NCT05627089

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

Trial Health

45
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
105mo left

Started Jul 2023

Longer than P75 for all trials

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress25%
Jul 2023Jan 2035

First Submitted

Initial submission to the registry

November 9, 2022

Completed
16 days until next milestone

First Posted

Study publicly available on registry

November 25, 2022

Completed
7 months until next milestone

Study Start

First participant enrolled

July 1, 2023

Completed
9.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2033

Expected
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2035

Last Updated

January 30, 2024

Status Verified

January 1, 2024

Enrollment Period

9.5 years

First QC Date

November 9, 2022

Last Update Submit

January 29, 2024

Conditions

Rheumatoid ArthritisMyositis

Keywords

Intestinal MicrobiomeImmune cellsCytokinesRheumatoid ArthritisMyositisAutoimmune diseaseImmunosuppressive medicationDietDisease Activity

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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 Outcomes (3)

  • Change in IL-1, IL-6, CXCL10 and Immune Cell Population due to Immunosuppressive Medication

    10 years

  • Change in IL-1, IL-6, CXCL10 and Immune Cell Population due to changes in the intestinal microbiome

    10 years

  • Change in IL-1, IL-6, CXCL10 and Immune Cell Population due to Intestinal Inflammation

    10 years

Study Arms (1)

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • Subject is less than 18 years old

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (19)

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

    BACKGROUND

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

    BACKGROUND

  • 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.

    PMID: 26212387BACKGROUND

  • 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.

    PMID: 34170211BACKGROUND

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

    PMID: 29920643BACKGROUND

  • 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.

    PMID: 28388917BACKGROUND

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

    PMID: 24763536BACKGROUND

  • 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.

    PMID: 22473918BACKGROUND

  • 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.

    PMID: 19962619RESULT

  • 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.

    PMID: 29651119RESULT

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

    RESULT

  • 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(2):314-24. doi: 10.1093/pm/pnv046.

    PMID: 26814279RESULT

  • 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.ijo.0802976.

    PMID: 15917857RESULT

  • 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. Scand J Rheumatol. 2014;43(4):273-8. doi: 10.3109/03009742.2013.852239. Epub 2014 Feb 7.

    PMID: 24797672RESULT

  • 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/s1807-59322011000700016.

    PMID: 21876977RESULT

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

    RESULT

  • 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):212-25. doi: 10.1016/s0002-8223(02)90050-7.

    PMID: 11846115RESULT

  • 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. 2001 Dec 15;154(12):1089-99. doi: 10.1093/aje/154.12.1089.

    PMID: 11744511RESULT

  • 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 OPEN study. Am J Epidemiol. 2003 Jul 1;158(1):1-13. doi: 10.1093/aje/kwg092.

    PMID: 12835280RESULT

Biospecimen

Retention: SAMPLES WITH DNA

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

MeSH Terms

Conditions

Arthritis, RheumatoidMyositisAutoimmune Diseases

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesImmune System DiseasesMuscular DiseasesNeuromuscular DiseasesNervous System Diseases
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 9, 2022

First Posted

November 25, 2022

Study Start

July 1, 2023

Primary Completion (Estimated)

January 1, 2033

Study Completion (Estimated)

January 1, 2035

Last Updated

January 30, 2024

Record last verified: 2024-01