A Study to Assess the Effect of Tocilizumab + DMARD Therapy on Signs and Symptoms in Patients With Moderate to Severe Active Rheumatoid Arthritis

NCT00106574 | Completed Phase 3

• 1 other identifier: WA18063
• Study Type: interventional
• Target: 1,220
• Locations: 19 countries
• Sites: 146

Brief Summary

This 2 arm study will compare the safety and efficacy, with regard to reduction of signs and symptoms, of tocilizumab versus placebo in combination with traditional Disease-Modifying Anti-Rheumatic Drug (DMARD) therapy in patients with moderate to severe active rheumatoid arthritis (RA) who have had an inadequate response to current DMARD therapy. Patients will be randomized to receive tocilizumab 8mg/kg iv or placebo iv every 4 weeks, in conjunction with stable DMARD therapy. The anticipated time on study treatment is 3-12 months, and the target sample size is 500+ individuals.

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

• Percentage of patients with ACR 20 response

  Week 24

Secondary Outcomes (3)

• Percentage of patients with ACR 50 and ACR 70 responses.

  Week 24

• Mean changes in parameters of ACR core set

  Week 24

• AEs, laboratory parameters, vital signs.

  Throughout study

Study Arms (2)

1

EXPERIMENTAL

Drug: tocilizumab [RoActemra/Actemra]

2

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Placebo DRUG

iv every 4 weeks

2

tocilizumab [RoActemra/Actemra] DRUG

8mg/kg iv every 4 weeks

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients at least 18 years of age with moderate to severe active RA for at least 6 months;
• inadequate response to current anti-rheumatic therapies, including 1 or more traditional DMARDs;
• stable DMARD therapy for at least 8 weeks before entering study;
• patients of reproductive potential must be using reliable methods of contraception.

You may not qualify if:

• major surgery (including joint surgery) within 8 weeks before entering study, or planned surgery within 6 months after entering study;
• patients who have previously failed treatment with an anti-tumor necrosis factor agent;
• women who are pregnant or breast-feeding.

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (146)

Unknown Facility

Mesa, Arizona, 85208, United States

Location

Unknown Facility

Paradise Valley, Arizona, 85253, United States

Location

Unknown Facility

Peoria, Arizona, 85381, United States

Location

Unknown Facility

Scottsdale, Arizona, 85258, United States

Location

Unknown Facility

Tucson, Arizona, 85723, United States

Location

Unknown Facility

Little Rock, Arkansas, 72205, United States

Location

Unknown Facility

Los Angeles, California, 90048, United States

Location

Unknown Facility

Palm Desert, California, 92260, United States

Location

Unknown Facility

Palo Alto, California, 94304, United States

Location

Unknown Facility

San Jose, California, 95126, United States

Location

Unknown Facility

Upland, California, 91786, United States

Location

Unknown Facility

Newark, Delaware, 19713, United States

Location

Unknown Facility

Washington D.C., District of Columbia, 20006, United States

Location

Unknown Facility

Delray Beach, Florida, 33484, United States

Location

Unknown Facility

Jupiter, Florida, 33458, United States

Location

Unknown Facility

Palm Habor, Florida, 34684, United States

Location

Unknown Facility

Palm Harbor, Florida, 34684, United States

Location

Unknown Facility

Tampa, Florida, 33609, United States

Location

Unknown Facility

Chicago, Illinois, 60611, United States

Location

Unknown Facility

Chicago, Illinois, 60637, United States

Location

Unknown Facility

Springfield, Illinois, 62704, United States

Location

Unknown Facility

Vernon Hills, Illinois, 60061, United States

Location

Unknown Facility

Indianapolis, Indiana, 46202, United States

Location

Unknown Facility

Bowling Green, Kentucky, 42102, United States

Location

Unknown Facility

Baton Rouge, Louisiana, 70808, United States

Location

Unknown Facility

Shreverport, Louisiana, 71103, United States

Location

Unknown Facility

Frederick, Maryland, 21702, United States

Location

Unknown Facility

Boston, Massachusetts, 02111, United States

Location

Unknown Facility

Lansing, Michigan, 48910, United States

Location

Unknown Facility

Duluth, Minnesota, 55805, United States

Location

Unknown Facility

Eagan, Minnesota, 55121, United States

Location

Unknown Facility

Saint Louis Park, Minnesota, 55426, United States

Location

Unknown Facility

Springfield, Missouri, 65807, United States

Location

Unknown Facility

St Louis, Missouri, 63117, United States

Location

Unknown Facility

Lincoln, Nebraska, 68516, United States

Location

Unknown Facility

Reno, Nevada, 89502, United States

Location

Unknown Facility

Clifton, New Jersey, 07012, United States

Location

Unknown Facility

Haddon Heights, New Jersey, 08035, United States

Location

Unknown Facility

New Brunswick, New Jersey, 08903, United States

Location

Unknown Facility

Albuquerque, New Mexico, 87131, United States

Location

Unknown Facility

New York, New York, 10021, United States

Location

Unknown Facility

Plainview, New York, 11803, United States

Location

Unknown Facility

Roslyn, New York, 11576, United States

Location

Unknown Facility

Smithtown, New York, 11787, United States

Location

Unknown Facility

Syracuse, New York, 13210, United States

Location

Unknown Facility

Durham, North Carolina, 27704, United States

Location

Unknown Facility

Raleigh, North Carolina, 27609, United States

Location

Unknown Facility

Winston-Salem, North Carolina, 27157, United States

Location

Unknown Facility

Beachwood, Ohio, 44122, United States

Location

Unknown Facility

Cincinnati, Ohio, 45219, United States

Location

Unknown Facility

Dayton, Ohio, 45408, United States

Location

Unknown Facility

Gallipolis, Ohio, 45631, United States

Location

Unknown Facility

Oklahoma City, Oklahoma, 73103, United States

Location

Unknown Facility

Oklahoma City, Oklahoma, 73112, United States

Location

Unknown Facility

Tulsa, Oklahoma, 74104, United States

Location

Unknown Facility

Medford, Oregon, 97504, United States

Location

Unknown Facility

Allentown, Pennsylvania, 18103, United States

Location

Unknown Facility

Bethlehem, Pennsylvania, 18015, United States

Location

Unknown Facility

Philadelphia, Pennsylvania, 19152, United States

Location

Unknown Facility

Pittsburgh, Pennsylvania, 15261, United States

Location

Unknown Facility

Rockledge, Pennsylvania, 19046, United States

Location

Unknown Facility

Willow Grove, Pennsylvania, 19090, United States

Location

Unknown Facility

Johnston, Rhode Island, 02919, United States

Location

Unknown Facility

Charleston, South Carolina, 29406, United States

Location

Unknown Facility

Hixson, Tennessee, 37343, United States

Location

Unknown Facility

Nashville, Tennessee, 37203, United States

Location

Unknown Facility

Austin, Texas, 78705, United States

Location

Unknown Facility

Houston, Texas, 77074, United States

Location

Unknown Facility

Mesquite, Texas, 75150, United States

Location

Unknown Facility

Burlington, Vermont, 05401, United States

Location

Unknown Facility

Arlington, Virginia, 22204, United States

Location

Unknown Facility

Spokane, Washington, 99204, United States

Location

Unknown Facility

Tacoma, Washington, 98405, United States

Location

Unknown Facility

Vancouver, Washington, 98664, United States

Location

Unknown Facility

La Crosse, Wisconsin, 54601, United States

Location

Unknown Facility

Milwaukee, Wisconsin, 53226, United States

Location

Unknown Facility

Buenos Aires, C1015ABO, Argentina

Location

Unknown Facility

Buenos Aires, C1428DQG, Argentina

Location

Unknown Facility

Rosario, S2000PBJ, Argentina

Location

Unknown Facility

Parkville, 3052, Australia

Location

Unknown Facility

Sydney, 2050, Australia

Location

Unknown Facility

Campinas, 13060-803, Brazil

Location

Unknown Facility

Goiânia, 74653-050, Brazil

Location

Unknown Facility

Rio de Janeiro, 20551-030, Brazil

Location

Unknown Facility

Winnipeg, Manitoba, R3A 1M3, Canada

Location

Unknown Facility

Hamilton, Ontario, L8N 2B6, Canada

Location

Unknown Facility

Ottawa, Ontario, K1H 1A2, Canada

Location

Unknown Facility

Québec, Quebec, G1V 3M7, Canada

Location

Unknown Facility

Saskatoon, Saskatchewan, S7N 0W8, Canada

Location

Unknown Facility

Beijing, 100032, China

Location

Unknown Facility

Beijing, 100044, China

Location

Unknown Facility

Shanghai, 200127, China

Location

Unknown Facility

Shanghai, 200433, China

Location

Unknown Facility

San José, 10103, Costa Rica

Location

Unknown Facility

Hradec Králové, 500 05, Czechia

Location

Unknown Facility

Prague, 128 50, Czechia

Location

Unknown Facility

Prague, 140 59, Czechia

Location

Unknown Facility

Helsinki, 00280, Finland

Location

Unknown Facility

Jyväskylä, 40620, Finland

Location

Unknown Facility

Boulogne-Billancourt, 92104, France

Location

Unknown Facility

Clermont-Ferrand, 63003, France

Location

Unknown Facility

Grenoble, 38042, France

Location

Unknown Facility

Limoges, 87042, France

Location

Unknown Facility

Marseille, 13285, France

Location

Unknown Facility

Montpellier, 34295, France

Location

Unknown Facility

Nantes, 44035, France

Location

Unknown Facility

Paris, 75181, France

Location

Unknown Facility

Pierre-Bénite, 69495, France

Location

Unknown Facility

Rennes, 35203, France

Location

Unknown Facility

Saint-Etienne, 4200, France

Location

Unknown Facility

Tours, 37044, France

Location

Unknown Facility

Aachen, 52064, Germany

Location

Unknown Facility

Essen, 45239, Germany

Location

Unknown Facility

Hildesheim, 31134, Germany

Location

Unknown Facility

München, 80335, Germany

Location

Unknown Facility

Osnabrück, 49074, Germany

Location

Unknown Facility

Sendenhorst, 48324, Germany

Location

Unknown Facility

Stuttgart, 70469, Germany

Location

Unknown Facility

Hong Kong, 852, Hong Kong

Location

Unknown Facility

Tuenmen, 852, Hong Kong

Location

Unknown Facility

León, 37000, Mexico

Location

Unknown Facility

Mexico City, 07760, Mexico

Location

Unknown Facility

Mexico City, 14050, Mexico

Location

Unknown Facility

Tijuana, 22320, Mexico

Location

Unknown Facility

Panama City, 32400, Panama

Location

Unknown Facility

Moscow, 105203, Russia

Location

Unknown Facility

Moscow, 115522, Russia

Location

Unknown Facility

Moscow, 117049, Russia

Location

Unknown Facility

Ryazan, 390026, Russia

Location

Unknown Facility

Saint Petersburg, 190068, Russia

Location

Unknown Facility

Saint Petersburg, 191015, Russia

Location

Unknown Facility

Tula, 300053, Russia

Location

Unknown Facility

Durban, 4001, South Africa

Location

Unknown Facility

Pretoria, 0002, South Africa

Location

Unknown Facility

Radiokop, 2040, South Africa

Location

Unknown Facility

Barakaldo, 48903, Spain

Location

Unknown Facility

Madrid, 28040, Spain

Location

Unknown Facility

Madrid, 28046, Spain

Location

Unknown Facility

Málaga, 29010, Spain

Location

Unknown Facility

Pontevedra, 36001, Spain

Location

Unknown Facility

Santiago de Compostela, 15706, Spain

Location

Unknown Facility

Stockholm, 171 76, Sweden

Location

Unknown Facility

Umeå, 90185, Sweden

Location

Unknown Facility

Bangkok, 10330, Thailand

Location

Unknown Facility

Bangkok, 10400, Thailand

Location

Unknown Facility

Chiang Mai, 50200, Thailand

Location

Related Publications (4)

• Welsh P, Tuckwell K, McInnes IB, Sattar N. Effect of IL-6 receptor blockade on high-sensitivity troponin T and NT-proBNP in rheumatoid arthritis. Atherosclerosis. 2016 Nov;254:167-171. doi: 10.1016/j.atherosclerosis.2016.10.016. Epub 2016 Oct 8.

  PMID: 27744141 DERIVED

• Keystone EC, Anisfeld A, Ogale S, Devenport JN, Curtis JR. Continued benefit of tocilizumab plus disease-modifying antirheumatic drug therapy in patients with rheumatoid arthritis and inadequate clinical responses by week 8 of treatment. J Rheumatol. 2014 Feb;41(2):216-26. doi: 10.3899/jrheum.130489. Epub 2014 Jan 15.

  PMID: 24429164 DERIVED

• Wang J, Bansal AT, Martin M, Germer S, Benayed R, Essioux L, Lee JS, Begovich A, Hemmings A, Kenwright A, Taylor KE, Upmanyu R, Cutler P, Harari O, Marchini J, Criswell LA, Platt A. Genome-wide association analysis implicates the involvement of eight loci with response to tocilizumab for the treatment of rheumatoid arthritis. Pharmacogenomics J. 2013 Jun;13(3):235-41. doi: 10.1038/tpj.2012.8. Epub 2012 Apr 10.

  PMID: 22491018 DERIVED

• Genovese MC, McKay JD, Nasonov EL, Mysler EF, da Silva NA, Alecock E, Woodworth T, Gomez-Reino JJ. Interleukin-6 receptor inhibition with tocilizumab reduces disease activity in rheumatoid arthritis with inadequate response to disease-modifying antirheumatic drugs: the tocilizumab in combination with traditional disease-modifying antirheumatic drug therapy study. Arthritis Rheum. 2008 Oct;58(10):2968-80. doi: 10.1002/art.23940.

  PMID: 18821691 DERIVED

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

tocilizumab

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2005
• First Posted: March 28, 2005
• Study Start: April 1, 2005
• Primary Completion: December 1, 2007
• Study Completion: December 1, 2007
• Last Updated: November 2, 2016

Record last verified: 2016-11

Locations

DE (7); AR (3); ZA (3); PA (1); BR (3); ES (6); CN (4); CZ (3); US (76); CA (5); CO (1); FR (12); ME (4); RU (7); TH (3); SE (2); AU (2); FI (2); HK (2)