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New treatment option for Psoriatic Arthritis
Official title A Study to Evaluate the Impact of Upadacitinib on Spondyloarthritis Outcomes in Patients With Active Psoriatic Arthritis
ClinicalTrials.gov ID: NCT06454188
What this study is testing
What is Upadacitinib 15 MG [Rinvoq]?
Upadacitinib 15 MG [Rinvoq] is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for psoriatic arthritis.
Also referred to as Rinvoq.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- A Randomized, Placebo-controlled, Multicenter, Study to Evaluate the Impact of Upadacitinib on Spondyloarthritis Outcomes in Patients with Active Psoriatic Arthritis (UP-SPOUT)
- Phase 4: studies an already-approved treatment
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Subject ≥18 of age at the screening visit.
- Subject must be able to understand and willing to adhere to all protocol requirements and voluntarily sign and date an informed consent, approved by...
- Diagnosis of PsA by their treating rheumatologist.
- Classification of PsA according to the CASPAR criteria19: Inflammatory articular disease (joint, spine, or entheseal) AND at least 3 points of the...
- Evidence of axial involvement (e.g., active inflammation, structural changes) that has been demonstrated by previous imaging techniques (e.g...
You likely can't join if
- , including inadequate response to 2 NSAIDs (inclusion criterion #9 - all countries), bioDMARD (Canada), and TNFi (US). The ASAS Classification...
- If people are currently taking bioDMARD therapy, they may be recruited after an appropriate wash-out period of bioDMARD prior to the screening MRI...
- Active infection(s) requiring treatment with parenteral anti-infectives within 30 days, or oral anti-infectives within 14 days prior to the baseline...
- Confirmed COVID-19: the baseline visit must be at least 14 days from onset of signs/symptoms or positive SARS-CoV-2 test; symptomatic people must...
- Suspected COVID-19: people with signs/symptoms suggestive of COVID-19, known exposure, or high-risk behavior should undergo molecular (e.g., PCR)...
- History of recurrent (more than one episode) herpes zoster or disseminated/multi-dermatomal (a single episode) herpes zoster or disseminated (a...
See the full eligibility criteria
Who can join
- Subject ≥18 of age at the screening visit.
- Subject must be able to understand and willing to adhere to all protocol requirements and voluntarily sign and date an informed consent, approved by an Independent Ethics Committee (IEC)/institutional review board...
- Diagnosis of PsA by their treating rheumatologist.
- Classification of PsA according to the CASPAR criteria19: Inflammatory articular disease (joint, spine, or entheseal) AND at least 3 points of the following categories: a) Evidence of psoriasis: (Score for one of the...
- Evidence of axial involvement (e.g., active inflammation, structural changes) that has been demonstrated by previous imaging techniques (e.g., radiography, MRI, CT), is considered indicative of axial disease by central...
- Screening/baseline MRI demonstrates definite active inflammation on MRI of SIJ and/or spine (ASAS definition of positive MRI and ≥4 SIJ quadrants with BME and/or ≥4 vertebral units with BME (in the absence of...
- Presence of chronic back pain in the 3 months prior to screening.
- Active disease as defined by a BASDAI value of ≥4 and TBP score of ≥4 (on a 0-10 NRS scale) at screening and baseline.
- History of an inadequate response to at least two different NSAIDs over a period of 4 weeks in total at the maximum recommended or tolerated doses, or intolerance/contraindication (e.g., allergic reaction...
- For all females of child-bearing potential: must not have a positive serum pregnancy test at the Screening Visit and must have a negative urine pregnancy test at Baseline prior to the first dose of study drug (local...
- Female people of childbearing potential must practice at least 1 protocol-specified method of birth control that is effective from Study Day 1 through at least 30 days after the last dose of study drug (local practices...
- Females must not be pregnant, breastfeeding, or considering becoming pregnant during the study and for approximately 30 days after the last dose of study drug. Females must commit to one of the following methods of...
- Combined (estrogen- and progestogen-containing) hormonal birth control (oral, intravaginal, transdermal, injectable) associated with inhibition of ovulation initiated at least 30 days prior to study baseline.
- Progestogen-only hormonal birth control (oral, injectable, implantable) associated with inhibition of ovulation initiated at least 30 days prior to study baseline.
- Bilateral tubal occlusion/ligation (can be via hysteroscopy, provided a hysterosalpingogram confirms success of the procedure) (For Japan: only bilateral tubal ligation).
- Intrauterine device (IUD).
- Intrauterine hormone-releasing system (IUS).
- Vasectomized sexual partner (the partner has received medical confirmation of the surgical success of the vasectomy and is the sole sexual partner of the trial subject).
- Practice true abstinence (unless not acceptable per local practices), defined as: refraining from heterosexual intercourse when this is in line with the preferred and usual lifestyle of the subject (periodic abstinence...
- If required per local practices, females of childbearing potential must commit to using 2 methods of contraception (either 2 highly effective methods or 1 highly effective method combined with 1 effective method)...
- Progestogen-only oral hormonal contraception, where inhibition of ovulation is not the primary mode of action, initiated at least 30 days prior to baseline.
- Male or female condom with or without spermicide.
- Cap, diaphragm, or sponge with spermicide.
- A combination of male condom with a cap, diaphragm, or sponge with spermicide (double barrier method).
- In questionable cases of menopausal status, a blood sample with simultaneous levels of follicle stimulating hormone (FSH) above 40 U/l and estradiol below 30 pg/ml is confirmatory.
- people who are regularly taking NSAIDs or analgesics (including mild opioids) as part of their PsA therapy are required to be on a stable dose/dose regimen for at least 14 days prior to the baseline visit. If entering...
- people taking oral corticosteroids must be on an average daily and stable dose of ≤10mg/day prednisone or equivalent for at least 14 days prior to the baseline visit.
- people taking topical therapies (e.g., topical JAKi, salicylic acid preparations, corticosteroids, retinoids) are allowed, but must be on a stable dose at least 4 weeks prior to the BL visit.
- people entering the study on the following concomitant csDMARDs must be on a stable dose as indicated below for at least 28 days prior to the baseline Visit (in case of Leflunomide washout must be either 8 weeks or 4...
- MTX (≤ 25 mg/week); or
- Sulfasalazine (SSZ) (≤ 3 g/day); or
- Hydroxychloroquine (≤ 400 mg/day); or
- Chloroquine (≤ 250 mg/day); or
- Leflunomide (≤ 20 mg/day); or
- Apremilast (≤ 60 mg/day)
- people must have been treated for ≥ 3 consecutive months prior to the study entry with DMARD therapy (including csDMARD and/or bDMARD) and/or for ≥4 weeks of NSAID therapy (if csDMARDs are not indicated for their axial...
- people recruited in Europe: people must have previously been treated with one or more DMARD (csDMARD as defined in inclusion criterion 15, and/or bDMARD) and deemed to be inadequate responders and/or intolerant.
- people recruited in the US: people must be TNFi-IR. In this study, an IR to TNFi therapy will be defined as patients who discontinue TNFi due to lack of how well it works based on the investigators' assessment or...
- people recruited in Canada: people must have previously been treated with one or more DMARD (csDMARD as defined in inclusion criterion 15, and/or bDMARD) and deemed to be inadequate responders and/or intolerant.
- Up to 20 patients presenting with purely axial disease and current psoriasis (at the time of screening) may be included in the study. These patients may have had a past history of joint involvement, but do not currently...
What rules you out
- , including inadequate response to 2 NSAIDs (inclusion criterion #9 - all countries), bioDMARD (Canada), and TNFi (US). The ASAS Classification Criteria for axSpA are provided in Appendix A.
- If people are currently taking bioDMARD therapy, they may be recruited after an appropriate wash-out period of bioDMARD prior to the screening MRI. Prior exposure to a bioDMARD is allowed for no more than 75 people, and...
- Active infection(s) requiring treatment with parenteral anti-infectives within 30 days, or oral anti-infectives within 14 days prior to the baseline Visit; Chronic recurring infection and/or active viral infection that...
- Confirmed COVID-19: the baseline visit must be at least 14 days from onset of signs/symptoms or positive SARS-CoV-2 test; symptomatic people must have recovered, defined as resolution of fever without use of...
- Suspected COVID-19: people with signs/symptoms suggestive of COVID-19, known exposure, or high-risk behavior should undergo molecular (e.g., PCR) testing to rule out SARS-CoV-2 infection or must be asymptomatic for 14...
- History of recurrent (more than one episode) herpes zoster or disseminated/multi-dermatomal (a single episode) herpes zoster or disseminated (a single episode) herpes simplex.
- Primary or secondary immunodeficiency.
- Current clinical signs and symptoms suggestive for tuberculosis.
- Tuberculosis Interferon Gamma Release Assay (IGRA) serum test and abnormal chest x-ray (positive x-ray) suggestive of past or present tuberculosis (both at screening, may be accepted if performed within 180 days prior...
- Chronic infection with hepatitis B virus. At screening HBsAg and anti-HBc will be tested. Patients who are HBsAg positive will be excluded. In case of HBsAg negativity, but anti-HBc positivity, participation in the...
- Chronic infection with hepatitis C (HCV) (HCV ribonucleic acid (RNA) detectable in any subject with anti-HCV antibody (HCV Ab), or Human Immunodeficiency Virus (HIV) infection confirmed by positive anti-HIV antibody...
- Female people who are breastfeeding, pregnant, or plan to become pregnant during the study or within 4 weeks following the last dose of study drug.
- people with chronic inflammatory articular disease (other than PsO or PsA or SpA), or systemic autoimmune diseases, e.g., systemic lupus erythematosus, Sjögren´s syndrome, RA, unequivocal chronic fatigue syndrome, or...
- Concomitant treatment with strong inductors or inhibitors of cytochrome P450 3A (e.g., Ketoconazole, Fluconazole, Rifampicin, Clarithromycin, St-John´s-wort). Strong CYP3A Inhibitors:
- Boceprevir
- Cobicistat
- Clarithromycin
- Conivaptan
- Grapefruit (fruit or juice)
- Indinavir
- Itraconazole
- Ketoconazole
- Lopinavir/Ritonavir
- Mibefradil
- Nefazodone
- Nelfinavir
- Posaconazole
- Ritonavir
- Saquinavir
- Telaprevir
- Telithromycin
- Troleandomycin
- Voriconazole Strong CYP3A Inducers:
- Carbamazepine
- Phenytoin
- Rifampin
- Rifapentine
- St. John's Wort Information regarding potential drug interactions with upadacitinib can be located in the upadacitinib Investigator's Brochure.
- Prior treatment with upadacitinib or another JAK-inhibitor or TYK2-inhibitor.
- History of hypersensitivity to any component of upadacitinib tablets.
- Treatment with intravenous, intramuscular or intraarticular/periarticular, or intrarectal steroids within 4 weeks prior to baseline Visit; treatment with oral steroids in a dose of \>10 mg prednisolone equivalent per...
- Subject must not have been treated with any investigational drug of chemical or biologic nature within a minimum of 30 days or five half-lives (whichever is longer) prior to the first dose of study drug or is currently...
- History of an infected joint prosthesis at any time, with the prosthesis still in situ.
- Actual malignancies or history of malignancies with curative treatment within 5 years prior to screening, except successfully treated non-metastatic squamous cell or basal cell carcinoma of the cutis or carcinoma in...
- A subject with any condition possibly affecting oral drug absorption, e.g., gastrectomy, clinically significant diabetic gastroenteropathy, or certain types of bariatric surgery such as gastric bypass. Procedures such...
- Significant trauma or surgery procedure within 4 weeks prior to baseline or any preplanned elective surgery during the study period.
- Evidence of other severe uncontrolled gastrointestinal, hepatic (serum albumin \ 10), renal, pulmonary, cardiovascular, nervous or endocrine disorders.
- Any history of prior cardiovascular event, including but not limited to cerebrovascular accident, myocardial infarction, coronary stenting, and aorto-coronary bypass surgery.
- History of thrombosis and/or hematological disorder increasing the propensity to thrombosis.
- Any subject who has been vaccinated with live or attenuated vaccines within the 4 weeks prior to the first dose of study medication or is to be vaccinated with these vaccines at any time during treatment or within 4...
- Examples of live vaccines include, but are not limited to, the following:
- Monovalent live influenza A (H1N1) (intranasal);
- Seasonal trivalent live influenza (intranasal);
- Zostavax (herpes zoster, live attenuated);
- Rotavirus;
- Varicella (chicken pox);
- Measles-mumps-rubella or measles-mumps-rubella-varicella;
- Oral polio vaccine;
- Smallpox;
- Yellow fever;
- Bacille Calmette-Guérin;
- Typhoid (oral).
- Administration of inactivated (non-replicating) vaccines is permitted prior to or during the study according to local practice guidelines. Examples of common vaccines that are inactivated, toxoid or biosynthetic...
- Any of the following lab abnormalities detected at screening:
- Hemoglobin \<8 g/dl;
- Absolute neutrophil count \<1.0 x 109/L (\<1000/mm3)
- Absolute lymphocyte count \<0.50 x 109/L (\<750/mm3)
- Platelet count \<100 x 109/L (\<100,000/mm3).
- Patients with contraindications for the MRI including but not limited to claustrophobia, seizure disorders, presence of an implanted electronic device (e.g. heart pacemaker, insulin pump, etc.) or metal implants not...
The study team makes the final eligibility decision.
Where it's taking place
- Cleveland, Ohio, United States
- Portland, Oregon, United States
- Philadelphia, Pennsylvania, United States
- Ottawa, Ontario, Canada
- Québec, Quebec, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Cleveland, Ohio, United States; Portland, Oregon, United States; Philadelphia, Pennsylvania, United States; Ottawa, Ontario, Canada; Québec, Quebec, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.