NCT06601595

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

Spondyloarthropathy in Inflammatory Bowel Disease Patients and Evaluation of Its Response to TNF Inhibitors in Assiut University Hospital

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: Mohamed Nasr · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Inflammatory Bowel Disease (IBD)
• Spondylarthropathies
• TNF-alpha Inhibitors

Interventions

Type	Name	Description
DRUG	TNF inhibitors	tumour necrosis factor inhibitors approved as treatments for ulcerative colitis and/or Crohns disease
DRUG	conventional ibd medical treatment	Conventional therapies for ulcerative colitis and Crohns disease (CD) include aminosalicylates, corticosteroids, thiopurines, methotrexate other than anti-tumor necrosis factor agents.

Timeline

• Start date: 2024-10-01
• Primary completion: 2026-01-01
• Completion: 2026-03-01
• First posted: 2024-09-19
• Last updated: 2024-09-19