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

You may not qualify if:

• Patients have participated within the past 3 months or are currently participating in another study with an investigational drug (or medical device).
• Patients who are unable to speak and read German .
• 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.
• 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.
• +7 more criteria