Study on the Effects of Filgotinib for Adults with Active Axial Spondyloarthritis

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What is this study about?

This clinical trial is focused on studying the effects of a medication called filgotinib in adults with a condition known as axial spondyloarthritis. Axial spondyloarthritis 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 will use Jyseleca tablets, which contain the active ingredient filgotinib, in doses of 100 mg and 200 mg. Some participants will receive a placebo, which looks like the filgotinib tablets but does not contain the active ingredient, to help compare the effects of the actual medication.

The purpose of the study is to evaluate how well filgotinib works in reducing the signs and symptoms of axial spondyloarthritis. Participants will be randomly assigned to receive either the filgotinib tablets or the placebo. The study will be conducted in a double-blind manner, meaning neither the participants nor the researchers will know who is receiving the actual medication or the placebo. This helps ensure that the results are not influenced by expectations about the treatment. The study will last for a period of time, during which participants will take the tablets orally and attend regular check-ups to monitor their condition and any changes in their symptoms.

Throughout the study, the effectiveness of filgotinib will be assessed by looking at various measures of disease activity and quality of life. These assessments will include changes in pain levels, physical function, and overall well-being. The study aims to provide valuable information about the potential benefits and safety of filgotinib for people living with axial spondyloarthritis. Participants will be closely monitored for any side effects or adverse reactions to ensure their safety during the trial.

Who Can Join the Study?

  • You must be a male or female who is 18 years of age or older at the time of signing the consent form.
  • You must have a confirmed diagnosis of axial spondyloarthritis, which is a type of long-term inflammatory arthritis that primarily affects the spine, by a specialist such as a rheumatologist (a doctor who specializes in joints, muscles, and bones).
  • For those in the first group of the study, you must have evidence of radiographic sacroiliitis, which means an X-ray shows inflammation or damage in the sacroiliac joints (the joints connecting the lower spine to the pelvis). This requires a history of back pain lasting at least 12 weeks that started before age 45, along with specific patterns of joint changes seen on an X-ray.
  • For those in the second group of the study, you must meet the criteria for non-radiographic axial spondyloarthritis, which means you have symptoms of the disease and inflammation visible on an MRI (a detailed imaging test using magnets), but the changes are not yet visible on a standard X-ray.
  • You must show signs of active disease, measured by a BASDAI score (a questionnaire used to measure how much the disease is affecting your daily life) of 4 or higher, and a spinal pain score of 4 or higher on a scale of 0 to 10.
  • You must have a history of not getting enough relief from at least two different NSAIDs (non-steroidal anti-inflammatory drugs, which are medicines used to reduce pain and swelling), or you must be unable to take these medicines due to side effects.
  • If you have used bDMARDs (biologic disease-modifying antirheumatic drugs, which are advanced medicines that target specific parts of the immune system), you must have used no more than two of them that were stopped because they did not work or caused problems.
  • If you are continuing to take csDMARDs (conventional synthetic disease-modifying antirheumatic drugs, which are standard medicines used to slow down disease progression), you may use a maximum of two types and must have taken them at a stable dose for at least 12 weeks before the study begins.
  • You cannot take methotrexate (a common medicine used for arthritis) and leflunomide (another medicine used for arthritis) at the same time during the study.

Who Cannot Join the Study?

  • You have previously used a Janus kinase inhibitor, which is a type of medicine that works by blocking specific proteins in the body to reduce inflammation.
  • You have had surgery to treat symptoms in your limbs, such as synovectomy (removal of the lining of a joint) or arthroplasty (replacement or repair of a joint), or any major surgery involving anesthesia (medicine used to make you sleep or numb pain) within the last 12 weeks, or if you have major surgery planned.
  • You have been diagnosed with other musculoskeletal disorders (conditions affecting muscles and bones) or systemic inflammatory conditions (diseases that cause inflammation throughout the whole body), such as osteoarthritis, gout, rheumatoid arthritis, psoriatic arthritis, lupus, scleroderma, fibromyalgia, or COVID-19 syndrome.
  • You have active Crohn’s disease or ulcerative colitis, which are types of inflammatory bowel disease (conditions that cause swelling and irritation in the digestive tract).
  • You have a history of malignancy (cancer) or myelo- or lymphoproliferative disorders (conditions where the body produces too many blood cells) within the last 5 years, including certain skin cancers or cervical cancer.
  • You have an active autoimmune disease (a condition where the immune system attacks the body’s own healthy cells) that could make the study unsafe or interfere with results, such as uveitis (inflammation in the eye), thyroiditis (inflammation of the thyroid gland), or peptic ulcer disease (sores in the stomach or intestine).
  • You have a history of opportunistic infections (infections that occur more often in people with weakened immune systems) or immunodeficiency syndrome (a condition where the immune system is not working properly).
  • The doctor believes that participating in the study is not in your best interest due to other health conditions, such as a high risk of cardiovascular problems (heart or blood vessel issues like a heart attack or stroke).
  • You have a current significant infection or a history of a serious infection that required hospital stay or strong antibiotics within the last 12 weeks.
  • You have a condition that prevents you from having an MRI (a medical imaging test that uses strong magnets to see inside the body).
  • You use opioid analgesics (strong pain medicines) at a high daily dose or have had changes in your pain medicine dose within the last 2 weeks.
  • You have used systemic immunomodulating therapies (medicines that change how the immune system works) within the last 4 weeks, such as azathioprine, cyclosporine, or antimalarials.
  • You have complete spinal ankylosis, which means your spine has become stiff and fused together due to bone growth.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Narodowy Instytut Geriatrii Reumatologii I Rehabilitacji Im Prof. Dr Hab. Med. Eleonory Reicher Warsaw Poland
Cliniques Universitaires Saint-Luc Woluwe-Saint-Lambert Belgium
Hippokration Hospital Athens Greece
Centre Hospitalier Universitaire Rouen Rouen France
University Of Debrecen Debrecen Hungary
Laiko General Hospital Of Athens Athens Greece
Fakultni nemocnice Motol a Homolka Prague Czechia
Charite Universitaetsmedizin Berlin KöR Berlin Germany
Vilniaus universiteto ligonine Santaros klinikos VšĮ Vilnius Lithuania
Universitaetsklinikum Wuerzburg AöR Wuerzburg Germany
Katholieke Universiteit te Leuven Leuven Belgium
Fondazione Policlinico Universitario Agostino Gemelli IRCCS Rome Italy
Universitair Ziekenhuis Gent Gent Belgium
Universitair Medisch Centrum Groningen Groningen The Netherlands
Azienda Sanitaria Universitaria Friuli Centrale Udine Italy
Centre Hospitalier Lyon Sud Pierre Benite France
Hospital Universitario Marques De Valdecilla Santander Spain
Fundacion Para La Investigacion Biomedica Del Hospital Universitario La Paz Madrid Spain
Centrul Medical De Diagnostic Si Tratament Ambulator Neomed S.R.L. Brasov Romania
Azienda Ospedaliera Universitaria Universita’ Degli Studi Della Campania Luigi Vanvitelli Naples Italy
University General Hospital Of Heraklion Heraklion Greece
Medisch Spectrum Twente Enschede The Netherlands
Medical Center Medconsult Pleven OOD Pleven Bulgaria
University General Hospital Attikon Athens Greece
Université Libre de Bruxelles – Hôpital Erasme Brussels Belgium
Parc Tauli Hospital Universitari Sabadell Spain
Diagnostic Consultative Centre Ascendent OOD Sofia Bulgaria
Kliiniliste Uuringute Keskus OÜ Tartu Estonia
Poliklinika Vlatka Cavka d.o.o. Zagreb Croatia
Klinički bolnički centar Rijeka (Clinical Hospital Center Rijeka) Rijeka Croatia
Centre Hospitalier Universitaire d’Orléans Orléans France
Universita’ Campus Bio-medico Di Roma Rome Italy
Hopital Ambroise Pare Boulogne-Billancourt France
Fakultni Nemocnice U Sv Anny V Brne Brno-Stred Czechia
Hospital Universitario Virgen De Valme Sevilla Spain
Ko-Med Centra Kliniczne Sp. z o.o. Zamosc Poland
University Of Pecs Pecs Hungary
Futuremeds Sp. z o.o. Wroclaw Poland
Istituto Ortopedico Rizzoli Bologna Italy
Zuyderland Medisch Centrum Stichting Geleen The Netherlands
Hospital Edouard Herriot Lyon France
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo Italy
Hospital Universitario Basurto Bilbao Spain
Medical Plus s.r.o. Uherske Hradiste Czechia
Hospital Marina Baixa De La Vila Joiosa Villajoyosa Spain
Twoja Przychodnia Nowosolskie Centrum Medyczne Sp. z o.o. Nowa Sol Poland
Silmedic Sp. z o.o. Katowice Poland
MVZ Rheumatologie und Autoimmunmedizin Hamburg GmbH Hamburg Germany
Umbal – Prof. D-R Stoyan Kirkovich AD Stara Zagora Bulgaria
Revmatologie s.r.o. Brno-Sever Czechia
Hospital Universitario Hermanos Trias y Pujol. Institut Catalá d’Oncología (ICO) Badalona Spain
Medical Center 1 Sevlievo EOOD Sevlievo Bulgaria

Other Sites

Site Name City Country Status
Revita Kft. Budapest Hungary
Dkc Fokus-5 Lzip OOD Sofia Bulgaria
Medical Center Rodopimed EOOD Kirdzhali Bulgaria
Osteo-Medic s.c. Artur Racewicz, Jerzy Supronik Bialystok Poland
Aqua-Med Consulting S.R.L. Constanta Romania
CENTRUM MEDYCZNE REUMA PARK Warsaw Poland
Klaipedos universiteto ligonine VšĮ Klaipeda Lithuania
Medical Center Teodora EOOD Ruse Bulgaria
Arthrohelp s.r.o. Pardubice Czechia
Revmacentrum MUDr. Mostera s.r.o. Brno-Zidenice Czechia
MUDR. Zuzana URBANOVA Prague Czechia
Rxdjxvhrdpzfuh Ubxaa Prague Czechia
Mskzklqsh Idhwbkbddu Cbmpeceb Skjopwcb Smk z otjx Warsaw Poland
Mvrndxx Cnqjwz Howk Erkg Sofia Bulgaria
Duijh Hjjuzd Ccxd Sxkxdr Bucharest Romania
Aslimk Nsdyw Hohdpewg Athens Greece
Czpzdse Glnef Sxqmrcds Santiago De Compostela Spain
Edj Nqsamnlpeazn Skt z oflj Warsaw Poland
Oyvtkf Exxcmioisood Cwnlbzj Kfpw Zalaegerszeg Hungary
Kihyfzwxrt Fekl Fjtxhw Kuseob Kistarcsa Hungary
Ppmasoa Kgbmhuy Hodmezovasarhely Hungary
Mlrzgzrxaocpfjn Sfhnon Ramnicu Valcea Romania
Mauijintkc Ou Tartu Estonia
Ushjdm Mtfcwbs Czwgzl Eirt Plovdiv Bulgaria
Ducxmzcgff Chnfdbcbxm Ctnzfn Xdfo Safxu Lmre Sofia Bulgaria
Mokrzgegqjn Tsepshctsar Pqvakfl Etme Sofia Bulgaria
Mgwkvczg mmpzgxc avlrnjc &xxyjol Mluu &nakyyq Shmup Sofia Bulgaria
Npszafv Rzxagf Ksunblm Bytom Poland
Mfnalqo Dwctyahxwc Slifxe Craiova Romania
Cbw Hynijq Mons Belgium
Tgeuk Phkicnztkhf Pfrzytedze Ckkzpgi Mbniquum Snu z owzf Szczecin Poland
Kafiiprbe Fflosxotw Ix Meoykjvwuseff Vovdaxnwnendabnva Gwz Planegg Germany
Uhykk Srbwdmnl Otw Sofia Bulgaria
Rujkdvjizavqy Rkuwktzphx Herne Germany
Lakrjcgc shuvjlxxs mxqsbx uccnnnmrbpzp Kyffl lbdmwnpp Kaunas Lithuania
Ujjqtbrqnu Mzddnytkcbn Hxpnxfrx Foc Acmfaw Tazsurvcb &rvrlof Phaekzf As Plovdiv Bulgaria
Mvzaiim Ccuqphz Lbmiznqaqf Bejw Leeuwarden The Netherlands
Urofsdazqe Mdphuaydrliw Humzncfl Fnw Aucyeh Tgqxewfhr Erfzmjedaqfd Ptoaypx Ltyx Plovdiv Bulgaria
Slgkfjwe Jgbvtdsd Dd Uufezvd Bzlrj Bacau Romania
Vtzioevy sgkbcv Moravska Ostrava A Privoz Czechia
Vhnb Viron Mboceks Bxo Szekesfehervar Hungary
Enran Omoxesq Bumvz Kowqrxgxvvg Tovcqu Pruld Sevpbt Olsztyn Poland
Rfxfhj Sol z oxrk Lublin Poland
Ao Cslzxks Mgkutjip Saa z okvz Poznan Poland
Ctq Otxawtn sxgjzt Moravska Ostrava A Privoz Czechia
Rsaoogtoohg Genk Belgium
Puoeunuebh ssnbso Zlin Czechia
Kfdwcm cdav pzpetwogku Pyxzld ilmjsnmnyzk Kaunas Lithuania
Azoxddlpi segxds Trebovice Czechia
Vzjirxjhufm sdrhse Brno Czechia
Ctf Cwzsa abqu Prague Czechia
Pomiva Mwf Ksfrwc Cracow Poland
Czskziu Kjhmubhielyjyllfab Jmrbdtszmwb Bcsgyxogggbppmerbknsqgzp Lhcxnvl sgtxx Elblag Poland

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Belgium Belgium
Not recruiting
15.03.2023
Bulgaria Bulgaria
Not recruiting
15.03.2023
Croatia Croatia
Not recruiting
15.03.2023
Czechia Czechia
Not recruiting
15.03.2023
Estonia Estonia
Not recruiting
15.03.2023
France France
Not recruiting
15.03.2023
Germany Germany
Not recruiting
15.03.2023
Greece Greece
Not recruiting
15.03.2023
Hungary Hungary
Not recruiting
15.03.2023
Italy Italy
Not recruiting
15.03.2023
Lithuania Lithuania
Not recruiting
15.03.2023
Poland Poland
Not recruiting
15.03.2023
Romania Romania
Not recruiting
15.03.2023
Spain Spain
Not recruiting
15.03.2023
The Netherlands The Netherlands
Not recruiting
15.03.2023

Trial locations

Investigated Drugs:

Filgotinib is an oral medication being tested to see how well it works and how safe it is for adults with active axial spondyloarthritis. It is used to help manage the signs and symptoms of this condition.

Investigated Diseases:

Axial spondyloarthritis – This is a type of inflammatory disease that primarily affects the spine and the joints connecting the spine to the pelvis. It is characterized by ongoing inflammation in the axial skeleton. As the condition develops, it can lead to persistent pain and stiffness in the lower back and hips. Over time, the inflammation may cause the vertebrae to fuse together, which limits the movement of the spine. The progression often involves changes in the sacroiliac joints located at the base of the spine.

Trial ID:
2022-501354-10-01
Protocol code:
GLPG0634-CL-336
Trial Phase:
Therapeutic confirmatory (Phase III)

Other Trials to Consider

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  • Study on the Effects of Upadacitinib for Patients with Active Psoriatic Arthritis and Axial Spondyloarthritis

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    Investigated Drugs:
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