A Study of Glucocorticoid Use to Evaluate Systematic Methylprednisolone Reduction in Patients With Rheumatoid Arthritis on Background RoActemra/Actemra (Tocilizumab) (ACT-ALONE)

Sponsor
Hoffmann-La Roche
Study ID
NCT01219933
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • methylprednisolone — DRUG
    starting dose \>/= 1 mg and \</= 20 mg orally daily, according to dose-reduction schedule
  • tocilizumab [RoActemra/Actemra] — DRUG
    background therapy: 8 mg/kg iv every 4 weeks

Study Details

This open-label, single-arm study will assess the use of glucocorticoids (GC) in daily clinical practice and will evaluate the dose reduction of glucocorticoids once low disease activity is achieved in patients with rheumatoid arthritis tre ated with GC and background RoActemra/Actemra (tocilizumab) 8mg/kg intravenously every 4 weeks. In the non-interventional phase, the use of GC in daily clinical Belgian practice will be evaluated and described. This period of maximum 6 mont hs will allow those patients to obtain the inclusion criteria for the secondary interventional phase. In the interventional phase, a systematic GC dose reductio n schedule will be evaluated in patients having achieved low disease activity wh ile receiving the same background therapy with RoActemra/Actemra 8 mg/kg. Methyl prednisolone will be given from a starting dose of \>/= 1 mg to \</=20 mg orally d aily and will be tapered down. The anticipated study duration is up to 13 months

Key Dates

Start date
Jan 31, 2011
Status verified
Jan 2015
Primary completion
Mar 31, 2013
Completion
Mar 31, 2013

Study Design

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

Arms

  • Experimental: 1

Primary Outcome Measure

Median GC Dose Taken During the Noninterventional Phase [ Time Frame: V1 and V2 (up to 6 months after V1) ]

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