Clinical trial NCT06601595: Prevelance of Axial Spondylosis Arthritis in Inflammatory Bowel Disease and Its RESPONSE to Tumour Necrosis Factor (TNF) Inhibitors Treatment in Assiut University Hospital
Official title: Spondyloarthropathy in Inflammatory Bowel Disease Patients and Evaluation of Its Response to TNF Inhibitors in Assiut University Hospital
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Inflammatory Bowel Disease (IBD)
Spondylarthropathies
TNF-alpha Inhibitors
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: IBD patients (ulcerative colitis , Crohs disease ) in gastroenterology department ,ASSUIT UNIVERSITY hospital and EL RAGHY hospital inpatient and outpatient clinics

Brief summary: Prevelance of axial spondylosis arthritis in inflammatory bowel disease and its RESPONSE to tumour necrosis factor (TNF) inhibitors TREATMENT

Detailed description: Inflammatory bowel disease \[IBD\], encompassing Crohn's disease and ulcerative colitis, represents a chronic inflammatory disease entity that mainly affects the gastrointestinal tract.1 Extraintestinal manifestations, however, frequently occur and may involve different organ systems.2 Among the most common extraintestinal manifestations are spondyloarthritis \[SpA\], here defined as ankylosing spondylitis, psoriatic arthritis, enteropathic arthritis, reactive arthritis, and undifferentiated spondyloarthritis diagnosis.3 This group of rheumatic diseases share a similar clinical presentation with involvement of the spine, sacroiliac joints, peripheral arthritis, and frequently also enthesitis.4 Both IBD and SpA are also highly heritable diseases, and genome-wide and family-based association studies have demonstrated evidence of a shared genetic basis between IBD and SpA.5-6 Comorbidity with SpA has been associated with disability and decreased quality of life in IBD patients.7 In some IBD patients, these complications of SpA can lead to greater morbidity than the typical gastrointestinal symptoms for IBD.8 Even though lower back pain is commonly reported by IBD patients with SpA, early symptoms related to SpA may be mild and not always recognisable. However, an early diagnosis of SpA is important since a delayed diagnosis may potentially lead to a more severe disease course and poor treatment responses in patients with SpA.9 Infliximab is a genetically constructed immunoglobulin (Ig)G1 murine-human chimeric monoclonal antibody that binds the soluble subunit and the membrane-bound precursor of tumor necrosis factor-α (TNF-α). Consequently, it helps to decrease the biological activity of TNF-α (10). Neutralization of TNF-α has been suggested as a therapeutic strategy for patients with inflammatory bowel disease (IBD), rheumatoid arthritis (RA), spondyloarthropathy (SpA) and various other chronic inﬂammatory conditions (11).

Eligibility criteria: Inclusion Criteria:IBD patients (ulcerative colitis , Crohn\&amp;amp;#39;s disease )on TNF inhibitors Data collected included SPA and IBD variables, demographics, concurrent medications, co-morbidities and autoimmune serology.

They fulfil criteria of axial SPA Clinical Criteria 12 Low back pain ≥ 3 months, improved by exercise and not relieved by rest Limitation of lumbar spine in sagittal and frontal planes Limitation of chest expansion (relative to normal values corrected for age and sex) Radiological Criteria Bilateral grade 2-4 sacroiliitis, or; Unilateral 3-4 sacroiliitis Assessment of disease activity of SPA 13 Patient fulfill criteria of IBD 14 Assessment of IBD activity (Esr , CRP ,Faecal calprotectin , CBC , albumin ,endoscopy, histopathology) Mayo score for U.C Crohn\&amp;amp;#39;s disease Activity index

Exclusion Criteria: Other autoimmune disease , DM, LCF ,CRF ,Malignancy , Mechanical low back pain, Fracture , Spondylolisthesis , Spine tumores , Kidney stones .

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Primary outcomes:
measure: prevalence of SPA in IBD patients
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Assiut University
name: Salwa salaheldin elgendi, professor doctor
role: STUDY_DIRECTOR
affiliation: Assiut University
name: hossam Mahmoud AbdulWahab, assistant professor
role: PRINCIPAL_INVESTIGATOR
References:
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