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A Study of Tocilizumab Added to DMARDs in Patients With Moderate to Severe Rheumatoid Arthritis and an Inadequate Response to DMARDs.
A Study of Tocilizumab Added to DMARDs in Patients With Moderate to Severe Rheumatoid Arthritis and an Inadequate Response to DMARDs.

NCT00996203

CompletedPhase 4

Sponsor: Hoffmann-La Roche

Conditions: Rheumatoid Arthritis

Interventions: tocilizumab [RoActemra/Actemra], DMARDs (disease-modifying antirheumatic drugs)

Countries: Russia

This open-label single arm study will evaluate the efficacy and safety of tocilizumab added to traditional disease-modifying antirheumatic drugs (DMARDs) in patients with moderate to severe active rheumatoid arthritis and an inadequate response to DMARDs. Patients will receive tocilizumab 8 mg/kg by intravenous infusion every 4 weeks for 24 weeks, in addition to their current non-biologic DMARDs at stable doses. Anticipated time on study treatment is 24 weeks, and the target sample size is 200.

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 active rheumatoid arthritis of \>/=6 months duration
* inadequate clinical response to current non-biologic DMARDs
* current DMARDs must be at stable dose for 8 weeks prior to study entry
* oral corticosteroids (\</=10mg/day prednisone or equivalent) and NSAIDs must be at stable dose for \>/=4 weeks prior to screening

Exclusion Criteria:

* rheumatic autoimmune disease other than RA
* history of or current inflammatory joint disease other than RA
* previous treatment with any biologic DMARD
* functional class IV as defined by the ACR classification
* intra-articular or parenteral corticosteroids within 6 weeks prior to screening
Locations (28)
  • Chelyabinsk, Russia
  • Cherkess, Russia
  • Irkutsk, Russia
  • Izhevsk, Russia
  • Kaliningrad, Russia
  • Kemerovo, Russia
  • Kirov, Russia
  • Krasnodar, Russia
  • Kursk, Russia
  • Moscow, Russia
  • Moscow, Russia
  • Moscow, Russia
  • Moscow, Russia
  • Moscow, Russia
  • Nizhny Novgorod, Russia
  • Petrozavodsk, Russia
  • Rostov-on-Don, Russia
  • Smolensk, Russia
  • Surgut, Russia
  • Tyumen, Russia
  • Ufa, Russia
  • Ulyanovsk, Russia
  • Veliky Novgorod, Russia
  • Voronezh, Russia
  • Voronezh, Russia
  • Yaroslavl, Russia
  • Yekaterinburg, Russia
  • Yekaterinburg, Russia