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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-510903-12-00

Enrollment

160

Registered

2024-06-24

Start date

Unknown

Completion date

2025-12-08

Last updated

2024-09-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Psoriatic arthritis

Brief summary

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

Detailed description

change (50%) in the molecular network before treatment as compared to after (week 4 and 16) treatment, change in composite clinical disease activity scores (MDA, ACR(20,50,70) response, DAS28) at week 16, 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

Interventions

DRUG5 MG

DRUGFoliumzuur Aurobindo 5 mg

DRUGtabletten

DRUGXELJANZ 5 mg film-coated tablets

DRUGMETHOTREXAAT SANDOZ 2

DRUGTABLETTEN

DRUGMethotrexaat Teva 20

DRUG0 mg

DRUGOplossing voor injectie in een voorgevulde pen

DRUGEnbrel 50 mg solution for injection in pre-filled syringe

DRUGMethotrexaat Teva 25

DRUGMethotrexaat Teva 15 mg

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Minimal Disease Activity (MDA) at week 16, Baseline molecular network profile (based on the composite systems medicine analysis)	—

Secondary

Measure	Time frame
change (50%) in the molecular network before treatment as compared to after (week 4 and 16) treatment, change in composite clinical disease activity scores (MDA, ACR(20,50,70) response, DAS28) at week 16, 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	—

Countries

Netherlands

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026