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

NCT06642207 | Recruiting

• 1 other identifier: soh-med-24-09-08ms
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Ankylosing Spondylitis

Keywords

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

Outcome Measures

Primary Outcomes (2)

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

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

  6 months

• Platelet count association with disease activity in patients with Ankylosing Spondylitis

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

  6 months

Study Arms (2)

group A

Diagnostic Test: CBC

group B

Diagnostic Test: CBC

Interventions

CBC DIAGNOSTIC_TEST

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

group A; group B

Eligibility Criteria

• Age: 16 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

1. Patients fulfill the Assessment in Spondyloarthritis International Society (ASAS) classification criteria for Axial Spondyloarthritis. \[13\] 2. Patients with disease duration more than 6 months. 3. Patients who failed conventional treatment and on bDMARDs (IL17 or Anti-TNF-α). 4. Age above 16 years old. 5. Patient cooperative and can answer questions. 6. Patients who are able and willing to give written informed consent

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sohag University: lead

Study Sites (1)

Sohag university Hospital

Sohag, Egypt

RECRUITING

Related Publications (4)

• Braun J, Sieper J. Ankylosing spondylitis. Lancet. 2007 Apr 21;369(9570):1379-1390. doi: 10.1016/S0140-6736(07)60635-7.

  PMID: 17448825 BACKGROUND

• Molto A, Nikiphorou E. Comorbidities in Spondyloarthritis. Front Med (Lausanne). 2018 Mar 12;5:62. doi: 10.3389/fmed.2018.00062. eCollection 2018.

  PMID: 29594122 BACKGROUND

• Reveille JD. Biomarkers for diagnosis, monitoring of progression, and treatment responses in ankylosing spondylitis and axial spondyloarthritis. Clin Rheumatol. 2015 Jun;34(6):1009-18. doi: 10.1007/s10067-015-2949-3. Epub 2015 May 5.

  PMID: 25939520 BACKGROUND

• van der Heijde D, Lie E, Kvien TK, Sieper J, Van den Bosch F, Listing J, Braun J, Landewe R; Assessment of SpondyloArthritis international Society (ASAS). ASDAS, a highly discriminatory ASAS-endorsed disease activity score in patients with ankylosing spondylitis. Ann Rheum Dis. 2009 Dec;68(12):1811-8. doi: 10.1136/ard.2008.100826. Epub 2008 Dec 5.

  PMID: 19060001 BACKGROUND

MeSH Terms

Conditions

Spondylitis, Ankylosing

Condition Hierarchy (Ancestors)

Axial Spondyloarthritis; Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Ankylosis; Joint Diseases; Arthritis

Central Study Contacts

manar G abd elfattah, resident

CONTACT

01032330664; manar_abdelfattah_post@med.sohag.edu.eg

Osama S Daif Allah, assistant professor

CONTACT

01006425746

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI 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

Study Record Dates

• First Submitted: October 1, 2024
• First Posted: October 15, 2024
• Study Start: October 1, 2024
• Primary Completion: July 1, 2025
• Study Completion: October 1, 2025
• Last Updated: October 30, 2024

Record last verified: 2024-10

Locations

EG (1)