A Study of RoActemra/Actemra (Tocilizumab) in Combination With Methotrexate in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Disease-Modifying Antirheumatic Drugs (DMARDs) (ALABASTER)

Sponsor
Hoffmann-La Roche
Study ID
NCT01235507
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • methotrexate — DRUG
    stable dose as prescribed
  • tocilizumab [RoActemra/Actemra] — DRUG
    8 m/kg (maximum 800 mg) intravenously every 4 weeks for a total of 6 infusions

Study Details

This open-label, single arm study will assess the safety and efficacy of RoActem ra/Actemra (tocilizumab) in combination with methotrexate in patients with activ e moderate to severe rheumatoid arthritis who have an inadequate response to dis ease-modifying antirheumatic drugs (DMARDs). Patients will receive RoActemra/Act emra at a dose of 8 mg/kg (maximum 800 mg) intravenously every 4 weeks for a tot al of 6 infusions. Methotrexate will be continued at a stable dose. Anticipated time on study treatment is 24 weeks.

Key Dates

Start date
Feb 28, 2011
Status verified
Nov 2014
Primary completion
Dec 31, 2012
Completion
Dec 31, 2012

Study Design

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

Arms

  • Experimental: Single Arm

Primary Outcome Measure

Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and AEs of Special Interest (AESIs) [ Time Frame: Screening Visit, Baseline, Weeks 4, 8, 12, 16, 20 and 24 ]

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