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

Completed

• Conditions: Rheumatoid Arthritis
• Interventions: Drug: Tocilizumab

• Registration Number: NCT02234960
• Lead Sponsor: Hoffmann-La Roche

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-08
• Study First Submitted: 2014-09-05
• Study First Submitted QC: 2014-09-05
• Study First Posted: 2014-09-09
• Primary Completion: 2016-07
• Study Completion: 2016-07
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-01
• Last Update Posted: 2016-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 102

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cohort of RA Participants	Tocilizumab	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Change From Baseline in DAS28 Over Time	Baseline up to Month 6
Time to Discontinuation	Baseline up to Month 6
Change From Baseline in C-Reactive Protein (CRP) Over Time	Baseline up to Month 6
Percentage of Participants With Adverse Events (AEs) Or Serious AEs (SAEs)	Baseline up to Month 6
Percentage of Participants With Systemic Symptoms at Baseline Versus Without Systemic Symptoms at Baseline	Baseline
Change from Baseline in Erythrocyte Sedimentation Rate (ESR) Over Time	Baseline up to Month 6
Percentage of Participants With Monotherapy Versus Combination Therapy with Methotrexate	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
Percentage of Participants With Discontinuations Due to Lack of Efficacy	Baseline up to Month 6