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NCT Number: NCT06642207

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

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.

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Key information

Age range

16 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Sohag university Hospital

Sohag, Egypt

Location status: Recruiting

Location contact

Magdy M Amin, professor

CONTACT

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CBC

Diagnostic Test

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

Primary outcomes

  1. Effect of IL17 Inhibitor in comparison with Anti-TNFα on Platelet count

    Time frame: 6 months

    Evaluate the effect of IL-17 inhibitor and Anti-TNF-αon platelet count in AS patients.

  2. Platelet count association with disease activity in patients with Ankylosing Spondylitis

    Time frame: 6 months

    Platelet count as indicator of disease activity and follow up of AS patients

Study contacts

Contact information is provided by the study sponsor or research team.

Osama S Daif Allah, assistant professor

CONTACT

01006425746

manar G abd elfattah, resident

CONTACT

[email protected]

01032330664

Sponsors and collaborators

Lead sponsor

Sohag University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 15, 2024
Registry last updated
Oct 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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