Inflammatory Marker in Ibd and Peripheral Arthritis | NCT05705232

Studies
Inflammatory Marker in Ibd and Peripheral Arthritis

NCT05705232

Sponsor

Assiut University

Status

Unknown status

Last Update Posted

Feb 24, 2023Actual

Enrollment

150Estimated

Phase

Not provided

Conditions

IBD-Inflammatory Bowel Disease

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 1, 2023Estimated

Primary Completion Date

Jul 1, 2024Estimated

Completion Date

Dec 1, 2024Estimated

First Submitted Date

Jan 20, 2023

First Submission Date that Met QC Criteria

Jan 20, 2023

First Posted Date

Jan 30, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 22, 2023

Last Update Posted Date

Feb 24, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The Objective Of This Study Is To Estimate The Correlation Between Disease Activity In IBD, Inflammatory Markers And Peripheral Arthritis After Exclusion Of Other Causes Arthritis

Detailed Description

Inflammatory Bowel Diseases (IBD) Are Chronic Relapsing Inflammatory Disorder Of The Gastrointestinal Tract (GIT) , Which Represented Mainly By Ulcerative Colitis (UC) And Crohn's Disease .

IBD Is To Be Considered Systemic Disease Since They Are Often Associated With Extra intestinal Manifestation, Especially During Activity, Which Reflect A Pathogenic Mechanism As Arthritis ,Erythema Nodosum ,Pyoderma Gangrenosum , Apthous Ulceration ,Iritis And Uveitis.

Peripheral Arthritis (Pa) Is Observed Rather Than Frequently, The Arthritis Involves Predominantly The Joint Of The Lower Limb ,And In Most Cases It Accompanies The Activity Of The Intestinal Disease Pauciarticular, Asymmetric, Migratory And Non Deforming.

Predicting Relapse By Measuring Non Invasive Biomarkers Could Allow Early Treatment Adaptation .Several Studies Have Shown A Correlation Between Intestinal Inflammation And Serum C-Reactive Protein Or Fecal Calprotectin Levels .

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

150Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Correlation between IBD Patients Presented With Peripheral Arthritis and degree of Disease activity	Estimate The Correlation Between Disease Activity In IBD, Inflammatory Markers And Peripheral Arthritis After Exclusion Of Other Causes Arthritis	1/2/2023to 1/12/2024

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

1-Pt Above 18 Yrs. 2- IBD Pt. Confirmed By Colonoscopy 3- IBD Patient with Arthritis During Activity

Exclusion Criteria:

1-Age Below 18 Yrs. Old 2-Arthritis Of Other Causes Than IBD PT

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

80 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Patient With inclusion criteria attending Internal Medicine Department clinics ,Assiut University Hospital

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Mostafa Mansor	Contact	01009966187		mma13plus@gmail.com
Nabila Fayek	Contact	01226341796		ameenabila3@gamil.com

Overall Officials

Name	Affiliation	Role
Eman Mohamed	Assiut University	Study Director
Mostafa Mansor	Assiut University	Principal Investigator
Nabila Fayek

Locations

Not provided

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
11709609	Background	Palm O, Moum B, Jahnsen J, Gran JT. The prevalence and incidence of peripheral arthritis in patients with inflammatory bowel disease, a prospective population-based study (the IBSEN study). Rheumatology (Oxford). 2001 Nov;40(11):1256-61. doi: 10.1093/rheumatology/40.11.1256.

ID	Term
D005759	Gastroenteritis
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases
D007410	Intestinal Diseases