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

Information source: Hoffmann-La Roche
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Rheumatoid Arthritis

Intervention: Tocilizumab 162 mg (Drug); Placebo (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Hoffmann-La Roche

Official(s) and/or principal investigator(s):
Clinical Trials, Study Director, Affiliation: Hoffmann-La Roche


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.

Clinical Details

Official title: A Randomized, Double-blind, Parallel Group Study of Safety and the Effect on Clinical Outcome of Tocilizumab Subcutaneous (sc) Versus Placebo sc in Combination With Traditional Disease Modifying Anti-rheumatic Drugs (DMARDs) in Patients With Moderate to Severe Active Rheumatoid Arthritis

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Percentage of Patients With an American College of Rheumatology 20 (ACR20) Response at Week 24

Secondary outcome:

Percentage of Patients With ACR50 and ACR70 Responses at Week 24

Time to Onset of ACR20, ACR50, and ACR70 Responses

Change From Baseline in Tender Joint Count (TJC) and Swollen Joint Count (SJC) at Week 24

Change From Baseline in C-reactive Protein at Week 24

Change From Baseline in Erythrocyte Sedimentation Rate at Week 24

Change From Baseline in the Patient's and the Physician's Global Assessment of Disease Activity Visual Analog (VAS) Score

Change From Baseline in the Patient's Pain Visual Analog Score

Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 24

Percentage of Patients With an Improvement of ≥ 0.3 Units From Baseline in the HAQ-DI Score at Week 24

Change From Baseline in Disease Activity Score 28 (DAS28) at Week 24

Percentage of Patients With a DAS28 Score ≤ 3.2 (DAS28 Low Disease Activity) at Week 24

Percentage of Patients With a DAS28 Score < 2.6 (DAS28 Remission) at Week 24

Percentage of Patients With Good, Moderate, or no European League Against Rheumatism (EULAR) Responses at Week 24

Change From Baseline in the Van Der Heijde Modified Sharp Radiographic Score at Week 24

Change From Baseline in the Physical and Mental Component Scores of the Short Form 36 (SF-36) Health Survey at Week 24

Change From Baseline in Hemoglobin at Week 24


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


Inclusion Criteria:

- Adult patients, ≥ 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 anti-rheumatic 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


- History of malignancy, active or recurrent infections, positive to hepatitis B

surface antigen or hepatitis C antibody, active tuberculosis, serious allergy to biologics, or a history of diverticular disease or other symptomatic GI conditions that might predispose to perforations. Other inclusion and exclusion criteria applied to the study.

Locations and Contacts

Buenos Aires C1015ABO, Argentina

Córdoba 5000, Argentina

San Miguel de Tucuman 4000, Argentina

Cairns 4870, Australia

Kogarah 2217, Australia

Curitiba 80060-240, Brazil

Goiania 74043-011, Brazil

Juiz de Fora 36010-570, Brazil

Porto Alegre 90610-000, Brazil

Porto Alegre 91350-200, Brazil

Rio de Janeiro 22271-100, Brazil

Salvador 40050-410, Brazil

Sao Paulo 04266-010, Brazil

Sao Paulo 05437-010, Brazil

Sao Paulo 5403900, Brazil

São Paulo 04026-000, Brazil

São Paulo 1244030, Brazil

Vitoria 29055-450, Brazil

Plovdiv 4002, Bulgaria

Plovdiv 4003, Bulgaria

Sofia 1612, Bulgaria

Sofia 2233, Bulgaria

Varna 9010, Bulgaria

Bogota, Colombia

Chia-cundinamarca, Colombia

Medellin, Colombia

Athens 11527, Greece

Athens 15121, Greece

Thessaloniki 54636, Greece

Guatemala City 01010, Guatemala

Guatemala City 01013, Guatemala

Guatemala City 01015, Guatemala

Budapest 1036, Hungary

Debrecen 4004, Hungary

Ashkelon 78306, Israel

Beer Sheva 84101, Israel

Haifa 31048, Israel

Haifa 31096, Israel

Ramat Gan 52621, Israel

Rishon Lezion, Israel

Tel Aviv 64239, Israel

Batu Caves 68100, Malaysia

Kota Kinabalu 88586, Malaysia

Kuala Lumpur 50603, Malaysia

Chihuahua 31000, Mexico

Culiacan 80000, Mexico

Guadalajara 44158, Mexico

Leon 37320, Mexico

Merida 97000, Mexico

Mexicali 21100, Mexico

Mexico 44620, Mexico

Morelia 58070, Mexico

Obregon 85000, Mexico

Queretaro 76000, Mexico

Queretaro 76178, Mexico

Otahuhu 1006, New Zealand

Panama City 32400, Panama

Cebu 6000, Philippines

Davao 8006, Philippines

Manila 1780, Philippines

Bytom 41902, Poland

Dzialdowo 13-200, Poland

Elblag 82-300, Poland

Koscian 64-000, Poland

Krakow 31-121, Poland

Torun 87-100, Poland

Warszawa 02-653, Poland

Kemerovo 650099, Russian Federation

Moscow 115522, Russian Federation

Moscow 117049, Russian Federation

Moscow 129327, Russian Federation

Novosibirsk 630099, Russian Federation

Petrozavodsk 185019, Russian Federation

Ryazan 390026, Russian Federation

Saint-petersburg 197341, Russian Federation

St Petersburg 197022, Russian Federation

St Petersburg 190068, Russian Federation

UFA 450005, Russian Federation

Voronezh 394066, Russian Federation

Durban 4013, South Africa

Pinelands 7405, South Africa

Pretoria 0002, South Africa

La Coruna 15006, Spain

Oviedo 33006, Spain

Sevilla 41009, Spain

Fribourg 1708, Switzerland

Genève 1211, Switzerland

Lausanne 1011, Switzerland

Zürich 8063, Switzerland

Bangkok 10400, Thailand

Bangkok 10700, Thailand

Calgary, Alberta T2N 2T9, Canada

Peoria, Arizona 85381, United States

Scottsdale, Arizona 85258, United States

Tucson, Arizona 85723, United States

Tucson, Arizona 85724, United States

Fullerton, California 92835, United States

San Diego, California 92108, United States

San Leandro, California 94578, United States

West Hills, California 91307, United States

Trumbull, Connecticut 06611, United States

Boca Raton, Florida 33486, United States

Jupiter, Florida 33458, United States

Ormond Beach, Florida 32174, United States

Sarasota, Florida 34292, United States

Gainesville, Georgia 30501, United States

Idaho Falls, Idaho 83404, United States

Meridan, Idaho 83642, United States

Springfield, Illinois 62704, United States

Vernon Hills, Illinois 60061, United States

Winnipeg, Manitoba R3A 1M3, Canada

Winnipeg, Manitoba R3N 0K6, Canada

Crofton, Maryland 21114, United States

Hagerstown, Maryland 21740, United States

Wheaton, Maryland 20902, United States

Flowood, Mississippi 39232, United States

Jackson, Mississippi 39202, United States

Saint Louis, Missouri 63128, United States

St Louis, Missouri 63141, United States

Lincoln, Nebraska 68516, United States

Brooklyn, New York 11201, United States

Belmont, North Carolina 28012, United States

Charlotte, North Carolina 28204, United States

Charlotte, North Carolina 28207, United States

Charlotte, North Carolina 28211, United States

Oklahoma City, Oklahoma 73104, United States

London, Ontario N6A 4V2, Canada

Ottawa, Ontario K1H 1A2, Canada

Allentown, Pennsylvania 18103, United States

Bethlehem, Pennsylvania 18015, United States

Duncansville, Pennsylvania 16635, United States

Wexford, Pennsylvania 15090, United States

Wyomissing, Pennsylvania 19610, United States

Pointe-claire, Quebec H9R 3J1, Canada

Memphis, Tennessee 38104, United States

Dallas, Texas 75246, United States

Fort Worth, Texas 76107, United States

Houston, Texas 77034, United States

Houston, Texas 77459, United States

San Antonio, Texas 78232, United States

Tacoma, Washington 98405, United States

Additional Information

Starting date: March 2011
Last updated: July 7, 2015

Page last updated: August 23, 2015

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