Predictors of Response to Tofacitinib Treatment in Rheumatoid Arthritis Patients

Completed

• Conditions: Rheumatoid Arthritis

• Registration Number: NCT04079920
• Lead Sponsor: Pfizer

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-08-05
• Study First Submitted QC: 2019-09-04
• Study First Posted: 2019-09-06
• Study Start: 2020-09-22
• Primary Completion: 2023-02-08
• Study Completion: 2023-02-08
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-18
• Last Update Posted: 2023-05-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 198

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.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Rate of Low Disease Activity (LDA)	month 6	Percentage of participants with Disease Score Activity (DAS28) less than 3.2.
Rate of remission	month 6	Percentage of participants with a Disease Activity Score (DAS28) less than 2.6

Trial Locations

Locations (17)

Nearchou 18; 🇬🇷 Crete, Greece

251 Air Force Hospital of Athens; 🇬🇷 Athens, Greece

University General Hospital of Athens "Attikon"; 🇬🇷 Athens, Attiki, Greece

General Hospital of Athens Gennimatas; 🇬🇷 Athens, Greece

Ippokrateio General Hospital of Athens; 🇬🇷 Athens, Greece

Naval Hospital of Athens; 🇬🇷 Athens, Greece

Laiko General Hospital of Athens; 🇬🇷 Athens, 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

University General Hospital of Patras; 🇬🇷 Patras, Greece

Agios Andreas General Hospital of Patra; 🇬🇷 Patra, Greece

EUROMEDICA General Clinic of Thessaloniki; 🇬🇷 Thessaloniki, Greece

Euromedica Kyanous Stavros General Clinic; 🇬🇷 Thessaloniki, Greece

Asklipieio General Hospital of Voula; 🇬🇷 Voula, Greece

General Hospital of Thessaloniki Ippokrateio; 🇬🇷 Thessaloniki, Greece