Phase 4 Psoriatic Arthritis 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 who are 18 years of age or older at the time of their screening visit.
• People who are able to understand the study requirements and are willing to sign a consent form before any study procedures begin.
• People who have been diagnosed with Psoriatic Arthritis (PsA) by a rheumatologist.
• People whose PsA has been classified using a standard scoring system called CASPAR criteria, which involves having inflammatory joint, spine, or tendon disease, plus evidence of psoriasis and other related features that add up to a required score.
• People who have evidence of spine or joint involvement confirmed by previous imaging such as X-ray, MRI, or CT scan, and confirmed by independent specialist review.
• People whose MRI scan at the start of the study shows definite active inflammation in the spine or sacroiliac joints (the joints at the base of the spine), as assessed by specialist readers.
• People who have had chronic back pain for at least 3 months before the screening visit.
• People with active disease shown by specific scoring tools (BASDAI score of 4 or more and a back pain score of 4 or more out of 10) at both screening and the baseline visit.
• People who have tried at least two different anti-inflammatory pain medications (NSAIDs) at the highest recommended or tolerated doses for a total of at least 4 weeks without adequate relief, or who cannot take NSAIDs due to side effects or other medical reasons.
• Women who could become pregnant must have a negative pregnancy test at screening and again before the first dose of study medication.
• Women who could become pregnant must use at least one highly effective form of contraception from the start of the study until at least 30 days after the last dose (some locations may require two methods). Accepted methods include hormonal contraception that prevents ovulation, an IUD or hormone-releasing device, tubal ligation, a vasectomised partner (with medical confirmation), or true abstinence from heterosexual intercourse in line with the person's usual lifestyle. Periodic methods such as calendar-based tracking or withdrawal are not accepted.
• People who are regularly taking anti-inflammatory pain medications (NSAIDs) or pain relief (including mild opioids) must be on a stable dose for at least 14 days before the baseline visit. Strong opioids (except certain paracetamol/codeine or paracetamol/hydrocodone combinations) must not have been used within 14 days before the baseline visit.
• People taking oral steroid medications must be on a stable dose of no more than the equivalent of 10mg per day of prednisone for at least 14 days before the baseline visit.
• People using topical skin treatments (such as topical steroids or salicylic acid) must have been on a stable dose for at least 4 weeks before the baseline visit.
• People taking certain disease-modifying medications (csDMARDs) such as methotrexate, sulfasalazine, hydroxychloroquine, chloroquine, leflunomide, or apremilast must be on a stable dose within specified limits for at least 28 days before the baseline visit. Up to two of these medications may be taken together, except methotrexate and leflunomide cannot be combined.
• People who have been on disease-modifying treatment (csDMARD and/or bDMARD) for at least 3 consecutive months, or NSAID therapy for at least 4 weeks, before joining the study, but who still have active disease — or who had to stop previous treatment due to side effects or toxicity.
• People recruited in Europe or Canada must have previously tried one or more disease-modifying medications (csDMARD or bDMARD) and not responded adequately or not tolerated them.
• People recruited in the United States must have previously tried a TNF-inhibitor medication and either not responded adequately or not tolerated it.
• People who are currently on a biological disease-modifying medication (bioDMARD) may be considered after an appropriate period of stopping that medication before the screening MRI (specific waiting periods vary by medication, ranging from 4 to 20 weeks depending on which medication was used). Prior use of up to two bioDMARDs may be acceptable within set limits.

Who may not be able to join:

• People who have an active infection requiring intravenous antibiotics within the past 30 days, or oral antibiotics within the past 14 days before the baseline visit, or who have a chronic or recurring infection that the study doctor considers a safety concern.
• People with a confirmed COVID-19 diagnosis unless at least 14 days have passed since symptoms started or a positive test, and symptoms (including fever) have fully resolved.
• People with suspected COVID-19 who have symptoms, known exposure, or high-risk behaviour, unless a molecular test (such as PCR) rules out infection, or they have been symptom-free for 14 days after a potential exposure.
• People with a history of herpes zoster (shingles) occurring more than once, or a single episode that spread widely across the body, or a single episode of widely spread herpes simplex.
• People with a primary or secondary immune system deficiency.
• People who currently have signs or symptoms suggesting tuberculosis (TB).
• People who test positive on a TB blood test (IGRA) and have an abnormal chest X-ray suggesting past or present TB. People with a positive TB blood test but a normal chest X-ray and no symptoms may be able to participate after completing at least 2 weeks of standard preventive TB treatment, as long as they do not need to take rifampin alongside the study medication (confirm with trial site).
• People with a chronic hepatitis B infection (those who test positive for HBsAg). People who test negative for HBsAg but positive for anti-HBc may still be eligible if their hepatitis B DNA test is negative and liver function is normal (confirm with trial site).
• People with a chronic hepatitis C infection where the virus is detectable in the blood, or people with HIV confirmed by a positive antibody test.
• Women who are breastfeeding, pregnant, or planning to become pregnant during the study or within 4 weeks after the last dose of study medication.
• People with other chronic inflammatory joint diseases (other than psoriasis, PsA, or related spinal conditions), or systemic autoimmune conditions such as lupus, Sjögren's syndrome, or rheumatoid arthritis. People with Crohn's disease or ulcerative colitis may be considered if they have had no active symptoms in the 4 weeks before the baseline visit.
• People who are currently taking certain medications that strongly affect how the body processes drugs (specific CYP3A inhibitors or inducers), including ketoconazole, clarithromycin, rifampin, carbamazepine, phenytoin, and St. John's Wort, among others (confirm with trial site for the full list).
• People who have previously been treated with upadacitinib (the study drug) or any other JAK-inhibitor or TYK2-inhibitor medication.
• People with a known allergy to any ingredient in upadacitinib tablets.
• People who have received steroid injections (into a vein, muscle, joint, or rectum) within 4 weeks before the baseline visit, or who are taking oral steroids at more than 10mg per day of prednisolone equivalent.
• People who have taken any other experimental drug within 30 days or five half-lives (whichever is longer) before the first dose of study medication, or who are currently in another interventional clinical study.
• People who have ever had an infected joint prosthesis (artificial joint) that is still in place.
• People who currently have cancer, or who had cancer treated within the past 5 years, except for certain successfully treated skin cancers (non-spreading squamous or basal cell skin cancer) or cervical carcinoma in situ.
• People with a condition that significantly affects how oral medication is absorbed, such as having had a gastric bypass or most of the stomach surgically removed (confirm with trial site).
• People who have had major surgery or significant physical trauma within 4 weeks before the baseline visit, or who have planned surgery during the study period.
• People with severe uncontrolled conditions affecting the liver, kidneys, gut, lungs, heart, nervous system, or hormones.
• People with any history of a cardiovascular event, including stroke, heart attack, coronary stenting, or bypass surgery.
• People with a history of blood clots (thrombosis) or a blood disorder that increases the risk of clotting.
• People who have received a live or live-attenuated vaccine within 4 weeks before the first dose of study medication, or who plan to receive one at any point during treatment or within 4 weeks after the last dose. Examples include certain flu nasal sprays, shingles (Zostavax), chickenpox, measles-mumps-rubella, oral polio, yellow fever, and oral typhoid vaccines. Non-live (inactivated) vaccines are generally permitted. When possible, COVID-19 vaccination should not occur within 7 days before or after starting the study drug.
• People whose blood test results at screening show any of the following: haemoglobin below 8 g/dl, very low neutrophil count, very low lymphocyte count, or platelet count below 100,000 per cubic millimetre.
• People who are unable to have an MRI scan, for example due to claustrophobia, seizure disorders, certain implanted electronic devices (such as a pacemaker or insulin pump), metal implants that are not confirmed as MRI-safe, suspected magnetic metal foreign bodies in the body, or large tattoos made with metal-containing inks.

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