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Attivo ma non reclutanteFASE3INTERVENTISTICO

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.

A colpo d'occhio

Stato
Attivo ma non reclutante
Fase
FASE3
Sponsor
Janssen Ricerca & Sviluppo, LLC
Obiettivo di iscrizione
1,054
Inizio
17 Jun 2021
Completamento stimato
05 Oct 2027

Risultati

Risultati di questo studio

Pubblicato February 2026

I risultati di questo studio sono stati pubblicati.

Risultato principale
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.
Risultati completi nel registro

Di cosa tratta questo studio?

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.

Punti chiave

  • 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.

Chi può essere idoneo?

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.

Questo studio potrebbe fare al caso tuo?

Rispondi a queste domande rapide per vedere se potresti essere idoneo. Questo è solo una guida — il team di ricerca prende la decisione finale.

  1. Hai 18 anni o più?
  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?
Rispondi a ogni domanda per vedere il tuo risultato.

Cosa comporta la partecipazione?

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.

Rischi e benefici potenziali

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

Domande comuni

Che cos'è il guselkumab?

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

Che cos'è l'artrite psoriasica?

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

Che cos'è un 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.

Perché questo studio è importante?

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

Posso lasciare lo studio una volta che mi sono unito?

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

Come saperne di più

Parla sempre con il tuo medico di base o specialista prima di decidere di partecipare a uno studio.

Discussione

Discussione della comunità

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