Predictors of Response to Tofacitinib Treatment in Rheumatoid Arthritis Patients

NCT04079920 | Completed Results

• 2 other identifiers: A3921342TREAT-RA
• Study Type: observational
• Target: 198
• Locations: 1 country
• Sites: 18

Brief 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

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Remission and Low Disease Activity (LDA) at Month 6 Assessed Using 28-Joint Disease Activity Score C-Reactive Protein (DAS28-4 CRP)

  Remission is defined as DAS28-4 CRP less than (\<) 2.6 and DAS28-4 CRP \< 3.2 corresponds to LDA. DAS28-4 CRP is a composite endpoint, calculated using 4 variables (represented by '-4' in the name). It includes components: tender joint count (TJC) and swollen joint count ((SJC) \[both out of 28 evaluated joints\], CRP milligram per liter (mg/l) and Patient's Global Assessment of Arthritis Disease Activity (PtGA) recorded on 100 millimeter (mm) visual analogue scale (VAS) (scores ranging 0 \[no disease activity\] to 100 mm \[maximum disease activity\], higher scores=more disease activity). DAS28-4 CRP is calculated as: 0.56 \* square root (sqrt) (TJC) + 0.28 \* sqrt (SJC) + 0.36 \* ln (CRP+1) + 0.014\*PtGA + 0.96; where ln = natural logarithm.

  Month 6

Secondary Outcomes (28)

• Percentage of Participants With Remission and LDA at Month 12 Assessed Using DAS28-4 CRP

  Month 12

• Change From Baseline in DAS28-4 (ESR) and DAS28-4 (CRP)

  Baseline, Months 3, 6 and 12

• Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Months 3, 6 and 12

  Baseline, Months 3, 6 and 12

• Number of Participants With Remission According to Simplified Disease Activity Index (SDAI) <=3.3 at Months 3, 6, and 12

  Months 3, 6 and 12

• Number of Participants With Remission According to Clinical Disease Activity Index (CDAI) <=2.8 at Months 3, 6, and 12

  Months 3, 6 and 12

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients presenting in outpatient clinics of Hospitals in Greece (secondary care)

You may qualify if:

• Adult subjects with moderately to severely active rheumatoid arthritis who start treatment with tofacitinib in usual clinical practice conditions in compliance with the label
• Patients aged ≥ 18 years
• Confirmed Diagnosis of Rheumatoid Arthritis by rheumatologist
• 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 .
• Patients eligible for tofacitinib treatment according to current approved Summary of Product Characteristics (SmPC).
• 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.

You may not qualify if:

• Patients meeting any of the following criteria will not be included in the study:
• Contraindications to Xeljanz® according to SmPC.
• Hypersensitivity to the active substance (tofacitinib) or to any of the excipients.
• Active tuberculosis (TB), serious infections, such as sepsis, or opportunistic infections.
• Subjects who have received any previous treatment with tofacitinib or other JAK inhibitors.
• Subjects who are investigational site staff members or subjects who are Pfizer employees directly involved in the conduct of the trial.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (18)

University General Hospital of Athens "Attikon"

Athens, Attica, 12462, Greece

Location

251 Air Force Hospital of Athens

Athens, 11525, Greece

Location

General Hospital of Athens Gennimatas

Athens, Greece

Location

Ippokrateio General Hospital of Athens

Athens, Greece

Location

Laiko General Hospital of Athens

Athens, Greece

Location

Naval Hospital of Athens

Athens, Greece

Location

Nearchou 18

Crete, Greece

Location

Univerisity General Hospital of Heraklion

Heraklion, Greece

Location

University General Hospital of Ioannina

Ioannina, 45500, Greece

Location

KAT General Hospital of Attica

Kfisia, Greece

Location

Univerisity General Hospital of Larisa

Larissa, 41110, Greece

Location

Univerisity General Hospital of Larisa

Larissa, Greece

Location

University General Hospital of Patras

Pátrai, 26500, Greece

Location

Agios Andreas General Hospital of Patra

Pátrai, Greece

Location

Euromedica General Clinic of Thessaloniki

Thessaloniki, Greece

Location

Euromedica Kyanous Stavros General Clinic

Thessaloniki, Greece

Location

General Hospital of Thessaloniki Ippokrateio

Thessaloniki, Greece

Location

Asklipieio General Hospital of Voula

Voula, Greece

Location

Related Links

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

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2019
• First Posted: September 6, 2019
• Study Start: September 22, 2020
• Primary Completion: February 8, 2023
• Study Completion: February 8, 2023
• Last Updated: June 8, 2025
• Results First Posted: June 8, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

GR (18)