A Study of Glucocorticoid Use to Evaluate Systematic Methylprednisolone Reduction in Patients With Rheumatoid Arthritis on Background RoActemra/Actemra (Tocilizumab) (ACT-ALONE)
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: methylprednisolone; tocilizumab [RoActemra/Actemra]
Intervention description: starting dose >/= 1 mg and </= 20 mg orally daily, according to dose-reduction schedule; background therapy: 8 mg/kg iv every 4 weeks
Intervention MeSH terms: Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 68.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      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
    

Eligibility criteria:

        Inclusion Criteria:

        Non-interventional phase

          -  Adult patients, >/=18 years of age

          -  Moderate to severe active rheumatoid arthritis defined as Disease Activity Score using
             28-joint count (DAS28) >/=5.1

          -  Patients with inadequate clinical response to a current treatment with 2 or more
             non-biologic disease-modifying anti-rheumatic drugs (DMARDs), one of them being
             methotrexate (MTX) optimally administered during a period of more than 3 months or
             inadequate response to a current anti-TNF therapy

          -  Current use of oral glucocorticoids started at least 4 weeks prior to enrolment
             Interventional phase

          -  Patients enrolled in the non-interventional phase

          -  Patients with low disease activity defined as DAS28 </=3.2 at Visit 2

          -  Use of oral glucocorticoids with methylprednisolone equivalent dose of >/=1mg and
             </=20mg/day at Visit 2

        Exclusion Criteria:

        Non-interventional & interventional phase

          -  Rheumatic autoimmune disease other than rheumatoid arthritis, or significant systemic
             involvement secondary to rheumatoid arthritis

          -  Functional class IV as defined by the American College of Rheumatology (ACR)
             Classification of Functional Status in rheumatoid arthritis

          -  Prior history or current inflammatory joint disease other than rheumatoid arthritis
             (e.g. gout)