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Rheumatoid ArthritisNCT03624179

Study of Some Risk Factors for Developing RA

An observational study of Rheumatoid Arthritis, run by Assiut University.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Any ageHealthy volunteers can take part
Conditions the study is for
Rheumatoid Arthritis
How many people
60 participants
Where
No sites listed yet
Study dates
15 Aug 2018to 20 Sep 2018
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Study population: patients with rheumatoid arthritis

Who may be able to join

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

Who cannot join

  • patients with rheumatoid arthritis on vit D supplements
  • patient refusal
  • patient not fullfill american collegue of rheumatology 2010 citeria for diagnosis pf rheumatoid arthritis

Trial locations and contacts

No sites are listed yet.

Ebtsam M Abd El Hakeem, MIS contact

01065889869

smilemostafa@gmail.com

EL Badry I Abo Elnour, MD contact

01091131611

aboelnour@aun.edu.eg

About this study

Official title: Study of Some Risk Factors for Developing Rheumatoid Arthritis

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.

Read the detailed 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
Medical subject headings
Arthritis, Rheumatoid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT03624179
Study groupRoleWhat they receive
Rheumatoid arthritis patientscomplete blood count, Erythrocyte sedimentation rate, C reactive protien ,rheumatoid factor,Anti cyclic citrullinated peptide antibody
healthy controlcomplete blood count, Erythrocyte sedimentation rate, C reactive protien ,rheumatoid factor,Anti cyclic citrullinated peptide antibody

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. vitamin D level

    blood sample using ELISA kits

    Measured: one month

  2. Body mass index

    weight in kg/m^2

    Measured: one month

Secondary outcomes (2)

  1. Anti cyclic citrullnated peptide antibodies

    blood sample using ELISA

    Measured: one month

  2. Rheumatoid factor antibody

    blood sample

    Measured: one month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Aug 2018
  2. Study start15 Aug 2018 (estimated)
  3. Primary completion15 Sep 2018 (estimated)
  4. Study completion20 Sep 2018 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03624179
Sponsor's protocol ID
AssiutU9
Status last verified
Aug 2018
First submitted
11 Jul 2018
Last updated
10 Aug 2018
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Almodovar PI. Dermatology diagnosis. Tuberculoid leprosy. Bol Asoc Med P R. 1986 Dec;78(12):514-5. No abstract available.

    PubMed 3468952

  • 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.

    PubMed 22119899

  • 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. doi: 10.1164/arrd.1985.131.6.831.

    PubMed 4003932

  • 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. No abstract available.

    PubMed 165046

  • 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. doi: 10.1099/00222615-35-6-345.

    PubMed 1753392

  • 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. doi: 10.1002/art.20621.

    PubMed 15529351

  • 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. doi: 10.1002/jcp.1041380102.

    PubMed 2783422

  • 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. doi: 10.1016/s0049-0172(03)00084-2.

    PubMed 14625816

  • 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 Oct 9.

    PubMed 19819109

  • 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):668-74. doi: 10.1002/acr.21593.

    PubMed 22344961

  • 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. doi: 10.1002/art.20553.

    PubMed 15476204

  • 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. doi: 10.1136/ard.60.10.934.

    PubMed 11557649

Questions about this trial

What is this clinical trial studying?

An observational study of Rheumatoid Arthritis, run by Assiut University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 10 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Ebtsam M Abd El Hakeem, MIS (01065889869, smilemostafa@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

vitamin D level (time frame: one month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03624179, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2018.

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Study of Some Risk Factors for Developing RA | AzTrials