A Study of RoActemra/Actemra (Tocilizumab) Given Subcutaneously in Combination With Traditional DMARDs in Patients With Moderate to Severe Active Rheumatoid Arthritis

Conditions

• Rheumatoid Arthritis

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Tocilizumab 162 mg — DRUG
  Tocilizumab will be supplied in a ready-to-use, single-use, pre-filled syringe. Patients and/or caregivers will be trained to administer the injection.
• Placebo — DRUG
  Placebo will be supplied in a ready-to-use, single-use, pre-filled syringe. Patients and/or caregivers will be trained to administer the injection.

Study Details

This randomized, parallel-group, placebo-controlled, multicenter study will evaluate the reduction in disease activity and the safety of tocilizumab (RoActemra/Actemra) in combination with traditional disease-modifying anti-rheumatic drugs (DMARDs) in patients with active, moderate to severe rheumatoid arthritis. In the double-blind part of the study, patients will be randomized to receive either 162 mg tocilizumab or placebo subcutaneously every 2 weeks for 24 weeks using a pre-filled syringe. In the open-label part of the study, patients will be randomized to receive 162 mg tocilizumab subcutaneously every 2 weeks from Week 24 to Week 96 using a pre-filled syringe or an auto-injector.

Key Dates

Start date

Mar 31, 2011

Status verified

Jul 2015

Primary completion

May 31, 2012

Completion

Nov 30, 2013

Study Design

Enrollment

656 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Tocilizumab 162 mg sc
  Patients will receive tocilizumab 162 mg subcutaneously (sc) every 2 weeks for 24 weeks.
• Placebo Comparator: Placebo sc
  Patients will receive placebo subcutaneously (sc) every 2 weeks for 24 weeks.

Primary Outcome Measure

Percentage of Patients With an American College of Rheumatology 20 (ACR20) Response at Week 24 [ Time Frame: Baseline to Week 24 ]

Locations (44)

Find similar trials in Peoria, AZ

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