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Rheumatoid ArthritisNCT02234960

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

An observational study of Rheumatoid Arthritis, run by Hoffmann-La Roche at 15 sites in Poland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Rheumatoid Arthritis
What is being tested?
Tocilizumab
How many people
102 participants
Where
15 sitesPoland
Study dates
Aug 2014to Jul 2016
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: 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.

Who may be able to join

  • 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

Who cannot join

  • N/A

Trial locations and contacts

15 sites in 1 country.

15 sites in 1 country

Poland15 sites

  • Study site

    Bydgoszcz, 85-168

  • Study site

    Bydgoszcz, 85-681

  • Study site

    Bytom, 41-902

  • Study site

    Gmina Śrem, 63-100

  • Study site

    Krakow, 30-119

  • Study site

    Krakow

  • Study site

    Lublin, 20-954

  • Study site

    Olsztyn, 10-045

  • Study site

    Poznan, 61-285

  • Study site

    Sieradz, 98-200

  • Study site

    Sopot, 81-759

  • Study site

    Starachowice, 27-200

  • Study site

    Sucha Beskidzka, 34-200

  • Study site

    Ustroń, 43-450

  • Study site

    Wroclaw, 50-981

Other trials in Poland

About this study

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)

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.

Being tested
Tocilizumab
Medical subject headings
Arthritis, Rheumatoid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TocilizumabDrug

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

Study groups in NCT02234960
Study groupRoleWhat they receive
Cohort of RA ParticipantsParticipants 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.
Receives: Drug: Tocilizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: Month 6

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

    Measured: Month 6

Secondary outcomes (9)

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

    Measured: Baseline up to Month 6

  2. Time to Discontinuation

    Measured: Baseline up to Month 6

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

    Measured: Baseline up to Month 6

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

    Measured: Baseline

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

    Measured: Month 3

  6. Change From Baseline in DAS28 Over Time

    Measured: Baseline up to Month 6

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

    Measured: Baseline up to Month 6

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

    Measured: Baseline up to Month 6

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

    Measured: Baseline up to Month 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Sep 2014 (estimated)
  2. Study startAug 2014
  3. Primary completionJul 2016
  4. Study completionJul 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
102 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02234960
Sponsor's protocol ID
ML29444
Status last verified
Nov 2016
First submitted
5 Sep 2014
Last updated
2 Nov 2016
Results posted
No

Questions about this trial

What is this clinical trial studying?

An observational study of Rheumatoid Arthritis, run by Hoffmann-La Roche at 15 sites in Poland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With Remission as Assessed by Disease Activity Score 28 (DAS28 < 2.6) After 6 Months of Treatment (time frame: Month 6). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02234960.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2016.

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