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Rheumatoid ArthritisNCT02552940

An Observational Study to Evaluate the Clinical Effectiveness, Quality of Life, Safety and Tolerability of Tocilizumab (TCZ) in Patients With Rheumatoid Arthritis (RA) in Daily Clinical Practice

An observational study of Rheumatoid Arthritis, run by Hoffmann-La Roche at 22 sites in 2 countries.

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

This observational trial will evaluate the effectiveness, the consistency of evaluation scores, quality of life, safety and tolerability of TCZ administered subcutaneously (SC) in participants with RA in daily clinical practice. 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
140 participants
Where
22 sitesin 2 countries
Study dates
31 Oct 2015to 23 Oct 2017
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: Participant with a diagnosis of moderate to severe RA defined as DAS28 more than or equal to (>=) 3.7, naïve to TCZ and in whom the treating physician has made the decision to commence TCZ SC in accordance with the label and reimbursement criteria

Who may be able to join

  • Participants naive to TCZ or who have received TCZ SC treatment within 8 weeks prior to the enrolment visit can be included
  • Participants in whom the treating physician has made the decision to commence TCZ SC in accordance with the label and reimbursement criteria

Who cannot join

  • Participants who have received TCZ >8 weeks prior to the enrolment visit
  • Participants who have previously received TCZ SC
  • Participants who have received treatment with any investigational agent within 4 weeks before starting treatment with TCZ SC

Trial locations and contacts

22 sites in 2 countries.

22 sites in 2 countries

Belgium21 sites

  • ASZ Aalst

    Aalst, 9300

  • AZ Sint Lucas Brugge

    Assebroek, 8310

  • AZ Sint Jan

    Bruges, 8000

  • CHU St Pierre (César de Paepe)

    Brussels, 1000

  • HIS (Etterbeek Ixelles)

    Brussels, 1050

  • Hospital Erasme; Neurologie

    Brussels, 1070

  • AZ Sint Blasius (Dendermonde)

    Dendermonde, 9200

  • UZ Antwerpen

    Edegem, 2650

  • Reumacentrum Genk

    Genk, 3600

  • Reumaclinic

    Genk, 3600

  • GHdC Site Saint-Joseph

    Gilly (Charleroi), 6000

  • AZ Groeninge

    Kortrijk, 8500

  • CHU Sart-Tilman

    Liège, 4000

  • Private Practice

    Lokeren, 9160

  • CHU UCL Mont-Godinne

    Mont-godinne, 5530

  • AZ Damiaan

    Ostend, 8400

  • AZ Oudenaarde

    Oudenaarde, 9700

  • AZ Alma vzw (Sijsele)

    Sijsele, 8340

  • AZ Sint Jozef Malle

    Westmalle, 2390

  • Sint Augustinus Wilrijk

    Wilrijk, 2610

  • CVBA Diagnosecentrum Voorkempen

    Zoersel, 2980

Other trials in Belgium

Luxembourg1 site

  • Höpital Kirchberg; Rheumatology

    Luxembourg, 2540

Other trials in Luxembourg

About this study

Official title: A PROSPECTIVE, NON-INTERVENTIONAL STUDY TO EVALUATE THE CLINICAL EFFECTIVENESS, THE CONSISTENCY OF EVALUATION SCORES, QUALITY OF LIFE, SAFETY AND TOLERABILITY OF TOCILIZUMAB SUBCUTANEOUS IN PATIENTS WITH RHEUMATOID ARTHRITIS IN DAILY CLINICAL PRACTICE

This observational trial will evaluate the effectiveness, the consistency of evaluation scores, quality of life, safety and tolerability of TCZ administered subcutaneously (SC) in participants with RA in daily clinical practice.

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

    Also called RoACTEMRA

    Participants with RA receive TCZ SC, as per routine clinical practice and are followed for approximately 6 months.

Study groups in NCT02552940
Study groupRoleWhat they receive
Rheumatoid Arthritis participants treated with Tocilizumab SCParticipants with RA receive TCZ SC, as per routine clinical practice and are followed for approximately 6 months.
Receives: Drug: Tocilizumab

What is being measured

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

  1. Correlation coefficient between DAS28 - erythrocyte sedimentation rate (DAS28-ESR) and Clinical Disease Activity Index (CDAl)

    Measured: Up to Week 24

Secondary outcomes (22)

  1. Correlation Coefficient Between CDAI and simplified disease activity index (SDAI) and Between SDAI and DAS28-ESR

    Measured: Up to Week 24

  2. Percentage of participants to achieve low disease activity (LDA) using DAS28 (less than or equal to [<=] 3.2), CDAl (<=10.0) and SDAI (<=11 .0)

    Measured: Up to Week 24

  3. Time to achieve low disease activity (LDA) using DAS28 (<= 3.2), CDAl (<=10.0) and SDAI (<=11 .0)

    Measured: Up to week 24

  4. Percentage of participants to achieve disease remission using DAS28-ESR (<2.6), CDAl (<=2.8) and SDAI (<=3.3)

    Measured: Up to Week 24

  5. Time to achieve disease remission using DAS28-ESR (<2.6), CDAl (<=2.8) and SDAI (<=3.3)

    Measured: Up to Week 24

  6. Percentage of participants to achieve a clinically meaningful improvement in DAS28-ESR (reduction of at least 1.2 units)

    Measured: Up to Week 24

  7. Time to achieve a clinically meaningful improvement in DAS28-ESR (reduction of at least 1.2 units)

    Measured: Up to Week 24

  8. Percentage of participants to achieve a major and minor improvement in CDAl (more than or equal to [>=]13.9 and >=6.7, respectively) and SDAI (>=17.1 and >=6.9, respectively)

    Measured: Up to Week 24

  9. Time to achieve a major and minor improvement in CDAl (>=13.9 and >=6.7, respectively) and SDAI (>=17.1 and >=6.9, respectively)

    Measured: Up to Week 24

  10. Change from baseline in total tender joint count (TJC)

    Measured: Up to Week 24

  11. Change from baseline in total swollen joint count (SJC)

    Measured: Up to Week 24

  12. Percentage of participants having TJC <=1

    Measured: Up to Week 24

  13. Percentage of participants having SJC <=1

    Measured: Up to Week 24

  14. Patient Global Assessment of disease activity visual analogue scale (VAS) score

    Measured: Up to Week 24

  15. Physician Global Assessment of disease activity VAS score

    Measured: Up to Week 24

  16. Percentage of participants having CRP <=1mg/dl

    Measured: Up to Week 24

  17. Health Assessment Questionnaire Disability Index (HAQ-DI)

    Measured: Up to Week 24

  18. EQ-5D-5L Health Questionnaire (EuroQoL)

    Measured: Up to Week 24

  19. Morisky Medication-Taking Adherence Scale (MMAS)

    Measured: Up to Week 24

  20. Percentage of participants using TCZ in monotherapy

    Measured: At baseline

  21. Percentage of participants using TCZ in combination with disease-modifying antirheumatic drug's (DMARD's)

    Measured: At baseline

  22. Percentage of participants presenting a high inflammation (DAS28-ESR >5.1)

    Measured: At baseline

Timeline

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

  1. First posted17 Sep 2015 (estimated)
  2. Study start31 Oct 2015
  3. Primary completion23 Oct 2017
  4. Study completion23 Oct 2017

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
Case-control
Time perspective
Prospective
Enrolment
140 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02552940
Sponsor's protocol ID
ML29691
Status last verified
May 2018
First submitted
16 Sep 2015
Last updated
11 May 2018
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 22 sites in 2 countries.

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 2 inclusion and 3 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 11 May 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 22 sites in Belgium, Luxembourg. 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?

Correlation coefficient between DAS28 - erythrocyte sedimentation rate (DAS28-ESR) and Clinical Disease Activity Index (CDAl) (time frame: Up to Week 24). 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 NCT02552940.

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 11 May 2018.

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