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

• Register: ClinicalTrials.gov
• Last refreshed on: 14 November 2016
• Main ID: NCT02234960
• Date of registration: 05/09/2014
• Prospective Registration: No
• Primary sponsor: Hoffmann-La Roche
• Public title: Local, Non-Interventional Study of RoActemra (Tocilizumab) in Poland (ACT-POL): First-Line Treatment in Routine Clinical Practice of Participants With Rheumatoid Arthritis (RA)
• Scientific 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)
• Date of first enrolment: August 2014
• Target sample size: 102
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02234960
• Study type: Observational
• Study design: Observational Model: Cohort, Time Perspective: Prospective
• Phase: N/A

Countries of recruitment

Poland

Contacts

• Name: Clinical Trials
• Affiliation: Hoffmann-La Roche

Key inclusion & exclusion 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:



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Rheumatoid Arthritis

Intervention(s)

Drug: Tocilizumab

Primary Outcome(s)

Percentage of Participants with Low Disease Activity as Assessed by DAS28 (DAS28 [Time Frame: Month 6]

Percentage of Participants With Remission as Assessed by Disease Activity Score 28 (DAS28 < 2.6) After 6 Months of Treatment [Time Frame: Month 6]

Secondary Outcome(s)

Percentage of Participants With Monotherapy Versus Combination Therapy with Methotrexate [Time Frame: Baseline up to Month 6]

Percentage of Participants With Systemic Symptoms at Baseline Versus Without Systemic Symptoms at Baseline [Time Frame: Baseline]

Change From Baseline in DAS28 Over Time [Time Frame: Baseline up to Month 6]

Change from Baseline in Erythrocyte Sedimentation Rate (ESR) Over Time [Time Frame: Baseline up to Month 6]

Percentage of Participants with Remission (DAS28 <2.6) and Low Disease Activity (DAS28 [Time Frame: Month 3]

Percentage of Participants With Adverse Events (AEs) Or Serious AEs (SAEs) [Time Frame: Baseline up to Month 6]

Percentage of Participants With Discontinuations Due to Lack of Efficacy [Time Frame: Baseline up to Month 6]

Time to Discontinuation [Time Frame: Baseline up to Month 6]

Change From Baseline in C-Reactive Protein (CRP) Over Time [Time Frame: Baseline up to Month 6]

Secondary ID(s)

ML29444

Source(s) of Monetary Support

Please refer to primary and secondary sponsors