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

NCT01232569 | Completed Phase 3 Results

• 2 other identifiers: NA252202010-019912-18
• Study Type: interventional
• Target: 656
• Locations: 22 countries
• Sites: 141

Brief Summary

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.

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

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

  A patient had an ACR20 response if there was at least a 20% improvement, ie, reduction from baseline, in tender and swollen joint counts (28 assessed joints) and in at least 3 of the following 5 parameters: Separate patient and physician assessments of patient disease activity in the previous 24 hours on a visual analog scale (VAS, left end=no disease activity \[symptom-free and no arthritis symptoms\], right end=maximum disease activity; patient assessment of pain in previous 24 hours on a VAS (left end=no pain and right end=unbearable pain); Health Assessment Questionnaire-Disability Index (20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities, 0=without difficulty to 3=unable to do); and acute-phase reactant (either C-reactive protein or erythrocyte sedimentation rate).

  Baseline to Week 24

Secondary Outcomes (16)

• Percentage of Patients With ACR50 and ACR70 Responses at Week 24

  Baseline to Week 24

• Time to Onset of ACR20, ACR50, and ACR70 Responses

  Baseline to Week 24

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

  Baseline to Week 24

• Change From Baseline in C-reactive Protein at Week 24

  Baseline to Week 24

• Change From Baseline in Erythrocyte Sedimentation Rate at Week 24

  Baseline to Week 24

Study Arms (2)

Tocilizumab 162 mg sc

EXPERIMENTAL

Patients will receive tocilizumab 162 mg subcutaneously (sc) every 2 weeks for 24 weeks.

Drug: Tocilizumab 162 mg

Placebo sc

PLACEBO COMPARATOR

Patients will receive placebo subcutaneously (sc) every 2 weeks for 24 weeks.

Drug: Placebo

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.

Also known as: RoActemra, Actemra

Tocilizumab 162 mg sc

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.

Placebo sc

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (141)

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Peoria, Arizona, 85381, United States

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Scottsdale, Arizona, 85258, United States

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Tucson, Arizona, 85723, United States

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Tucson, Arizona, 85724, United States

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Fullerton, California, 92835, United States

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San Diego, California, 92108, United States

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San Leandro, California, 94578, United States

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West Hills, California, 91307, United States

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Trumbull, Connecticut, 06611, United States

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Boca Raton, Florida, 33486, United States

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Jupiter, Florida, 33458, United States

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Ormond Beach, Florida, 32174, United States

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Sarasota, Florida, 34292, United States

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Gainesville, Georgia, 30501, United States

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Idaho Falls, Idaho, 83404, United States

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Meridan, Idaho, 83642, United States

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Springfield, Illinois, 62704, United States

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Vernon Hills, Illinois, 60061, United States

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Crofton, Maryland, 21114, United States

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Hagerstown, Maryland, 21740, United States

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Wheaton, Maryland, 20902, United States

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Flowood, Mississippi, 39232, United States

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Jackson, Mississippi, 39202, United States

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St Louis, Missouri, 63128, United States

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St Louis, Missouri, 63141, United States

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Lincoln, Nebraska, 68516, United States

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Brooklyn, New York, 11201, United States

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Belmont, North Carolina, 28012, United States

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Charlotte, North Carolina, 28204, United States

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Charlotte, North Carolina, 28207, United States

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Charlotte, North Carolina, 28211, United States

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Oklahoma City, Oklahoma, 73104, United States

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Allentown, Pennsylvania, 18103, United States

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Bethlehem, Pennsylvania, 18015, United States

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Duncansville, Pennsylvania, 16635, United States

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Wexford, Pennsylvania, 15090, United States

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Wyomissing, Pennsylvania, 19610, United States

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Memphis, Tennessee, 38104, United States

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Dallas, Texas, 75246, United States

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Fort Worth, Texas, 76107, United States

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Houston, Texas, 77034, United States

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Houston, Texas, 77459, United States

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San Antonio, Texas, 78232, United States

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Tacoma, Washington, 98405, United States

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Buenos Aires, C1015ABO, Argentina

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Córdoba, 5000, Argentina

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San Miguel de Tucumán, 4000, Argentina

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Cairns, 4870, Australia

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Kogarah, 2217, Australia

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Curitiba, 80060-240, Brazil

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Goiânia, 74043-011, Brazil

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Juiz de Fora, 36010-570, Brazil

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Porto Alegre, 90610-000, Brazil

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Porto Alegre, 91350-200, Brazil

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Rio de Janeiro, 22271-100, Brazil

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Salvador, 40050-410, Brazil

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São Paulo, 04026-000, Brazil

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São Paulo, 04266-010, Brazil

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São Paulo, 05437-010, Brazil

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São Paulo, 1244030, Brazil

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São Paulo, 5403900, Brazil

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Vitória, 29055-450, Brazil

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Plovdiv, 4002, Bulgaria

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Plovdiv, 4003, Bulgaria

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Sofia, 1612, Bulgaria

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Sofia, 2233, Bulgaria

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Varna, 9010, Bulgaria

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Calgary, Alberta, T2N 2T9, Canada

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Winnipeg, Manitoba, R3A 1M3, Canada

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Winnipeg, Manitoba, R3N 0K6, Canada

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London, Ontario, N6A 4V2, Canada

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Ottawa, Ontario, K1H 1A2, Canada

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Pointe-Claire, Quebec, H9R 3J1, Canada

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Bogotá, Colombia

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Chia-cundinamarca, Colombia

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Medellín, Colombia

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Athens, 11527, Greece

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Athens, 15121, Greece

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Thessaloniki, 54636, Greece

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Guatemala City, 01010, Guatemala

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Guatemala City, 01013, Guatemala

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Guatemala City, 01015, Guatemala

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Budapest, 1036, Hungary

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Debrecen, 4004, Hungary

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Ashkelon, 78306, Israel

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Beersheba, 84101, Israel

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Haifa, 31048, Israel

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Haifa, 31096, Israel

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Ramat Gan, 52621, Israel

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Rishon LeZiyyon, Israel

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Tel Aviv, 64239, Israel

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Batu Caves, 68100, Malaysia

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Kota Kinabalu, 88586, Malaysia

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Kuala Lumpur, 50603, Malaysia

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Chihuahua City, 31000, Mexico

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Culiacán, 80000, Mexico

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Guadalajara, 44158, Mexico

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León, 37320, Mexico

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Mexicali, 21100, Mexico

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Mérida, 97000, Mexico

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México, 44620, Mexico

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Morelia, 58070, Mexico

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Obregón, 85000, Mexico

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Querétaro, 76000, Mexico

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Querétaro, 76178, Mexico

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Otahuhu, 1006, New Zealand

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Panama City, 32400, Panama

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Cebu, 6000, Philippines

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Davao City, 8006, Philippines

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Manila, 1780, Philippines

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Bytom, 41902, Poland

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Działdowo, 13-200, Poland

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Elblag, 82-300, Poland

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Kościan, 64-000, Poland

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Krakow, 31-121, Poland

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Torun, 87-100, Poland

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Warsaw, 02-653, Poland

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Kemerovo, 650099, Russia

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Moscow, 115522, Russia

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Moscow, 117049, Russia

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Moscow, 129327, Russia

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Novosibirsk, 630099, Russia

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Petrozavodsk, 185019, Russia

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Ryazan, 390026, Russia

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Saint Petersburg, 190068, Russia

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Saint Petersburg, 197022, Russia

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Saint Petersburg, 197341, Russia

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Ufa, 450005, Russia

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Voronezh, 394066, Russia

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Durban, 4013, South Africa

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Pinelands, 7405, South Africa

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Pretoria, 0002, South Africa

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A Coruña, 15006, Spain

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Oviedo, 33006, Spain

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Seville, 41009, Spain

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Fribourg, 1708, Switzerland

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Geneva, 1211, Switzerland

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Lausanne, 1011, Switzerland

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Zurich, 8063, Switzerland

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Bangkok, 10400, Thailand

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Bangkok, 10700, Thailand

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Related Publications (1)

• Kivitz A, Olech E, Borofsky M, Zazueta BM, Navarro-Sarabia F, Radominski SC, Merrill JT, Rowell L, Nasmyth-Miller C, Bao M, Wright S, Pope JE. Subcutaneous tocilizumab versus placebo in combination with disease-modifying antirheumatic drugs in patients with rheumatoid arthritis. Arthritis Care Res (Hoboken). 2014 Nov;66(11):1653-61. doi: 10.1002/acr.22384.

  PMID: 24942540 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

Results Point of Contact

• Title: Medical Communications
• Organization: Hoffmann-La Roche

800 821-8590

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

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

Study Record Dates

• First Submitted: November 1, 2010
• First Posted: November 2, 2010
• Study Start: March 1, 2011
• Primary Completion: May 1, 2012
• Study Completion: November 1, 2013
• Last Updated: July 29, 2015
• Results First Posted: October 23, 2013

Record last verified: 2015-07

Locations

RU (12); CO (3); AU (2); PH (3); MY (3); NZ (1); PA (1); ZA (3); TH (2); ME (11); HU (2); CH (4); BR (13); BU (5); CA (6); IL (7); GR (3); AR (3); GU (3); PL (7); US (44); ES (3)