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

Sponsor
Hoffmann-La Roche
Study ID
NCT02010216
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Mar 31, 2010
Status verified
Sep 2014
Primary completion
Jul 31, 2010
Completion
Jul 31, 2010

Study Design

Enrollment
23 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

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

Primary Outcome Measure

Change From Baseline in Disease Activity 28 (DAS28) Score [ Time Frame: Baseline, Week 12 ]

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