#1 Clinical Trials Search in Europe

Meloxicam

Clinical trials are investigating Meloxicam in patients with axial spondyloarthritis. These studies look at how well it helps control disease activity and compare it with other treatments, including TNF blockers. The main focus is on adults who have already failed NSAID therapy in outpatient care.

Table of Contents

Trial overview

This clinical study is interventional, which means researchers give the study treatments and then measure the results.[1] It is designed to compare repeated high-dose NSAID therapy with direct treatment using a TNF blocker in people with axial spondyloarthritis who have failed NSAID therapy in outpatient care.[1]

Meloxicam is one of the NSAIDs listed in the study treatment group.[1]

Who is being studied

The trial focuses on patients with axial spondyloarthritis, a disease that affects the spine and nearby joints.[1] The brief summary says the study is for patients who have already failed NSAID therapy in outpatient care, so the target group has not done well enough with earlier NSAID treatment.[1]

The study does not give more detailed entry rules in the source data, such as age limits or exact lab requirements.[1]

Treatments being compared

The study includes several NSAIDs, such as diclofenac, indometacin, ibuprofen, acemetacin, etoricoxib, Meloxicam, celecoxib, and naproxen.[1] These are compared with a TNF blocker called Remsima, which is listed in both infusion and injection forms.[1]

In simple terms, the researchers are asking whether treatment with NSAIDs, including Meloxicam, can help patients reach a better disease state as well as or differently from a TNF blocker.[1]

Trial phase and size

This study is in Phase 3.[1] Phase 3 studies usually compare treatments in larger groups of patients and look closely at how well they work.[1]

The planned enrollment is 100 participants.[1] That means the study is expected to include about 100 patients in total.[1]

What researchers measure

The main outcome is the proportion of patients on NSAID treatment versus TNF blocker treatment who reach low disease activity after 12 weeks.[1] Low disease activity is measured using ASDAS, and the target is a score below 2.1.[1]

This endpoint tells researchers how many patients improve enough to be considered less active in their disease after the treatment period.[1]

What this means for patients

For patients, this trial is mainly about finding out whether Meloxicam, as part of the NSAID group, can help control axial spondyloarthritis better in people who have not responded well to earlier NSAID treatment.[1] The study is not testing all possible uses of Meloxicam; it is focused on one disease group and one main treatment question.[1]

The data available here show a direct comparison between treatment strategies, which can help researchers understand which approach may be more effective for lowering disease activity over 12 weeks.[1]

Trial ID Phase Condition studied Status Enrollment
2024-513213-13-00 Phase 3 Axial Spondyloarthritis Authorised 100

FAQ

  • What are clinical trials of Meloxicam trying to find out? They are studying whether Meloxicam can help patients reach low disease activity in axial spondyloarthritis. The trial also compares it with other NSAIDs and a TNF blocker.
  • Who may be included in these trials? The trial data describe patients with axial spondyloarthritis who have failed NSAID therapy in outpatient care. This means people whose symptoms were not controlled well enough with earlier NSAID treatment.
  • What phase is the Meloxicam trial? The trial is in Phase 3. This phase usually means the treatment is being tested in a larger group to compare how well it works.
  • What condition is being studied? The condition is axial spondyloarthritis. This is a long-term inflammatory disease that mainly affects the spine and nearby joints.
  • What outcome is being measured? The main outcome is the proportion of patients who reach low disease activity after 12 weeks. Low disease activity means the disease is better controlled and less active.

Ongoing Clinical Trials on Meloxicam

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

    Recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Germany

Glossary

  • Axial spondyloarthritis: A long-term inflammatory disease that mainly affects the spine and sacroiliac joints, which are the joints between the spine and pelvis.
  • NSAID: A non-steroidal anti-inflammatory drug. This is a common type of medicine used to reduce pain and inflammation.
  • TNF blocker: A treatment that blocks tumor necrosis factor, a substance in the body that can drive inflammation.
  • Biosimilar: A medicine that is very similar to an already approved biologic medicine and is designed to work in the same way.
  • Phase 3: A later stage of clinical testing where a treatment is studied in a larger group of patients to compare how well it works.
  • Interventional study: A study where participants receive a treatment so researchers can measure the effect.
  • Enrollment: The number of people planned to take part in a study.
  • Primary outcome: The main result the researchers want to measure to answer the study question.
  • Low disease activity: A state where the disease is still present but is controlled better and causes fewer symptoms.
  • ASDAS: A score used to measure disease activity in axial spondyloarthritis. A lower score means less active disease.

References

  1. https://clinicaltrials.gov/study/2024-513213-13-00