A Study of Glucocorticoid Use to Evaluate Systematic Methylprednisolone Reduction in Patients With Rheumatoid Arthritis on Background RoActemra/Actemra (Tocilizumab) (ACT-ALONE)
Information source: Hoffmann-La Roche
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Rheumatoid Arthritis
Intervention: methylprednisolone (Drug); tocilizumab [RoActemra/Actemra] (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Hoffmann-La Roche Official(s) and/or principal investigator(s): Clinical Trials, Study Director, Affiliation: Hoffmann-La Roche
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
Clinical Details
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 design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Median GC Dose Taken During the Noninterventional PhaseNumber of Participants With GC Switches During the Noninterventional Phase Type of GC Taken at the End of the Noninterventional Phase Percentage of Participants in the Interventional Phase Who Achieved LDA and Discontinued Oral GC Within 20 Weeks
Secondary outcome: Percentage of Participants Able to Acheive LDA Assessed Using DAS28 While Receiving Oral GC on Background Tocilizumab Treatment During the Noninterventional PhasePercentage of Participants Acheiving Remission Assessed Using DAS28 While Receiving Oral GC on Background TocilizumabTreatment During the Noninterventional Phase Percentage of Participants With Erosions During the NonInterventional Phase Number of Erosions During the NonInterventional Phase Percentage of Participants Positive for Rheumatoid Factor (RF) During the Noninterventional Phase Percentage of Participants Positive for Anti-cyclic Citrullinated Peptide (Anti-CCP) Antibody During the Noninterventional Phase Health Assessment Questionnaire Disability Index (HAQ-DI) During the Noninterventional Phase DAS28-CRP During the Noninterventional Phase DAS28-ESR During the Noninterventional Phase Clinical Disease Activity Index (CDAI) During the Noninterventional Phase Median Time Interval Between V1 and V2 Median Dose of Tocilizumab During the Noninterventional Phase Number of Participants With Changes in Tocilizumab Dose During the Noninterventional Phase Percentage of Participants With Changes in RA Treatment During the Noninterventional Phase Percentage of Participants Able to Start the GC Reduction Phase at V3 Percentage of Participants Able to Reduce Oral GCs by ≥50 Percent (%) During the Interventional Phase by V9 Percentage of Participants Able to Discontinue GCs During the Interventional Phase by V9 Time-Averaged GC Dose Changes During the Interventional Phase DAS28-CRP During the Interventional Phase HAQ-DI During the Interventional Phase VAS-Physician's Global Assessment of Disease Activity (GDA) During the Interventional Phase VAS for Pain (VAS-Pain) During the Interventional Phase SJC and TJC During the Interventional Phase Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score During the Interventional Phase Short-Form 36 (SF-36) Mental Component Score (MCS) and Physical Component Score (PCS) During the Interventional Phase SF-36 Subscale Scores During the Interventional Phase CDAI Score During the Interventional Phase Percentage of Participants With LDA or Remission During the Interventional Phase Assessed Using CDAI Percentage of Participants With LDA or Remission During the Interventional Phase Assessed Using DAS28-CRP
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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)
Locations and Contacts
Aalst 9300, Belgium
Brugge 8000, Belgium
Bruxelles 1020, Belgium
Bruxelles 1070, Belgium
Charleroi 6000, Belgium
Edegem 2650, Belgium
Genk 3600, Belgium
Gilly 6060, Belgium
Godinne 5530, Belgium
Haine-Saint-Paul 7100, Belgium
Heusy 4802, Belgium
Kortrijk 8500, Belgium
La Louviere 7100, Belgium
Liege 4000, Belgium
Oostende 8400, Belgium
Wilrijk 2610, Belgium
Additional Information
Starting date: January 2011
Last updated: January 15, 2015
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