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Effect of IL17 Inhibitor in Comparison With Anti-TNF in Patients With Ankylosing Spondylitis

Effect of IL17 Inhibitor in Comparison With Anti-TNF- α on Platelet Count and Its Association With Disease Activity in Patients With Ankylosing Spondylitis

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06642207
Enrollment
50
Registered
2024-10-15
Start date
2024-10-01
Completion date
2025-10-31
Last updated
2024-10-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ankylosing Spondylitis

Keywords

Ankylosing Spondylitis, Anti-TNF, IL17 Inhibitor, IL17, Platelet, Piology

Brief summary

Ankylosing spondylitis (AS) is a chronic, inflammatory autoimmune disease characterized by axial bone inflammation. The main clinical manifestations include back pain and progressive spinal rigidity, as well as inflammation of the hips, shoulders, and peripheral joints. Also, extra-articular manifestations, such as psoriasis, uveitis, and inflammatory bowel disease (IBD). Indicators of inflammation such as erythrocyte sedimentation rate (ESR) and Creactive protein (CRP), which are typically elevated in AS patients, particularly when peripheral joints are involved, these tests ultimately do not reflect the disease process and have limited sensitivity and specificity. Disease activity in AS has been measured by the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), which includes only patient-reported measures. The assessment of Spondyloarthritis International society (ASAS) developed a new AS disease activity score (ASDAS) that combines patient-reported assessments with erythrocyte sedimentation rate (ESR) or C-reactive protein (CRP). Although platelets play important functions in hemostasis and thrombosis, their functions in controlling immunity and inflammation have drawn more attention recently. Platelets are known to have a key role in controlling inflammatory processes in a variety of pathological states. Overactivated platelets can induce inflammation, which in turn can increase the risk of the development of atherosclerosis, thrombosis, and cardiovascular disorders. Inflammatory diseases, including inflammatory bowel disease (IBD), have platelets play a crucial role in their development. The first-line recommended treatment for active AS is NSAIDs. Tumor necrosis factor (TNF) inhibitors have completely changed the therapy options for patients who have not improved despite receiving standard NSAID treatment. TNF inhibitors can, however, cause tolerability problems in certain patients or inadequate responses in others, and their effectiveness may gradually diminish. Interleukin (IL)-17 inhibitors are among the new therapeutic alternatives that are currently accessible for these individuals.

Interventions

DIAGNOSTIC_TESTCBC

to compare platelet count in Ankylosing Spondylitis patients in treatment with Anti-TNF- α and patients with IL17 Inhibitor

Sponsors

Sohag University
Lead SponsorOTHER

Study design

Observational model
CASE_CROSSOVER
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
16 Years to 60 Years
Healthy volunteers
Yes

Inclusion criteria

* Patients fulfill the Assessment in Spondyloarthritis International Society (ASAS) classification criteria for Axial Spondyloarthritis. * Patients with disease duration more than 6 months. * Patients who failed conventional treatment and on bDMARDs (IL17 or Anti-TNF-α). * Age above 16 years old. * Patient cooperative and can answer questions. * Patients who are able and willing to give written informed consent.

Exclusion criteria

* Other rheumatologic or collagen diseases. * Age below 16 years and above 60 years. * Uncooperative patients. * Patient not able and willing to give written informed consent. * Patient with other causes of platelet dysfunction, count irregularity.

Design outcomes

Primary

MeasureTime frameDescription
Effect of IL17 Inhibitor in comparison with Anti-TNFα on Platelet count6 monthsEvaluate the effect of IL-17 inhibitor and Anti-TNF-αon platelet count in AS patients.
Platelet count association with disease activity in patients with Ankylosing Spondylitis6 monthsPlatelet count as indicator of disease activity and follow up of AS patients

Countries

Egypt

Contacts

Primary Contactmanar G abd elfattah, resident
manar_abdelfattah_post@med.sohag.edu.eg01032330664
Backup ContactOsama S Daif Allah, assistant professor
01006425746

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026