Tofa-Predict

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Universitair Medisch Centrum Utrecht

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Immune System Diseases [C20], Diseases [C] - Musculoskeletal Diseases [C05]

Trial duration

completed 8 Dec 2025

Decision date (initial)

2024-06-24

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Pfizer

External identifiers

EU CT number

2024-510903-12-00

EudraCT number

2017-003900-28

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Others

Identify pre-treatment profiles with integrated clinical, transcriptomic, metabolomic, proteomic, flow cytometric, and imaging data that predict response to treatment with tofacitinib, in DMARD-naïve and DMARD non-responsive PsA patients

Secondary objectives 2

1. - Compare clinical efficacy of treatment with tofacitinib, methotrexate and etanercept in DMARD-naïve and DMARD-non-responsive patients with active PsA
2. - Determine (medication specific) molecular mechanisms predicting and underlying clinical response to tofacitinib in comparison to methotrexate and etanercept in active PsA

Conditions and MedDRA coding

Psoriatic arthritis

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 7

1. • Age 18-75 years old
2. 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)
3. • Meets CASPAR criteria for psoriatic arthritis
4. • Disease duration of at least 8 weeks
5. • Evidence of active arthritis based upon ≥2 swollen joints and ≥2 tender joints
6. • Subjects are to discontinue active psoriasis treatment prior to being enrolled in the study.
7. Inclusion criteria for the csDMARD-naïve group (Arm 1): • No history of csDMARD use or bDMARD therapy use

Exclusion criteria 4

1. • Currently have pustular psoriasis only
2. • 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.
3. • 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.
4. • Current or recent history of a severe, progressive or uncontrolled renal, hepatic, hematological, gastrointestinal, metabolic (including hypercholersterolemia), endocrine, pulmonary, cardiovascular, or neurologic disease.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

1. Minimal Disease Activity (MDA) at week 16
2. Baseline molecular network profile (based on the composite systems medicine analysis)

Secondary endpoints 3

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

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Comparator 5

Auxiliary 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Universitair Medisch Centrum Utrecht

Sponsor organisation

Universitair Medisch Centrum Utrecht

Address

Heidelberglaan 100

City

Utrecht

Postcode

3584 CX

Country

Netherlands

Scientific contact point

Organisation

Universitair Medisch Centrum Utrecht

Contact name

dr. S.Mastbergen

Public contact point

Organisation

Universitair Medisch Centrum Utrecht

Contact name

dr. S.Mastbergen

Locations

1 EU/EEA country · 6 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 4 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications