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

NCT01219933 | Completed Phase 4 Results

• 2 other identifiers: ML252522010-019694-15
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 16

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

Outcome Measures

Primary Outcomes (4)

• Median GC Dose Taken During the Noninterventional Phase

  During the noninterventional phase of the study participants received GC as prescribed by the physician. Doses of all GC administered are expressed as MP equivalents.

  V1 and V2 (up to 6 months after V1)

• Number of Participants With GC Switches During the Noninterventional Phase

  During the noninterventional phase of the study, once LDA was achieved, GC was switched to MP tablets.

  V1 and V2 (up to 6 months after V1)

• Type of GC Taken at the End of the Noninterventional Phase

  During the noninterventional phase of the study participants received GC as prescribed by the physician.

  V1 and V2 (up to 6 months after V1)

• Percentage of Participants in the Interventional Phase Who Achieved LDA and Discontinued Oral GC Within 20 Weeks

  The percentage of participants with rheumatoid arthritis (RA) with LDA was defined as DAS28 ≤3.2, able to discontinue oral GC within 20 weeks and at the latest at V8, confirmed at the Consolidation Visit without loss of clinical response defined as DAS28 (CRP) \>3.2.

  Visits 3 (7 months), 4 (8 months), 5 (9 months), 6 (10 months), 7 (11 months), and 8 (12 months)

Secondary Outcomes (29)

• Percentage of Participants Able to Acheive LDA Assessed Using DAS28 While Receiving Oral GC on Background Tocilizumab Treatment During the Noninterventional Phase

  V1 and V2 (up to 6 months after V1)

• Percentage of Participants Acheiving Remission Assessed Using DAS28 While Receiving Oral GC on Background TocilizumabTreatment During the Noninterventional Phase

  V1 and V2 (up to 6 months after V1)

• Percentage of Participants With Erosions During the NonInterventional Phase

  V1 and V2 (up to 6 months after V1)

• Number of Erosions During the NonInterventional Phase

  V1 and V2 (up to 6 months after V1)

• Percentage of Participants Positive for Rheumatoid Factor (RF) During the Noninterventional Phase

  V1 and V2 (up to 6 months after V1)

Study Arms (1)

1

EXPERIMENTAL

Drug: methylprednisolone; Drug: tocilizumab [RoActemra/Actemra]

Interventions

methylprednisolone DRUG

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

1

tocilizumab [RoActemra/Actemra] DRUG

background therapy: 8 mg/kg iv every 4 weeks

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (16)

Unknown Facility

Aalst, 9300, Belgium

Location

Unknown Facility

Bruges, 8000, Belgium

Location

Unknown Facility

Brussels, 1020, Belgium

Location

Unknown Facility

Brussels, 1070, Belgium

Location

Unknown Facility

Charleroi, 6000, Belgium

Location

Unknown Facility

Edegem, 2650, Belgium

Location

Unknown Facility

Genk, 3600, Belgium

Location

Unknown Facility

Gilly, 6060, Belgium

Location

Unknown Facility

Godinne, 5530, Belgium

Location

Unknown Facility

Haine-Saint-Paul, 7100, Belgium

Location

Unknown Facility

Heusy, 4802, Belgium

Location

Unknown Facility

Kortrijk, 8500, Belgium

Location

Unknown Facility

La Louvière, 7100, Belgium

Location

Unknown Facility

Liège, 4000, Belgium

Location

Unknown Facility

Ostend, 8400, Belgium

Location

Unknown Facility

Wilrijk, 2610, Belgium

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Methylprednisolone; tocilizumab

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Results Point of Contact

• Title: Medical Communications
• Organization: Hoffmann- LaRoche

genentech@druginfo.com

1-800-821-8590

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2010
• First Posted: October 13, 2010
• Study Start: January 1, 2011
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: January 19, 2015
• Results First Posted: January 19, 2015

Record last verified: 2015-01

Locations

BE (16)