IBDNCT05693311
Inflammatory Bowel Disease Related Joint Manifestations
An observational study of IBD and Joint Diseases, run by Youstina Yosry Soliman.
Trial summary
The main purpose of this research is to identify incidence of jiunt manifestations by its both types axial and periphral in IBD patients, its types , relation to IBD activity, lines of treatment using and how they are effective in prevention and in treatment of these joint manifestations. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- IBD, Joint Diseases
- How many people
- 217 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2023to 1 Mar 2025
- 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 18 to 90 years
- All sexes
- Adult, Older adult
Study population: patients with inflammatory bowel disease attending IBD clinic in EL-RAGHY LIVERHOSPITAL.
Who may be able to join
- Patients previously diagnosed by colonoscopy and biopsy of IBD either crhons disease or ulcerative colitis from2017 to 2022 attending IBD clinic in EL-RAGHY LIVERHOSPITAL.
Who cannot join
- Patients with a known diagnosis of any other joint disease like:
- autoimmune disease like SLE , RA , psoriasis
- Osteoarthritis
- Gouty arthritis
- Malignancy
- Polymyalgia rheumatica
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Inflammatory Bowel Disease Related Joint Manifestations Including the Incidence, Types, Relation to Disease Activity and Types of Treatment
The main purpose of this research is to identify incidence of jiunt manifestations by its both types axial and periphral in IBD patients, its types , relation to IBD activity, lines of treatment using and how they are effective in prevention and in treatment of these joint manifestations.
Read the detailed description
Inflammatory bowel disease (IBD) is a chronic immune-mediated disorder divided into two large types Crohn disease and ulcerative colitis. Crohn disease may affect any part of the gastrointestinal tract (GIT), whereas Ulcerative colitis affects the large intestine . IBD is also described to cause remissions and relapses or activity. IBD is a multisystem condition that affects mainly the gastrointestinal, musculoskeletal, ocular, and cutaneous systems. Those complications that arise outside the intestinal inflammation are known as extra intestinal manifestations (EIMs) of IBD, EIMs present in 5% to 50% of all IBD patients these may be :skin, eyes, kidneys, liver, anaemia.
In a focused point musculoskeletal manifestations being the most common EIM with a incidence about 40%. It was divided into:
- Axial type (spondyloarthropathy) B. Peripheral type divided into : 1.Type 1 (pauciarticular). 2.Type 2 (polyarticular) In this research we shall focus on the confirmed data for diagnosis of IBD by history , lab investigations \& colonoscopy and biopsy including disease location . Then onset of joint manifestations in relation to both intestinal \& other extra intestinal manifestations . The effect of disease activity on routine lab investigations including CBC, kidney function , liver function , ESR, CRP \& on imaging like x-ray .
Also the effect of disease activity on joint manifestations is an important point to be discussed .
For this purpose, a validated detailed questionnaire according to farisoğullari 2021 consisting of six questions was asked (1). Have you ever had swelling or pain in fingers , toes or any other joint with no apparent reason? (2).Has an entire finger or toe becomes swollen, making it look like a 'sausage' ? (3). Have you had pain in your heels? (4). Have you ever had back pain lasting at least 3 months that was not injury related? (5). Do you have low back pain in the morning after resting that improves with exercise? (6). Do you wake up at night because of low back pain?.
The response of joint manifestations to different routes of treatment of IBD is also of great importance , A good response of back pain to a full dose of non-steroidal anti-inflammatory drugs was defined as "not anymore present "or "much better". Immunomodulators have been efficacious in patients with peripheral arthritis and other extra-intestinal manifestations, but they are not effective for the treatment of axial symptoms of spondylitis.
The treatment of peripheral involvement and/or enthesitis and/or dactylitis is based on local steroid injections, while sulfasalazine and/or low doses of systemic steroids may be useful in case of inadequate response to intra-articular steroids. Sulfasalazine induces only a little improvement in peripheral arthritis. Immunomodulators such as methotrexate, azathioprine, cyclosporine and leflunomide were also effective.
- Conditions
- IBD, Joint Diseases
- Keywords
- IBD, periphral and axial spondylopathy
- Medical subject headings
- Joint Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
The joint manifestations in Inflammatory bowel disease patients.
The main purpose of this research is to identify incidence of joint manifestations by its both types axial and peripheral in crohns disease and ulcerative colitis patients, relation to the disease activity,other extra intestinal manifestations, lines of treatment used and how they are effective in prevention and in treatment of these joint manifestations.
Measured: 2017 to 2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2023
- Study start1 Mar 2023 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion1 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for IBDStudies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 217 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Youstina Yosry Soliman
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Youstina Yosry Soliman, Assiut University
- Investigators
- Mohamed Ali, ass.prof doc, Study director, assiut univeristy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05693311
- Sponsor's protocol ID
- Joint manifestations in IBD
- Status last verified
- Jan 2023
- First submitted
- 24 Dec 2022
- Last updated
- 20 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Voulgari PV. Rheumatological manifestations in inflammatory bowel disease. Ann Gastroenterol. 2011;24(3):173-180.
PubMed 24713717Fragoulis GE, Liava C, Daoussis D, Akriviadis E, Garyfallos A, Dimitroulas T. Inflammatory bowel diseases and spondyloarthropathies: From pathogenesis to treatment. World J Gastroenterol. 2019 May 14;25(18):2162-2176. doi: 10.3748/wjg.v25.i18.2162.
PubMed 31143068Di Carlo M, Luchetti MM, Benfaremo D, Di Donato E, Mosca P, Maltoni S, Benedetti A, Gabrielli A, Grassi W, Salaffi F. The DETection of Arthritis in Inflammatory boweL diseases (DETAIL) questionnaire: development and preliminary testing of a new tool to screen patients with inflammatory bowel disease for the presence of spondyloarthritis. Clin Rheumatol. 2018 Apr;37(4):1037-1044. doi: 10.1007/s10067-017-3937-6. Epub 2017 Dec 4.
PubMed 29204760
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inflammatory Bowel Disease Related Joint Manifestations Including the Incidence, Types, Relation to Disease Activity and Types of Treatment
- ClinicalTrials.gov ID
- NCT05693311
- Acronym / sponsor ID
- Joint manifestations in IBD
- Conditions
- IBD, Joint Diseases
- Keywords
- IBD, periphral and axial spondylopathy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 217 participants (estimated)
- Lead sponsor
- Youstina Yosry SolimanUniversity, hospital or other
- Study start
- 1 Mar 2023 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 1 Mar 2025 (estimated)
- First posted
- 20 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 main purpose of this research is to identify incidence of jiunt manifestations by its both types axial and periphral in IBD patients, its types , relation to IBD activity, lines of treatment using and how they are effective in prevention and in treatment of these joint manifestations.
Detailed description
Inflammatory bowel disease (IBD) is a chronic immune-mediated disorder divided into two large types Crohn disease and ulcerative colitis. Crohn disease may affect any part of the gastrointestinal tract (GIT), whereas Ulcerative colitis affects the large intestine . IBD is also described to cause remissions and relapses or activity. IBD is a multisystem condition that affects mainly the gastrointestinal, musculoskeletal, ocular, and cutaneous systems. Those complications that arise outside the intestinal inflammation are known as extra intestinal manifestations (EIMs) of IBD, EIMs present in 5% to 50% of all IBD patients these may be :skin, eyes, kidneys, liver, anaemia.
In a focused point musculoskeletal manifestations being the most common EIM with a incidence about 40%. It was divided into:
- Axial type (spondyloarthropathy) B. Peripheral type divided into : 1.Type 1 (pauciarticular). 2.Type 2 (polyarticular) In this research we shall focus on the confirmed data for diagnosis of IBD by history , lab investigations \& colonoscopy and biopsy including disease location . Then onset of joint manifestations in relation to both intestinal \& other extra intestinal manifestations . The effect of disease activity on routine lab investigations including CBC, kidney function , liver function , ESR, CRP \& on imaging like x-ray .
Also the effect of disease activity on joint manifestations is an important point to be discussed .
For this purpose, a validated detailed questionnaire according to farisoğullari 2021 consisting of six questions was asked (1). Have you ever had swelling or pain in fingers , toes or any other joint with no apparent reason? (2).Has an entire finger or toe becomes swollen, making it look like a 'sausage' ? (3). Have you had pain in your heels? (4). Have you ever had back pain lasting at least 3 months that was not injury related? (5). Do you have low back pain in the morning after resting that improves with exercise? (6). Do you wake up at night because of low back pain?.
The response of joint manifestations to different routes of treatment of IBD is also of great importance , A good response of back pain to a full dose of non-steroidal anti-inflammatory drugs was defined as "not anymore present "or "much better". Immunomodulators have been efficacious in patients with peripheral arthritis and other extra-intestinal manifestations, but they are not effective for the treatment of axial symptoms of spondylitis.
The treatment of peripheral involvement and/or enthesitis and/or dactylitis is based on local steroid injections, while sulfasalazine and/or low doses of systemic steroids may be useful in case of inadequate response to intra-articular steroids. Sulfasalazine induces only a little improvement in peripheral arthritis. Immunomodulators such as methotrexate, azathioprine, cyclosporine and leflunomide were also effective.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- patients with inflammatory bowel disease attending IBD clinic in EL-RAGHY LIVERHOSPITAL.
Key inclusion criteria (1 listed)
- Patients previously diagnosed by colonoscopy and biopsy of IBD either crhons disease or ulcerative colitis from2017 to 2022 attending IBD clinic in EL-RAGHY LIVERHOSPITAL.
Key exclusion criteria (6 listed)
- Patients with a known diagnosis of any other joint disease like:
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
The joint manifestations in Inflammatory bowel disease patients.
Time frame: 2017 to 2024
The main purpose of this research is to identify incidence of joint manifestations by its both types axial and peripheral in crohns disease and ulcerative colitis patients, relation to the disease activity,other extra intestinal manifestations, lines of treatment used and how they are effective in prevention and in treatment of these joint manifestations.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2023.
- Background: PubMed 24713717Voulgari PV. Rheumatological manifestations in inflammatory bowel disease. Ann Gastroenterol. 2011;24(3):173-180.
- Background: PubMed 31143068Fragoulis GE, Liava C, Daoussis D, Akriviadis E, Garyfallos A, Dimitroulas T. Inflammatory bowel diseases and spondyloarthropathies: From pathogenesis to treatment. World J Gastroenterol. 2019 May 14;25(18):2162-2176. doi: 10.3748/wjg.v25.i18.2162.
- Background: PubMed 29204760Di Carlo M, Luchetti MM, Benfaremo D, Di Donato E, Mosca P, Maltoni S, Benedetti A, Gabrielli A, Grassi W, Salaffi F. The DETection of Arthritis in Inflammatory boweL diseases (DETAIL) questionnaire: development and preliminary testing of a new tool to screen patients with inflammatory bowel disease for the presence of spondyloarthritis. Clin Rheumatol. 2018 Apr;37(4):1037-1044. doi: 10.1007/s10067-017-3937-6. Epub 2017 Dec 4.
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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.
Mohamed Ali, ass.prof doc study director
assiut univeristy
Questions about this trial
What is this clinical trial studying?
An observational study of IBD and Joint Diseases, run by Youstina Yosry Soliman.
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 6 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 20 Jan 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 Youstina soliman, doctor (01286515639, youstinayosry.55@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The joint manifestations in Inflammatory bowel disease patients. (time frame: 2017 to 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 NCT05693311, which also lists 3 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 20 Jan 2023.