ClinicalTrials.gg
CompletedNCT03291457COGNOSUpdated May 18, 2020

A Study to Evaluate the Use of Glucocorticoids in Combination With Tocilizumab in Daily Clinical Practice

An observational study in Rheumatoid Arthritis, sponsored by Hoffmann-La Roche. Completed at 22 sites in Belgium. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-05-18.

Sponsored by Hoffmann-La Roche · Observational

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Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
101
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 219 studies in Arthritis, Rheumatoid by Hoffmann-La Roche — 2 open to participants now, 2 under way, none of them phase 3. Arthritis, Rheumatoid · Hoffmann-La Roche.

Enrollment
53rd of 78
101 · median 182
Started
2017
with 3 others
Observational
78 of 219
none open now
Registered
217th of 219
by date

Among the 219 studies in Arthritis, Rheumatoid by Hoffmann-La Roche, this one is the 53rd largest by enrollment of the 78 observational ones that give a count, is one of 4 that started in 2017, is one of 78 observational ones, and was the 217th registered.

Arthritis, Rheumatoid

3,334 studies on the registry are indexed under Arthritis, Rheumatoid; 444 are open to participants now.

Browse Arthritis, Rheumatoid studies →

Open to participants now

2 of the 219 studies in Arthritis, Rheumatoid by Hoffmann-La Roche are open now, in 12 countries. Recruiting first, the newest first:

By country, each count listing its studies:

All 2 open studies →

Who these studies take

Of the 293 Arthritis, Rheumatoid studies recruiting now, 150 (51%) set no upper age limit and 109 (37%) stop at 75 or younger; 15 take children under 18; 36 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 219 studies in Arthritis, Rheumatoid by Hoffmann-La Roche, or all of them as a file.
02

Study summary

This prospective, multicenter, observational study will evaluate the use of concomitant glucocorticoid therapy in adults with rheumatoid arthritis (RA) being treated with tocilizumab in daily clinical practice. Participants will be observed for up to 52 weeks after starting treatment with tocilizumab. All visits and assessments will be performed as per routine clinical practice, with no study-specific visits or interventions.

03

Conditions studied

  • Rheumatoid Arthritis
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

This study will follow participants with RA who are receiving glucocorticoids prior to start of tocilizumab in daily clinical practice.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Diagnosis of moderate to severe RA, defined as DAS28 greater than or equal to 3.7
  • Naive to tocilizumab, or received tocilizumab within 8 weeks prior to enrollment
  • Physician has made decision to commence IV or SC tocilizumab in accordance with label and reimbursement criteria
  • Treated with for RA when starting tocilizumab treatment

Exclusion criteria

Exclusion Criteria:

  • Treatment with any agent within 4 weeks or 5 half-lives before tocilizumab
  • Continuous or regular treatment with oral for any indication other than RA
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
101 participants (actual)
Patient registry
No

Groups and cohorts

  • Glucocorticoids + Tocilizumab

    Participants with RA who are receiving glucocorticoid treatment will be observed for up to 52 weeks after starting tocilizumab.

    Drug: Tocilizumab · Drug: Glucocorticoid Agent

Interventions

  • For intravenous (IV) tocilizumab, the recommended dosage is 8 milligrams per kilogram (mg/kg) once every 4 weeks. For subcutaneous (SC) tocilizumab, the recommended dosage is 162 milligrams (mg) once weekly. However, because of the observational nature of the study, dosing and treatment duration is at the discretion of the physician in accordance with local clinical practice and local labeling.

    Also known as: RoActemra

  • DrugGlucocorticoid Agent

    Because of the observational nature of the study, the choice of glucocorticoid agent, as well as dosing and treatment duration, is at the discretion of the physician in accordance with local clinical practice and local labeling.

06

What researchers measure

Primary outcomes

  1. Percentage of Participants Who Are Able to Discontinue Use of Glucocorticoid without Loss of Disease Control According to Disease Activity Score Based on 28 Joints (DAS28)

    Time frame: Week 52

  2. Percentage of Participants Who Are Able to Reduce Use of Glucocorticoid by 50 Percent (%) or More without Loss of Disease Control According to DAS28

    Time frame: Week 52

  3. Percentage of Participants by Reason for Glucocorticoid Dose Modification

    Time frame: Baseline up to Week 52

Secondary outcomes

  1. Glucocorticoid Dose

    Time frame: Baseline; Weeks 24 and 52

  2. Percentage of Participants Who Are Able to Reduce Use of Glucocorticoid by 25%, 50%, 75%, or 100%

    Time frame: Weeks 24 and 52

  3. Percentage of Participants in Need of Glucocorticoid Dose Increase by 25%, 50%, 75%, or 100%

    Time frame: Weeks 24 and 52

  4. Time to First Glucocorticoid Dose Reduction

    Time frame: Baseline up to Week 52

  5. Time to Glucocorticoid Discontinuation

    Time frame: Baseline up to Week 52

  6. Percentage of Participants in Remission According to DAS28 with Glucocorticoid Dose Reduction

    Time frame: Baseline up to Week 52

  7. Percentage of Participants in Remission According to DAS28 with Glucocorticoid Dose Reduction of At Least 25%, 50%, or 75%

    Time frame: Baseline up to Week 52

  8. Percentage of Participants in Remission According to DAS28 Who Discontinued Glucocorticoids

    Time frame: Baseline up to Week 52

  9. Percentage of Participants with Low Disease Activity (LDA) According to DAS28 with Glucocorticoid Dose Reduction

    Time frame: Baseline up to Week 52

  10. Percentage of Participants with LDA According to DAS28 with Glucocorticoid Dose Reduction of At Least 25%, 50%, or 75%

    Time frame: Baseline up to Week 52

  11. Percentage of Participants with LDA According to DAS28 Who Discontinued Glucocorticoids

    Time frame: Baseline up to Week 52

  12. Glucocorticoid Dose among Participants in Remission According to DAS28

    Time frame: Baseline up to Week 52

  13. Glucocorticoid Dose among Participants with LDA According to DAS28

    Time frame: Baseline up to Week 52

  14. Correlation between DAS28 Score and Glucocorticoid Dose

    Time frame: Baseline up to Week 52

  15. Percentage of Participants with Adverse Events

    Time frame: Baseline up to Week 52

07

Study locations

22 sites
  • ASZ Aalst
    Aalst, 9300, Belgium
  • Onze Lieve Vrouwziekenhuis Aalst
    Aalst, 9300, Belgium
  • Dr. Huppertz - Marx pgmbh
    Amel, 4770, Belgium
  • Private Practice Els Van Essche
    Bonheiden, 2820, Belgium
  • AZ Sint Jan
    Brugge, 8000, Belgium
  • CHU St Pierre (César de Paepe)
    Bruxelles, 1000, Belgium
  • Hospital Erasme
    Bruxelles, 1070, Belgium
  • Rhumarc sciv sprl
    Céroux-Mousty, 1341, Belgium
  • UZ Antwerpen
    Edegem, 2650, Belgium
  • Rhumaconsult sciv sprl; Private Practice
    Forchies-la-Marche, 6141, Belgium
  • Reumacentrum Genk
    Genk, 3600, Belgium
  • Reumaclinic
    Genk, 3600, Belgium
  • AZ Sint Lucas (Sint Lucas)
    Gent, 9000, Belgium
  • GHdC Site Saint-Joseph
    Gilly (Charleroi), 6000, Belgium
  • CHC MontLégia
    Liege, 4000, Belgium
  • Heilig Hartziekenhuis vzw
    Lier, 2500, Belgium
  • CHU de Liège; Rhumatologie
    Liège, 4000, Belgium
  • Private Practice; Reumatologie
    Mechelen, 2800, Belgium
  • AZ Damiaan
    Oostende, 8400, Belgium
  • AZ Alma vzw (Sijsele)
    Sijsele, 8340, Belgium
  • AZ Turnhout Sint Jozef
    Turnhout, 2300, Belgium
  • AZ Sint Jozef Malle
    Westmalle, 2390, Belgium
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Mar 2017 to primary completion in Dec 2019, 32 months.

Of 155 industry-sponsored observational studies under Arthritis, Rheumatoid, half reached primary completion within 61 months of starting (the median), counting those still running; a quarter within 32 and three quarters within 116. This study's 32 months is below that.

Counting every sponsor, half of 391 studies reached it within 50 months; a quarter within 25 and three quarters within 113.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 20, 2017
First posted
Sep 25, 2017
StartActual
Mar 30, 2017
Primary completionActual
Dec 4, 2019
CompletionActual
Dec 4, 2019
Last update
May 18, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 18, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03291457
Lead sponsor
Hoffmann-La Roche
Responsible party
Sponsor
First posted
Sep 25, 2017
Start date
Mar 30, 2017
Primary completion
Dec 4, 2019
Completion
Dec 4, 2019
Last update
May 18, 2020

Study contacts

Clinical Trials
study director · Hoffmann-La Roche

Oversight

FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2020. You cannot join it, but the record below documents what was studied.

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