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

Rheumatoid Arthritis Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02234960
• Other study ID #: ML29444
• Status: Completed
• Phase: N/A
• First received: September 5, 2014
• Last updated: November 1, 2016
• Start date: August 2014
• Est. completion date: July 2016

Study information

• Verified date: November 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Poland: Wydzial Monitorowania Niepozadanych Dzialan Produktow Leczniczych, Urzad Rejestracji Produktow Leczniczych, Wyrobów Medycznych i Produktów Biobójczych
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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:

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With Remission as Assessed by Disease Activity Score 28 (DAS28 < 2.6) After 6 Months of Treatment		Month 6	No
Primary	Percentage of Participants with Low Disease Activity as Assessed by DAS28 (DAS28 </= 3.2) After 6 Months of Treatment		Month 6	No
Secondary	Change from Baseline in Erythrocyte Sedimentation Rate (ESR) Over Time		Baseline up to Month 6	No
Secondary	Time to Discontinuation		Baseline up to Month 6	No
Secondary	Percentage of Participants With Monotherapy Versus Combination Therapy with Methotrexate		Baseline up to Month 6	No
Secondary	Percentage of Participants With Systemic Symptoms at Baseline Versus Without Systemic Symptoms at Baseline		Baseline	No
Secondary	Percentage of Participants with Remission (DAS28 <2.6) and Low Disease Activity (DAS28 </= 3.2) After 3 Months of Treatment		Month 3	No
Secondary	Change From Baseline in DAS28 Over Time		Baseline up to Month 6	No
Secondary	Change From Baseline in C-Reactive Protein (CRP) Over Time		Baseline up to Month 6	No
Secondary	Percentage of Participants With Discontinuations Due to Lack of Efficacy		Baseline up to Month 6	No
Secondary	Percentage of Participants With Adverse Events (AEs) Or Serious AEs (SAEs)		Baseline up to Month 6	No