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

Phase 1

• Conditions: Rheumatoid arthritis; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2017-002753-11-FI
• Lead Sponsor: Tampere University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-11-08
• Last Update Posted: 29 November 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 24

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

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

Study & Design

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

Primary Outcome Measures

Name	Time	Method
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?<br><br>Are the previously observed alterations in the activity of JAK-STAT pathways in patients with RA reversible upon tofacitinib treatment?<br><br>Can the signaling profile or cytokine levels at baseline be utilized as a biomarker for tofacitinib treatment response?<br><br>Do the inhibitory effects of tofacitinib on JAK-STAT pathways correlate with the clinical response or plasma cytokine levels?<br>;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 Outcome Measures

Name	Time	Method
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.<br><br>The change in the activity of STAT proteins during tofacitinib treatment will be correlated with the clinical response and plasma cytokine levels.<br>;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.