Clinical trial NCT05627089: Rheumatoid Arthritis and Myositis Cohort
Official title: Rheumatoid Arthritis and Myositis Cohort
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Rheumatoid Arthritis
Myositis
Keywords: Intestinal Microbiome
Immune cells
Cytokines
Rheumatoid Arthritis
Myositis
Autoimmune disease
Immunosuppressive medication
Diet
Disease Activity
Lead sponsor: Attune Health Research, Inc.
Sponsor class: INDUSTRY
Collaborators: name: ONCOtracker Inc
First posted: 2022-11-25
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients seen with Rheumatoid Arthritis or Myositis who are at least 18 years of age will be eligible for the study.

Brief 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 research purposes.

Specific research objectives of this cohort include:

1. Observe the response that immunosuppressive medications have on the immune cell population and cytokines in individuals with RA or Myositis.
2. Observe the role that the intestinal microbiome has on the immune cell population and cytokines in individuals with RA or Myositis.
3. 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in IL-1, IL-6, CXCL10 and Immune Cell Population due to Immunosuppressive Medication
timeFrame: 1 year
measure: Change in IL-1, IL-6, CXCL10 and Immune Cell Population in response to Intestinal Microbiome
timeFrame: 1 year
measure: Change in IL-1, IL-6, CXCL10 and Immune Cell Population in response to Intestinal Inflammation
timeFrame: 1 year
Secondary outcomes:
measure: Change in IL-1, IL-6, CXCL10 and Immune Cell Population due to Immunosuppressive Medication
timeFrame: 10 years
measure: Change in IL-1, IL-6, CXCL10 and Immune Cell Population due to changes in the intestinal microbiome
timeFrame: 10 years
measure: Change in IL-1, IL-6, CXCL10 and Immune Cell Population due to Intestinal Inflammation
timeFrame: 10 years
Other outcomes:
Locations:
Study officials:
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