A Stratification trial to determine key immunological factors predicting Tofacitinib efficacy in Psoriatic Arthritis (PsA). TOFA-PREDICT

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 160

Inclusion Criteria

• Age 18-75 years old
• 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 arm 1:
o No history of csDMARD use or bDMARD therapy use
• Inclusion criteria arm 2:
o Current use of methotrexate, sulfasalazine or leflunomide on the highest
tolerated dosage 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.
o *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.
o No history of tsDMARD therapy use (JAKi, abatacept)

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 enrolment 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

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Main study parameters/endpoints:<br /><br>-Minimal Disease Activity (MDA) at week 16<br /><br>-Baseline molecular network profile (based on the composite systems medicine<br /><br>analysis)</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>-change (50%) in the molecular network before treatment as compared to after<br /><br>(week 4 and 16) treatment<br /><br>-change in composite clinical disease activity scores (MDA, ACR(20,50,70)<br /><br>response, DAS28) at week 16.<br /><br>-change in individual clinical parameters that make up the composite scores<br /><br>(i.e. PASI score (reduction of 50%, 75%, 90%), joint count, CRP, ESR,<br /><br>QOL-measures) at week 16</p><br>

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