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Rheumatoid Arthritis and Myositis Cohort

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ClinicalTrials.gov Identifier: NCT05627089
Recruitment Status : Withdrawn (Decided not to move forward)
First Posted : November 25, 2022
Last Update Posted : January 30, 2024
Sponsor:
Collaborator:
ONCOtracker Inc
Information provided by (Responsible Party):
Swamy Venuturupalli, Attune Health Foundation

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.

Condition or disease
Rheumatoid Arthritis 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.

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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
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.




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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
Blood, serum, plasma, urine, stool, synovial tissue, skin tissue, muscle tissue, extract DNA and RNA, endoscopy aspirate


Information from the National Library of Medicine

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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
Study Population
All patients seen with Rheumatoid Arthritis or Myositis who are at least 18 years of age will be eligible for the study.
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
Publications of Results:
Instruments available for use in Assessment Center . Secondary Instruments available for use in Assessment Center. https://www.assessmentcenter.net/documents/InstrumentLibrary.pdf.
Sciences NCIDoCCP. DHQIII Diet History Questionnaire Secondary DHQIII Diet History Questionnaire https://epi.grants.cancer.gov/dhq3/.

Other Publications:
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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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Swamy Venuturupalli, Attune Health Foundation:
Intestinal Microbiome
Immune cells
Cytokines
Rheumatoid Arthritis
Myositis
Autoimmune disease
Immunosuppressive medication
Diet
Disease Activity
Additional relevant MeSH terms:
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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