Rheumatoid Arthritis and Myositis Cohort

NCT ID: NCT05627089

Last Updated: 2024-01-30

Basic Information

• Recruitment Status: WITHDRAWN
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-07-01
• Study Completion Date: 2035-01-01

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.

Conditions

Rheumatoid Arthritis; Myositis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

No interventions assigned to this group

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ONCOtracker Inc

INDUSTRY

Sponsor Role: collaborator

Attune Health Research, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Swamy Venuturupalli

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

References

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Other Identifiers

RAMC2022

Identifier Type: -

Identifier Source: org_study_id