Rheumatoid Arthritis and Myositis Cohort

Rheumatoid Arthritis Clinical Trial

Official title:

Rheumatoid Arthritis and Myositis Cohort

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05627089
• Other study ID #: RAMC2022
• Status: Withdrawn
• Start date: July 1, 2023
• Est. completion date: January 1, 2035

Study information

• Verified date: January 2024
• Source: Attune Health Research, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 1, 2035
• Est. primary completion date: January 1, 2033
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Myositis
• Rheumatoid Arthritis

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Attune Health Research, Inc.	ONCOtracker Inc

References & Publications (19)

Anderson 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. — View Citation

Bethesda. National Institutes of Health Autoimmune Disease Coordinating Committee Report. The Institutes, 2002.

Bigaard 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.ij — View Citation

Chen 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/s1807-5932201100070 — View Citation

De Luca F, Shoenfeld Y. The microbiome in autoimmune diseases. Clin Exp Immunol. 2019 Jan;195(1):74-85. doi: 10.1111/cei.13158. — View Citation

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 — View Citation

Fransen 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. — View Citation

Instruments available for use in Assessment Center . Secondary Instruments available for use in Assessment Center. https://www.assessmentcenter.net/documents/InstrumentLibrary.pdf.

Konijn 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. — View Citation

Rider 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. — View Citation

Sciences NCIDoCCP. DHQIII Diet History Questionnaire Secondary DHQIII Diet History Questionnaire https://epi.grants.cancer.gov/dhq3/.

Services USDoHaH. Progress in Autoimmune Diseases and Research. National Institutes of Health: The autoimmune Diseases Coordinating Committee, 2005:1-126.

Singh 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. — View Citation

Subar AF, Kipnis V, Troiano RP, Midthune D, Schoeller DA, Bingham S, Sharbaugh CO, Trabulsi J, Runswick S, Ballard-Barbash R, Sunshine J, Schatzkin A. Using intake biomarkers to evaluate the extent of dietary misreporting in a large sample of adults: the — View Citation

Subar AF, Thompson FE, Kipnis V, Midthune D, Hurwitz P, McNutt S, McIntosh A, Rosenfeld S. Comparative validation of the Block, Willett, and National Cancer Institute food frequency questionnaires : the Eating at America's Table Study. Am J Epidemiol. 200 — View Citation

Thompson FE, Subar AF, Brown CC, Smith AF, Sharbaugh CO, Jobe JB, Mittl B, Gibson JT, Ziegler RG. Cognitive research enhances accuracy of food frequency questionnaire reports: results of an experimental validation study. J Am Diet Assoc. 2002 Feb;102(2):2 — View Citation

Vieira SM, Pagovich OE, Kriegel MA. Diet, microbiota and autoimmune diseases. Lupus. 2014 May;23(6):518-26. doi: 10.1177/0961203313501401. — View Citation

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. — View Citation

Xu 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. — View Citation

* Note: There are 19 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 year
Primary	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.	1 year
Primary	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.	1 year
Secondary	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.	10 years
Secondary	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.	10 years
Secondary	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.	10 years