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

Purpose

This randomized, parallel-group, placebo-controlled, multicenter study will evaluate the reduction in disease activity and the safety of RoActemra/Actemra (tocilizumab) in combination with traditional disease-modifying antirheumatic 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 RoActemra/Actemra 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 RoActemra/Actemra subcutaneously every 2 weeks from Week 24 to Week 96 using a pre-filled syringe or an autoinjector.

Condition	Intervention	Phase
Rheumatoid Arthritis	Drug: tocilizumab [RoActemra/Actemra] Drug: placebo	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	A Randomized, Double-blind, Parallel Group Study of the Safety and the Effect on Clinical Outcome of Tocilizumab SC Versus Placebo SC in Combination With Traditional Disease Modifying Antirheumatic Drugs (DMARDs) in Patients With Moderate to Severe Active Rheumatoid Arthritis

Resource links provided by NLM:

MedlinePlus related topics: Rheumatoid Arthritis

Drug Information available for: Tocilizumab

U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:

Reduction in disease activity according to American College of Rheumatology (ACR) 20 criteria [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
Safety (incidence of adverse events) [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Prevention of progression of structural damage [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
Improvement of physical function [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
Pharmacokinetics (change in RoActemra/Actemra serum levels) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Pharmacodynamics (interleukin levels) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Immunogenicity of RoActemra/Actemra [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Enrollment:	656
Study Start Date:	March 2011
Estimated Study Completion Date:	April 2014
Estimated Primary Completion Date:	April 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: A1	Drug: tocilizumab [RoActemra/Actemra] 162 mg subcutaneously using a pre-filled syringe every two weeks for 24 weeks Drug: tocilizumab [RoActemra/Actemra] 162 mg subcutaneously using an autoinjector every 2 weeks from week 24 to week 96
Experimental: A2	Drug: tocilizumab [RoActemra/Actemra] 162 mg subcutaneously using a pre-filled syringe every two weeks for 24 weeks Drug: tocilizumab [RoActemra/Actemra] 162 mg subcutaneously using a pre-filled syringe every 2 weeks from week 24 to week 96
Placebo Comparator: B1	Drug: placebo subcutaneously using a pre-filled syringe every two weeks for 24 weeks Drug: tocilizumab [RoActemra/Actemra] 162 mg subcutaneously using an autoinjector every 2 weeks from week 24 to week 96
Placebo Comparator: B2	Drug: placebo subcutaneously using a pre-filled syringe every two weeks for 24 weeks Drug: tocilizumab [RoActemra/Actemra] 162 mg subcutaneously using a pre-filled syringe every 2 weeks from week 24 to week 96

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Adult patients, >/=18 years of age
Moderate to severe rheumatoid arthritis of >/=6 months duration
Receiving treatment on an outpatient basis
Swollen joint count (SJC) >/=6 (66 joint count) and tender joint count (TJC) >/=8 (68 joint count) at screening and study start
On a stable dose of disease-modifying antirheumatic drugs for at least 8 weeks prior to study start

Exclusion Criteria:

Major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months following randomization
Rheumatic autoimmune disease other than rheumatoid arthritis, Secondary Sjögren's syndrome with rheumatoid arthritis is allowed
Functional class IV as defined by the American College of Rheumatology (ACR) Classification of Functional Status in Rheumatoid Arthritis
Diagnosis of juvenile idiopathic arthritis or juvenile rheumatoid arthritis and/or rheumatoid arthritis before the age of 16 years
Prior history of or current inflammatory joint disease other than rheumatoid arthritis

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01232569

Show 141 Study Locations

Sponsors and Collaborators

Hoffmann-La Roche

Investigators

Study Director:

Clinical Trials

Hoffmann-La Roche

More Information

No publications provided

Responsible Party:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT01232569 History of Changes
Other Study ID Numbers:	NA25220, 2010-019912-18
Study First Received:	November 1, 2010
Last Updated:	December 3, 2012
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases

Autoimmune Diseases
Immune System Diseases
Antirheumatic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013