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

Shandong University

Status and phase: Active, not recruiting; Phase 4

Conditions: Ankylosing Spondylitis

Treatments: Drug: Adalimumab Ab; Drug: Secukinumab 150 mg/ml; Drug: NSAID; Drug: Thalidomide Pill

Study type: Interventional

Funder types: Other

Identifiers

NCT05527444

effecacy of bioagents-AS QiluH

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 4 patient groups

Randomized-SEC group

Experimental group

Description:

actived AS patients naïve to ADA and SEC

Treatment:

Drug: NSAID

Drug: Secukinumab 150 mg/ml

Drug: Thalidomide Pill

Randomized-ADA group

Experimental group

Description:

actived AS patients naïve to ADA and SEC

Treatment:

Drug: NSAID

Drug: Thalidomide Pill

Drug: Adalimumab Ab

Non-Randomized-SEC group

Experimental group

Description:

AS patients who previously had inadequate response to ADA

Treatment:

Drug: NSAID

Drug: Secukinumab 150 mg/ml

Drug: Thalidomide Pill

Non-Randomized-ADA group

Experimental group

Description:

AS patients who previously had inadequate response to SEC

Treatment:

Drug: NSAID

Drug: Thalidomide Pill

Drug: Adalimumab Ab