DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



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
Information obtained from ClinicalTrials.gov on December 08, 2011
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Rheumatoid Arthritis

Intervention: tocilizumab [RoActemra/Actemra] (Drug); placebo (Drug); tocilizumab [RoActemra/Actemra] (Drug); tocilizumab [RoActemra/Actemra] (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Hoffmann-La Roche

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

Overall contact:
Please reference Study ID Number: NA25220, Phone: 888-662-6728 (U.S. Only), Email: genentechclinicaltrials@druginfo.com

Summary

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.

Clinical Details

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

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

Primary outcome:

Reduction in disease activity according to American College of Rheumatology (ACR) 20 criteria

Safety (incidence of adverse events)

Secondary outcome:

Prevention of progression of structural damage

Improvement of physical function

Pharmacokinetics (change in RoActemra/Actemra serum levels)

Pharmacodynamics (interleukin levels)

Immunogenicity of RoActemra/Actemra

Eligibility

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

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

Locations and Contacts

Please reference Study ID Number: NA25220, Phone: 888-662-6728 (U.S. Only), Email: genentechclinicaltrials@druginfo.com

Buenos Aires C1015ABO, Argentina; Active, not recruiting

Córdoba 5000, Argentina; Active, not recruiting

San Miguel de Tucuman 4000, Argentina; Active, not recruiting

Cairns 4870, Australia; Active, not recruiting

Kogarah 2217, Australia; Active, not recruiting

Curitiba 80060-240, Brazil; Active, not recruiting

Goiania 74110-120, Brazil; Active, not recruiting

Juiz de Fora 36010-570, Brazil; Active, not recruiting

Porto Alegre 90610-000, Brazil; Active, not recruiting

Porto Alegre 91350-200, Brazil; Active, not recruiting

Rio de Janeiro 22271-100, Brazil; Not yet recruiting

Salvador 40050-410, Brazil; Active, not recruiting

Sao Paulo 01244-030, Brazil; Active, not recruiting

Sao Paulo 04266-010, Brazil; Active, not recruiting

Sao Paulo 05437-010, Brazil; Active, not recruiting

São Paulo 05403-000, Brazil; Active, not recruiting

São Paulo 04026-000, Brazil; Active, not recruiting

Vitoria 29055-450, Brazil; Not yet recruiting

Plovdiv 4002, Bulgaria; Active, not recruiting

Plovdiv 4003, Bulgaria; Active, not recruiting

Sofia 1612, Bulgaria; Active, not recruiting

Sofia 1612, Bulgaria; Not yet recruiting

Sofia 2233, Bulgaria; Active, not recruiting

Varna 9010, Bulgaria; Active, not recruiting

Bogota, Colombia; Active, not recruiting

Chia-cundinamarca, Colombia; Active, not recruiting

Medellin, Colombia; Active, not recruiting

Athens 11521, Greece; Completed

Athens 11527, Greece; Not yet recruiting

Thessaloniki 54636, Greece; Active, not recruiting

Guatemala City 01015, Guatemala; Not yet recruiting

Guatemala City 01010, Guatemala; Recruiting

Guatemala City 01010, Guatemala; Active, not recruiting

Budapest 1036, Hungary; Recruiting

Budapest 1023, Hungary; Not yet recruiting

Debrecen 4004, Hungary; Not yet recruiting

Gyula 5700, Hungary; Not yet recruiting

Ashkelon 78306, Israel; Active, not recruiting

Beer Sheva 84101, Israel; Active, not recruiting

Haifa 31096, Israel; Active, not recruiting

Haifa 34362, Israel; Not yet recruiting

Haifa 31048, Israel; Active, not recruiting

Ramat Gan 52621, Israel; Active, not recruiting

Rishon Lezion 70300, Israel; Active, not recruiting

Tel Aviv 64239, Israel; Not yet recruiting

Batu Caves 68100, Malaysia; Active, not recruiting

Kuala Lumpur 50603, Malaysia; Recruiting

Sabah 88586, Malaysia; Recruiting

Chihuahua 31000, Mexico; Active, not recruiting

Culiacan 80000, Mexico; Active, not recruiting

Guadalajara 44158, Mexico; Active, not recruiting

Leon 37000, Mexico; Active, not recruiting

Merida 97000, Mexico; Active, not recruiting

Mexicali 21100, Mexico; Active, not recruiting

Mexico 44620, Mexico; Active, not recruiting

Morelia 58070, Mexico; Active, not recruiting

Obregon 85000, Mexico; Recruiting

Queretaro 76178, Mexico; Recruiting

Queretaro 76000, Mexico; Recruiting

Otahuhu 1006, New Zealand; Not yet recruiting

Panama City 32400, Panama; Recruiting

Cebu City 6000, Philippines; Active, not recruiting

Davao City 8000, Philippines; Active, not recruiting

Manila 1780, Philippines; Active, not recruiting

Bytom 41-902, Poland; Active, not recruiting

Dzialdowo 13-200, Poland; Active, not recruiting

Elblag 82-300, Poland; Active, not recruiting

Konskie 26-200, Poland; Not yet recruiting

Koscian 64-000, Poland; Active, not recruiting

Krakow 31-121, Poland; Not yet recruiting

Poznan 61-545, Poland; Not yet recruiting

Sopot 81-759, Poland; Not yet recruiting

Szczecin 71-252, Poland; Not yet recruiting

Torun 87-100, Poland; Active, not recruiting

Warszawa 02-653, Poland; Active, not recruiting

Wroclaw 50-556, Poland; Not yet recruiting

Kemerovo 650099, Russian Federation; Active, not recruiting

Moscow 115522, Russian Federation; Active, not recruiting

Moscow 119049, Russian Federation; Active, not recruiting

Moscow 129327, Russian Federation; Active, not recruiting

Novosibirsk 630047, Russian Federation; Not yet recruiting

Petrozavodsk 185019, Russian Federation; Active, not recruiting

Ryazan 390026, Russian Federation; Active, not recruiting

St Petersburg 197341, Russian Federation; Active, not recruiting

St Petersburg 190068, Russian Federation; Active, not recruiting

St Petersburg 197022, Russian Federation; Active, not recruiting

UFA 450005, Russian Federation; Active, not recruiting

Voronezh 394066, Russian Federation; Active, not recruiting

Durban 4013, South Africa; Active, not recruiting

Pinelands 7405, South Africa; Active, not recruiting

Pretoria 0002, South Africa; Active, not recruiting

La Coruna 15006, Spain; Active, not recruiting

Oviedo 33006, Spain; Active, not recruiting

Sevilla 41009, Spain; Active, not recruiting

Fribourg 1708, Switzerland; Not yet recruiting

Genève 1211, Switzerland; Not yet recruiting

Lausanne 1011, Switzerland; Active, not recruiting

Zürich 8063, Switzerland; Not yet recruiting

Bangkok 10700, Thailand; Active, not recruiting

Bangkok 10400, Thailand; Active, not recruiting

Calgary, Alberta T2N 2T9, Canada; Completed

Peoria, Arizona 85381, United States; Active, not recruiting

Scottsdale, Arizona 85258, United States; Active, not recruiting

Tucson, Arizona 85724, United States; Recruiting

Tuscon, Arizona 85723, United States; Active, not recruiting

Fullerton, California 92835, United States; Active, not recruiting

San Diego, California 92108, United States; Active, not recruiting

San Leandro, California 94578, United States; Active, not recruiting

West Hills, California 91307, United States; Active, not recruiting

Trumbull, Connecticut 06611, United States; Active, not recruiting

Boca Raton, Florida 33486, United States; Active, not recruiting

Jupiter, Florida 33458, United States; Active, not recruiting

Ormond Beach, Florida 32174, United States; Recruiting

Sarasota, Florida 34292, United States; Recruiting

Gainesville, Georgia 30501, United States; Recruiting

Idaho Falls, Idaho 83404, United States; Recruiting

Meridan, Idaho 83642, United States; Active, not recruiting

Springfield, Illinois 62704, United States; Active, not recruiting

Vernon Hills, Illinois 60061, United States; Active, not recruiting

Winnipeg, Manitoba R3A 1M3, Canada; Active, not recruiting

Winnipeg, Manitoba R3N 0K6, Canada; Active, not recruiting

Crofton, Maryland 21114, United States; Active, not recruiting

Hagerstown, Maryland 21740, United States; Active, not recruiting

Wheaton, Maryland 20902, United States; Active, not recruiting

Flowood, Mississippi 39232, United States; Active, not recruiting

Jackson, Mississippi 39202, United States; Active, not recruiting

Saint Louis, Missouri 63128, United States; Active, not recruiting

St Louis, Missouri 63141, United States; Active, not recruiting

Lincoln, Nebraska 68516, United States; Active, not recruiting

Brooklyn, New York 11201, United States; Active, not recruiting

Belmont, North Carolina 28012, United States; Terminated

Charlotte, North Carolina 28210, United States; Recruiting

Charlotte, North Carolina 28207, United States; Active, not recruiting

Charlotte, North Carolina 28204, United States; Recruiting

Oklahoma City, Oklahoma 73104, United States; Active, not recruiting

London, Ontario N6A 4V2, Canada; Active, not recruiting

Ottawa, Ontario K1H 1A2, Canada; Active, not recruiting

Allentown, Pennsylvania 18103, United States; Terminated

Bethlehem, Pennsylvania 18015, United States; Active, not recruiting

Duncansville, Pennsylvania 16635, United States; Active, not recruiting

West Reading, Pennsylvania 19611, United States; Active, not recruiting

Wexford, Pennsylvania 15090, United States; Terminated

Pointe-claire, Quebec H9R 3J1, Canada; Active, not recruiting

Memphis, Tennessee 38104, United States; Active, not recruiting

Dallas, Texas 75246, United States; Not yet recruiting

Fort Worth, Texas 76107, United States; Recruiting

Houston, Texas 77074, United States; Active, not recruiting

Nassau Bay, Texas 77058, United States; Active, not recruiting

San Antonio, Texas 78232, United States; Not yet recruiting

Tacoma, Washington 98405, United States; Terminated

Additional Information

Starting date: March 2011
Last updated: December 5, 2011

Page last updated: December 08, 2011

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2012