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CompletedNCT01388309Updated Nov 2, 2016

An Observational Study of RoActemra/Actemra (Tocilizumab) in Patients With Rheumatoid Arthritis Who Have an Inadequate Response to DMARDs

An observational study in Rheumatoid Arthritis, sponsored by Hoffmann-La Roche. Completed at 4 sites in Slovakia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-11-02.

Sponsored by Hoffmann-La Roche · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
64
Ages
18 Years and older
Sex
All
01

Study summary

This observational study will evaluate in clinical practice the change in Disease Activity Score (DAS28) in patients with rheumatoid arthritis and an inadequate response to DMARDs who are initiated on treatment with RoActemra/Actemra (tocilizumab). Data will be collected from eligible patients (on 8 mg/kg or 4 mg/kg intravenously every 4 weeks, with or without methotrexate) for 12 months.

02

Conditions studied

  • Rheumatoid Arthritis
03

In context

Arthritis, Rheumatoid

2,962 studies on the registry are indexed under Arthritis, Rheumatoid; 396 are open to participants now.

This study's enrollment of 64 is below the median of 176 across 854 observational studies indexed under Arthritis, Rheumatoid.

Browse Arthritis, Rheumatoid studies →

Lead sponsor

Hoffmann-La Roche is the lead sponsor of 2,099 studies on the registry; 88 are open to participants now.

Of its 324 completed or terminated interventional studies of FDA-regulated products, 245 (76%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Patients with rheumatoid arthritis and an inadequate response to DMARDs who are initiated on treatment with RoActemra/Actemra

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

  • Adult patients, >/= 18 years of age
  • Moderate to severe active rheumatoid arthritis
  • Inadequate response or intolerance to previous therapy with one or more traditional DMARDs

Exclusion criteria

Exclusion Criteria:

  • Pregnant or lactating women
  • Active infection
  • Positive for hepatitis B, hepatitis C or HIV infection
  • Concomitant anti-TNF drugs
  • Contraindications to treatment with RoActemra/Actemra
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
64 participants (actual)

Groups and cohorts

  • Cohort
06

What researchers measure

Primary outcomes

  1. Disease activity score (DAS28)

    Time frame: 12 months

Secondary outcomes

  1. DAS 28 (subgroup on monotherapy)

    Time frame: 12 months

  2. DAS 28 (subgroup on 4 mg/kg dose)

    Time frame: 12 months

  3. Safety: Incidence of adverse events

    Time frame: 12 months

07

Study locations

4 sites
  • Banská Bystrica, 975 17, Slovakia
  • Bratislava, 826 06, Slovakia
  • Košice, 04011, Slovakia
  • Piešťany, 921 12, Slovakia
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jul 2011, a primary completion of Mar 2013 and a completion of Mar 2013. It does not say whether these dates are actual or estimated.

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

Registered
Jul 4, 2011
First posted
Jul 6, 2011
Start
Jul 2011
Primary completionActual
Mar 2013
CompletionActual
Mar 2013
Last update
Nov 2, 2016
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 Nov 2, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01388309
Lead sponsor
Hoffmann-La Roche
Responsible party
Sponsor
First posted
Jul 6, 2011
Start date
Jul 2011
Primary completion
Mar 2013
Completion
Mar 2013
Last update
Nov 2, 2016

Study contacts

Clinical Trials
study director · Hoffmann-La Roche
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2016. You cannot join it, but the record below documents what was studied.

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