Predictors of Response to Tofacitinib Treatment in Rheumatoid Arthritis Patients

Rheumatoid Arthritis Clinical Trial

— TREAT-RA  

Official title:

BASELINE VARIABLES PREDICTING TREATMENT RESPONSE AT 6 MONTHS IN ADULT RHEUMATOID ARTHRITIS PATIENTS TREATED WITH TOFACITINIB 5MG BID IN A NON-INTERVENTIONAL SETTING (TREAT - RA)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04079920
• Other study ID #: A3921342
• Secondary ID: TREAT-RA
• Status: Completed
• Start date: September 22, 2020
• Est. completion date: February 8, 2023

Study information

• Verified date: May 2023
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This is a 24-month, prospective, non-interventional, multi-center study with primary aim to identify baseline characteristics of patients that predict response at 6 months of treatment. The study also aims to describe the treatment patterns of RA patients prescribed tofacitinib in a real-world setting and assess the effect of treatment on patient quality of life and physical function. Finally the study will assess the use of healthcare resources and costs in patients with RA treated with tofacitinib in Greece. The planned recruitment period is 12 months. The planned observation period of each patient is 12 months. In this time period up to 4 visits will be documented. The study will be reviewed and approved by the Central Regulatory Committee for NIS and IRB Board of each participating site

Recruitment information / eligibility

• Status: Completed
• Enrollment: 198
• Est. completion date: February 8, 2023
• Est. primary completion date: February 8, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult subjects with moderately to severely active rheumatoid arthritis who start treatment with tofacitinib in usual clinical practice conditions in compliance with the label

1. Patients aged = 18 years

2. Confirmed Diagnosis of Rheumatoid Arthritis by rheumatologist

3. Patients with moderate to severe RA diagnosed according to local practice who have already been started on treatment with tofacitinib, for at most seven working days .

4. Patients eligible for tofacitinib treatment according to current approved Summary of Product Characteristics (SmPC).

5. Evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study.

Exclusion Criteria:

• Patients meeting any of the following criteria will not be included in the study:

1. Exclusion Criteria according to the Xeljanz® SmPC.

2. Contraindications to Xeljanz® according to SmPC.

3. Hypersensitivity to the active substance (tofacitinib) or to any of the excipients.

4. Active tuberculosis (TB), serious infections, such as sepsis, or opportunistic infections.

5. Receipt of any investigational drug within 3 months before study inclusion as well as currently not participating in an interventional clinical trial.

6. Subjects who have received any previous treatment with tofacitinib or other JAK inhibitors.

7. Subjects who are investigational site staff members or subjects who are Pfizer employees directly involved in the conduct of the trial.

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Locations

Country	Name	City	State
Greece	251 Air Force Hospital of Athens	Athens
Greece	General Hospital of Athens Gennimatas	Athens
Greece	Ippokrateio General Hospital of Athens	Athens
Greece	Laiko General Hospital of Athens	Athens
Greece	Naval Hospital of Athens	Athens
Greece	University General Hospital of Athens "Attikon"	Athens	Attiki
Greece	Nearchou 18	Crete
Greece	Univerisity General Hospital of Heraklion	Heraklion
Greece	University General Hospital of Ioannina	Ioannina
Greece	KAT General Hospital of Attica	Kfisia
Greece	Univerisity General Hospital of Larisa	Larisa
Greece	Univerisity General Hospital of Larisa	Larisa
Greece	Agios Andreas General Hospital of Patra	Patra
Greece	University General Hospital of Patras	Patras
Greece	EUROMEDICA General Clinic of Thessaloniki	Thessaloniki
Greece	Euromedica Kyanous Stavros General Clinic	Thessaloniki
Greece	General Hospital of Thessaloniki Ippokrateio	Thessaloniki
Greece	Asklipieio General Hospital of Voula	Voula

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of Low Disease Activity (LDA)	Percentage of participants with Disease Score Activity (DAS28) less than 3.2.	month 6
Primary	Rate of remission	Percentage of participants with a Disease Activity Score (DAS28) less than 2.6	month 6

External Links

•   To obtain contact information for a study center near you, click here.