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

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)

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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]