Phase 4 Psoriasis Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People aged between 18 and 80 years old
• People who have been diagnosed with psoriatic arthritis (PsA) for at least 6 months before joining, and who meet a standard set of classification criteria for PsA at the screening visit
• People whose psoriatic arthritis has not responded well enough to standard treatments, or who could not tolerate them (specifically methotrexate and/or TNF-blocking medications)
• People who have used certain non-biologic arthritis medications (such as methotrexate, sulfasalazine, hydroxychloroquine, or leflunomide) for at least 3 months, or anti-inflammatory pain medications (NSAIDs) for at least 4 weeks, for their psoriatic arthritis
• People for whom a doctor and relevant regulatory authorities consider the medication guselkumab to be an appropriate treatment option, either alone or combined with methotrexate
• People with a pain score above 15 mm on a standard pain scale (VAS) at the time of joining
• People with a disease activity score (DAPSA) above 14 at the time of joining
• People whose psoriatic arthritis fits at least one recognised pattern of the disease (confirm with trial site for which patterns apply)
• People who have at least 1 tender joint and at least 1 swollen joint in the limbs
• People with a C-reactive protein (a blood marker of inflammation) level of 0.3 mg/dL or higher
• People who have swelling in the wrist or knee joints
• People who have either never used biologic medications before, or who have previously used up to 2 TNF-blocking biologic medications that were stopped due to lack of benefit or intolerance, as assessed by the treating doctor
• People currently using certain non-biologic arthritis medications, provided the dose has been stable for the required period and causes no serious side effects (confirm exact requirements with trial site)
• People currently using anti-inflammatory pain medications (NSAIDs) or other pain relievers for PsA, provided the dose has been stable for at least 2 weeks before the first study treatment
• People who are willing to avoid complementary therapies for PsA or psoriasis (such as acupuncture or certain traditional medicines) from 2 weeks before the first study treatment through to week 52
• People who have given written informed consent to participate

Who may not be able to join:

• People diagnosed with fibromyalgia according to current classification criteria
• People with other inflammatory conditions (such as rheumatoid arthritis, lupus, or Lyme disease) that could interfere with assessing how well guselkumab is working
• People who have previously been treated with more than 2 TNF-blocking biologic medications
• People who have received certain TNF-blocking medications too recently before the start of the study (the required gap varies by medication — confirm with trial site)
• People who have previously been treated with guselkumab
• People diagnosed with a psychiatric disorder according to current diagnostic criteria
• People who are pregnant or breastfeeding
• People who have received steroid medications (either by injection into a joint or taken systemically throughout the body) in the 3 months before joining
• People who have previously received certain other biologic medications, including ustekinumab, abatacept, secukinumab, ixekizumab, and others (confirm full list with trial site)
• People who have previously received JAK inhibitor medications (such as tofacitinib or baricitinib) or apremilast
• People who have received certain immune-suppressing medications within 4 weeks before the first study treatment (confirm specific medications with trial site)
• People who have received non-biologic arthritis medications other than the four permitted ones (methotrexate, sulfasalazine, hydroxychloroquine, leflunomide) within 4 weeks before the first study treatment
• People currently using two or more of the permitted non-biologic arthritis medications at the time of joining
• People with a history of, or currently experiencing, severe or uncontrolled problems affecting the kidneys, liver, heart, blood vessels, lungs, digestive system, hormones, nervous system, blood, or metabolism
• People with unstable heart or cardiovascular disease, such as a recent serious cardiac event or hospitalisation for heart problems within the 3 months before screening
• People with a current cancer diagnosis or a history of cancer within the past 5 years (some exceptions may apply for certain treated skin and cervical conditions — confirm with trial site)
• People with a history of lymphoma or other lymph-related conditions, or signs suggesting such conditions
• People with a history of chronic or frequently recurring infections, including certain serious fungal, urinary, or chest infections, or open or infected skin wounds
• People who have received an organ transplant (with a possible exception for corneal transplants done more than 3 months before the study — confirm with trial site)
• People with a history of infection in a joint prosthesis that has not been removed or replaced
• People who have had a serious infection, or been hospitalised or received intravenous antibiotics for an infection, within 2 months before screening
• People who have had a shingles (herpes zoster) infection within 2 months before screening
• People who are pregnant, breastfeeding, or planning a pregnancy within 12 weeks after the last dose of the study medication (this applies to both men and women)
• People who have received, or are expected to receive, a live virus or bacterial vaccine within 3 months before the first study treatment
• People who have received a BCG vaccination within 12 months before screening
• People with known allergies or serious reactions to biologic medications, or to proteins used in making such medications
• People with known allergies or intolerance to guselkumab or any of its ingredients
• People with a history of certain serious granulomatous infections (such as histoplasmosis or coccidioidomycosis)
• People with an abnormal chest X-ray taken within 3 months before the first study treatment that suggests cancer, serious heart or lung disease, or active infection including tuberculosis (TB)
• People who have ever had a non-tuberculosis mycobacterial infection or certain other opportunistic infections
• People with HIV infection
• People who test positive for hepatitis B virus at screening
• People who test positive for hepatitis C virus antibodies at screening, unless specific negative test conditions have been met (confirm with trial site)
• People who have had major surgery requiring general anaesthesia within 8 weeks before screening, or who have major surgery planned during the study period (minor procedures under local anaesthesia may be acceptable — confirm with trial site)

Important: Always verify eligibility with the trial site directly before applying.