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Direct comparison between NSAIDs and biosimilar TNFa blockers in patients with axial spondyloarthritis
EU CTIS ID: 2024-513213-13-00
What this study is testing
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.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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.
You likely can't join if
- 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.
See the full eligibility criteria
Who can join
- 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.
What rules you out
- 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.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.