CLINICAL TRIAL

Guselkumab for Arthritis, Psoriatic

Recruiting · 18+ · All Sexes · Valencia, Spain

This study is evaluating whether guselkumab can help reduce symptoms of psoriatic arthritis.

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About the trial for Arthritis, Psoriatic

Eligible Conditions
Arthritis, Psoriatic · Arthritis

Treatment Groups

This trial involves 3 different treatments. Guselkumab is the primary treatment being studied. Participants will be divided into 3 treatment groups. Some patients will receive a placebo treatment. The treatments being tested are in Phase 4 and have been shown to be safe and effective in humans.

Experimental Group 1
Guselkumab
DRUG
Experimental Group 2
Guselkumab
DRUG
+
Placebo
DRUG
Experimental Group 3
Guselkumab
DRUG
+
Placebo
DRUG

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Guselkumab
FDA approved
Placebo
1995
Completed Phase 3
~2670

Eligibility

This trial is for patients born any sex aged 18 and older. There are 5 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Have a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score of at least 4, and have a spinal pain score (on a visual analog scale [VAS]) of at least 4
Have active plaque psoriasis, with at least 1 psoriatic plaque of >= 2 centimeter (cm) diameter and/or nail changes consistent with psoriasis, or documented history of plaque psoriasis
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Up to 60 weeks
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Up to 60 weeks.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Guselkumab will improve 1 primary outcome and 19 secondary outcomes in patients with Arthritis, Psoriatic. Measurement will happen over the course of Baseline and Week 24.

Change from Baseline in SPARCC Score for MRI Spine at Week 24
BASELINE AND WEEK 24
Change from baseline in SPARCC score for MRI spine at week 24 among the participants with a positive MRI of the spine at baseline will be reported. The SPARCC scoring system for the spine scores the 6 discovertebral units considered by the reader as the most abnormal, and then separately assesses each quadrant of 3 adjacent sagittal slices, with additional points for "depth" and high "intensity" of the lesion.
Percentage of Participants who Achieve a >= 50 % Improvement from Baseline in BASDAI Score at Week 24
BASELINE AND WEEK 24
Percentage of participants who achieve a >= 50 % improvement from baseline in BASDAI score at week 24 will be reported.
Change from Baseline in Spondyloarthritis Research Consortium of Canada (SPARCC) Score for Magnetic Resonance Imaging (MRI) Sacroiliac (SI) Joints at Week 24
BASELINE AND WEEK 24
Change from baseline in SPARCC score for MRI SI joints at week 24 among the participants with a positive MRI of the sacroiliac joints at baseline will be reported. SPARCC method focuses on the cartilaginous portion of the SI joint, and scores presence (score of 1) versus absence (score of 0) of bone marrow edema in each SI joint quadrant.
Change from Baseline in Disease Activity Index for Psoriatic Arthritis (DAPSA) at Week 24
BASELINE AND WEEK 24
DAPSA assessed the joint domain of psoriatic arthritis (PsA) and was derived from the sum of the following components: tender joint count (0-68), swollen joint count (0-66), CRP level (milligram/deciliter [mg/dL], value less than [<] lower limit of quantification [LLOQ] is considered equal to half of the value of LLOQ for numerical calculations), participant assessment of pain (0-10 cm VAS, 0=no pain, 10=worst possible pain), and participant's global assessment of disease activity on arthritis (0 to 10 cm VAS, 0=excellent and 10=poor). A higher score indicates more active disease activity. Negative changes from baseline indicate improvement of PsA disease activity. The assessment does not have a score range with an upper or lower bound.
Change from Baseline in Ankylosing Spondylitis Disease Activity Score-C-Reactive Protein (ASDAS-CRP) at Week 24
BASELINE AND WEEK 24
The ASDAS-CRP is a composite of 5 disease activity variables with only partial overlap. The 4 self-reported items included in this index are back pain (VAS), duration of morning stiffness, peripheral pain/swelling, and participant global assessment of disease activity; these are combined with the C-reactive protein (CRP) value. Selected cut-offs for improvement scores are: a change greater than or equal to (>=) 1.1 units for "clinically important improvement" and a change >= 2.0 units for "major improvement.
Change from Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score at Week 24
BASELINE AND WEEK 24
BASDAI is a self-assessment tool that consists of 6 questions relating to 5 major symptoms of ankylosing spondylitis: fatigue, spinal pain, joint pain, enthesitis, qualitative morning stiffness and quantitative morning stiffness. First 5 items were scored on a 10 centimeter (cm) visual analog scale (VAS) ranging from 0 equals to (=) none to 10=very severe. Quantitative morning stiffness was scored on a 10 cm VAS ranging from 0=0 hours to 10=2 or more hours. 2 scores for qualitative and quantitative morning stiffness were averaged, and total BASDAI score was average of the 5 scores of each symptom, ranging from 0 (none) to 10 (very severe). Higher scores indicate greater disease severity.
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Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the signs of arthritis, psoriatic?

Psoriatic arthritis, psoriatic arthritis + rheumatoid arthritis and psoriatic arthritis + rheumatoid arthritis + ankylosing spondylitis might have a similar presentation of joint signs and symptoms, but also a more severe form of the disease.

Anonymous Patient Answer

Can arthritis, psoriatic be cured?

We used to think that all forms of arthritis had a permanent nature, as there were many cases that did not respond to therapies. Now however, there are [clinic trials of disease remission]. The patient who will come for the therapy will be thoroughly analysed to ascertain their specific background. Then, the treatment will be determined accordingly. There are several treatments available to treat a patient with arthritis, including medications such as medications and biologics. The biologic medications are an important tool in relieving all forms of arthritis. For a patient that is in a certain phase of arthritis, it can be difficult to decide which therapy is better for the patient at that particular phase. The best clinical trials can help find the proper treatment for patient.

Anonymous Patient Answer

What are common treatments for arthritis, psoriatic?

Treatments for arthritis and psoriatic disease have been very similar to treatments for osteoarthritis. While steroids have been mostly restricted to mild cases, other drugs including COX-2 inhibitors, methotrexate and thiazolidinediones are also used (although, the latter group are largely restricted to those with more severe cases of the condition). While physiotherapy is often considered an adjunct or optional technique to joint replacement, it is generally preferred and is often successful in alleviating joint and nerve pain if it is used. Medication in arthritis or psoriasis is not so much targeted towards the symptoms (as are medications of arthritis or psoriatic disease), but towards relieving underlying causes.

Anonymous Patient Answer

What is arthritis, psoriatic?

A joint count, ESR, and HGA are generally useful tools in making a probable diagnosis of axial PsA. If there is doubt, a combination of joint counts with ESR and HGA results can be considered (e.g., two or more of joint counts, ESR, or HGA values >10 for the first of 2 joint counts). In general, radiographs are used only if (1) physical examination suggests a specific diagnosis other than axial PsA, (2) physical examination fails to distinguish between axial PsA and other diseases, or (3) radiographic findings suggest a specific diagnostic opinion.

Anonymous Patient Answer

What causes arthritis, psoriatic?

The development of [psoriatic arthritis](https://www.withpower.com/clinical-trials/psoriatic-arthritis) is unknown. The most likely causes are infections or exposure to cigarette smoke. The exact mechanism involved in the development of psoriatic arthritis is unknown and requires further evaluation. The presence of arthritis in patients with psoriasis is the hallmark symptom (signature symptom) for psoriatic arthritis, but joint manifestations may vary considerably between patients. Patients who develop psoriatic arthritis often have substantial pain and functional impairment. There is no cure for psoriatic arthritis. However, an intervention based on education and exercise can significantly improve symptoms.

Anonymous Patient Answer

How many people get arthritis, psoriatic a year in the United States?

Arthritis is very common and in 2006 there were an estimated 5.7 million affected in the United States. About 0.8 million of these were afflicted with [psoriatic arthritis](https://www.withpower.com/clinical-trials/psoriatic-arthritis). Arthritis affects nearly 1 million in the United States each year, and since arthritis is the cause of many chronic disabling conditions it has a significant economic importance in the United States.

Anonymous Patient Answer

What does guselkumab usually treat?

GLS-100 is effective in patients with rheumatoid arthritis and in patients with psoriasis. Compared with conventional therapies such as infliximab and adalimumab, GLS-100 is associated with few, serious, side effects requiring treatment adjustments. GLS-100 is an effective biologic option that should be considered if others have failed, especially in patients not responsive to conventional therapy.

Anonymous Patient Answer

What are the common side effects of guselkumab?

The common side effects reported in studies of guselkumab during dosing were injection-site reactions, [back pain](https://www.withpower.com/clinical-trials/back-pain), upper respiratory tract infections, skin rash, headache, itch, fatigue, weakness, nausea, dizziness, anxiety, constipation, and joint pain. These side effects are more common with increased dosage than with low dosage.

Anonymous Patient Answer

Is guselkumab safe for people?

There are no safety concerns regarding guselkumab in patients with psoriasis. This is contrary to a previous belief, and highlights the need for careful monitoring of patients receiving guselkumab.

Anonymous Patient Answer

Does guselkumab improve quality of life for those with arthritis, psoriatic?

The most important finding from the GURAGE study was that the addition of GLCs, when the patients were already receiving regular MTX therapy, resulted in improved OASI scores. Thus, clinicians and patients may benefit from the use of GLCs in combination with MTX.

Anonymous Patient Answer

Have there been other clinical trials involving guselkumab?

No positive/negative trial in any of the above indications has been reported. We recommend that when using guselkumab in clinical trials a special form of registration is needed in the country where it is being used. Guselkumab may be used for a subgroup of patients after having obtained the necessary ethics approval.

Anonymous Patient Answer

What are the latest developments in guselkumab for therapeutic use?

Guselkumab binds to the TNF alpha pathway, leading to the modulation of the production of cytokines and chemokines, and is associated with the improvement of skin and joint symptoms. Its mechanism of action is still not entirely clear.

Anonymous Patient Answer
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