A Study to Evaluate the Impact of Upadacitinib on Spondyloarthritis Outcomes in Patients With Active Psoriatic Arthritis

Phase 4

Not yet recruiting

• Conditions: Psoriatic Arthritis; Spondyloarthritis, Axial

• Registration Number: NCT06454188
• Lead Sponsor: CARE ARTHRITIS LTD.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-6-6
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Not yet recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Inclusion Criteria:<br><br> 1. Subject =18 of age at the screening visit.<br><br> 2. Subject must be able to understand and willing to adhere to all protocol<br> requirements and voluntarily sign and date an informed consent, approved by an<br> Independent Ethics Committee (IEC)/institutional review board (IRB), prior to the<br> initiation of any screening or study-specific procedures.<br><br> 3. Diagnosis of PsA by their treating rheumatologist.<br><br> 4. Classification of PsA according to the CASPAR criteria19: Inflammatory articular<br> disease (joint, spine, or entheseal) AND at least 3 points of the following<br> categories:<br><br> a) Evidence of psoriasis: (Score for one of the following) i) Current psoriasis - 2<br> points (Psoriatic skin or scalp disease present today as judged by a dermatologist<br> or rheumatologist) ii) Personal history of psoriasis - 1 point (A history of<br> psoriasis that may be obtained from the subject, family physician, dermatologist,<br> rheumatologist, or other qualified health care provider) iii) Family history of<br> psoriasis - 1 point (A history of psoriasis in a first- or second-degree relative<br> according to subject report) b) Psoriatic nail dystrophy - 1 point i) Typical<br> psoriatic nail dystrophy, including onycholysis, pitting, and hyperkeratosis,<br> observed on current physical examination c) A negative test for rheumatoid factor -<br> 1 point i) By any method except latex, but preferably by enzyme-linked immunosorbent<br> assay (ELISA) or nephelometry, according to the local laboratory reference range d)<br> Dactylitis: (Score for 1 of the following) i) Current dactylitis - 1 point (Swelling<br> of an entire digit) ii) History of dactylitis - 1 point (A history of dactylitis<br> recorded by a rheumatologist) e) Radiologic evidence of juxta-articular new bone<br> formation - 1 point i) Ill-defined ossification near joint margins (but excluding<br> osteophyte formation) on plain radiographs of the hand or foot.<br><br> 5. Evidence of axial involvement (e.g., active inflammation, structural changes) that<br> has been demonstrated by previous imaging techniques (e.g., radiography, MRI, CT),<br> is considered indicative of axial disease by central reader assessment (2 readers<br> and adjudicator).<br><br> 6. Screening/baseline MRI demonstrates definite active inflammation on MRI of SIJ<br> and/or spine (ASAS definition of positive MRI and =4 SIJ quadrants with BME and/or<br> =4 vertebral units with BME (in the absence of degenerative disc disease at those<br> discovertebral units with BME)) as determined by central readers.<br><br> 7. Presence of chronic back pain in the 3 months prior to screening.<br><br> 8. Active disease as defined by a BASDAI value of =4 and TBP score of =4 (on a 0-10 NRS<br> scale) at screening and baseline.<br><br> 9. History of an inadequate response to at least two different NSAIDs over a period of<br> 4 weeks in total at the maximum recommended or tolerated doses, or<br> intolerance/contraindication (e.g., allergic reaction, gastrointestinal symptoms or<br> signs, severe arterial hypertension, etc.) for NSAIDs.<br><br> 10. For all females of child-bearing potential: must not have a positive serum pregnancy<br> test at the Screening Visit and must have a negative urine pregnancy test at<br> Baseline prior to the first dose of study drug (local practices may require serum<br> pregnancy testing at Baseline). Subjects with a borderline serum pregnancy test at<br> Screening must have absence of clinical suspicion of pregnancy or other pathological<br> causes of borderline results and a serum pregnancy test =3 days later to document<br> continued lack of a positive result (unless prohibited by local requirements).<br><br> 1. Female subjects of childbearing potential must practice at least 1<br> protocol-specified method of birth control that is effective from Study Day 1<br> through at least 30 days after the last dose of study drug (local practices may<br> require 2 methods of birth control). Female subjects of non-childbearing<br> potential do not need to use birth control.<br><br> 2. Females must not be pregnant, breastfeeding, or considering becoming pregnant<br> during the study and for approximately 30 days after the last dose of study<br> drug. Females must commit to one of the following methods of highly effective<br> birth control:<br><br> - Combined (estrogen- and progestogen-containing) hormonal birth control<br> (oral, intravaginal, transdermal, injectable) associated with inhibition<br> of ovulation initiated at least 30 days prior to study baseline.<br><br> - Progestogen-only hormonal birth control (oral, injectable, implantable)<br> associated with inhibition of ovulation initiated at least 30 days prior<br> to study baseline.<br><br> - Bilateral tubal occlusion/ligation (can be via hysteroscopy, provided a<br> hysterosalpingogram confirms success of the procedure) (For Japan: only<br> bilateral tubal ligation).<br><br> - Intrauterine device (IUD).<br><br> - Intrauterine hormone-releasing system (IUS).<br><br> - Vasectomized sexual partner (the partner has received medical confirmation<br> of the surgical success of the vasectomy and is the sole sexual partner of<br> the trial subject).<br><br> - Practice true abstinence (unless not acceptable per local practices),<br> defined as: refraining from heterosexual intercourse when this is in line<br> with the preferred and usual lifestyle of the subject (periodic abstinence<br> [e.g., calendar, ovulation, symptothermal, post-ovulation methods] and<br> withdrawal are not acceptable).<br><br> 11. If required per local practices, females of childbearing potential must commit to<br> using 2 methods of contraception (either 2 highly effective methods or 1 highly<br> effective method combined with 1 effective method). Effective methods of birth<br> control are the following:<br><br> - Progestogen-only oral hormonal contraception, where inhibition of ovulation is<br> not the primary mode of action, initiated at least 30 days prior to baseline.<br><br> - Male or female condom with or without spermicide.<br><br> - Cap, diaphragm, or sponge with spermicide.<br><br> - A combination of male condom with a cap, diaphragm, or sponge with spermicide<br> (double barrier method).<br><br> - In questionable cases of menopausal status, a blood sample with simultaneous<br> levels of follicle stimulating hormone (FSH) above 40 U/l and estradiol below<br> 30 pg/ml is confirmatory.<br><br> 12. Subjects who are regularly taking NSAIDs or analgesics (including mild opioids) as<br> part of their PsA therapy are required to be on a stable dose/dose regimen for at<br> least 14 days prior to the baseline visit. If entering the study on concomitant<br> tramadol, combination of acetaminophen/paracetamol and codeine or combination of<br> acetaminophen/paracetamol and hydrocodone, and/or non-opioid analgesics, subject<br> must be on stable dose(s) for at least 14 days prior to the baseline Visit. However,<br> subject must not have used opioid analgesics (except for combination of<br> acetaminophen/paracetamol and codeine or combination of acetaminophen/paracetamol<br> and hydrocodone which are allowed) within 14 days prior to the BL Visit.<br>

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change from baseline in the (SPARCC) MRI inflammation score (for SIJ and spine) at 12 weeks of therapy with upadacitinib vs placebo in the DMARD-IR (conventional and/or biologic) subgroup

Secondary Outcome Measures

Name	Time	Method
Change from baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS-CRP) at Week 12 with upadacitinib vs placebo in the DMARD-IR (conventional and/or biologic) subgroup;Change from Baseline in BASDAI at Week 12 with upadacitinib vs placebo in the DMARD-IR (conventional and/or biologic) subgroup;Change from baseline in the (SPARCC) MRI inflammation score (for SIJ and spine) at 12 weeks of therapy with upadacitinib vs placebo in the overall population (NSAID-IR, c-DMARD-IR and and bio-DMARD-IR);Change from baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS-CRP) at Week 12 with upadacitinib vs placebo in the overall population (NSAID-IR, c-DMARD-IR and and bio-DMARD-IR);Change from Baseline in BASDAI at Week 12 with upadacitinib vs placebo in the overall population (NSAID-IR, c-DMARD-IR and and bio-DMARD-IR);Incidence of Adverse Events (AEs), AEs leading to withdrawal from study drug, and serious AEs (SAEs).