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A Study of RoActemra/Actemra (Tocilizumab) in Adult Patients With Rheumatoid Arthritis (SVOBODA Programme)

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Roche

Status and phase

Completed
Phase 4

Conditions

Rheumatoid Arthritis

Treatments

Drug: tocilizumab [RoActemra/Actemra]

Study type

Interventional

Funder types

Industry

Identifiers

NCT02010216
ML23037

Details and patient eligibility

About

This open-label, single arm study evaluated the efficacy and safety of RoActemra/Actemra (tocilizumab) in patients with rheumatoid arthritis. Patients received RoActemra/Actemra 8 mg/kg intravenously every 4 weeks, alone or in combination with standard anti-rheumatic therapy, for 12 weeks.

Enrollment

23 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Adult patients, ≥ 18 years of age
  • Confirmed moderate or severe rheumatoid arthritis
  • Intolerability or absence of effect or decrease in effect of rheumatoid arthritis treatment with disease modifying antirheumatic drugs (DMARDs)

Exclusion criteria

  • Presence of infectious diseases [tuberculosis (Tb), human immunodeficiency virus (HIV), virus hepatitis A/B/C]
  • Inadequate hematologic, renal or liver function
  • Peptic ulcer disease (in acute phase)
  • Pregnant and lactating women

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

23 participants in 1 patient group

tocilizumab [RoActemra/Actemra]
Experimental group
Description:
Participants received tocilizumab 8 mg/kg by intravenous infusion every 4 weeks for 12 weeks (3 cycles).
Treatment:
Drug: tocilizumab [RoActemra/Actemra]

Trial contacts and locations

6

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Data sourced from clinicaltrials.gov

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