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

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Roche

Status and phase

Completed
Phase 4

Conditions

Rheumatoid Arthritis

Treatments

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

Study type

Interventional

Funder types

Industry

Identifiers

NCT01034397
2009-012218-30
ML22648

Details and patient eligibility

About

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.

Enrollment

54 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

54 participants in 2 patient groups, including a placebo group

1
Experimental group
Treatment:
Drug: non-biological DMARDs
Drug: tocilizumab [RoActemra/Actemra]
2
Placebo Comparator group
Treatment:
Drug: non-biological DMARDs
Drug: placebo

Trial contacts and locations

11

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Data sourced from clinicaltrials.gov

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