Study on Long-Term Safety and Effectiveness of Bimekizumab for Adults with Active Axial Spondyloarthritis

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What is this study about?

This clinical trial is focused on studying the long-term effects of a medication called bimekizumab in adults with a condition known as Axial Spondyloarthritis. This condition is a type of arthritis that primarily affects the spine and the joints connecting the spine to the pelvis, causing inflammation and pain. The study also includes participants with specific forms of this condition, such as Ankylosing Spondylitis and Nonradiographic Axial Spondyloarthritis.

The purpose of the study is to assess how safe and tolerable bimekizumab is over a long period. Participants will receive bimekizumab as a solution for injection, which is administered under the skin. The study will monitor participants for any side effects and how well they tolerate the medication. The study will also evaluate the effectiveness of bimekizumab in managing symptoms of the disease over time.

Participants in the study will be observed for changes in their condition at various intervals, such as weeks 28, 52, and 112. The study aims to gather information on the incidence of any adverse events and the overall impact of the treatment on the participants’ quality of life and disease activity. This information will help determine the long-term benefits and risks of using bimekizumab for treating Axial Spondyloarthritis and its related conditions.

1 joining the study

Upon joining the study, you will be assessed to ensure you meet the necessary criteria. This includes confirming that you have completed a previous study and are considered reliable and capable of following the study protocol.

2 receiving medication

You will receive the medication bimekizumab, which is a solution for injection. The medication is administered through a method called subcutaneous use, meaning it is injected under the skin.

3 medication schedule

The specific dosage and frequency of the medication will be determined by the study protocol. It is important to adhere to the schedule provided by the study team.

4 regular check-ups

You will have regular visits to monitor your health and the effects of the medication. These visits will include assessments to ensure the medication is safe and effective for you.

5 monitoring side effects

Throughout the study, any side effects or adverse events will be closely monitored. This is to ensure your safety and to understand how the medication affects you.

6 assessments at specific weeks

At weeks 28, 52, and 112, specific assessments will be conducted to evaluate your response to the medication. These assessments will measure improvements in your condition and any changes in your quality of life.

7 completion of the study

Upon completing the study, a final assessment will be conducted to gather comprehensive data on your experience and the long-term effects of the medication.

Who Can Join the Study?

The study participant must be considered reliable and capable of following the study plan. This means they should be able to understand and complete questionnaires, attend scheduled visits, and take medication as instructed by the study doctor.
In the opinion of the study doctor, the participant is expected to benefit from being part of this study.
The participant must have completed a previous study identified as AS0010 or AS0011.
Participants can be of any gender.
Participants should be adults, typically aged 18 years and older.

Who Cannot Join the Study?

Patients who do not have active axial spondyloarthritis cannot participate. This is a condition affecting the spine and joints.
Patients who are not within the specified age range cannot participate. The study is open to certain age groups only.
Patients who are part of a vulnerable population cannot participate. This means people who might need special protection or care.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

Site Name	City	Country	Status
Medizinische Hochschule Hannover	Hanover	Germany
Futuremeds Sp. z o.o.	Wroclaw	Poland

Other Sites

Site Name	City	Country
Pratia Prague s.r.o.	Prague	Czechia
Revmatologicky Ustav	Prague	Czechia
Reumed Sp. z o.o.	Lublin	Poland
MVZ Rheumatologie und Autoimmunmedizin Hamburg GmbH	Hamburg	Germany
Reumaclinic	Genk	Belgium
Centrum Medyczne Oporow	Wroclaw	Poland
Rheumatologische Schwerpunktpraxis	Berlin	Germany
Medical Plus s.r.o.	Uherske Hradiste	Czechia
PV-Medical s.r.o.	Zlin	Czechia
Polyclinique De Limoges	Limoges	France
Fejer Varmegyei Szent Gyoergy Egyetemi Oktato Korhaz	Szekesfehervar	Hungary
Niepubliczny Zaklad Opieki Zdrowotnej Biogenes Sp. z o.o	Wroclaw	Poland
University Of Debrecen	Debrecen	Hungary
Affidea Praha s.r.o.	Prague	Czechia
Pratia Pardubice a.s.	Pardubice	Czechia
Medyczne Centrum Hetmanska	Poznan	Poland
Hopital Ambroise Pare	Boulogne-Billancourt	France
Universidade De Santiago De Compostela	Santiago De Compostela	Spain
Pratia S.A.	Skorzewo	Poland
St. Elisabeth Gruppe GmbH Katholische Kliniken Rhein-Ruhr	Herne	Germany
Rheumazentrum Ratingen	Ratingen	Germany
Universitaetsklinikum Leipzig AöR	Leipzig	Germany
MUDR. Zuzana URBANOVA	Prague	Czechia
Rwymixacrjsk sphkbe	Brno-Sever	Czechia
Meyknfsqw Iigznmsdml Clprjuzu Srzqtgcv Sob z oqoe	Warsaw	Poland
Hzuakyhq Usrtoftwupege ds A Cnjpgf	A Coruna Galicia	Spain

Trial status

Country	Status	Recruitment Start
Belgium	Not recruiting	29.06.2020
Czechia	Not recruiting	29.06.2020
France	Not recruiting	29.06.2020
Germany	Not recruiting	29.06.2020
Hungary	Not recruiting	29.06.2020
Poland	Not recruiting	29.06.2020
Spain	Not recruiting	29.06.2020

Trial locations

Investigated drugs:

Bimekizumab

Bimekizumab is a medication used in this clinical trial to help people with certain types of arthritis, specifically axial spondyloarthritis, ankylosing spondylitis, and nonradiographic axial spondyloarthritis. These conditions cause inflammation in the spine and other joints, leading to pain and stiffness. Bimekizumab works by blocking specific proteins in the body that are involved in the inflammation process. By doing this, it aims to reduce the symptoms of these conditions, such as pain and swelling, and improve the overall quality of life for patients. The trial is focused on understanding how safe and tolerable this medication is when used over a long period.

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 may cause new bone formation, leading to the fusion of the vertebrae, which can reduce flexibility and mobility. 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:

2023-506527-28-00

Protocol code:

AS0014

NCT ID:

NCT04436640

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Long-Term Safety and Effectiveness of Bimekizumab for Adults with Active Axial Spondyloarthritis

What is this study about?

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