Direct comparison between NSAIDs and biosimilar TNFa blockers in patients with axial spondyloarthritis

Trial details

Who runs it

St. Elisabeth Gruppe GmbH Katholische Kliniken Rhein-Ruhr

Trial code

EU 2024-513213-13-00

Record updated

2025. szeptember 6.

Original description

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.Read full original descriptionShow less

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.

Inclusion: 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.

Exclusion: Patients have participated within the past 3 months or are currently participating in another study with an investigational drug (or medical device); Patients who have received a live vaccination within the last 8 weeks prior to baseline; Patients with any contraindication to perform MRI or failure to perform MRI prior to baseline; 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; Contraindication to TNF blocker or NSAID therapy; Pre-treatment with a b- or ts-DMARD; 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 clinically important active infections; Chronic infection such as hepatitis B or C infection; Immunocompromised patients or history of HIV infection; 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; Patients have a known hypersensitivity to any component of Remsima or the NSAIDs used in the study; 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; 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; Female patients who are breastfeeding, pregnant, or plan to become pregnant during the study; Female patients with positive urine pregnancy test; Patients who are unable to speak and read German ; Patients who possibly are dependent on the Sponsor, the Principal Investigator or Investigator (e.g., family members); Have participated in this study before; Patients must not have any other inflammatory arthritis, e.g., RA, systemic lupus erythematosus, sarcoidosis, or others.

EU CTIS 2024-513213-13-00