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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-10-01

Study Completion Date

2025-10-31

Brief Summary

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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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Detailed Description

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Conditions

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Ankylosing Spondylitis

Study Design

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Observational Model Type

CASE_CROSSOVER

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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group A

CBC

Intervention Type DIAGNOSTIC_TEST

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

group B

CBC

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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CBC

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.

Minimum Eligible Age

16 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Manar Gamal Abdelfattah

Effect of IL17 Inhibitor in comparison with Anti-TNF- α on Platelet count and its association with disease activity in patients with Ankylosing Spondylitis

Responsibility Role PRINCIPAL_INVESTIGATOR