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Triamcinolone Hexacetonide

Clinical trials are studying Triamcinolone Hexacetonide in people with juvenile idiopathic arthritis, rheumatoid arthritis, and carpal tunnel syndrome. These studies look at whether it helps improve disease control or treatment success, and they measure outcomes such as remission, symptom scores, and the need for surgery.

Table of Contents

Overview of the trial program

The trial data show three interventional studies of Triamcinolone Hexacetonide in different patient groups.[1][2][3] The studies focus on juvenile idiopathic arthritis, carpal tunnel syndrome, and rheumatoid arthritis.[1][2][3] Two trials are authorised and one is completed.[1][2][3]

Juvenile idiopathic arthritis study

NCT04614311, called The My-JIA trial, is a Phase 3 study in children and young people with juvenile idiopathic arthritis.[1] It enrolled 188 participants and is completed.[1] The study asks whether adding intra-articular glucocorticoid injections, meaning steroid injections into the joint, to TNF inhibitor treatment helps more patients reach sustained inactive disease.[1]

The main endpoint is the proportion of participants with sustained inactive disease according to the Wallace 2011 criteria and no intra-articular or oral glucocorticoid use from week 24 to week 36.[1] In simple terms, the trial checks whether joint injections help children stay well for a longer time without needing more steroid treatment.[1]

Carpal tunnel syndrome study

NCT05306548, called NOR-CACTUS, is a Phase 3 study in people with carpal tunnel syndrome.[2] It is authorised and plans to include 258 participants.[2] The study compares an injection-based strategy with ultrasound-guided injections, up to two injections, scheduled follow-up visits, and surgery if needed, against a strategy where surgery is the main treatment.[2]

The primary outcome is successful treatment after one year, defined as a Boston Carpal Tunnel Questionnaire Symptom Score of 1.5 or lower.[2] This means the study is testing whether starting with injections can work as well as surgery for improving symptoms over 12 months.[2]

Rheumatoid arthritis study

NCT01491815 is a multicenter, randomized, open-label, blinded-assessor Phase 3 study in early rheumatoid arthritis.[3] It is authorised and has an enrollment of 705 participants.[3] The study compares active conventional therapy with three biologic treatments and also looks at two de-escalation strategies in people who respond to treatment.[3]

De-escalation means reducing treatment after a person has responded well.[3] Triamcinolone Hexacetonide appears in the treatment list as an intra-articular injection option in this study.[3] The study is designed to see how many patients reach remission and how joint damage changes over time.[3]

Main endpoints and outcome measures

Across the three studies, the main outcomes focus on disease control and treatment success.[1][2][3] In juvenile idiopathic arthritis, the endpoint is sustained inactive disease without extra steroid use between weeks 24 and 36.[1] In carpal tunnel syndrome, the endpoint is symptom score improvement at one year.[2] In rheumatoid arthritis, the endpoints include remission at week 24 and progression of the Sharp van der Heijde score at 48 weeks, which tracks joint damage on X-ray.[3]

Trial design, phases, and participants

All three studies are interventional trials, which means the researchers assign treatments and then measure what happens.[1][2][3] The data include Phase 3 studies for juvenile idiopathic arthritis, carpal tunnel syndrome, and rheumatoid arthritis, plus one Phase 4 study in early rheumatoid arthritis.[1][2][3] The target populations are children or young people with juvenile idiopathic arthritis, adults with carpal tunnel syndrome, and people with early rheumatoid arthritis.[1][2][3]

Trial ID Phase Condition studied Status Enrollment
NCT04614311 Phase 3 Juvenile Idiopathic Arthritis Completed 188
NCT05306548 Phase 3 Carpal Tunnel Syndrome Authorised 258
NCT01491815 Phase 3 Rheumatoid Arthritis Authorised 705

FAQ

  • What conditions are being studied with Triamcinolone Hexacetonide? The trials in this data study juvenile idiopathic arthritis, rheumatoid arthritis, and carpal tunnel syndrome. Each trial looks at a different treatment goal, such as disease control, remission, or symptom relief.
  • Who can take part in these trials? The target groups are patients with juvenile idiopathic arthritis, early rheumatoid arthritis, or carpal tunnel syndrome. Each study has its own entry rules, so not every person with these conditions will qualify.
  • What phases are the Triamcinolone Hexacetonide trials? The trials listed here are Phase 3 studies, and one is a Phase 4 study. Phase 3 studies usually compare treatments in larger groups, while Phase 4 studies look at treatment use after earlier testing.
  • What do the trials measure? The studies measure outcomes such as sustained inactive disease, remission, symptom score improvement, and treatment success after one year. One rheumatoid arthritis study also measures joint damage on X-ray using a score called the Sharp van der Heijde score.
  • Are these trials completed? One trial in juvenile idiopathic arthritis is completed. The other two trials are authorised, which means they have been approved to start or continue.

Ongoing Clinical Trials on Triamcinolone Hexacetonide

  • Study Comparing Conventional Therapy and Biologic Treatments for Early Rheumatoid Arthritis Using Hydroxychloroquine, Abatacept, and Azathioprine in Responsive Patients

    Not yet recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    Denmark Iceland Norway Sweden

  • Study on the Effectiveness of Triamcinolone Hexacetonide Injections for Juvenile Idiopathic Arthritis in Patients Starting TNF Inhibitor Treatment

    Not recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    Norway

  • Study Comparing Injection Therapy with Triamcinolone Acetonide and Triamcinolone Hexacetonide to Surgery for Carpal Tunnel Syndrome in Adults

    Not recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    Norway

Glossary

  • Juvenile Idiopathic Arthritis: A type of arthritis that begins in childhood. It causes joint inflammation, pain, swelling, and stiffness.
  • Rheumatoid Arthritis: A long-term disease where the immune system attacks the joints, causing pain, swelling, and possible joint damage.
  • Carpal Tunnel Syndrome: A condition where a nerve in the wrist is pressed or squeezed, which can cause numbness, pain, or weakness in the hand.
  • Phase 3: A later stage of clinical testing where a treatment is studied in larger groups to see how well it works and how safe it is compared with another option.
  • Phase 4: A study phase done after earlier testing, often to learn more about how a treatment performs in regular use.
  • Interventional study: A trial where researchers assign one or more treatments and then measure the results.
  • Remission: A period when signs and symptoms of a disease are very low or absent.
  • Inactive disease: A state where a disease shows no clear active signs.
  • CDAI: A score used in rheumatoid arthritis to measure how active the disease is.
  • Sharp van der Heijde score: An X-ray scoring system used to measure joint damage over time in rheumatoid arthritis.
  • Boston Carpal Tunnel Questionnaire Symptom Score: A questionnaire score that measures how bad carpal tunnel symptoms are.
  • Ultrasound-guided injection: An injection placed with the help of ultrasound imaging so it can be directed more accurately.

References