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Completed

NCT Number: 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)

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.

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Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Bydgoszcz, Poland

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tocilizumab

Drug

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

Primary outcomes

  1. Percentage of Participants With Remission as Assessed by Disease Activity Score 28 (DAS28 < 2.6) After 6 Months of Treatment

    Time frame: Month 6

  2. Percentage of Participants with Low Disease Activity as Assessed by DAS28 (DAS28 </= 3.2) After 6 Months of Treatment

    Time frame: Month 6

Secondary outcomes

  1. Change from Baseline in Erythrocyte Sedimentation Rate (ESR) Over Time

    Time frame: Baseline up to Month 6

  2. Time to Discontinuation

    Time frame: Baseline up to Month 6

  3. Percentage of Participants With Monotherapy Versus Combination Therapy with Methotrexate

    Time frame: Baseline up to Month 6

  4. Percentage of Participants With Systemic Symptoms at Baseline Versus Without Systemic Symptoms at Baseline

    Time frame: Baseline

  5. Percentage of Participants with Remission (DAS28 <2.6) and Low Disease Activity (DAS28 </= 3.2) After 3 Months of Treatment

    Time frame: Month 3

  6. Change From Baseline in DAS28 Over Time

    Time frame: Baseline up to Month 6

  7. Change From Baseline in C-Reactive Protein (CRP) Over Time

    Time frame: Baseline up to Month 6

  8. Percentage of Participants With Discontinuations Due to Lack of Efficacy

    Time frame: Baseline up to Month 6

  9. Percentage of Participants With Adverse Events (AEs) Or Serious AEs (SAEs)

    Time frame: Baseline up to Month 6

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study 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)

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Sep 9, 2014
Registry last updated
Nov 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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