Ankylosing spondylitis.
Jürgen Braun, Joachim Sieper
https://pubmed.ncbi.nlm.nih.gov/17448825Actively Recruiting
Age: 16Years - 60Years
All Genders
Healthy Volunteers
ID06642207
Effect of IL17 Inhibitor Compared With Anti-TNF-Alpha on Platelet Count and Disease Activity in Patients With Ankylosing Spondylitis
Led by Sohag University · Updated on 2024-10-30
50
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying ankylosing spondylitis (AS), a chronic autoimmune disease causing inflammation in the spine and joints, often accompanied by symptoms like back pain, stiffness, and inflammation in hips, shoulders, and other areas. The study focuses on comparing the effects of two treatments, IL-17 inhibitors and anti-TNF alpha drugs, especially regarding their influence on platelet counts and how these relate to disease activity. The trial also considers the role of platelets in inflammation and the limitations of current disease activity measures. Participants in this observational study receive either IL-17 inhibitors or anti-TNF alpha treatments as part of their ongoing care. Researchers will compare platelet counts between these groups using complete blood count (CBC) tests. The study evaluates these effects over a 6-month period to understand how platelet levels associate with disease activity and inflammation control under these therapies. During the study, participants will have blood tests to measure platelet counts and assessments of their disease activity. Data collected will include patient-reported outcomes and laboratory markers like erythrocyte sedimentation rate and C-reactive protein. The study requires participants to be cooperative and able to provide informed consent. The total involvement spans at least six months, during which researchers monitor the relationship between platelet counts and disease status to better understand treatment impacts.
CONDITIONS
Brief Title
Effect of IL17 Inhibitor in Comparison With Anti-TNF in Patients With Ankylosing Spondylitis
Who Can Participate
Age: 16Years - 60Years
All Genders
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- 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 are on bDMARDs (IL17 or Anti-TNF-alpha).
- Age above 16 years old.
- Patient cooperative and can answer questions.
- Patients who are able and willing to give written informed consent.
You will not qualify if you...
- 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 or count irregularity.
AI-Screening
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Complete this quick 3-step screening to check your eligibility
1
2
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Diagnostic Evaluation
Duration - 6 months
Participants undergo blood tests to compare platelet counts between those treated with Anti-TNF-alpha and those treated with IL17 Inhibitor.
Periodic visits for blood sample collection over 6 months
Long-term Monitoring
Duration - 6 months
Participants are observed to assess the association of platelet counts with disease activity in Ankylosing Spondylitis.
Periodic visits for disease activity assessments over 6 months
Trial Site Locations
Total: 1 location
1
Sohag university Hospital
Sohag, Egypt
Actively Recruiting
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Research Team
M
manar G abd elfattah, resident
O
Osama S Daif Allah, assistant professor
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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Published Research Related To This Trial
Comorbidities in Spondyloarthritis.
Anna Moltó, Elena Nikiphorou
https://pubmed.ncbi.nlm.nih.gov/29594122Biomarkers for diagnosis, monitoring of progression, and treatment responses in ankylosing spondylitis and axial spondyloarthritis.
John D Reveille
https://pubmed.ncbi.nlm.nih.gov/25939520ASDAS, a highly discriminatory ASAS-endorsed disease activity score in patients with ankylosing spondylitis.
D van der Heijde, E Lie, T K Kvien...
https://pubmed.ncbi.nlm.nih.gov/19060001