Phase 4
Completed N=68
A Study of Glucocorticoid Use to Evaluate Systematic Methylprednisolone Reduction in Patients With Rheumatoid Arthritis on Background RoActemra/Actemra (Tocilizumab) (ACT-ALONE)
Source: ClinicalTrials.gov NCT01219933 ↗Enrolled (actual)
68
Serious AEs
4.5%
Results posted
Jan 2015
Primary outcomePrimary: Median GC Dose Taken During the Noninterventional Phase — 6; 6; 4; 0 mg
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
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Median GC Dose Taken During the Noninterventional Phase |
6; 6; 4; 0; 320 | — |
| PRIMARY Number of Participants With GC Switches During the Noninterventional Phase |
— | — |
| PRIMARY Type of GC Taken at the End of the Noninterventional Phase |
70.0; 28.0; 2.0 | — |
| PRIMARY Percentage of Participants in the Interventional Phase Who Achieved LDA and Discontinued Oral GC Within 20 Weeks |
58.1 | — |
| SECONDARY Percentage of Participants Able to Acheive LDA Assessed Using DAS28 While Receiving Oral GC on Background Tocilizumab Treatment During the Noninterventional Phase |
72.1 | — |
| SECONDARY Percentage of Participants Acheiving Remission Assessed Using DAS28 While Receiving Oral GC on Background TocilizumabTreatment During the Noninterventional Phase |
41.2 | — |
| SECONDARY Percentage of Participants With Erosions During the NonInterventional Phase |
47.4; 41.7 | — |
| SECONDARY Number of Erosions During the NonInterventional Phase |
5.1; 3.2 | — |
| SECONDARY Percentage of Participants Positive for Rheumatoid Factor (RF) During the Noninterventional Phase |
56.4; 52.4 | — |
| SECONDARY Percentage of Participants Positive for Anti-cyclic Citrullinated Peptide (Anti-CCP) Antibody During the Noninterventional Phase |
75.0; 83.3 | — |
| SECONDARY Health Assessment Questionnaire Disability Index (HAQ-DI) During the Noninterventional Phase |
1.7; 1.2; -0.5 | — |
| SECONDARY DAS28-CRP During the Noninterventional Phase |
5.4; 2.9; -2.5 | — |
| SECONDARY DAS28-ESR During the Noninterventional Phase |
5.8; 3.3; -2.7 | — |
| SECONDARY Clinical Disease Activity Index (CDAI) During the Noninterventional Phase |
33.8; 14.6; -20.4 | — |
| SECONDARY Median Time Interval Between V1 and V2 |
2.3 | — |
| SECONDARY Median Dose of Tocilizumab During the Noninterventional Phase |
8.0 | — |
| SECONDARY Number of Participants With Changes in Tocilizumab Dose During the Noninterventional Phase |
1 | — |
| SECONDARY Percentage of Participants With Changes in RA Treatment During the Noninterventional Phase |
15.2 | — |
| SECONDARY Percentage of Participants Able to Start the GC Reduction Phase at V3 |
87.8 | — |
| SECONDARY Percentage of Participants Able to Reduce Oral GCs by ≥50 Percent (%) During the Interventional Phase by V9 |
93.3 | — |
| SECONDARY Percentage of Participants Able to Discontinue GCs During the Interventional Phase by V9 |
3.3 | — |
| SECONDARY Time-Averaged GC Dose Changes During the Interventional Phase |
341.8 | — |
| SECONDARY DAS28-CRP During the Interventional Phase |
2.2; 2.3; 0.2 | — |
| SECONDARY HAQ-DI During the Interventional Phase |
1.0; 0.8; 0.0 | — |
| SECONDARY VAS-Physician's Global Assessment of Disease Activity (GDA) During the Interventional Phase |
16.6; 16.7; 3.1 | — |
| SECONDARY VAS for Pain (VAS-Pain) During the Interventional Phase |
19.9; 24.9; 6.9 | — |
| SECONDARY SJC and TJC During the Interventional Phase |
0.9; 0.4; -0.3; 0.9; 1.8; 1.0 | — |
| SECONDARY Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score During the Interventional Phase |
37.5; 35.6; 8.8 | — |
| SECONDARY Short-Form 36 (SF-36) Mental Component Score (MCS) and Physical Component Score (PCS) During the Interventional Phase |
47.0; 46.2; -4.4; 42.5; 41.8; -2.1 | — |
| SECONDARY SF-36 Subscale Scores During the Interventional Phase |
41.52; 41.92; -1.80; 40.61; 39.85; -2.79 | — |
| SECONDARY CDAI Score During the Interventional Phase |
5.6; 6.5; 1.4 | — |
| SECONDARY Percentage of Participants With LDA or Remission During the Interventional Phase Assessed Using CDAI |
85.0; 27.5; 82.9; 39.0; 81.6; 47.4 | — |
| SECONDARY Percentage of Participants With LDA or Remission During the Interventional Phase Assessed Using DAS28-CRP |
90.5; 73.8; 85.4; 73.2; 88.6; 71.4 | — |
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 /=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)
Data sourced from ClinicalTrials.gov (NCT01219933). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.