TOFA-PREDICT

Phase 1

• Conditions: Psoriatic arthritis; MedDRA version: 21.0Level: LLTClassification code: 10037160Term: Psoriatic arthritis Class: 10028395; Therapeutic area: Diseases [C] - Immune System Diseases [C20]; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: CTIS2024-510903-12-00
• Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-05-28
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

•Age 18-75 years old, Inclusion criteria for the csDMARD-IR group (Arm 2): •Current use of methotrexate, sulfasalazine or leflunomide on the highest tolerated and on a stable dosage for at least 4 weeks prior to randomization. Highest dosage accepted respectively are max =25mg/wk, 20mg/day and 3000mg/day. •History of use of max. 1 bDMARD prior to inclusion is allowed, except: •Prior use of etanercept •Primary failure (total non-response at start) on other TNFi (adalimumab, golimumab, infliximab, certolizumab). Patients that have had a loss of response on their first TNFi are allowed to participate. •No history of tsDMARD therapy use (JAKi, abatacept), •Meets CASPAR criteria for psoriatic arthritis, •Disease duration of at least 8 weeks, •Evidence of active arthritis based upon =2 swollen joints and =2 tender joints, •Subjects are to discontinue active psoriasis treatment prior to being enrolled in the study., Inclusion criteria for the csDMARD-naïve group (Arm 1): •No history of csDMARD use or bDMARD therapy use

Exclusion Criteria

•Currently have pustular psoriasis only, •Participation in other studies involving investigational drug(s) (Phases 1-4) within 4 weeks before the current study begins and/or during study participation. Participation in any observational studies during study participation., •Pregnant females, breastfeeding females, females of child-bearing potential not using highly effective contraception or not agreeing to continue highly effective contraception for at least one ovulatory cycle after last dose of investigational product or females planning pregnancy. Women of childbearing potential must test negative for pregnancy prior to enrollment in this study., •Current or recent history of a severe, progressive or uncontrolled renal, hepatic, hematological, gastrointestinal, metabolic (including hypercholersterolemia), endocrine, pulmonary, cardiovascular, or neurologic disease.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified