Clinical trial NCT04079920: Predictors of Response to Tofacitinib Treatment in Rheumatoid Arthritis Patients
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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2019-09-06
Enrollment: 198
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients presenting in outpatient clinics of Hospitals in Greece (secondary care)

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


Eligibility criteria: 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.

Primary outcomes:
measure: 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)
timeFrame: Month 6
Secondary outcomes:
measure: Percentage of Participants With Remission and LDA at Month 12 Assessed Using DAS28-4 CRP
timeFrame: Month 12
measure: Change From Baseline in DAS28-4 (ESR) and DAS28-4 (CRP)
timeFrame: Baseline, Months 3, 6 and 12
measure: Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Months 3, 6 and 12
timeFrame: Baseline, Months 3, 6 and 12
measure: Number of Participants With Remission According to Simplified Disease Activity Index (SDAI) <=3.3 at Months 3, 6, and 12
timeFrame: Months 3, 6 and 12
measure: Number of Participants With Remission According to Clinical Disease Activity Index (CDAI) <=2.8 at Months 3, 6, and 12
timeFrame: Months 3, 6 and 12
measure: Number of Participants With Remission According to DAS28-4 ESR<2.6 at Months 3, 6, and 12
timeFrame: Months 3, 6 and 12
measure: Number of Participants With Remission According to DAS28-4 CRP <2.6 at Months 3, 6, and 12
timeFrame: Months 3, 6 and 12
measure: Number of Participants With LDA According to SDAI <=11 at Months 3, 6, and 12
timeFrame: Months 3, 6 and 12
measure: Number of Participants With LDA According to CDAI <=10 at Months 3, 6, and 12
timeFrame: Months 3, 6 and 12
measure: Number of Participants With LDA According to DAS28-4 ESR (<3.2) at Months 3, 6, and 12
timeFrame: Months 3, 6 and 12
measure: Number of Participants With LDA According to DAS28-4 CRP<=3.2 at Months 3, 6, and 12
timeFrame: Months 3, 6 and 12
measure: Percentage of Participants Achieving HAQ-DI Response at Months 3,6 and 12
timeFrame: Months 3, 6 and 12
measure: Change From Baseline in European Quality of Life (EuroQol) -5 Dimensions (EQ-5D) Health State Profile at Months 3, 6 and 12
timeFrame: Baseline, Months 3, 6 and 12
measure: Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Questionnaire Score at Months 3, 6 and 12
timeFrame: Baseline, Months 3, 6 and 12
measure: Change From Baseline in Mean Duration of Morning Stiffness at Day 1 and 2 of Months 3, 6 and 12
timeFrame: Baseline, Day 1 and 2 of Months 3, 6 and 12
measure: Change From Baseline in the Work Productivity and Activity Impairment (WPAI) Questionnaire at Months 3, 6 and 12
timeFrame: Baseline, Months 3, 6 and 12
measure: Percentage of Participants With Treatment Satisfaction at Baseline and Month 12
timeFrame: Baseline, Month 12
measure: Patient Global Assessment (PtGA) at Baseline, Months 3, 6 and 12
timeFrame: Baseline, Months 3, 6 and 12
measure: Physician Global Assessment (PhGA) at Baseline, Months 3, 6 and 12
timeFrame: Baseline, Months 3, 6 and 12
measure: Number of Participants as Per Treatment Received
timeFrame: Up to 12 months
measure: Median Number of Visits to Rheumatologist or Other Rheumatoid Arthritis (RA) Specialist Since Last Visit
timeFrame: Months 3, 6 and 12
measure: Number of Participants With Diagnostic Test Since Last Visit
timeFrame: Months 3, 6 and 12
measure: Number of Participants According to the Type of Diagnostic Test
timeFrame: Months 3, 6 and 12
measure: Number of Diagnostic Tests Since Last Visit
timeFrame: Months 3, 6 and 12
measure: Number of Participants Hospitalized Since Last Visit
timeFrame: Months 3, 6 and 12
measure: Number of Participants Hospitalized in Daycare and Night Care Since Last Visit
timeFrame: Months 3, 6 and 12
measure: Mean Number of Days Participants Were Hospitalized Since Last Visit
timeFrame: Baseline, Months 3, 6 and 12
measure: Number of Participants According to Reason for Hospitalization Since Last Visit
timeFrame: Months 3, 6 and 12
Other outcomes:
Locations:
city: Athens
country: Greece
facility: University General Hospital of Athens "Attikon"
state: Attiki
city: Athens
country: Greece
facility: 251 Air Force Hospital of Athens
city: Athens
country: Greece
facility: General Hospital of Athens Gennimatas
city: Athens
country: Greece
facility: Ippokrateio General Hospital of Athens
city: Athens
country: Greece
facility: Laiko General Hospital of Athens
city: Athens
country: Greece
facility: Naval Hospital of Athens
city: Crete
country: Greece
facility: Nearchou 18
city: Heraklion
country: Greece
facility: Univerisity General Hospital of Heraklion
city: Ioannina
country: Greece
facility: University General Hospital of Ioannina
city: Kfisia
country: Greece
facility: KAT General Hospital of Attica
city: Larisa
country: Greece
facility: Univerisity General Hospital of Larisa
city: Larisa
country: Greece
facility: Univerisity General Hospital of Larisa
city: Patras
country: Greece
facility: University General Hospital of Patras
city: Patra
country: Greece
facility: Agios Andreas General Hospital of Patra
city: Thessaloniki
country: Greece
facility: Euromedica General Clinic of Thessaloniki
city: Thessaloniki
country: Greece
facility: Euromedica Kyanous Stavros General Clinic
city: Thessaloniki
country: Greece
facility: General Hospital of Thessaloniki Ippokrateio
city: Voula
country: Greece
facility: Asklipieio General Hospital of Voula
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: