NCT01705730

A Non-Interventional Study of Rheumatoid Arthritis Patients Treated With RoActemra/Actemra (Tocilizumab) in Monotherapy

Completed Results posted Last updated 4 September 2018

What this trial tests

trial testing tocilizumab in Rheumatoid Arthritis in 71 participants. Completed in 12 December 2014.

Timeline

31 July 2012

Primary endpoint
12 December 2014

12 December 2014

Quick facts

Lead sponsor	Hoffmann-La Roche
Status	Completed
Study type	OBSERVATIONAL
Enrollment	71
Start date	31 July 2012
Primary completion	12 December 2014
Estimated completion	12 December 2014
Sites	17 locations across Belgium

Drugs / interventions tested

• tocilizumab (tocilizumab) — full drug profile →

Conditions studied

• Rheumatoid Arthritis — all drugs for Rheumatoid Arthritis →

Sponsor

Hoffmann-La Roche — full company profile →

Who can join

18 and older, any sex, with Rheumatoid Arthritis. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Percentage of Participants on Tocilizumab Treatment at Month 6 After Treatment Initiation Primary · Month 6 after treatment initiation

Group	Value	95% CI
Tocilizumab	79.4	67.9 – 88.3

Number of Participants With Disease-Modifying Antirheumatic Drugs (DMARDs) Intolerance and Inadequate Response Secondary · Baseline

DMARD Intolerance

Group	Value	95% CI
Tocilizumab	1

Inadequate Response

Group	Value	95% CI
Tocilizumab	67

Number of Participants With Inadequate Response to Other Biologics Secondary · Baseline

Group	Value	95% CI
Tocilizumab	35

Time to Addition of Disease-Modifying Anti-rheumatic Drugs (DMARDs) Secondary · Month 6

The time to DMARD addition equals to the time (days) between tocilizumab start and first start date of DMARDs.

Group	Value	95% CI
Tocilizumab	84	84 – 84

Percentage of Participants Who Had DMARDs During Study Secondary · Month 6

Hydroxychoroquine

Group	Value	95% CI
Tocilizumab	0.0

Sulfasalazine

Group	Value	95% CI
Tocilizumab	0.0

Methotrexate

Group	Value	95% CI
Tocilizumab	100.0

Leflunomide

Group	Value	95% CI
Tocilizumab	0.0

Gold compunds

Group	Value	95% CI
Tocilizumab	0.0

Cyclosporine

Group	Value	95% CI
Tocilizumab	0.0

Azatioprine

Group	Value	95% CI
Tocilizumab	0.0

Other DMARD

Group	Value	95% CI
Tocilizumab	0.0

Number of Participants With Dose Reductions Secondary · 6 months

Group	Value	95% CI
Tocilizumab	4

Number of Participants With Starting Tocilizumab After Failing DMARDs Secondary · Baseline

Group	Value	95% CI
Tocilizumab	33

Number of Participants With Starting Tocilizumab After Stopping Other Biologic Agents Secondary · Baseline

Group	Value	95% CI
Tocilizumab	35

Number of Dose Modifications Per Participant at Month 6 Secondary · Month 6

Number of dose modification per participant at Month 6 was reported.

Group	Value	95% CI
Tocilizumab	0.1	± 0.2

Mean Dosing Interval Per Participant at Month 6 Secondary · Month 6

Group	Value	95% CI
Tocilizumab	25.86	± 2.64

Percentage of Participants Discontinued From Tocilizumab for Safety Versus Efficacy Secondary · Month 6

Adverse Event

Group	Value	95% CI
Tocilizumab	61.5

Lack of efficacy

Group	Value	95% CI
Tocilizumab	7.7

Other

Group	Value	95% CI
Tocilizumab	30.8

Time for Restoration of Initial Dosing Regimen Secondary · Month 6

Group	Value	95% CI
Tocilizumab	NA	NA – NA

Adverse events — posted to ClinicalTrials.gov

Time frame: Month 6. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Tocilizumab

Serious: 3/68 (4%)

Deaths: —

Serious adverse events (3 terms)

Reaction	System	Tocilizumab
Sarcoidosis	Immune system disorders	—
Depression	Psychiatric disorders	—
Infarction	Vascular disorders	—

Most-reported serious reactions: Sarcoidosis, Depression, Infarction.

Data from ClinicalTrials.gov NCT01705730 adverse events section.

Sponsor's own description

This observational study will evaluate the use and efficacy of RoActemra/Actemra (tocilizumab) in monotherapy in routine clinical practice in participants with rheumatoid arthritis. Eligible participants initiated on RoActemra/Actemra treatment according to the licensed label will be followed for 6 months.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.