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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04315818
Other study ID # MIF
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date March 2021
Est. completion date September 2023

Study information

Verified date March 2020
Source Assiut University
Contact Eman Ahmed, professor
Phone 01066643425
Email e_omran@hotmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Rheumatoid Arthritis is a chronic debilitating inflammatory autoimmune disease of unknown etiology .


Description:

Although the pathogenesis of Rheumatoid Arthritis is multifactorial, the contribution of cytokines is undoubtedly pivotal in the progression of the inflammatory process. One cytokine gaining recognition for its importance in the inflammatory process is Macrophage migration inhibitory factor . Macrophage Migration Inhibitory Factor is a multipotent cytokine involved in a broad range of functions including induction of proinflammatory mediators as well as demonstrated roles in both innate and adaptive immunity. It was originally identified in the culture medium of activated T lymphocytes as a soluble factor that inhibit random migration of macrophages . Macrophage Migration Inhibitory Factor induces synoviocytes expression of key proinflammatory genes including TNF, IL-1, IL-6, IL-8. Moreover, it also regulates the function of endothelial cells and B cells and is implicated in the control of synoviocytes proliferation and apoptosis via direct effects on the expression of the tumor suppressor protein P53. In Rheumatoid Arthritis, increased Macrophage Migration Inhibitory Factor levels have been demonstrated in serum, synovial fluid and tissue correlating with disease activity. Hydroxyapatite 25 vitamin D3 is a hormone primarily synthesized in human skin under the stimulation of ultraviolet radiation. Beyond its endocrine role in bone metabolism, Vitamin D3 is endowed with remarkable immunomodulatory properties. The effects of Vitamin D3 on the immune system include the enhancement of microbicidal ability of monocytes macrophages and the down-modulation of inflammatory cytokines produced by T lymphocytes. Some epidemiological studies have reported an inverse association between serum 25(OH)vitamin D3 concentrations and Rheumatoid Arthritis disease activity and severity. In addition, some studies have reported inverse correlations between serum 25(OH)vitamin D3 and circulating inflammatory markers and cytokines.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 70
Est. completion date September 2023
Est. primary completion date September 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Any patient aged 18 or older - satisfying 2010 ACR/ EULAR Rheumatoid Arthritis classification criteria will be included . Exclusion Criteria: - Any patient with arthritis other than Rheumatoid Arthritis - Individuals with other autoimmune diseases

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

References & Publications (5)

Bilsborrow JB, Doherty E, Tilstam PV, Bucala R. Macrophage migration inhibitory factor (MIF) as a therapeutic target for rheumatoid arthritis and systemic lupus erythematosus. Expert Opin Ther Targets. 2019 Sep;23(9):733-744. doi: 10.1080/14728222.2019.1656718. Epub 2019 Aug 20. Review. — View Citation

Ishikawa LLW, Colavite PM, Fraga-Silva TFC, Mimura LAN, França TGD, Zorzella-Pezavento SFG, Chiuso-Minicucci F, Marcolino LD, Penitenti M, Ikoma MRV, Sartori A. Vitamin D Deficiency and Rheumatoid Arthritis. Clin Rev Allergy Immunol. 2017 Jun;52(3):373-388. doi: 10.1007/s12016-016-8577-0. Review. — View Citation

Kim KW, Kim HR. Macrophage migration inhibitory factor: a potential therapeutic target for rheumatoid arthritis. Korean J Intern Med. 2016 Jul;31(4):634-42. doi: 10.3904/kjim.2016.098. Epub 2016 May 12. Review. — View Citation

Llamas-Covarrubias MA, Valle Y, Navarro-Hernández RE, Guzmán-Guzmán IP, Ramírez-Dueñas MG, Rangel-Villalobos H, Estrada-Chávez C, Muñoz-Valle JF. Serum levels of macrophage migration inhibitory factor are associated with rheumatoid arthritis course. Rheumatol Int. 2012 Aug;32(8):2307-11. doi: 10.1007/s00296-011-1951-6. Epub 2011 May 24. — View Citation

Santos LL, Morand EF. The role of macrophage migration inhibitory factor in the inflammatory immune response and rheumatoid arthritis. Wien Med Wochenschr. 2006 Jan;156(1-2):11-8. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary The Relation Between Macrophage Migration Inhibitory Factor (MIF) and 25(OH) Vitamin D3 Serum Levels in Rheumatoid Arthritis evaluate the role of Macrophage Migration Inhibitory Factor serum levels in Rheumatoid Arthritis and its relation with disease activity.
evaluate the role of 25(OH)vitamin D3 serum levels in Rheumatoid Arthritis patients and its relation to disease severity.
detect the relationship between Macrophage Migration Inhibitory Factor and 25(OH)vitamin D3 serum levels in Rheumatoid Arthritis patients
october,2022
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