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Aktiv, aber nicht rekrutierendPHASE3INTERVENTIONELL

A Study of Guselkumab in Participants With Active Psoriatic Arthritis

This research is investigating a new medication, guselkumab, for individuals living with active psoriatic arthritis, a condition that causes painful and swollen joints, and can also affect the skin. The main goal is to find out how effective guselkumab is at reducing these symptoms and improving overall quality of life, compared to a placebo (a treatment that looks the same but has no active medicine). This is a Phase 3 study, which means it's a later stage of research, usually involving more people, to confirm if the new medicine works and is safe. The study will look at how guselkumab helps with joint pain, swelling, and skin changes caused by psoriatic arthritis.

Auf einen Blick

Status
Aktiv, aber nicht rekrutierend
Phase
PHASE3
Sponsor
Janssen Research & Development, LLC
Einschreibeziel
1,054
Starten
17 Jun 2021
Geschätzte Fertigstellung
05 Oct 2027
Psoriasis-Arthritis

Ergebnisse

Ergebnisse dieser Studie

Veröffentlicht February 2026

Die Ergebnisse dieser Studie wurden veröffentlicht.

Hauptausgang
Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 20 Response at Week 24
ACR 20 response: \>=20% improvement from baseline (bl) in both swollen (66 joints), tender (68 joints) joint count, \>=20% improvement from bl in 3 of 5 assessments: patient's assessment of pain using visual analog scale (VAS; 0-100mm, 0=no pain, 100=worst possible pain), patient's global assessment of disease activity (arthritis, VAS; 0-100mm, 0=excellent, 100=poor), physician's global assessment of disease activity (VAS; 0-100mm, 0=no arthritis activity,100=extremely active arthritis), HAQ-DI (questionnaire assessing 8 functional areas; 0-3, 0=no difficulty, 3=inability to perform task in area), and CRP. Natural Disaster (ND)-site inaccessible due to COVID-19. Major Disruption (MD)-disruption involving Ukraine and neighboring countries/territories. Intercurrent event (ICE) handling: Composite-discontinue study drug not due to ND/MD, initiate/increase DMARD/oral corticosteroid, initiate prohibited PsA treatment; Hypothetical-discontinue/severe noncompliance of study drug due to ND/MD.
Vollständige Ergebnisse im Register

Worum geht es in dieser Studie?

This study is looking into a new medicine called guselkumab for people who have active psoriatic arthritis. Psoriatic arthritis is a type of arthritis that affects some people who have psoriasis, a skin condition. It can cause joints to become painful, stiff, and swollen, and can also affect other parts of the body like the nails. The goal of this research is to see if guselkumab can help reduce these symptoms and improve a person's quality of life. This is really important because finding effective treatments can make a big difference for people living with psoriatic arthritis.

During the study, some participants will receive guselkumab, while others will receive a 'placebo.' A placebo looks just like the real medicine but contains no active drug. This allows the researchers to fairly compare the effects of guselkumab against no treatment, helping them understand if any improvements are truly due to the new medicine. This kind of study helps scientists gather strong evidence about how well a new treatment works and if it's safe.

The findings from this study will help doctors and patients understand if guselkumab could be a good treatment option for psoriatic arthritis in the future. It's about finding better ways to manage the condition and improve health for those affected by it.

Wichtige Erkenntnisse

  • This study is testing a new medicine called guselkumab for psoriatic arthritis.
  • It aims to see if guselkumab can reduce joint pain, swelling, and other symptoms.
  • Some participants will receive the study medicine, others a dummy treatment (placebo).
  • You would need to have active psoriatic arthritis that hasn't fully responded to previous treatments.
  • Regular health checks and clinic visits would be part of your participation.
  • You can stop participating at any time without affecting your normal care.

Wer könnte berechtigt sein?

To join this study, you would need to have active psoriatic arthritis that hasn't fully improved with previous treatments like certain anti-rheumatic drugs, apremilast, or anti-inflammatory medicines. Your doctor would confirm your psoriatic arthritis diagnosis, and you'd need to have specific signs of active disease, such as at least three swollen and three tender joints, and certain levels of a protein called C-reactive protein (CRP) in your blood.

You also need to have at least two joints in your hands or feet showing some damage on X-rays, and your psoriatic arthritis should affect certain types of joints, or you should have active psoriasis on your skin or nails. Participants must be 18 years old or older.

However, you couldn't take part if you have allergies to the study medicine, or if you have other inflammatory conditions like rheumatoid arthritis or lupus, as these might make it hard to tell if guselkumab is working specifically for psoriatic arthritis. You also wouldn't be able to join if you've already had certain types of biologic treatments or specific new medications called JAK inhibitors, or if you've recently taken certain strong medicines that suppress your immune system.

Könnte diese Studie für Sie geeignet sein?

Beantworten Sie diese kurzen Fragen, um zu sehen, ob Sie möglicherweise berechtigt sind. Dies ist nur ein Leitfaden – das Forschungsteam trifft die endgültige Entscheidung.

  1. Sind Sie 18 Jahre alt oder älter?
  2. Do you have active psoriatic arthritis that other medicines haven't fully helped?
  3. Do you have at least three swollen and three tender joints?
  4. Have you NOT previously received certain biologic treatments or specific new medications called JAK inhibitors?
  5. Do you have active psoriasis on your skin or nails, or certain types of joint involvement?
  6. Are you able to attend regular clinic visits and follow study instructions?
Beantworten Sie jede Frage, um Ihr Ergebnis zu sehen.

Was beinhaltet die Teilnahme?

If you decide to take part in this study, you would receive either the study medicine, guselkumab, or a placebo (a dummy medicine). You wouldn't know which one you're receiving, and neither would your doctor, which helps to keep the study fair. You would have regular visits to the clinic for assessments, which will likely include physical examinations, blood tests, and possibly X-rays, to see how your psoriatic arthritis is responding to the treatment.

These visits are important for monitoring your health and checking for any side effects. You'd be asked to follow specific instructions about taking the study medication. The study will involve a number of visits over a period of time, and the research team will explain the full schedule to you before you agree to participate. They will also keep a close eye on your progress and well-being throughout the entire study.

Potenzielle Risiken und Vorteile

Taking part in this study might offer potential benefits, such as receiving a new treatment that could improve your psoriatic arthritis symptoms. You would also be closely monitored by healthcare professionals. However, there are also potential risks, including side effects from the study medication, which will be fully explained to you. The placebo treatment means you might not receive any active medicine for a period. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (280)

  • Rheumatology Associates
    Verifizierte Postleitzahl
    Birmingham, Vereinigte Staaten
  • Arizona Arthritis and Rheumatology Research PLLC
    Verifizierte Postleitzahl
    Flagstaff, United States
  • Arizona Arthritis & Rheumatology Associates PC
    Verifizierte Postleitzahl
    Glendale, Vereinigte Staaten
  • Arizona Arthritis & Rheumatology Research, PLLC
    Verifizierte Postleitzahl
    Tucson, Vereinigte Staaten
  • Advanced Medical Research
    Verifizierte Postleitzahl
    La Palma, United States
  • Rheumatology Center of San Diego
    Verifizierte Postleitzahl
    San Diego, Vereinigte Staaten
  • Medvin Clinical Research, Inc.
    Verifizierte Postleitzahl
    Whittier, Vereinigte Staaten
  • Heuer M.D. Research
    Verifizierte Postleitzahl
    Orlando, Vereinigte Staaten
  • The Arthritis Center, Inc.
    Verifizierte Postleitzahl
    Palm Harbor, United States
  • Forcare Clinical Research Inc
    Verifizierte Postleitzahl
    Tampa, Vereinigte Staaten
  • Klein And Associates M D P A
    Verifizierte Postleitzahl
    Hagerstown, United States
  • Advanced Rheumatology
    Verifizierte Postleitzahl
    Okemos, United States

Häufige Fragen

Was ist Guselkumab?

Guselkumab is a medicine being tested to see if it can help people with psoriatic arthritis by reducing their symptoms.

Was ist Psoriasis-Arthritis?

Psoriatic arthritis is a type of arthritis that causes joint pain, swelling, and stiffness, often affecting people who also have psoriasis, a skin condition.

Was ist ein Placebo?

A placebo is a 'dummy' treatment that looks like the real medicine but contains no active drug. It helps researchers compare the new medicine's effects accurately.

Warum ist diese Studie wichtig?

This study aims to find out if guselkumab is an effective and safe treatment for psoriatic arthritis, potentially offering a new option for patients.

Can I leave the study once I've joined?

Yes, you can choose to leave the study at any time, for any reason, and this won't affect your regular medical care.

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