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

NCT ID: NCT05527444

Last Updated: 2023-11-18

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-15
• Study Completion Date: 2024-12-31

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.

Conditions

Ankylosing Spondylitis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Randomized-SEC group

actived AS patients naïve to ADA and SEC

Group Type: EXPERIMENTAL

Secukinumab 150 mg/ml

Intervention Type: DRUG

Secukinumab 150 mg will be administered at Baseline, Week 1, 2, 3, 4, 6, 8 followed by dosing every 4 weeks until Week 24

NSAID

Intervention Type: DRUG

stable dose

Thalidomide Pill

Intervention Type: DRUG

If patients have inadequate response to bioagents, thalidomide 50 mg will be administered at 12 week followed by dosing everyday until Week 24.

Randomized-ADA group

actived AS patients naïve to ADA and SEC

Group Type: EXPERIMENTAL

Adalimumab Ab

Intervention Type: DRUG

adalimumab biosimilar 40 mg will be administered at Baseline followed by dosing every 2 weeks until Week 24

NSAID

Intervention Type: DRUG

stable dose

Thalidomide Pill

Intervention Type: DRUG

If patients have inadequate response to bioagents, thalidomide 50 mg will be administered at 12 week followed by dosing everyday until Week 24.

Non-Randomized-SEC group

AS patients who previously had inadequate response to ADA

Group Type: EXPERIMENTAL

Secukinumab 150 mg/ml

Intervention Type: DRUG

Secukinumab 150 mg will be administered at Baseline, Week 1, 2, 3, 4, 6, 8 followed by dosing every 4 weeks until Week 24

NSAID

Intervention Type: DRUG

stable dose

Thalidomide Pill

Intervention Type: DRUG

If patients have inadequate response to bioagents, thalidomide 50 mg will be administered at 12 week followed by dosing everyday until Week 24.

Non-Randomized-ADA group

AS patients who previously had inadequate response to SEC

Group Type: EXPERIMENTAL

Adalimumab Ab

Intervention Type: DRUG

adalimumab biosimilar 40 mg will be administered at Baseline followed by dosing every 2 weeks until Week 24

NSAID

Intervention Type: DRUG

stable dose

Thalidomide Pill

Intervention Type: DRUG

If patients have inadequate response to bioagents, thalidomide 50 mg will be administered at 12 week followed by dosing everyday until Week 24.

Interventions

Secukinumab 150 mg/ml

Secukinumab 150 mg will be administered at Baseline, Week 1, 2, 3, 4, 6, 8 followed by dosing every 4 weeks until Week 24

Intervention Type: DRUG

Adalimumab Ab

adalimumab biosimilar 40 mg will be administered at Baseline followed by dosing every 2 weeks until Week 24

Intervention Type: DRUG

NSAID

stable dose

Intervention Type: DRUG

Thalidomide Pill

If patients have inadequate response to bioagents, thalidomide 50 mg will be administered at 12 week followed by dosing everyday until Week 24.

Intervention Type: DRUG

Other Intervention Names

Secukinumab; Adalimumab

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Qilu Hospital of Shandong University

OTHER

Sponsor Role: lead

Responsible Party

Qiang Shu

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yang Xiaoyun, Dr.

Role: STUDY_DIRECTOR

Qilu Hospital of Shandong University

Locations

Qilu Hospital

Jinan, Shandong, China

Countries

China

Other Identifiers

effecacy of bioagents-AS QiluH

Identifier Type: -

Identifier Source: org_study_id