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

October 27, 2024 updated by: Manar Gamal Abdelfattah, Sohag University

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Osama S Daif Allah, assistant professor
  • Phone Number: 01006425746

Study Locations

  • Egypt
      • Sohag, Egypt
        • Recruiting
        • Sohag University Hospital
        • Contact:
          • Magdy M Amin, professor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

Yes

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
group A
Diagnostic test: CBC
to compare platelet count in Ankylosing Spondylitis patients in treatment with Anti-TNF- α and patients with IL17 Inhibitor
group B
Diagnostic test: CBC
to compare platelet count in Ankylosing Spondylitis patients in treatment with Anti-TNF- α and patients with IL17 Inhibitor

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6 months
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.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sohag University

Collaborators

sohag university hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2024

Primary Completion (Estimated)

July 1, 2025

Study Completion (Estimated)

October 1, 2025

Study Registration Dates

First Submitted

October 1, 2024

First Submitted That Met QC Criteria

October 11, 2024

First Posted (Actual)

October 15, 2024

Study Record Updates

Last Update Posted (Actual)

October 30, 2024

Last Update Submitted That Met QC Criteria

October 27, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • soh-med-24-09-08ms

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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