The effect of the new anti-rheumatic drug tofacitinib on cytokine-induced inflammatory pathways in patients with rheumatoid arthritis

The effect of tofacitinib on the activity of JAK-STAT pathways in patients with rheumatoid arthritis (RA) - TofaSTAT17

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-002753-11-FI

Enrollment

Registered

2017-11-08

Start date

2018-01-25

Completion date

Unknown

Last updated

2021-11-29

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

Conditions

Rheumatoid arthritis

Interventions

Trade Name: Xeljanz Product Name: Xeljanz Product Code: PRD4862257 Pharmaceutical Form: Tablet CAS Number: 540737-29-9 Other descriptive name: TOFACITINIB CITRATE Concentration unit: mg milligram(s) C

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: RA patients with active RA (DAS28 >3.2) despite treatment with methotrexate and other synthetic disease-modifying anti-rheumatic drugs Synthetic DMARD and prednisolone (0-10 mg/day) treatment allowed during the trial Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 16 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 8

Exclusion criteria

Exclusion criteria: Prior biologic or JAK inhibitor treatment Patient has contra-indication to tofacitinib treatment

Design outcomes

Primary

Measure	Time frame
Main Objective: Which JAK-STAT pathways are significantly inhibited by tofacitinib in vivo? ;Secondary Objective: Are the effects of tofacitinib in vivo cell-type specific? Are the previously observed alterations in the activity of JAK-STAT pathways in patients with RA reversible upon tofacitinib treatment? Can the signaling profile or cytokine levels at baseline be utilized as a biomarker for tofacitinib treatment response? Do the inhibitory effects of tofacitinib on JAK-STAT pathways correlate with the clinical response or plasma cytokine levels? ;Primary end point(s): The effect of tofacitinib treatment on the activity of different JAK-STAT pathways. The change in the activity of different STAT proteins during the three month treatment will be calculated. ;Timepoint(s) of evaluation of this end point: Last study visit expected in October 2019. Evaluation of results will be done within 6 months of last study visit.	—

Measure

Time frame

Main Objective: Which JAK-STAT pathways are significantly inhibited by tofacitinib in vivo? ;Secondary Objective: Are the effects of tofacitinib in vivo cell-type specific? Are the previously observed alterations in the activity of JAK-STAT pathways in patients with RA reversible upon tofacitinib treatment? Can the signaling profile or cytokine levels at baseline be utilized as a biomarker for tofacitinib treatment response? Do the inhibitory effects of tofacitinib on JAK-STAT pathways correlate with the clinical response or plasma cytokine levels? ;Primary end point(s): The effect of tofacitinib treatment on the activity of different JAK-STAT pathways. The change in the activity of different STAT proteins during the three month treatment will be calculated. ;Timepoint(s) of evaluation of this end point: Last study visit expected in October 2019. Evaluation of results will be done within 6 months of last study visit.

—

Secondary

Measure	Time frame
Secondary end point(s): The clinical response (Eular response and a change in DAS28) will be correlated with the STAT phosphorylation profile and plasma cytokine levels at baseline. The change in the activity of STAT proteins during tofacitinib treatment will be correlated with the clinical response and plasma cytokine levels. ;Timepoint(s) of evaluation of this end point: Last study visit expected in October 2019. Evaluation of results will be done within 6 months of last study visit.	—

Measure

Time frame

Secondary end point(s): The clinical response (Eular response and a change in DAS28) will be correlated with the STAT phosphorylation profile and plasma cytokine levels at baseline. The change in the activity of STAT proteins during tofacitinib treatment will be correlated with the clinical response and plasma cytokine levels. ;Timepoint(s) of evaluation of this end point: Last study visit expected in October 2019. Evaluation of results will be done within 6 months of last study visit.

—

Countries

Finland

Contacts

Public ContactCentre for Rheumatology

Tampere University Hospital

pia.isomaki@uta.fi

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026