A Study With Tocilizumab [RoActemra/Actemra] Monotherapy or in Combination With Methotrexate in Patients With Rheumatoid Arthritis (PICTURE)

Sponsor
Hoffmann-La Roche
Study ID
NCT01063062
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • tocilizumab [RoActemra/Actemra] — DRUG
    8 mg/kg intravenous infusion every 4 weeks.
  • Methotrexate — DRUG
    methotrexate as per standard of care in clinical practice.

Study Details

This single-arm, open-label, multicenter study evaluated the safety and tolerability and the efficacy in reducing disease activity of tocilizumab \[RoActemra/Actemra\] as monotherapy or in combination with methotrexate in patients with active moderate to severe rheumatoid arthritis (RA). Patients were eligible to participate in this study if they are currently experiencing an inadequate response to a stable dose of a non-biologic disease-modifying antirheumatic drug (DMARD). Patients received 8 mg/kg tocilizumab \[RoActemra/Actemra\] as an intravenous infusion every 4 weeks for a total of 6 infusions. The anticipated time on study treatment was 24 weeks. The target sample size was 50-200 patients.

Key Dates

Start date
Feb 28, 2010
Status verified
Jul 2017
Primary completion
Jan 17, 2011
Completion
Jan 17, 2011

Study Design

Enrollment
107 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: tocilizumab
    Participants received an 8 mg/kg tocilizumab intravenous (IV) infusion once every 4 weeks for 24 weeks (6 infusions). Participants taking concomitant methotrexate (MTX) at Baseline remained on a stable dose as per standard of care at the Investigator's discretion.

Primary Outcome Measure

Percentage of Participants Achieving Disease Activity Score 28 (DAS28) Low Disease Activity [ Time Frame: Baseline to Week 24 (Weeks 4, 8, 12, 16, 20, 24) ]

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