The Clinical Efficacy and the Changes of Immune Cells Subsets With Bioagents in Ankylosing Spondylitis Patients

  • STATUS
    Recruiting
  • End date
    Dec 31, 2024
  • participants needed
    100
  • sponsor
    Qilu Hospital of Shandong University
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Updated on 7 October 2022
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methotrexate
adalimumab
secukinumab
NSAID
thalidomide
biosimilar
sulfasalazine

Summary

The purpose of this study is to evaluate the clinical efficacy, safety and immunological changes of secukinumab(sec) compared to adalimumab(ada) in patients with active ankylosing spondylitis(AS), who previously have an inadequate response to non-steroidal anti-inflammatory drugs (NSAIDs) or bioagents.

Description

Biologic naïve participants will be randomly assigned in a 2:1 ratio to receive secukinumab or adalimumab for 24 weeks. Participants with a history of an inadequate response to secukinumab or adalimumab, will be treated with the alternative drug (adalimumab or secukinumab) for 24 weeks. The disease activity and index of inmunology will be evaluated at weeks 0, 12, 24 up to 96 weeks.

Details
Condition Ankylosing Spondylitis
Treatment NSAID, Secukinumab 150 mg/ml, Adalimumab Ab, Thalidomide Pill
Clinical Study IdentifierNCT05527444
SponsorQilu Hospital of Shandong University
Last Modified on7 October 2022

Eligibility

 Yes No Not Sure

Inclusion Criteria

Patients who meet modified New York 1984 criteria for ankylosing spondylitis；
Age ≥18 years and ≤ 65 years；
ASDAS ≥ 1.3；
Concomitant drugs: use stable doses of NSAIDs alone for at least 4 weeks before the baseline period, stop other oral drugs such as methotrexate (MTX), sulfasalazine (SASP), glucocorticoids. Glucocorticoids can be injected locally after 12 weeks, NSAIDs keep stable for 12 weeks；
Willing to participate in this study, willing to medication and follow-up according to the treatment plan, and sign the informed consent

Exclusion Criteria

Patients with severe infections, tumors and damage to vital organs
Platelet counts(PLT) <80 x 10^9 / L, or white blood cell (WBC) <3 x10^9 / L
Propionate acid aminotransferase (ALT) or aspartate aminotransferase(AST) is two times higher than the upper limit of normal
Renal insufficiency: serum Cr ≥ 176 umol / L
Pregnant or nursing women (breastfeeding)
Patients has a history of malignancy (cure time in less than 5 years)
Patients with severe or poorly controlled hypertension, diabetes or cardiac dysfunction
Patients with current or previous Crohn's disease
Patients with current ulcerative colitis requiring immunosuppressive therapy
Any active infection Active viral hepatitis includes hepatitis B virus (HBV), hepatitis C virus (HCV), human papillomavirus (HPV). Active infections include small intestine herpes zoster virus (VZV), human immunodeficiency virus (HIV), syphilis or tuberculosis
Patients who have received live vaccines within 4 weeks before randomization or plan to receive live vaccines during the trial
Patients who had inadequate response, intolerance or contraindication for both adalimumab and secukinumab
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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