Clinical trial NCT01219933: A Study of Glucocorticoid Use to Evaluate Systematic Methylprednisolone Reduction in Patients With Rheumatoid Arthritis on Background RoActemra/Actemra (Tocilizumab) (ACT-ALONE)
Official title: An Open-label, Single-arm Study to Describe Glucocorticoid Use in Rheumatoid Arthritis Patients Treated With Tocilizumab in Daily Clinical Practice and to Evaluate Systematic Glucocorticoid Dose Reduction Once Low Disease Activity is Reached (ACT-ALONE)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Rheumatoid Arthritis
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2010-10-13
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


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)

Primary outcomes:
measure: Median GC Dose Taken During the Noninterventional Phase
timeFrame: V1 and V2 (up to 6 months after V1)
measure: Number of Participants With GC Switches During the Noninterventional Phase
timeFrame: V1 and V2 (up to 6 months after V1)
measure: Type of GC Taken at the End of the Noninterventional Phase
timeFrame: V1 and V2 (up to 6 months after V1)
measure: Percentage of Participants in the Interventional Phase Who Achieved LDA and Discontinued Oral GC Within 20 Weeks
timeFrame: Visits 3 (7 months), 4 (8 months), 5 (9 months), 6 (10 months), 7 (11 months), and 8 (12 months)
Secondary outcomes:
measure: Percentage of Participants Able to Acheive LDA Assessed Using DAS28 While Receiving Oral GC on Background Tocilizumab Treatment During the Noninterventional Phase
timeFrame: V1 and V2 (up to 6 months after V1)
measure: Percentage of Participants Acheiving Remission Assessed Using DAS28 While Receiving Oral GC on Background TocilizumabTreatment During the Noninterventional Phase
timeFrame: V1 and V2 (up to 6 months after V1)
measure: Percentage of Participants With Erosions During the NonInterventional Phase
timeFrame: V1 and V2 (up to 6 months after V1)
measure: Number of Erosions During the NonInterventional Phase
timeFrame: V1 and V2 (up to 6 months after V1)
measure: Percentage of Participants Positive for Rheumatoid Factor (RF) During the Noninterventional Phase
timeFrame: V1 and V2 (up to 6 months after V1)
measure: Percentage of Participants Positive for Anti-cyclic Citrullinated Peptide (Anti-CCP) Antibody During the Noninterventional Phase
timeFrame: V1 and V2 (up to 6 months after V1)
measure: Health Assessment Questionnaire Disability Index (HAQ-DI) During the Noninterventional Phase
timeFrame: V1 and V2 (up to 6 months after V1)
measure: DAS28-CRP During the Noninterventional Phase
timeFrame: V1 and V2 (up to 6 months after V1)
measure: DAS28-ESR During the Noninterventional Phase
timeFrame: V1 and V2 (up to 6 months after V1)
measure: Clinical Disease Activity Index (CDAI) During the Noninterventional Phase
timeFrame: V1 and V2 (up to 6 months after V1)
measure: Median Time Interval Between V1 and V2
timeFrame: V1 and V2 (up to 6 months after V1)
measure: Median Dose of Tocilizumab During the Noninterventional Phase
timeFrame: V1 and V2 (up to 6 months after V1)
measure: Number of Participants With Changes in Tocilizumab Dose During the Noninterventional Phase
timeFrame: V1 and V2 (up to 6 months after V1)
measure: Percentage of Participants With Changes in RA Treatment During the Noninterventional Phase
timeFrame: V1 and V2 (up to 6 months after V1)
measure: Percentage of Participants Able to Start the GC Reduction Phase at V3
timeFrame: V3 (7 months)
measure: Percentage of Participants Able to Reduce Oral GCs by ≥50 Percent (%) During the Interventional Phase by V9
timeFrame: V9 (24 weeks after V3)
measure: Percentage of Participants Able to Discontinue GCs During the Interventional Phase by V9
timeFrame: V9 (24 weeks after V3)
measure: Time-Averaged GC Dose Changes During the Interventional Phase
timeFrame: V3 (7 months) and CV (4 weeks after GC-free status, maximum of 24 weeks after V3)
measure: DAS28-CRP During the Interventional Phase
timeFrame: V3 (7 months) and CV (4 weeks after GC-free status, maximum of 24 weeks after V3)
measure: HAQ-DI During the Interventional Phase
timeFrame: Visit 3 (7 months) and CV (4 weeks after GC-free status, maximum of 24 weeks after V3)
measure: VAS-Physician's Global Assessment of Disease Activity (GDA) During the Interventional Phase
timeFrame: V3 (7 months) and CV (4 weeks after GC-free status, maximum of 24 weeks after V3)
measure: VAS for Pain (VAS-Pain) During the Interventional Phase
timeFrame: V3 (7 months) and CV (4 weeks after GC-free status, maximum of 24 weeks after V3)
measure: SJC and TJC During the Interventional Phase
timeFrame: V3 (7 months) and CV (4 weeks after GC-free status, maximum of 24 weeks after V3)
measure: Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score During the Interventional Phase
timeFrame: V3 (7 months) and CV (4 weeks after GC-free status, maximum of 24 weeks after V3)
measure: Short-Form 36 (SF-36) Mental Component Score (MCS) and Physical Component Score (PCS) During the Interventional Phase
timeFrame: V3 (7 months) and CV (4 weeks after GC-free status, maximum of 24 weeks after V3)
measure: SF-36 Subscale Scores During the Interventional Phase
timeFrame: V3 (7 months) and CV (4 weeks after GC-free status, maximum of 24 weeks after V3)
measure: CDAI Score During the Interventional Phase
timeFrame: V3 (7 months) and CV (4 weeks after GC-free status, maximum of 24 weeks after V3)
measure: Percentage of Participants With LDA or Remission During the Interventional Phase Assessed Using CDAI
timeFrame: Visits 3 (7 months), 4 (8 months), 5 (9 months), 6 (10 months), 7 (11 months), 8 (12 months), and 9 (24 weeks after V3) or CV (4 weeks after GC-free status, maximum of 24 weeks after V3)
measure: Percentage of Participants With LDA or Remission During the Interventional Phase Assessed Using DAS28-CRP
timeFrame: Visits 3 (7 months), 4 (8 months), 5 (9 months), 6 (10 months), 7 (11 months), 8 (12 months), 9 (24 weeks after V3) or CV (4 weeks after GC-free status, maximum of 24 weeks after V3)
Other outcomes:
Locations:
city: Aalst
country: Belgium
city: Brugge
country: Belgium
city: Bruxelles
country: Belgium
city: Bruxelles
country: Belgium
city: Charleroi
country: Belgium
city: Edegem
country: Belgium
city: Genk
country: Belgium
city: Gilly
country: Belgium
city: Godinne
country: Belgium
city: Haine-Saint-Paul
country: Belgium
city: Heusy
country: Belgium
city: Kortrijk
country: Belgium
city: La Louviere
country: Belgium
city: Liege
country: Belgium
city: Oostende
country: Belgium
city: Wilrijk
country: Belgium
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: