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Prevelance of Axial Spondylosis Arthritis in Inflammatory Bowel Disease and Its RESPONSE to Tumour Necrosis Factor (TNF) Inhibitors Treatment in Assiut University Hospital

M

Mohamed Nasr

Status

Not yet enrolling

Conditions

Spondylarthropathies
Inflammatory Bowel Disease (IBD)
TNF-alpha Inhibitors

Treatments

Drug: conventional ibd medical treatment
Drug: TNF inhibitors

Study type

Observational

Funder types

Other

Identifiers

NCT06601595
SPA in IBD and response TNFI

Details and patient eligibility

About

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

Full 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).

Enrollment

100 estimated patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:IBD patients (ulcerative colitis , Crohn'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's disease Activity index

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

Trial design

100 participants in 2 patient groups

(TNF) inhibitors
Description:
1- Patients taking biologic (infliximab) treatment
Treatment:
Drug: TNF inhibitors
conventional IBD medical Treatment
Description:
patients taking conventional IBD medical Treatment
Treatment:
Drug: conventional ibd medical treatment

Trial contacts and locations

0

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Central trial contact

Mohamed Nasr Mohamed, resident doctor; Salwa salaheldin ELgendi, professor doctor

Data sourced from clinicaltrials.gov

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