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Study on Tofacitinib for Patients with Early Active Axial Spondyloarthritis Who Did Not Respond to NSAIDs

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

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 connecting the spine to the pelvis. The study is investigating the effectiveness and safety of a medication called Tofacitinib, also known by its code name CP-690,550. Participants in the study will receive either Tofacitinib or a placebo, which is a substance with no active medication, to compare the outcomes.

The purpose of the study is to see if Tofacitinib can help achieve remission of the disease, meaning a reduction or disappearance of symptoms, in people with early active axial spondyloarthritis who have not responded well to at least one non-steroidal anti-inflammatory drug (NSAID). The study will last for 16 weeks, during which participants will take the medication or placebo orally, in the form of tablets. The study is designed to be double-blind, meaning neither the participants nor the researchers will know who is receiving the actual medication or the placebo, to ensure unbiased results.

Throughout the study, participants will be monitored for changes in their condition, including improvements in back pain and inflammation, as well as any side effects they may experience. The study aims to provide valuable information on whether Tofacitinib can be an effective treatment option for people with this form of arthritis, potentially leading to better management of the disease in the future.

The research process

The trial runs in 3 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    <b>study medication administration</b>

    You will receive either tofacitinib (10 mg taken twice daily as a film-coated tablet) or a placebo (a tablet with no active medicine, also taken twice daily).

    The placebo group will receive tablets that look identical to the tofacitinib tablets.

    You may also take naproxen (1000 mg as a tablet) as background medication.

  2. Step 2

    <b>monitoring and assessments</b>

    During the first 6 days, changes in total pain and nocturnal back pain (pain at night) will be recorded.

    At weeks 1, 2, and 3, assessments will be made regarding total back pain, nocturnal back pain, and total pain in the last 24 hours using a pain scale.

    At week 4, assessments will be conducted for disease activity, pain levels, fatigue, physical function, joint swelling, tender joints, and inflammation.

    If the disease activity is not sufficiently managed at week 4, treatment escalation to open label tofacitinib (where the medicine is no longer a secret) may occur.

    At weeks 8 and 12, assessments regarding pain levels will continue.

    At week 16, a final assessment of disease remission (a state where the axial spondyloarthritis is inactive), inflammation (measured by C-reactive protein or CRP), physical function, joint swelling, and chest expansion will be completed.

  3. Step 3

    <b>safety follow-up</b>

    Up to week 20, any adverse events (side effects or unexpected medical issues) will be monitored to ensure safety.

Who can join the trial?

16 criteria

  • You must be between 18 and 45 years old at the start of the study.
  • If you take NSAIDs (medicines used to reduce pain and swelling, like ibuprofen) or analgesics (painkillers), you must have been taking the same amount for at least 2 weeks.
  • If you take oral corticosteroids (strong medicines that reduce inflammation), your daily dose must be 10mg or less of prednisone (a specific type of steroid) or an equivalent medicine, and you must have been on this dose for at least 2 weeks.
  • If you take certain other medicines like Methotrexate, Sulfasalazine, or Mesalazine, you must have started them at least 12 weeks ago and kept the dose stable for at least 4 weeks.
  • If you take Methotrexate, you must also be taking a stable dose of folate (a B vitamin) and must not have had any serious harmful reactions to it in the past.
  • You must be able and willing to sign a written informed consent form, which is a document where you officially agree to participate in the study after being told all the details.
  • A rheumatologist (a doctor who specializes in joints, muscles, and bones) must confirm your diagnosis of Axial spondyloarthritis (a type of long-term inflammation that affects the spine).
  • You must meet specific medical criteria for your condition, including having back pain for at least 3 months that started before age 45.
  • Imaging tests like X-rays or MRI (special pictures of the inside of the body) must show sacroiliitis, which is inflammation in the joints of the lower spine and pelvis.
  • You may need to test positive for HLA-B27 (a specific marker found in the blood) or show other signs of the disease, such as enthesitis (inflammation where tendons or ligaments meet bone) or uveitis (inflammation inside the eye).
  • Your back pain must have lasted for 2 years or less, which is considered the early stage of this condition.
  • Your disease must be active, meaning you have a high score on the BASDAI (a questionnaire used to measure how much the disease is affecting you) and physical signs of inflammation.
  • Signs of inflammation must be visible through an MRI or by high levels of CRP (a substance in the blood that increases when there is inflammation in the body).
  • You must have had an inadequate response to at least one NSAID (non-steroidal anti-inflammatory drug), meaning the medicine did not control your pain or swelling even when taking the recommended dose.
  • If you are female, you must either not be able to have children or agree to use a reliable method of contraception (a way to prevent pregnancy) during the study and for 4 weeks after the last dose.
  • If you are male, you must either not be able to have children or agree to use a reliable method of contraception during the study and for 4 weeks after the last dose.

Who cannot join the trial?

32 criteria

  • You are currently using or have previously used biologics or targeted synthetic disease modifying antirheumatic drugs (bDMARDs or tsDMARDs), which are specialized medicines used to change how the immune system works to treat inflammation.
  • You have a current malignancy (cancer) or a history of cancer, except for certain skin cancers that have been removed or treated.
  • You have a condition that might prevent your body from absorbing medicine properly, such as having had gastrectomy (removal of part of the stomach), certain types of stomach surgery, or diabetic gastroenteropathy (a stomach problem caused by diabetes).
  • You have any serious current or long-term infections.
  • You have had a major injury or surgery within the last 4 weeks, or you have a planned surgery during the study.
  • You have severe, uncontrolled problems with your digestive system, hepatic (liver) function, renal (kidney) function, lungs, heart, nerves, or hormones.
  • You have a history of severe psychiatric illness (mental health conditions) that could make it difficult to follow the study rules or understand the results.
  • You have received a live or attenuated vaccine (a vaccine that uses a weakened version of a germ) within the last 6 weeks, or you plan to receive one during the study.
  • Your blood tests show low levels of hemoglobin (a protein in red blood cells that carries oxygen), neutrophils (white blood cells that fight infection), lymphocytes (white blood cells that help fight germs), or platelets (cells that help blood clot).
  • Your blood tests show high levels of liver enzymes like AST or ALT, or your creatinine-clearance (a measure of how well your kidneys filter waste) is too low.
  • You are considered a vulnerable patient, such as being living in an institution by legal order, or being an employee or family member of the people running the study.
  • The doctor believes you are not suitable for this specific study or for the medicines being tested.
  • You are breastfeeding, pregnant, or planning to become pregnant during the study or shortly after.
  • You cannot have an MRI (a medical imaging test using magnets) due to claustrophobia (fear of enclosed spaces), having an implanted electronic device like a pacemaker, having certain metal implants, or having large tattoos with metal-containing ink.
  • You have had an infection in the last 3 months that required staying in the hospital or receiving medicine through a vein.
  • You have a history of repeated herpes zoster (shingles) or herpes simplex (cold sores or genital herpes).
  • You have a weakened immune system, known as immunodeficiency, or a close family member has a hereditary version of this condition.
  • You show signs of tuberculosis (a serious bacterial infection) or have had a positive test for it.
  • You have a chronic infection with Hepatitis B or Hepatitis C, or a history of HIV.
  • You have a history of ankylosis of the spine (stiffness or fusion of the bones in the spine).
  • You have a history of lymphoproliferative disorders, which are conditions where white blood cells grow abnormally, such as lymphoma or leukemia (blood cancers).
  • You have other chronic inflammatory or autoimmune diseases (where the body attacks its own healthy cells), such as rheumatoid arthritis, lupus, or fibromyalgia.
  • You have previously used specific types of strong immune-suppressing medicines or treatments.
  • The doctor believes you are at risk for a GI perforation (a hole in the stomach or intestines).
  • You have a history of drug or alcohol abuse, unless you have been in full recovery for more than 6 months, or you currently use marijuana.
  • Your ECG (a test that records the electrical activity of your heart) shows abnormal patterns that could be unsafe.
  • You have taken certain other immune-modifying medicines, such as Leflunomide or Hydroxychloroquine, within the last 4 to 8 weeks.
  • You are taking medicines that interfere with how your body processes certain drugs through cytochrome CYP3A4 (an enzyme in the liver).
  • You are allergic to any ingredients in the study medicine, including lactose (milk sugar).
  • You have used glucocorticoids (strong anti-inflammatory steroids) via injection or in high oral doses within the last 2 weeks.
  • You are currently participating in another medical study.
  • You have an infected joint prosthesis (an artificial joint replacement that has an infection) still inside your body.
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Investigated drugs

  • Tofacitinib

    is a medication being tested to see how well it works in treating people with early active axial spondyloarthritis. It is taken by mouth and is intended to help reduce inflammation and achieve disease remission.

  • Naproxen

    is a medication used as background therapy. It is a common non-steroidal anti-inflammatory drug used to help relieve pain and reduce inflammation.

What is already known about the treatment

  • Tofacitinib

    This medication is taken by mouth in the form of a swallowed tablet. It is an established medicine used to treat various inflammatory conditions, such as rheumatoid arthritis and axial spondyloarthritis. It belongs to a group of drugs called JAK inhibitors, which work by blocking specific proteins inside cells that trigger the body's inflammatory response. By stopping these signals, the drug helps reduce swelling and pain caused by the immune system.

  • Naproxen

    This is a common medication taken orally in tablet form. It is widely used in medicine to relieve pain, reduce inflammation, and lower fever. Belonging to a class of drugs known as non-steroidal anti-inflammatory drugs (NSAIDs), it works by blocking the production of certain natural chemicals in the body that cause pain and swelling. This helps to manage discomfort in conditions like arthritis or muscle aches.

Investigated diseases

Axial spondyloarthritis - This condition is a type of inflammatory disease that primarily affects the spine and the joints connecting the spine to the pelvis. It involves chronic inflammation that can lead to pain and stiffness in the back and neck. Over time, the inflammation may cause the joints to become less flexible. In some cases, the body may develop new bone in the areas where the spine meets other bones, potentially limiting movement. The disease often follows a progressive course characterized by recurring episodes of discomfort.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-505050-18-00Protocol codeFASTLANE2022Estimated enrolment104 patientsSponsorCharite Universitaetsmedizin Berlin KöR

sourced from the EU Clinical Trials Register and site verification

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).