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)
1 other identifier
observational
102
1 country
15
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Aug 2014
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2014
CompletedFirst Submitted
Initial submission to the registry
September 5, 2014
CompletedFirst Posted
Study publicly available on registry
September 9, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2016
CompletedNovember 2, 2016
November 1, 2016
1.9 years
September 5, 2014
November 1, 2016
Conditions
Outcome Measures
Primary Outcomes (2)
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 Outcomes (9)
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 Systemic Symptoms at Baseline Versus Without Systemic Symptoms at Baseline
Baseline
Percentage of Participants with Remission (DAS28 <2.6) and Low Disease Activity (DAS28 </= 3.2) After 3 Months of Treatment
Month 3
- +4 more secondary outcomes
Study Arms (1)
Cohort of RA Participants
Participants with RA treated with tocilizumab at a dose and duration at the discretion of physician in accordance with the summary of product characteristics as per routine clinical practice were observed for a period of 6 months with the length of entire study for 24 months.
Interventions
Tocilizumab will be given according to summary of product characteristics as per clinical practice.
Eligibility Criteria
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.
You may qualify if:
- 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
You may not qualify if:
- N/A
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (15)
Unknown Facility
Bydgoszcz, 85-168, Poland
Unknown Facility
Bydgoszcz, 85-681, Poland
Unknown Facility
Bytom, 41-902, Poland
Unknown Facility
Gmina Śrem, 63-100, Poland
Unknown Facility
Krakow, 30-119, Poland
Unknown Facility
Krakow, Poland
Unknown Facility
Lublin, 20-954, Poland
Unknown Facility
Olsztyn, 10-045, Poland
Unknown Facility
Poznan, 61-285, Poland
Unknown Facility
Sieradz, 98-200, Poland
Unknown Facility
Sopot, 81-759, Poland
Unknown Facility
Starachowice, 27-200, Poland
Unknown Facility
Sucha Beskidzka, 34-200, Poland
Unknown Facility
Ustroń, 43-450, Poland
Unknown Facility
Wroclaw, 50-981, Poland
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 5, 2014
First Posted
September 9, 2014
Study Start
August 1, 2014
Primary Completion
July 1, 2016
Study Completion
July 1, 2016
Last Updated
November 2, 2016
Record last verified: 2016-11