Study on Ixekizumab for Rapid Pain Relief in Patients with Axial Spondyloarthritis

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What is this study about?

This clinical trial is focused on studying a condition known as axial spondyloarthritis, which is a type of arthritis that primarily affects the spine and the joints connected to the spine. The treatment being tested in this study is a medication called Ixekizumab, which is administered as a solution for injection using a pre-filled pen. The purpose of the study is to evaluate how quickly this medication can help control pain in patients with axial spondyloarthritis.

Participants in the study will receive the medication Ixekizumab and will be monitored over a period of time to observe changes in their pain levels. The study will use a technique called fMRI (functional Magnetic Resonance Imaging) to detect changes in brain activity related to pain. This imaging method helps researchers understand how the medication affects the brain’s response to pain. The study will compare brain activity before and after treatment with Ixekizumab to see if there are any significant changes.

Throughout the study, participants will receive regular injections of Ixekizumab and will undergo fMRI scans at specific intervals. The study aims to provide insights into the effectiveness of Ixekizumab in managing pain associated with axial spondyloarthritis, potentially offering a new treatment option for individuals living with this condition. Participants will be closely monitored by healthcare professionals to ensure their safety and well-being during the trial.

1 initial treatment phase

The treatment involves the use of ixekizumab, which is administered as a solution for injection using a pre-filled pen.

The medication is given through subcutaneous use, meaning it is injected under the skin.

During this phase, the primary goal is to observe changes in brain activity related to pain, using a technique called fMRI (functional magnetic resonance imaging).

The specific focus is on the BOLD signal, which helps in understanding the brain’s response to the treatment.

2 monitoring and assessment

The primary endpoint of the trial is to measure the change in the BOLD signal voxel count during the initial treatment phase.

This involves comparing the signal changes from day 17 to day 14 with those from day 3 to day 0.

The assessment helps in evaluating the early response of the central nervous system to the treatment.

3 ongoing treatment and follow-up

Participants are required to maintain their current NSAID (non-steroidal anti-inflammatory drugs) and/or analgesic therapy at a stable dose throughout the trial.

If applicable, glucocorticoids treatment should also be maintained at a stable dose.

Regular follow-up visits are necessary to monitor the progress and any changes in symptoms.

Who Can Join the Study?

Must be a male or female who is at least 18 years old.
If a woman can have children, she must have a negative pregnancy test and agree to use at least one reliable form of birth control during the study and for at least 10 weeks after the treatment ends.
Must understand and willingly sign a form agreeing to participate in the study.
Must be able to follow the study instructions and likely to attend and complete all required visits.
Must meet the ASAS classification criteria for axial spondyloarthritis (axSpA), which is a type of arthritis affecting the spine.
Must have a BASDAI score greater than 4. BASDAI is a tool used to measure the severity of symptoms in people with axial spondyloarthritis.
Must have a VAS pain score greater than 4 on a scale from 0 to 10. VAS is a way to measure pain intensity.
Must need treatment with bDMARDs due to active disease and not responding well to two NSAIDs at the highest dose they can tolerate. bDMARDs are a type of medication used to treat inflammation, and NSAIDs are non-steroidal anti-inflammatory drugs.
If currently taking NSAIDs or pain relief medication, the dose must have been stable for at least 2 weeks before the study starts and must remain stable during the study.
If currently taking Glucocorticoids (a type of steroid medication) at a dose of 10 mg or less per day, the dose must have been stable for at least 4 weeks before the study starts and must remain stable during the study.

Who Cannot Join the Study?

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Universitaetsklinikum Erlangen AöR	Erlangen	Germany

Trial status

Country	Status	Recruitment Start
Germany	Not recruiting	31.01.2024

Trial locations

Ixekizumab is a medication used in this clinical trial to target axial spondyloarthritis, a type of arthritis that primarily affects the spine and the joints connected to the spine. The main goal of using Ixekizumab in this study is to assess how quickly it can control pain by observing changes in brain activity through fMRI scans. This medication works by blocking certain proteins in the body that can cause inflammation and pain, potentially providing relief for patients with this condition.

Investigated diseases:

Axial spondyloarthritis

Axial Spondyloarthritis – Axial spondyloarthritis is a type of inflammatory arthritis that primarily affects the spine and the sacroiliac joints, which connect the lower spine to the pelvis. It is characterized by chronic back pain and stiffness, often beginning in early adulthood. The disease can lead to reduced flexibility and mobility in the spine over time. In some cases, it may also affect other joints and organs, such as the eyes or skin. The inflammation can cause new bone formation, leading to fusion of the vertebrae. This condition is part of a group of diseases known as spondyloarthropathies.

Trial ID:

2023-508976-12-00

Protocol code:

RAPIDA

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Ixekizumab for Rapid Pain Relief in Patients with Axial Spondyloarthritis

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