Study of Some Risk Factors for Developing RA

Rheumatoid Arthritis Clinical Trial

Official title:

Study of Some Risk Factors for Developing Rheumatoid Arthritis

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03624179
• Other study ID #: AssiutU9
• Status: Not yet recruiting
• Start date: August 15, 2018
• Est. completion date: September 20, 2018

Study information

• Verified date: August 2018
• Source: Assiut University
• Contact: Ebtsam M Abd El Hakeem, MIS
• Phone: 01065889869
• Email: smilemostafa[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Introduction Rheumatoid arthritis (RA), a chronic autoimmune disease of unknown etiology, .If not managed early , RA can result in irreversible, painful, and disabling joint damage. RA is often diagnosed using predefined criteria that necessitate clinical, laboratory, and radiologic examinations.

The prevalence of RA among adults is approximately 1-2% affecting women two to four times more often than men.Although RA risk increases with age, it can manifest at any stage of life, including childhood, adolescence, and adulthood.(1-4)( Karlson EW, Mandl LA, Hankinson SE, Grodstein F, Karlson EW, Mandl LA, Hankinson SE, Grodstein F., Karlson EW, Mandl LA, Hankinson SE, Grodstein F, Karlson EW, Mandl LA, Hankinson SE, Grodstein F) To date, a limited number of RA risk or protective factors have been identified, with genetic predisposition to autoimmune response (eg, HLA-DR4 gene) and repeated environmental exposures (eg, tobacco smoke) playing a major role.(3)(Karlson EW, Mandl LA, Hankinson SE, Grodstein F) Heritability of RA is well-established because the lifetime risk of RA and related autoimmune diseases (namely, systemic lupus erythematosus, ankylosing spondylitis, scleroderma, Sjo¨gren's syndrome, and hypothyroidism) increases 1.5 to 3 times in children of women diagnosed with RA.

Description:

Patients will answer the following the questationnaire:

Name age gender

1 Socio echonomic status (average salary \year) (Education) (Job) (residence)

1. Body mass index (height\wt2)

2. Disease duration in months.

3. Smoking (yes) (No) Passive smoker Ex smoker

4. Reproductive history:

• age of menarche….

• menstrual cycle….. regular or not……. P / C

• How many pregnancies…….. living.

• Abortion.

• patient age at first birth (….).

• breast feeding…..(yes)…….(no)

• use of contraceptives (yes)…pills injections IUD (N0)……

• Does patient get pregnant during disease?...(Yes)……(no)….. Does the arthritis improved (…)or got worse (…..) -flared during the purpurium.(yes) … (No)

• age of menupause…. 10 Exposure to sun….(yes)…..(No) 11 -Theraputic history… (Newly diagnosed)

• (Previously diagnosed),

• Does the patient receiving ttt? (yes) (Steroid)……. (NSAIDS)……. (2nd line drugs) (.Methotrexat(.…), Leflonamide (….) Hydroquine(….) (NO)……..

• The study will include 100 patients fullfilling ACR 2010

• Patients well subjected to

• Through clinical examination with emphysis on joints examination

• venous blood sampling will withdrawn and the following investigations will be done.

• Serum VIT D level

• Serum calcium and phosphorus

• Anti cyclic citrullinated peptide.

• ESR

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: September 20, 2018
• Est. primary completion date: September 15, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• patients with rheumatoid arthritis diagnosed based on american collegue of rheumatology 2010 criteria with no history of vit D therapy

Exclusion Criteria:

• patients with rheumatoid arthritis on vit D supplements

• patient refusal

• patient not fullfill american collegue of rheumatology 2010 citeria for diagnosis pf rheumatoid arthritis

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (12)

Almodóvar PI. Dermatology diagnosis. Tuberculoid leprosy. Bol Asoc Med P R. 1986 Dec;78(12):514-5. — View Citation

Clowse ME, Chakravarty E, Costenbader KH, Chambers C, Michaud K. Effects of infertility, pregnancy loss, and patient concerns on family size of women with rheumatoid arthritis and systemic lupus erythematosus. Arthritis Care Res (Hoboken). 2012 May;64(5): — View Citation

Cooper GS, Bynum ML, Somers EC. Recent insights in the epidemiology of autoimmune diseases: improved prevalence estimates and understanding of clustering of diseases. J Autoimmun. 2009 Nov-Dec;33(3-4):197-207. doi: 10.1016/j.jaut.2009.09.008. Epub 2009 Oc — View Citation

Ginns LC, Ryu JH, Rogol PR, Sprince NL, Oliver LC, Larsson CJ. Natural killer cell activity in cigarette smokers and asbestos workers. Am Rev Respir Dis. 1985 Jun;131(6):831-4. — View Citation

Hodges GR, Loker EF Jr. Letter: Fatal pneumonia cause: avirulent wild-type ADV-7 or vaccine strain ADV-7. Chest. 1975 Jun;67(6):740. — View Citation

Jankosky C, Deussing E, Gibson RL, Haverkos HW. Viruses and vitamin D in the etiology of type 1 diabetes mellitus and multiple sclerosis. Virus Res. 2012 Feb;163(2):424-30. doi: 10.1016/j.virusres.2011.11.010. Epub 2011 Nov 20. Review. — View Citation

Karlson EW, Mandl LA, Hankinson SE, Grodstein F. Do breast-feeding and other reproductive factors influence future risk of rheumatoid arthritis? Results from the Nurses' Health Study. Arthritis Rheum. 2004 Nov;50(11):3458-67. — View Citation

Kawakami M, Watanabe N, Ogawa H, Kato A, Sando H, Yamada N, Murase T, Takaku F, Shibata S, Oda T. Cachectin/TNF kills or inhibits the differentiation of 3T3-L1 cells according to developmental stage. J Cell Physiol. 1989 Jan;138(1):1-7. — View Citation

Mendes EN, Queiroz DM, Rocha GA, Nogueira AM, Carvalho AC, Lage AP, Barbosa AJ. Histopathological study of porcine gastric mucosa with and without a spiral bacterium ("Gastrospirillum suis"). J Med Microbiol. 1991 Dec;35(6):345-8. — View Citation

Merlino LA, Cerhan JR, Criswell LA, Mikuls TR, Saag KG. Estrogen and other female reproductive risk factors are not strongly associated with the development of rheumatoid arthritis in elderly women. Semin Arthritis Rheum. 2003 Oct;33(2):72-82. — View Citation

Padyukov L, Silva C, Stolt P, Alfredsson L, Klareskog L. A gene-environment interaction between smoking and shared epitope genes in HLA-DR provides a high risk of seropositive rheumatoid arthritis. Arthritis Rheum. 2004 Oct;50(10):3085-92. — View Citation

Reckner Olsson A, Skogh T, Wingren G. Comorbidity and lifestyle, reproductive factors, and environmental exposures associated with rheumatoid arthritis. Ann Rheum Dis. 2001 Oct;60(10):934-9. Erratum in: Ann Rheum Dis 2001 Dec;60(12):1161. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	vitamin D level	blood sample using ELISA kits	one month
Primary	Body mass index	weight in kg/m^2	one month
Secondary	Anti cyclic citrullnated peptide antibodies	blood sample using ELISA	one month
Secondary	Rheumatoid factor antibody	blood sample	one month