Clinical trial NCT02234960: Local, Non-Interventional Study of RoActemra (Tocilizumab) in Poland (ACT-POL): First-Line Treatment in Routine Clinical Practice of Participants With Rheumatoid Arthritis (RA)
Official title: 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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2014-09-09
Enrollment: 102
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: Participants with a diagnosis of moderate to severe RA who are inadequate responders to DMARDs, or participants who are intolerant to DMARDs, in a routine clinical practice setting in Poland.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Participants With Remission as Assessed by Disease Activity Score 28 (DAS28 < 2.6) After 6 Months of Treatment
timeFrame: Month 6
measure: Percentage of Participants with Low Disease Activity as Assessed by DAS28 (DAS28 </= 3.2) After 6 Months of Treatment
timeFrame: Month 6
Secondary outcomes:
measure: Change from Baseline in Erythrocyte Sedimentation Rate (ESR) Over Time
timeFrame: Baseline up to Month 6
measure: Time to Discontinuation
timeFrame: Baseline up to Month 6
measure: Percentage of Participants With Monotherapy Versus Combination Therapy with Methotrexate
timeFrame: Baseline up to Month 6
measure: Percentage of Participants With Systemic Symptoms at Baseline Versus Without Systemic Symptoms at Baseline
timeFrame: Baseline
measure: Percentage of Participants with Remission (DAS28 <2.6) and Low Disease Activity (DAS28 </= 3.2) After 3 Months of Treatment
timeFrame: Month 3
measure: Change From Baseline in DAS28 Over Time
timeFrame: Baseline up to Month 6
measure: Change From Baseline in C-Reactive Protein (CRP) Over Time
timeFrame: Baseline up to Month 6
measure: Percentage of Participants With Discontinuations Due to Lack of Efficacy
timeFrame: Baseline up to Month 6
measure: Percentage of Participants With Adverse Events (AEs) Or Serious AEs (SAEs)
timeFrame: Baseline up to Month 6
Other outcomes:
Locations:
city: Bydgoszcz
country: Poland
city: Bydgoszcz
country: Poland
city: Bytom
country: Poland
city: Krakow
country: Poland
city: Kraków
country: Poland
city: Lublin
country: Poland
city: Olsztyn
country: Poland
city: Poznań
country: Poland
city: Sieradz
country: Poland
city: Sopot
country: Poland
city: Srem
country: Poland
city: Starachowice
country: Poland
city: Sucha Beskidzka
country: Poland
city: Ustroń
country: Poland
city: Wrocław
country: Poland
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: