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

Roche

Status and phase

Completed

Phase 4

Conditions

Rheumatoid Arthritis

Treatments

Drug: tocilizumab [RoActemra/Actemra]

Drug: methylprednisolone

Study type

Interventional

Funder types

Industry

Identifiers

NCT01219933

2010-019694-15

ML25252

Details and patient eligibility

About

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

Enrollment

68 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)