Study Comparing Infliximab and NSAID Drug Combination for Patients with Axial Spondyloarthritis

3 1 1 1

What is this study about?

This clinical trial is focused on studying the treatment of axial spondyloarthritis, a type of arthritis that primarily affects the spine and the joints connecting the spine to the pelvis. The study will compare the effectiveness of two types of treatments: non-steroidal anti-inflammatory drugs (NSAIDs) and a type of medication known as a TNF blocker. The TNF blocker being used in this study is called infliximab, which is available in two forms: a solution for injection and a powder for infusion. The NSAIDs being studied include indometacin, etoricoxib, meloxicam, celecoxib, ibuprofen lysine, naproxen sodium, and diclofenac diethylamine.

The purpose of the study is to determine which treatment is more effective in achieving low disease activity in patients who have not responded well to NSAID therapy in outpatient care. Participants will receive either high-dose NSAID therapy or direct treatment with a TNF blocker. The study will last for a period of 24 weeks, during which the participants’ disease activity will be monitored at various intervals. The effectiveness of the treatments will be assessed by measuring the level of disease activity using a specific scale known as the Ankylosing Spondylitis Disease Activity Score (ASDAS).

Throughout the study, participants will undergo regular assessments, including MRI scans to check for inflammation in the spine and sacroiliac joints. The study aims to compare the proportion of patients who achieve low disease activity after 12 weeks of treatment, as well as other measures of improvement over the 24-week period. The study will also monitor any side effects or adverse events that may occur during the treatment. This research will help to better understand the potential benefits and risks of using NSAIDs versus TNF blockers in managing axial spondyloarthritis.

1 initial visit

Upon joining the clinical trial, you will attend an initial visit. During this visit, you will undergo a series of assessments to confirm your eligibility for the study. This includes a review of your medical history, a physical examination, and possibly some laboratory tests.

You will also be asked to sign a consent form, which indicates that you understand the trial and agree to participate. This form is approved by an ethics committee to ensure your rights and safety.

2 baseline assessment

At the baseline assessment, detailed measurements of your current health status will be taken. This includes evaluating your disease activity using specific criteria and possibly an MRI scan to assess inflammation in your joints.

These assessments help establish a starting point for your treatment and allow for comparison as the trial progresses.

3 treatment phase

During the treatment phase, you will be assigned to receive either a high-dose NSAID (non-steroidal anti-inflammatory drug) or a TNF blocker.

If you are in the NSAID group, you may receive medications such as etoricoxib, meloxicam, celecoxib, ibuprofen lysine, naproxen sodium, or diclofenac diethylamine. These are taken orally, and the specific dosage and frequency will be provided by the study team.

If you are in the TNF blocker group, you may receive infliximab either as a subcutaneous injection or an intravenous infusion. The dosage and frequency will be determined by the study protocol.

4 follow-up visits

Throughout the trial, you will have regular follow-up visits. These visits are scheduled at specific intervals, such as 4, 12, and 24 weeks, to monitor your progress and assess the effectiveness of the treatment.

During these visits, your disease activity will be evaluated, and any side effects or adverse events will be recorded. Adjustments to your treatment may be made based on these assessments.

5 final assessment

At the end of the trial, a final assessment will be conducted. This will include a comprehensive evaluation of your health status and the overall impact of the treatment.

The results from this assessment will help determine the success of the treatment in achieving low disease activity and improving your quality of life.

Who Can Join the Study?

The patient must sign a written informed consent form that has been approved by an ethics committee.
The patient must not have received certain types of medications called bDMARDs or ts-DMARDs before the start of the study.
Female patients who can have children must use an effective method of birth control during the study and for at least 6 months after the last dose of the study treatment.
Male patients who are not confirmed to be sterile must ensure that they or their partner use adequate birth control during the study.
The patient must be at least 18 years old at the start of the study.
The patient must be considered reliable and able to follow the study rules and schedule as judged by the study doctor.
The patient must have a diagnosis of r-axSpA (a type of arthritis) by a specialist doctor called a rheumatologist.
The patient must meet the ASAS classification criteria, which are specific guidelines used to diagnose the condition.
The patient must have high disease activity, which is measured by a score called ASDAS that is 2.1 or higher.
The patient must have a positive MRI (a type of imaging test) showing inflammation in certain joints or the spine.
The patient must agree to undergo planned MRI procedures during the study.
The patient must have previously tried and not benefited from NSAID therapy, which is a type of medication used to reduce inflammation and pain, in outpatient care.

Who Cannot Join the Study?

Patients who have not been diagnosed with Axial Spondyloarthritis cannot participate.
Patients who have not tried and failed NSAID therapy (a type of medication used to reduce inflammation and pain) in outpatient care cannot participate.
Patients who are not within the specified age range cannot participate.
Patients who are not part of the specified clinical trial group cannot participate.
Patients who are considered part of a vulnerable population cannot participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

No sites found in this category

Other Sites

Site Name	City	Country	Status
St. Elisabeth Gruppe GmbH Katholische Kliniken Rhein-Ruhr	Herne	Germany

Trial status

Country	Status	Recruitment Start
Germany	Recruiting	01.12.2024

Trial locations

Investigated drugs:

NSAIDs are a group of medications that help reduce inflammation, pain, and fever. They are commonly used to treat conditions like arthritis, where inflammation causes pain and stiffness. In this trial, NSAIDs are being used to see if they can help patients with axial spondyloarthritis achieve low disease activity when given in high doses repeatedly.

TNF blockers are a type of medication that targets a specific protein in the body called tumor necrosis factor (TNF). This protein is involved in causing inflammation, and by blocking it, these medications can help reduce inflammation and pain in conditions like axial spondyloarthritis. In this trial, a biosimilar version of a TNF blocker is being used to see if it can help patients who have not responded well to NSAID therapy achieve low disease activity.

Investigated diseases:

Axial spondyloarthritis

Axial Spondyloarthritis – Axial Spondyloarthritis is a chronic inflammatory disease primarily affecting the spine and the sacroiliac joints, which connect the lower spine to the pelvis. It is characterized by inflammation that can lead to pain and stiffness, particularly in the lower back and buttocks. Over time, the inflammation can cause new bone formation, leading to fusion of the vertebrae and reduced flexibility of the spine. The disease often begins in early adulthood and can progress slowly, with periods of increased symptoms and periods of remission. In some cases, it may also affect other joints and organs, such as the eyes and skin. The progression and severity of symptoms can vary widely among individuals.

Trial ID:

2024-513213-13-00

Protocol code:

DESTINATION

Trial Phase:

Therapeutic confirmatory (Phase III)

Other Trials to Consider

#1 Clinical Trials Search in Europe

Study Comparing Infliximab and NSAID Drug Combination for Patients with Axial Spondyloarthritis

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?