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

NCT ID: NCT01219933

Last Updated: 2015-01-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 68 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-01-31
• Study Completion Date: 2013-03-31

Brief 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

Conditions

Rheumatoid Arthritis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Group Type: EXPERIMENTAL

methylprednisolone

Intervention Type: DRUG

starting dose \>/= 1 mg and \</= 20 mg orally daily, according to dose-reduction schedule

tocilizumab [RoActemra/Actemra]

Intervention Type: DRUG

background therapy: 8 mg/kg iv every 4 weeks

Interventions

methylprednisolone

starting dose \>/= 1 mg and \</= 20 mg orally daily, according to dose-reduction schedule

Intervention Type: DRUG

tocilizumab [RoActemra/Actemra]

background therapy: 8 mg/kg iv every 4 weeks

Intervention Type: DRUG

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hoffmann-La Roche

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

Aalst, , Belgium

Bruges, , Belgium

Brussels, , Belgium

Brussels, , Belgium

Charleroi, , Belgium

Edegem, , Belgium

Genk, , Belgium

Gilly, , Belgium

Godinne, , Belgium

Haine-Saint-Paul, , Belgium

Heusy, , Belgium

Kortrijk, , Belgium

La Louvière, , Belgium

Liège, , Belgium

Ostend, , Belgium

Wilrijk, , Belgium

Countries

Belgium

Other Identifiers

2010-019694-15

Identifier Type: -

Identifier Source: secondary_id

ML25252

Identifier Type: -

Identifier Source: org_study_id