NCT05771363

Brief Summary

To examine the prevelance of autoimmune disorders and rheumatic manifestations in egyptian patients with inflammatory bowel diseases,and asses the relation between prevelance of autoimmune disorders ,rheumatic manifestations and disease activity of IBD

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
51

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2023

Status
unknown

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

First Submitted

Initial submission to the registry

March 5, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 16, 2023

Completed
16 days until next milestone

Study Start

First participant enrolled

April 1, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2024

Completed
Last Updated

March 16, 2023

Status Verified

March 1, 2023

Enrollment Period

1 year

First QC Date

March 5, 2023

Last Update Submit

March 5, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • frequency and risk factors for autoimmune disorders and rheumatic manifestations in Egyptian patients with inflammatory bowel diseases.

    to examine the prevelance of autoimmune disorders and rheumatological manifestations in Egyptian patients with inflammatory bowel diseases

    1year

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Cross-sectional studies are observational studies that analyze data from a population at a single point in time. They are often used to measure the prevalence of health outcomes, understand determinants of health, and describe features of a population. Unlike other types of observational studies, cross-sectional studies do not follow individuals up over time. They are usually inexpensive and easy to conduct. They are useful for establishing preliminary evidence in planning a future advanced study. This article reviews the essential characteristics, describes strengths and weaknesses, discusses methodological issues, and gives our recommendations on design and statistical analysis for cross-sectional studies in pulmonary and critical care medicine. A list of considerations for reviewers is also provided.

You may qualify if:

  • adult patients with adiagnosis of IBD according to the validated criteria. 2-patients\>18 years without aprevious diagnosis of SPA or other rheumatological manifestations.

You may not qualify if:

  • patients with active cancer or lymphoproliferative disease. 2-patients with uncontrolled diabetes. 3-patients with unstable ischeamic heart disease or congestive heart failure. 4-patients with acute renal failure. 5-patients already diagnosed with inflammatory or crystal induced arthropathies (including gout and calcium pyrophosphate dehydrate deposition disease) or other autoimmune diseases.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Lanna CC, Ferrari Mde L, Rocha SL, Nascimento E, de Carvalho MA, da Cunha AS. A cross-sectional study of 130 Brazilian patients with Crohn's disease and ulcerative colitis: analysis of articular and ophthalmologic manifestations. Clin Rheumatol. 2008 Apr;27(4):503-9. doi: 10.1007/s10067-007-0797-5. Epub 2007 Dec 21.

    PMID: 18097711BACKGROUND

Central Study Contacts

amaal fathi, master

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
physician

Study Record Dates

First Submitted

March 5, 2023

First Posted

March 16, 2023

Study Start

April 1, 2023

Primary Completion

April 1, 2024

Study Completion

June 1, 2024

Last Updated

March 16, 2023

Record last verified: 2023-03