ClinicalTrials.gg
Sign In
CompletedNCT01730456Updated Nov 2, 2016

A Long-Term Extension Study of RoActemra/Actemra (Tocilizumab) in Patients With Early Moderate to Severe Rheumatoid Arthritis Who Completed Study WA19926

A Phase 3 interventional study of tocilizumab [RoActemra/Actemra] in Rheumatoid Arthritis, sponsored by Hoffmann-La Roche. Completed at 1 site in North Macedonia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-11-02.

Sponsored by Hoffmann-La Roche · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
13
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

This multicenter, open-label, single arm, long-term extension study will evaluate the safety and efficacy of RoActemra/Actemra (tocilizumab) in patients with early moderate to severe rheumatoid arthritis who completed the WA19926 core study. Patients will receive RoActemra/Actemra 8 mg/kg intravenously every 4 weeks for up to 104 weeks.

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 13 is below the median of 94 across 2,027 interventional 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.

Browse Hoffmann-La Roche studies →

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

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
  • Patients who complete their last WA19926 core study visit (Week 104) and who may benefit from study drug treatment according to the Investigator's assessment
  • No current or recent adverse event or laboratory finding preventing the use of the study drug dose of RoActemra/Actemra 8 mg/kg at baseline visit
  • Receiving treatment on an outpatient basis
  • Females of childbearing potential must agree to use at least one adequate method of contraception, including a method with a failure rate of \<1% per year, during the treatment period

Exclusion criteria

Exclusion Criteria:

  • Pregnant or lactating women
  • Patients who have prematurely withdrawn from the WA19926 core study for any reason
  • Treatment with an investigational agent or cell-depleting therapies since the last administration of study drug in the WA19926 core study
  • Immunization with a live/attenuated vaccine since the last administration of study drug in the WA19926 core study
  • Diagnosis since last WA19926 visit (Week 104) of rheumatic autoimmune disease other than rheumatoid arthritis
  • Diagnosis since last WA19926 visit (Week 104) of inflammatory joint disease other than rheumatoid arthritis
  • Inadequate liver, hematologic or renal function
  • History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies
  • Known active or history of recurrent infections
  • Evidence of active malignant disease, malignancies within the previous 10 years (except for basal cell carcinoma of the skin that has been excised and cured), or breast cancer diagnosed within the previous 20 years
  • Uncontrolled disease states, such as asthma or inflammatory bowel disease, where flares are commonly treated with oral or parenteral corticosteroids
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
13 participants (actual)

Study arms

  • Experimental
    RoActemra/Actemra

    Drug: tocilizumab [RoActemra/Actemra]

Interventions

  • Drugtocilizumab [RoActemra/Actemra]

    Drug page: Tocilizumab

    8 mg/kg iv every 4 weeks, up to 104 weeks

06

What researchers measure

Primary outcomes

  1. Long-term safety: Incidence of adverse events

    Time frame: approximately 3 years

Secondary outcomes

  1. Change in disease activity: Disease Activity Score 28 - erythrocyte sedimentation rate (DAS28-ESR) and/or Simplified Disease Activity Index (SDAI)

    Time frame: from baseline to Week 104

  2. Change in total tender joint count (TJC) / swollen joint count (SJC)

    Time frame: from baseline to Week 104

  3. Proportion of patients achieving sustained drug-free remission, defined as clinical remission based on DAS28-ESR <2.6 and/or SDAI </=3 for two consecutive visits (every 12 weeks) followed by RoActemra/Actemra discontinuation after the 2nd visit

    Time frame: approximately 3 years

  4. Time to rheumatoid arthritis flare in patients who have entered drug-free remission

    Time frame: approximately 3 years

07

Study locations

1 site
  • Skopje, 1000, North Macedonia
08

Timeline

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

The record gives a start of Oct 2012, a primary completion of May 2015 and a completion of May 2015. 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
Nov 15, 2012
First posted
Nov 21, 2012
Start
Oct 2012
Primary completionActual
May 2015
CompletionActual
May 2015
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
NCT01730456
Lead sponsor
Hoffmann-La Roche
Responsible party
Sponsor
First posted
Nov 21, 2012
Start date
Oct 2012
Primary completion
May 2015
Completion
May 2015
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.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drug tested here: Tocilizumab

Other studies in this condition

Arthritis, Rheumatoid →

Other studies from this sponsor

Hoffmann-La Roche →

Start the discussion