Clinical trial NCT05527444: The Clinical Efficacy and the Changes of Immune Cells Subsets With Bioagents in Ankylosing Spondylitis Patients
Official title: The Clinical Efficacy and the Changes of Immune Cells Subsets With Bioagents in Ankylosing Spondylitis Patients
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE4
Conditions: Ankylosing Spondylitis
Keywords: secukinumab
adalimumab
Lead sponsor: Qilu Hospital of Shandong University
Sponsor class: OTHER
First posted: 2022-09-02
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

1. Patients who meet modified New York 1984 criteria for ankylosing spondylitis；
2. Age ≥18 years and ≤ 65 years；
3. ASDAS ≥ 1.3；
4. 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；
5. Willing to participate in this study, willing to medication and follow-up according to the treatment plan, and sign the informed consent.

Exclusion Criteria:

1. 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;
2. Patients with current or previous Crohn's disease;
3. Patients with current ulcerative colitis requiring immunosuppressive therapy;
4. 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;
5. Patients who have received live vaccines within 4 weeks before randomization or plan to receive live vaccines during the trial;
6. Patients who had inadequate response, intolerance or contraindication for both adalimumab and secukinumab.

Primary outcomes:
measure: Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS)
timeFrame: Baseline and Week 12
Secondary outcomes:
measure: Percentage of Participants With Assessment of SpondyloArthritis International Society (ASAS) 20 Response
timeFrame: Baseline and Week 12, 24, 96
measure: Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS)
timeFrame: Baseline and Week 24, 96
measure: Percentage of Participants With Assessment of SpondyloArthritis International Society (ASAS) 40 Response
timeFrame: Baseline and Week 12, 24, 96
measure: Percentage of Participants With Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 Response
timeFrame: Baseline and Week 12, 24, 96
measure: Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI)
timeFrame: Baseline and Week 12, 24, 96
measure: Change From Baseline in Linear Bath Ankylosing Spondylitis Metrology Index (BASMI[Lin])
timeFrame: Baseline and Week 12, 24, 96
measure: Change From Baseline in ASAS Health Index (HI)
timeFrame: Baseline and Week 12, 24, 96
measure: Change From Baseline in Erythrocyte Sedimentation Rate (ESR)
timeFrame: Baseline and Week 12, 24, 96
measure: Change From Baseline in C-reactive Protein (CRP)
timeFrame: Baseline and Week 12, 24, 96
measure: Change From Baseline in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES)
timeFrame: Baseline and Week 12, 24, 96
measure: modiifed stoke ankylosing spondylitis spine score (mSASSS)
timeFrame: Baseline and Week 96
measure: Dynamics of T Cell subset
timeFrame: Baseline and Baseline and Week 12, 24
Other outcomes:
Locations:
city: Jinan
country: China
facility: Qilu Hospital
state: Shandong
Study officials:
affiliation: Qilu Hospital of Shandong University
name: Yang Xiaoyun, Dr.
role: STUDY_DIRECTOR
References: