2024-513213-13-00招募中4 期
Direct comparison between NSAIDs and biosimilar TNFa blockers in patients with axial spondyloarthritis
St. Elisabeth Gruppe GmbH Katholische Kliniken Rhein-Ruhr1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年12月9日最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Comparison of the proportion of patients on NSAID vs TNF blocker treatment who have low disease activity (ASDAS <2.1) after 12 weeks of treatment.
研究概览
简要总结
To compare the potential to achieve low disease activity with repeated high-dose NSAID therapy with direct treatment with a TNF blocker in patients who have failed NSAID therapy in outpatient care.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •A written informed consent form approved by the Institutional Review Board (IRB)/Independent Ethics Committee (IEC) has been signed by the patients.
- •Patients must not have received pre -treatment b- and ts-DMARDs prior to the baseline visit ('bDMARD naïve').
- •Female patients of childbearing potential (FCBP) must use an effective method of contraception (including oral/parenteral/implantable hormonal contraceptives, intrauterine device or barrier, and spermicide or contraceptive methods considered at least as safe for contraception). FCBP must agree to use effective contraception during the study and for at least 6 months (according to the Summary of Product Characteristics) after the last dose of study treatment.
- •Male subjects who are not documented to be sterile must agree to ensure that they or their partner(s) use adequate contraception for the duration of the study.
- •Patients are at least 18 years of age at the time of the baseline visit.
- •Patients are considered reliable and are able to adhere to the protocol, comply with the schedule of visits, or take medications as judged by the investigator.
- •Diagnosis of r-axSpA by a rheumatologist.
- •Fulfilment of the ASAS classification criteria.
- •High disease activity status (ASDAS ≥2.1).
- •Positive MRI examination with inflammatory activity in the sacroiliac joint and/or the spine.
- •Patients must agree to the planned MRI procedures.
- •Patients must have failed NSAID therapy in outpatient care.
排除标准
- •Patients have participated within the past 3 months or are currently participating in another study with an investigational drug (or medical device).
- •Female patients who are breastfeeding, pregnant, or plan to become pregnant during the study.
- •Patients who have received a live vaccination within the last 8 weeks prior to baseline.
- •Current malignancy or history of malignancy, although patients with less than 3 completely excised basal cell carcinomas or with one successfully operated cervical carcinoma in situ more than 5 years prior to baseline may be included.
- •Patients with severe, progressive, and/or uncontrolled renal, hepatic, hematologic, endocrine, pulmonary, cardiac, or neurologic disease or with a history of such disease.
- •Patients with any other condition, including the presence of laboratory abnormalities, which, in the judgment of the investigator, makes the subject unsuitable for participation in the study.
- •Patients with any contraindication to perform MRI or failure to perform MRI prior to baseline.
- •Patients with clinically important active infections.
- •Female patients with positive urine pregnancy test.
- •Positive interferon gamma release assay (IGRA) test at screening and/or abnormal chest x -ray (within 3 months prior to baseline) suggestive for past or present tuberculosis.
- •Chronic infection such as hepatitis B or C infection.
- •Patients who are unable to speak and read German .
- •Immunocompromised patients or history of HIV infection.
- •Patients who possibly are dependent on the Sponsor, the Principal Investigator or Investigator (e.g., family members).
- •Have participated in this study before
- •Patients have a history of chronic alcohol or drug abuse.
- •Patients have a medical or psychiatric condition that, in the opinion of the investigator, would jeopardize or impair the ability to participate in this study.
- •Contraindication to TNF blocker or NSAID therapy.
- •Patients have a known hypersensitivity to any component of Remsima or the NSAIDs used in the study.
- •Pre-treatment with a b- or ts-DMARD.
- •Patients must not have any other inflammatory arthritis, e.g., RA, systemic lupus erythematosus, sarcoidosis, or others.
- •Patients must not have a secondary, non -inflammatory condition (e.g., osteoarthritis or fibromyalgia) that, in the opinion of the investigator, is sufficiently prominent to interfere with the evaluation of the effect of study drug on the primary diagnosis of axial SpA.
结局指标
主要结局
Comparison of the proportion of patients on NSAID vs TNF blocker treatment who have low disease activity (ASDAS <2.1) after 12 weeks of treatment.
Comparison of the proportion of patients on NSAID vs TNF blocker treatment who have low disease activity (ASDAS <2.1) after 12 weeks of treatment.
次要结局
- Comparison of the proportion of patients on NSAID vs TNF blocker treatment who have low disease activity (ASDAS <2.1) after 4 and 24 weeks of treatment.
- ASDAS-ID (inactive disease, ASDAS < 1.3), ASDAS -CII (clinically important improvement, Δ ≥ 1.1), ASDAS -MI (major improvement, Δ ≥ 2.0) after 4, 12 and 24 weeks.
- ASAS-20, ASAS-40 at 4, 12 and 24 weeks.
- BASDAI50 at weeks 4, 12 and 24 .
- Change from baseline in Total Back Pain (PtBP), Patient Global Assessment (PtGA). Physician Global Assessment (PhGA) and other measures of disease activity (BASDAI), function (BASFI) at week 2, 4, 6, 12, 24, mobility (BASMI) and quality of life (ASAS Health Index) at week 4, 12, 24 .
- Change from baseline in inflammatory activity in the MRI scan used for diagnosis at escalation and after 24 weeks.
- Change from baseline in Epionics spine dimensions after 24 weeks .
- Normalized net incremental area under the curve for ASDAS, Total Back Pain (PtBP), Patient Global Assessment (PtGA). Physician Global Assessment (PhGA) and other measures of disease activity (BASDAI), function (BASFI), mobility (BASMI, Epionics spine) and quality of life (ASAS Health Index).
- Time to achieve ASDAS-LDA and time to ASDAS-ID.
- Change from baseline in the laboratory examination (CRP) over the time of he examination period.
- Comparison of the proportion of patients who discontinue therapy due to intolerance or side effects.
- Incidence of adverse events and treatment emergent AEs and SAEs.
研究者
Rheumazentrum Ruhrgebiet
Scientific
St. Elisabeth Gruppe GmbH Katholische Kliniken Rhein-Ruhr
研究点 (1)
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