
- Background: PubMed 26212387Wang L, Wang FS, Gershwin ME. Human autoimmune diseases: a comprehensive update. J Intern Med. 2015 Oct;278(4):369-95. doi: 10.1111/joim.12395. Epub 2015 Jul 25.
- Background: PubMed 34170211Xu J, Yang Y. Gut microbiome and its meta-omics perspectives: profound implications for cardiovascular diseases. Gut Microbes. 2021 Jan-Dec;13(1):1936379. doi: 10.1080/19490976.2021.1936379.
- Background: PubMed 29920643De Luca F, Shoenfeld Y. The microbiome in autoimmune diseases. Clin Exp Immunol. 2019 Jan;195(1):74-85. doi: 10.1111/cei.13158.
- Background: PubMed 28388917Singh RK, Chang HW, Yan D, Lee KM, Ucmak D, Wong K, Abrouk M, Farahnik B, Nakamura M, Zhu TH, Bhutani T, Liao W. Influence of diet on the gut microbiome and implications for human health. J Transl Med. 2017 Apr 8;15(1):73. doi: 10.1186/s12967-017-1175-y.
- Background: PubMed 24763536Vieira SM, Pagovich OE, Kriegel MA. Diet, microbiota and autoimmune diseases. Lupus. 2014 May;23(6):518-26. doi: 10.1177/0961203313501401.
- Background: PubMed 22473918Anderson J, Caplan L, Yazdany J, Robbins ML, Neogi T, Michaud K, Saag KG, O'Dell JR, Kazi S. Rheumatoid arthritis disease activity measures: American College of Rheumatology recommendations for use in clinical practice. Arthritis Care Res (Hoboken). 2012 May;64(5):640-7. doi: 10.1002/acr.21649.
- Results publication: PubMed 19962619Fransen J, van Riel PL. The Disease Activity Score and the EULAR response criteria. Rheum Dis Clin North Am. 2009 Nov;35(4):745-57, vii-viii. doi: 10.1016/j.rdc.2009.10.001.
- Results publication: PubMed 29651119Rider LG, Aggarwal R, Machado PM, Hogrel JY, Reed AM, Christopher-Stine L, Ruperto N. Update on outcome assessment in myositis. Nat Rev Rheumatol. 2018 May;14(5):303-318. doi: 10.1038/nrrheum.2018.33. Epub 2018 Apr 12.
- Results publicationInstruments available for use in Assessment Center . Secondary Instruments available for use in Assessment Center. https://www.assessmentcenter.net/documents/InstrumentLibrary.pdf.
- Results publication: PubMed 26814279Deyo RA, Katrina Ramsey, Buckley DI, Michaels L, Kobus A, Eckstrom E, Forro V, Morris C. Performance of a Patient Reported Outcomes Measurement Information System (PROMIS) Short Form in Older Adults with Chronic Musculoskeletal Pain. Pain Med. 2016 Feb;17(2):314-24. doi: 10.1093/pm/pnv046.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Rheumatoid Arthritis and Myositis, run by Attune Health Research, Inc..
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 1 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: withdrawn, as of the sponsor's last update on 30 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in IL-1, IL-6, CXCL10 and Immune Cell Population due to Immunosuppressive Medication (time frame: 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05627089, which also lists 19 linked publications.
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 30 Jan 2024.