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

NCT05527444 | Unknown Phase 4

• 1 other identifier: effecacy of bioagents-AS QiluH
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Ankylosing Spondylitis

Keywords

secukinumab; adalimumab

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS)

  ASDAS is a composite index to assess disease activity in Ankylosing Spondylitis. ASDAS combines the following 5 disease activity variables using a weighted formula: Patient's assessment of total back pain (BASDAI Question 2; NRS score 0 \[none\] - 10 \[very severe\]) Patient global assessment of disease activity (NRS score 0 \[no activity\] - 10 \[severe activity\]) Peripheral pain/swelling (BASDAI Question 3; NRS score 0 \[none\] - 10 \[very severe\]) Duration of morning stiffness (BASDAI Question 6; NRS score 0 \[0 hours\] - 10 \[2 or more hours\]) High-sensitivity C-reactive protein (hs-CRP) in mg/L. The overall score ranges from 0 with no defined upper score; published ranges for disease activity states as defined by the ASDAS include Inactive disease (ASDAS \< 1.3) and very high disease (ASDAS \> 3.5). A negative change from Baseline score indicates improvement in disease activity.

  Baseline and Week 12

Secondary Outcomes (12)

• Percentage of Participants With Assessment of SpondyloArthritis International Society (ASAS) 20 Response

  Baseline and Week 12, 24, 96

• Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS)

  Baseline and Week 24, 96

• Percentage of Participants With Assessment of SpondyloArthritis International Society (ASAS) 40 Response

  Baseline and Week 12, 24, 96

• Percentage of Participants With Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 Response

  Baseline and Week 12, 24, 96

• Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI)

  Baseline and Week 12, 24, 96

Study Arms (4)

Randomized-SEC group

EXPERIMENTAL

actived AS patients naïve to ADA and SEC

Drug: Secukinumab 150 mg/ml; Drug: NSAID; Drug: Thalidomide Pill

Randomized-ADA group

EXPERIMENTAL

actived AS patients naïve to ADA and SEC

Drug: Adalimumab Ab; Drug: NSAID; Drug: Thalidomide Pill

Non-Randomized-SEC group

EXPERIMENTAL

AS patients who previously had inadequate response to ADA

Drug: Secukinumab 150 mg/ml; Drug: NSAID; Drug: Thalidomide Pill

Non-Randomized-ADA group

EXPERIMENTAL

AS patients who previously had inadequate response to SEC

Drug: Adalimumab Ab; Drug: NSAID; Drug: Thalidomide Pill

Interventions

Secukinumab 150 mg/ml 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

Also known as: Secukinumab

Non-Randomized-SEC group; Randomized-SEC group

Adalimumab Ab DRUG

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

Also known as: Adalimumab

Non-Randomized-ADA group; Randomized-ADA group

NSAID DRUG

stable dose

Non-Randomized-ADA group; Non-Randomized-SEC group; Randomized-ADA group; Randomized-SEC group

Thalidomide Pill 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; Non-Randomized-SEC group; Randomized-ADA group; Randomized-SEC group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Qilu Hospital of Shandong University: lead

Study Sites (1)

Qilu Hospital

Jinan, Shandong, 250012, China

Location

MeSH Terms

Conditions

Spondylitis, Ankylosing

Interventions

secukinumab; Adalimumab; Anti-Inflammatory Agents, Non-Steroidal; Thalidomide

Condition Hierarchy (Ancestors)

Axial Spondyloarthritis; Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Ankylosis; Joint Diseases; Arthritis

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Analgesics, Non-Narcotic; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Anti-Inflammatory Agents; Therapeutic Uses; Antirheumatic Agents; Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Yang Xiaoyun, Dr.

  Qilu Hospital of Shandong University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 6, 2022
• First Posted: September 2, 2022
• Study Start: March 15, 2022
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: November 18, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)