Rheumatoid Arthritis and Myositis Cohort
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| ClinicalTrials.gov Identifier: NCT05627089 |
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Recruitment Status :
Withdrawn
(Decided not to move forward)
First Posted : November 25, 2022
Last Update Posted : January 30, 2024
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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.
| Condition or disease |
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| Rheumatoid Arthritis Myositis |
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 Type : | Observational |
| Actual Enrollment : | 0 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | Rheumatoid Arthritis and Myositis Cohort |
| Estimated Study Start Date : | July 1, 2023 |
| Estimated Primary Completion Date : | January 1, 2033 |
| Estimated Study Completion Date : | January 1, 2035 |
| Group/Cohort |
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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. |
- 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.
- Change in IL-1, IL-6, CXCL10 and Immune Cell Population due to Immunosuppressive Medication [ Time Frame: 10 years ]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 due to changes in the intestinal microbiome [ Time Frame: 10 years ]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 due to Intestinal Inflammation [ Time Frame: 10 years ]Observe the connection between intestinal inflammation has on the immune cell population and cytokines in individuals with RA or Myositis.
Biospecimen Retention: Samples With DNA
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- 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
Exclusion Criteria:
- Subject is less than 18 years old
Other Publications:
| Responsible Party: | Swamy Venuturupalli, Principal Investigator, Attune Health Foundation |
| ClinicalTrials.gov Identifier: | NCT05627089 |
| Other Study ID Numbers: |
RAMC2022 |
| First Posted: | November 25, 2022 Key Record Dates |
| Last Update Posted: | January 30, 2024 |
| Last Verified: | January 2024 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Intestinal Microbiome Immune cells Cytokines Rheumatoid Arthritis Myositis |
Autoimmune disease Immunosuppressive medication Diet Disease Activity |
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Myositis Arthritis Arthritis, Rheumatoid Joint Diseases Musculoskeletal Diseases Rheumatic Diseases |
Connective Tissue Diseases Autoimmune Diseases Immune System Diseases Muscular Diseases Neuromuscular Diseases Nervous System Diseases |