NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

A Study of Tocilizumab Plus Non-biological DMARD in Patients With Moderate to Severe Rheumatoid Arthritis and an Inadequate Response to Non-biological DMARDs

NCT01034397

CompletedPhase 4

Sponsor: Hoffmann-La Roche

Conditions: Rheumatoid Arthritis

Interventions: tocilizumab [RoActemra/Actemra], placebo, non-biological DMARDs

Countries: Portugal

This randomized, double-blind, placebo-controlled study will use Magnetic Resonance Imaging (MRI) to assess the efficacy of tocilizumab plus non-biological DMARD in patients with moderate to severe rheumatoid arthritis who have had an inadequate response to non-biological DMARDS. Patients will be randomized to receive either intravenous tocilizumab at 8mg/kg (minimal dose 480mg, maximum dose 800mg) or placebo every 4 weeks, in addition to their stable dose of non-biological DMARD. Anticipated time on study treatment is 24 weeks, and target sample size is \<100.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* adult patients, \>/=18 years of age
* moderate to severe rheumatoid arthritis of \>/=6 months duration
* synovitis (swollen and tender joint) in the wrist of the dominant hand
* non-biologic DMARDs at stable dose for \>/=12 weeks prior to baseline
* oral corticosteroids at stable dose for at least 25 out of 28 days prior to baseline

Exclusion Criteria:

* rheumatic autoimmune disease other than RA
* history of or current inflammatory joint disease other than RA
* functional class IV (ACR classification)
* intraarticular or parenteral corticosteroids within 6 weeks prior to baseline
* previous treatment with a biologic agent for RA

Locations (11)

Almada, Portugal
Coimbra, Portugal
Coimbra, Portugal
Lisbon, Portugal
Lisbon, Portugal
Lisbon, Portugal
Lisbon, Portugal
Ponte de Lima, Portugal
Porto, Portugal
Porto, Portugal
Vila Nova de Gaia, Portugal