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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

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 Phase

Number 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 Phase

Percentage 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

- Use of oral glucocorticoids with methylprednisolone equivalent dose of >/=1mg and

- 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

Page last updated: August 23, 2015

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