Study to Compare the Efficacy of Tocilizumab With or Without Glucocorticoid Discontinuation in Rheumatoid Arthritis Participants

Sponsor
Hoffmann-La Roche
Study ID
NCT02573012
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Placebo matched to prednisone — DRUG
    Participants will receive placebo matched to prednisone orally for 24 weeks.
  • Prednisone — DRUG
    Participants will receive prednisone either at a constant dose of 5 mg/day, or 5 mg/day with 1 mg decrements every 4 weeks orally for 24 weeks.
  • Tocilizumab — BIOLOGICAL
    Participants will receive tocilizumab at a dose of 162 mg once a week subcutaneously for 24 weeks.

Study Details

This Phase IIIb/IV, two-arm, randomized, double-blind, placebo-controlled, parallel-group, international, multicenter trial compares the change in disease activity (as assessed by Disease Activity Score in 28 joints \[DAS28\] erythrocyte sedimentation rate \[ESR\]) from randomization to Week 24 post-randomization, in participants with stable low disease activity \[LDA\] (DAS28 ESR score less than or equal to \[\<=\] 3.2) who receive tocilizumab, and have been randomized to either continue or taper prednisone in a double-blinded fashion.

Key Dates

Start date
Mar 29, 2016
Status verified
Oct 2019
Primary completion
Feb 9, 2018
Completion
Feb 9, 2018

Study Design

Enrollment
314 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Tocilizumab+prednisone (constant dose)
    Participants will receive tocilizumab at a dose of 162 milligram (mg) once a week subcutaneously; and prednisone at a dose of 5 milligram per day (mg/day) or matching placebo orally for 24 weeks.
  • Experimental: Tocilizumab+prednisone (tapering dose)
    Participants will receive tocilizumab at a dose of 162 milligram (mg) once a week subcutaneously; and prednisone at a dose of 5 milligram per day (mg/day) with 1 mg decrements every 4 weeks or matching placebo orally for 24 weeks.

Primary Outcome Measure

Change From Baseline in Disease Activity Score in 28 Joints - Erythrocyte Sedimentation Rate (DAS28-ESR) at Week 24 Post-randomization [ Time Frame: Baseline to Week 24 ]

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