Local, Non-Interventional Study of RoActemra (Tocilizumab) in Poland (ACT-POL): First-Line Treatment in Routine Clinical Practice of Participants With Rheumatoid Arthritis (RA)

TOCILIZUMAB IN FIRST LINE BIOLOGIC TREATMENT OF PATIENTS WITH RHEUMATOID ARTHRITIS IN ROUTINE CLINICAL PRACTICE IN POLAND - MULTICENTER, NON-INTERVENTIONAL, PROSPECTIVE, OBSERVATIONAL STUDY (ACT-POL)

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02234960

Enrollment

102

Registered

2014-09-09

Start date

2014-08-31

Completion date

2016-07-31

Last updated

2016-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid Arthritis

Brief summary

The aim of this non-interventional, prospective, observational study is to assess the effectiveness and tolerability of RoActemra (tocilizumab) used as a first-line biologic treatment in participants with moderate to severe active RA who are inadequate responders to disease-modifying antirheumatic drugs (DMARDs), or participants who are intolerant to DMARDs, in a routine clinical practice setting in Poland. The length of the entire study will be 24 months.

Interventions

DRUGTocilizumab

Tocilizumab will be given according to summary of product characteristics as per clinical practice.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* participants at least 18 years of age * a diagnosis of moderate to severe RA * treating physician has made the decision to commence tocilizumab in first line biologic treatment (population of DMARDs inadequate responders or participants who are intolerant to DMARDs) in a routine clinical practice in Poland * informed consent

Exclusion criteria

N/A

Design outcomes

Primary

Measure	Time frame
Percentage of Participants With Remission as Assessed by Disease Activity Score 28 (DAS28 < 2.6) After 6 Months of Treatment	Month 6
Percentage of Participants with Low Disease Activity as Assessed by DAS28 (DAS28 </= 3.2) After 6 Months of Treatment	Month 6

Secondary

Measure	Time frame
Change from Baseline in Erythrocyte Sedimentation Rate (ESR) Over Time	Baseline up to Month 6
Time to Discontinuation	Baseline up to Month 6
Percentage of Participants With Monotherapy Versus Combination Therapy with Methotrexate	Baseline up to Month 6
Percentage of Participants With Discontinuations Due to Lack of Efficacy	Baseline up to Month 6
Percentage of Participants with Remission (DAS28 <2.6) and Low Disease Activity (DAS28 </= 3.2) After 3 Months of Treatment	Month 3
Change From Baseline in DAS28 Over Time	Baseline up to Month 6
Change From Baseline in C-Reactive Protein (CRP) Over Time	Baseline up to Month 6
Percentage of Participants With Systemic Symptoms at Baseline Versus Without Systemic Symptoms at Baseline	Baseline
Percentage of Participants With Adverse Events (AEs) Or Serious AEs (SAEs)	Baseline up to Month 6

Countries

Poland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026