IBD-Inflammatory Bowel DiseaseNCT05705232
Inflammatory Marker in Ibd and Peripheral Arthritis
An observational study of IBD-Inflammatory Bowel Disease, run by Assiut University.
Trial 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 Read more about this study
- Who is it for?
- Ages 16 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- IBD-Inflammatory Bowel Disease
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2023to 1 Dec 2024
- 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 16 to 80 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Patient With inclusion criteria attending Internal Medicine Department clinics ,Assiut University Hospital
Who may be able to join
- 1-Pt Above 18 Yrs. 2- IBD Pt. Confirmed By Colonoscopy 3- IBD Patient with Arthritis During Activity
Who cannot join
- 1-Age Below 18 Yrs. Old 2-Arthritis Of Other Causes Than IBD PT
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Correlation Between Disease Activity of Inflammatory Bowel Disease, Inflammatory Markers and Peripheral Arthritis .
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
Read the 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 .
- Conditions
- IBD-Inflammatory Bowel Disease
- Medical subject headings
- Inflammatory Bowel Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1/2/2023to 1/12/2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2023
- Study start1 Jul 2023 (estimated)
- Primary completion1 Jul 2024 (estimated)
- Study completion1 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for IBD-Inflammatory Bowel DiseaseStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mostafa Mansour Ali, Assiut University
- Investigators
- Eman Mohamed, Study director, Assiut UniversityMostafa Mansor, Principal investigator, Assiut UniversityNabila Fayek, Study chair, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05705232
- Sponsor's protocol ID
- IBD and peripheral arthritis
- Status last verified
- Feb 2023
- First submitted
- 20 Jan 2023
- Last updated
- 24 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 11709609
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between Disease Activity of Inflammatory Bowel Disease, Inflammatory Markers and Peripheral Arthritis .
- ClinicalTrials.gov ID
- NCT05705232
- Acronym / sponsor ID
- IBD and peripheral arthritis
- Conditions
- IBD-Inflammatory Bowel Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jul 2023 (estimated)
- Primary completion
- 1 Jul 2024 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 30 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 .
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 16 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patient With inclusion criteria attending Internal Medicine Department clinics ,Assiut University Hospital
Key inclusion criteria (1 listed)
- 1-Pt Above 18 Yrs. 2- IBD Pt. Confirmed By Colonoscopy 3- IBD Patient with Arthritis During Activity
Key exclusion criteria (1 listed)
- 1-Age Below 18 Yrs. Old 2-Arthritis Of Other Causes Than IBD PT
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Correlation between IBD Patients Presented With Peripheral Arthritis and degree of Disease activity
Time frame: 1/2/2023to 1/12/2024
Estimate The Correlation Between Disease Activity In IBD, Inflammatory Markers And Peripheral Arthritis After Exclusion Of Other Causes Arthritis
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2023.
- Background: PubMed 11709609Palm 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eman Mohamed study director
Assiut University
Mostafa Mansor principal investigator
Assiut University
Nabila Fayek study chair
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of IBD-Inflammatory Bowel Disease, 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 1 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 24 Feb 2023. 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 Mostafa Mansor (01009966187, mma13plus@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between IBD Patients Presented With Peripheral Arthritis and degree of Disease activity (time frame: 1/2/2023to 1/12/2024). 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 NCT05705232, which also lists 1 linked publication.
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 24 Feb 2023.