A Study to Assess the Effect of Tocilizumab + DMARD Therapy on Signs and Symptoms in Patients With Moderate to Severe Active Rheumatoid Arthritis

A Randomized, Double-blind Study of the Effect of Tocilizumab on Reduction in Signs and Symptoms in Patients With Moderate to Severe Active Rheumatoid Arthritis and Inadequate Response to DMARD Therapy

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00106574

Enrollment

1220

Registered

2005-03-28

Start date

2005-04-30

Completion date

2007-12-31

Last updated

2016-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid Arthritis

Brief summary

This 2 arm study will compare the safety and efficacy, with regard to reduction of signs and symptoms, of tocilizumab versus placebo in combination with traditional Disease-Modifying Anti-Rheumatic Drug (DMARD) therapy in patients with moderate to severe active rheumatoid arthritis (RA) who have had an inadequate response to current DMARD therapy. Patients will be randomized to receive tocilizumab 8mg/kg iv or placebo iv every 4 weeks, in conjunction with stable DMARD therapy. The anticipated time on study treatment is 3-12 months, and the target sample size is 500+ individuals.

Interventions

DRUGPlacebo

iv every 4 weeks

DRUGtocilizumab [RoActemra/Actemra]

8mg/kg iv every 4 weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* patients at least 18 years of age with moderate to severe active RA for at least 6 months; * inadequate response to current anti-rheumatic therapies, including 1 or more traditional DMARDs; * stable DMARD therapy for at least 8 weeks before entering study; * patients of reproductive potential must be using reliable methods of contraception.

Exclusion criteria

* major surgery (including joint surgery) within 8 weeks before entering study, or planned surgery within 6 months after entering study; * patients who have previously failed treatment with an anti-tumor necrosis factor agent; * women who are pregnant or breast-feeding.

Design outcomes

Primary

Measure	Time frame
Percentage of patients with ACR 20 response	Week 24

Secondary

Measure	Time frame
Percentage of patients with ACR 50 and ACR 70 responses.	Week 24
Mean changes in parameters of ACR core set	Week 24
AEs, laboratory parameters, vital signs.	Throughout study

Countries

Argentina, Australia, Brazil, Canada, China, Costa Rica, Czechia, Finland, France, Germany, Hong Kong, Mexico, Panama, Russia, South Africa, Spain, Sweden, Thailand, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 12, 2026