A Study to Compare Subcutaneous Versus Intravenous Administration of RoActemra/Actemra (Tocilizumab) in Participants With Moderate to Severe Active Rheumatoid Arthritis
A Randomized, Double-blind, Parallel Group Study of the Safety and Effect on Clinical Outcome of Tocilizumab SC Versus Tocilizumab IV, in Combination With Traditional Disease Modifying Anti-rheumatic Drugs (DMARDs), in Patients With Moderate to Severe Active Rheumatoid Arthritis
2 other identifiers
interventional
1,262
26 countries
216
Brief Summary
This randomized, double-blind, parallel group study compares the efficacy and safety of subcutaneous (sc) versus intravenous (iv) administration of tocilizumab in participants with moderate to severe active rheumatoid arthritis. Participants were randomized to receive either tocilizumab 162 mg sc weekly plus iv placebo every 4 weeks, or tocilizumab 8 mg/kg iv every 4 weeks plus sc placebo weekly during the double-blind period from baseline to Week 24. The double-blind period was followed by a 72-week open-label treatment with some switching of sc and iv administration. No placebo was administered in the open-label phase. Participants continued on their stable dose of disease-modifying antirheumatic drugs (DMARDs) throughout the study. Anticipated time on study treatment was 2 years.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 rheumatoid-arthritis
Started Sep 2010
Typical duration for phase_3 rheumatoid-arthritis
216 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 1, 2010
CompletedStudy Start
First participant enrolled
September 1, 2010
CompletedFirst Posted
Study publicly available on registry
September 3, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2012
CompletedResults Posted
Study results publicly available
February 12, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2013
CompletedJune 20, 2016
September 1, 2013
1.3 years
September 1, 2010
January 7, 2013
May 11, 2016
Conditions
Outcome Measures
Primary Outcomes (2)
Percentage of Participants Achieving an American College of Rheumatology Criteria (ACR20) Response at Week 24
ACR20 response is defined as a ≥ 20% improvement (reduction) compared with baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the five additional ACR core set variables: Patient's Assessment of Pain over the previous 24 hours using a Visual Analog Scale (VAS) where left end of the line 0=no pain to right end of the line 100=unbearable pain; Patient's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; Health Assessment Questionnaire: 20 questions in 8 areas (dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities) answered on a scale of 0=without difficulty to 3=unable to do; and acute-phase reactant (either C-reactive protein \[CRP\] or Erythrocyte Sedimentation Rate \[ESR\]).
Baseline, 24 weeks
Percentage of Participants With Adverse Events, Serious Adverse Events and Clinically Significant Laboratory Assessments
Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
Secondary Outcomes (17)
Percentage of Participants Achieving an American College of Rheumatology Criteria (ACR50) Response at Week 24
Baseline, 24 weeks
Percentage of Participants Achieving an American College of Rheumatology Criteria (ACR70) Response at Week 24
Baseline, 24 weeks
Percentage of Participants With Disease Activity Score 28 (DAS28) Remission at Week 24
Week 24
Percentage of Participants Achieving a Decrease of ≥ 0.3 in the Health Assessment Questionnaire-Disability Index (HAQ-DI) From Baseline to Week 24
Baseline, 24 Weeks
Percentage of Participants Who Withdrew Because of Lack of Therapeutic Response at Week 24
24 Weeks
- +12 more secondary outcomes
Study Arms (4)
Tocilizumab SC
EXPERIMENTALParticipants received tocilizumab 162 mg subcutaneous (SC) injection weekly plus placebo to tocilizumab intravenous (IV) infusion every 4 weeks for a total of 24 weeks in the double-blind period. Participants continued to receive tocilizumab 162 mg SC injection weekly for a total of 72 weeks in open label extension period. Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose continued throughout the study.
Tocilizumab IV
EXPERIMENTALParticipants received tocilizumab 8 mg/kg infusion (IV) every 4 weeks plus placebo to tocilizumab SC injection weekly for a total of 24 weeks in the double-blind period. Participants continued to receive tocilizumab 8 mg/kg IV infusion every 4 weeks for a total of 72 weeks in open label extension period. Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose continued throughout the study.
Tocilizumab SC Then Tocilizumab IV
EXPERIMENTALParticipants who received tocilizumab 162 mg subcutaneous (SC) injection weekly plus placebo to tocilizumab IV infusion every 4 weeks for 24 weeks in double blind treatment period switched to tocilizumab 8 mg/kg IV infusion every 4 weeks for a total of 72 weeks in open label extension period. Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose continued throughout the study.
Tocilizumab IV Then Tocilizumab SC
EXPERIMENTALParticipants who received tocilizumab 8 mg/kg infusion (IV) every 4 weeks plus placebo to tocilizumab SC injection weekly in double blind treatment period switched to tocilizumab 162 mg SC injection weekly for a total of 72 weeks in open label extension period. Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose will be continued throughout the study.
Interventions
Tocilizumab supplied in a single-use pre-filled syringe, with a needle safety device, delivering 162 mg/0.9 mL solution for subcutaneous injection once a week.
Tocilizumab supplied in vials as a sterile solution for 8 mg/kg intravenous infusion every 4 weeks.
Placebo tocilizumab supplied as a single-use pre-filled syringe with a needle safety device, delivering 0.9 mL sodium chloride for subcutaneous injection once a week for 24 weeks in the double-blind period.
Placebo to tocilizumab supplied as a solution in 10 mL vials containing polysorbate 80 and sucrose in water for infusion every 4 weeks for a total of 24 weeks in the double-blind period.
stable dose as prescribed
Eligibility Criteria
You may qualify if:
- Adult participants, ≥ 18 years of age
- Rheumatoid arthritis of ≥ 6 months duration, according to American College of Rheumatology (ACR) criteria
- Swollen joint count (SJC) ≥ 4 (66 joint count), tender joint count (TJC) ≥ 4 (68 joint count) at screening and baseline
- Inadequate response to current DMARD therapy
- Permitted DMARDs must be at stable dose for ≥ 8 weeks prior to baseline
- Oral corticosteroids (≤ 10 mg/day prednisone or equivalent) and NSAIDs (up to maximum recommended dose) must be at stable dose for ≥ 4 weeks prior to baseline
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 RA
- Functional class IV (ACR classification)
- Diagnosis of juvenile idiopathic arthritis (JIA) or juvenile rheumatoid arthritis (JRA) and/or RA before the age of 16
- Prior history of or current inflammatory joint disease other than RA
- Intra-articular or parenteral corticosteroids within 4 weeks prior to baseline
- Previous treatment with tocilizumab
- Active current or history of recurrent infection
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (216)
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Huntsville, Alabama, 35801, United States
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Tuscaloosa, Alabama, 35406, United States
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Tucson, Arizona, 85704, United States
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Tucson, Arizona, 85712, United States
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Long Beach, California, 90806, United States
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Los Angeles, California, 90048, United States
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Upland, California, 91786, United States
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Van Nuys, California, 91405, United States
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Denver, Colorado, 80230-7127, United States
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Bridgeport, Connecticut, 06606, United States
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Delray Beach, Florida, 33484, United States
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Miami, Florida, 33133, United States
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Ocala, Florida, 34474, United States
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Orlando, Florida, 32806, United States
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Palm Harbor, Florida, 34684, United States
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Pinellas Park, Florida, 33782, United States
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South Miami, Florida, 33143, United States
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Tampa, Florida, 33614, United States
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Coeur d'Alene, Idaho, 83814, United States
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Morton Grove, Illinois, 60053, United States
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Wichita, Kansas, 67208, United States
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Monroe, Louisiana, 71203, United States
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Petoskey, Michigan, 49770, United States
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Saint Claire Shores, Michigan, 48081, United States
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Eagan, Minnesota, 55121, United States
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Florissant, Missouri, 63031, United States
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St Louis, Missouri, 63117, United States
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St Louis, Missouri, 63131, United States
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Lebanon, New Hampshire, 03756, United States
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Clifton, New Jersey, 07012, United States
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Manalapan, New Jersey, 07726, United States
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Voorhees Township, New Jersey, 08043, United States
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Albuquerque, New Mexico, 87102, United States
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Albany, New York, 12206, United States
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Binghamton, New York, 13905, United States
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Orchard Park, New York, 14127, United States
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Asheville, North Carolina, 28803, United States
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Raleigh, North Carolina, 27609, United States
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Wilmington, North Carolina, 28401, United States
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Cincinnati, Ohio, 45219, United States
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Toledo, Ohio, 43623, United States
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Oklahoma City, Oklahoma, 73103, United States
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Tulsa, Oklahoma, 74135, United States
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Bethlehem, Pennsylvania, 18015, United States
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Charleston, South Carolina, 29406, United States
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Charleston, South Carolina, 29407, United States
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Knoxville, Tennessee, 37909, United States
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Memphis, Tennessee, 38119, United States
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Houston, Texas, 77004, United States
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San Antonio, Texas, 78217, United States
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Olympia, Washington, 98502, United States
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Seattle, Washington, 98122, United States
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Spokane, Washington, 99204, United States
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Wenatchee, Washington, 98801, United States
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Buenos Aires, B1878DVB, Argentina
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Buenos Aires, C1015ABO, Argentina
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Buenos Aires, C1428DQG, Argentina
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Rosario, S2000PBJ, Argentina
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Adelaide, 5011, Australia
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Adelaide, 5041, Australia
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Clayton, 3168, Australia
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Geelong, 3220, Australia
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Hobart, 7000, Australia
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Malvern East, 3145, Australia
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Maroochydore, 4558, Australia
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New Lambton, 2305, Australia
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Curitiba, 80060-240, Brazil
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Goiânia, 74110010, Brazil
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Juiz de Fora, 36010-570, Brazil
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Porto Alegre, 90035-903, Brazil
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Porto Alegre, 90610-000, Brazil
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São Paulo, 04039-000, Brazil
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São Paulo, 05403-000, Brazil
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São Paulo, 4037003, Brazil
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Sofia, 1606, Bulgaria
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Sofia, 1612, Bulgaria
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Sofia, 1784, Bulgaria
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Edmonton, Alberta, T5H 3V9, Canada
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Kelowna, British Columbia, V1Y 3G8, Canada
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Vancouver, British Columbia, V5Z 1L7, Canada
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St. John's, Newfoundland and Labrador, A1A 5E8, Canada
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St. John's, Newfoundland and Labrador, A1C 5B8, Canada
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Hamilton, Ontario, L8N 1Y2, Canada
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Hamilton, Ontario, L8N 2B6, Canada
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Kitchener, Ontario, N2M 5N6, Canada
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Ottawa, Ontario, K1Y 4G2, Canada
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St. Catharines, Ontario, L2N 7E4, Canada
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Windsor, Ontario, N8X 5A6, Canada
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Montreal, Quebec, H2L 1S6, Canada
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Québec, Quebec, G1V 3M7, Canada
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Rimouski, Quebec, G5L 3W1, Canada
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Sainte-Foy, Quebec, G1W 4R4, Canada
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Trois-Rivières, Quebec, G8Z 1Y2, Canada
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Saskatoon, Saskatchewan, S7K 0H6, Canada
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Barranquilla, Colombia
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Bogotá, Colombia
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Bordeaux, 33076, France
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Le Mans, 72037, France
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Marseille, 13285, France
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Montpellier, 34295, France
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Nantes, 44035, France
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Paris, 75679, France
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Strasbourg, 67098, France
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Toulouse, 31059, France
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Bad Bramstedt, 24576, Germany
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Berlin, 10117, Germany
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Berlin, 14059, Germany
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Cologne, 50924, Germany
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Dresden, 01067, Germany
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Essen, 45239, Germany
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Freiburg im Breisgau, 79106, Germany
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Gommern, 39245, Germany
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Heidelberg, 69120, Germany
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Herne, 44652, Germany
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Hildesheim, 31134, Germany
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Ludwigshafen, 67063, Germany
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Osnabrück, 49074, Germany
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Ratingen, 40882, Germany
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Rostock, 18059, Germany
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Würzburg, 97080, Germany
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Guatemala City, 01010, Guatemala
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Guatemala City, 01015, Guatemala
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Hong Kong, 852, Hong Kong
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Hong Kong, Hong Kong
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Arenzano, 16011, Italy
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Bergamo, 24128, Italy
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Catania, 95124, Italy
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Cona (ferrara), 44124, Italy
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Genova, 16132, Italy
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Napoli, 80131, Italy
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Pavia, 27100, Italy
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Pisa, 56100, Italy
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Potenza, 85100, Italy
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Reggio Emilia, 42100, Italy
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Udine, 33100, Italy
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Varese, 21100, Italy
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Klaipėda, 92288, Lithuania
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Šiauliai, 76231, Lithuania
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Vilnius, LT-08661, Lithuania
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Culiacán, 80000, Mexico
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Guadalajara, 44629, Mexico
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Guadalajara, 44690, Mexico
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León, 37000, Mexico
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Mexico Ctiy, 07760, Mexico
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Mérida, 97000, Mexico
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Miexico City, 06700, Mexico
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Morelia, 58070, Mexico
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Obregón, 85000, Mexico
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Querétaro, 76178, Mexico
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Saltillo, 25000, Mexico
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Torreón, 27000, Mexico
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Auckland, 2025, New Zealand
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Hamilton, 3240, New Zealand
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Tauranga, 3112, New Zealand
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Wellington, 6035, New Zealand
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Lima, 01, Peru
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Lima, LIMA 14, Peru
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Lima, Lima 41, Peru
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Cebu, 6000, Philippines
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Manila, 1000, Philippines
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Quezon, 1102, Philippines
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Bialystok, 15-351, Poland
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Lublin, 20-954, Poland
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Poznan, 60-218, Poland
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Warsaw, 01-157, Poland
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Ponce, 00716, Puerto Rico
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Bucharest, 011172, Romania
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Bucharest, 020475, Romania
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Bucharest, 020983, Romania
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Iași, 700661, Romania
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Moscow, 115522, Russia
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Moscow, 119991, Russia
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Novosibirsk, 630099, Russia
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Novosibirsk, 630117, Russia
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Ryazan, 390026, Russia
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Saint Petersburg, 190068, Russia
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Ulyanovsk, 432600, Russia
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Yaroslavl, 150030, Russia
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Yaroslavl, 150062, Russia
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Singapore, 119074, Singapore
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Cape Town, 7500, South Africa
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Durban, 4001, South Africa
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Parktown, 2000, South Africa
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Port Elizabeth, 6045, South Africa
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Stellenbosch, 7600, South Africa
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A Coruña, 15006, Spain
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Barakaldo, 48903, Spain
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Bilbao, 48013, Spain
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Madrid, 28007, Spain
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Madrid, 28046, Spain
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Málaga, 29010, Spain
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Mérida, 97500, Spain
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San Cristóbal de La Laguna, 38320, Spain
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Santander, 39008, Spain
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Santiago de Compostela, 15706, Spain
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Seville, 41009, Spain
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Torrelavega, 39300, Spain
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Valencia, 46009, Spain
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Bangkok, 10400, Thailand
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Bangkok, 10700, Thailand
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Chiang Mai, 50200, Thailand
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Khon Kaen, 40002, Thailand
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Cambridge, CB2 2QQ, United Kingdom
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Cannock, WS11 5XY, United Kingdom
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Coventry, CV2 2DX, United Kingdom
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Eastbourne, BN21 2UD, United Kingdom
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Exeter, EX2 5DW, United Kingdom
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Harrogate, HG2 7SX, United Kingdom
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Ipswich, IP4 5PD, United Kingdom
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London, E11 1NR, United Kingdom
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Metropolitan Borough of Wirral, CH49 5PE, United Kingdom
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Middlesbrough, TS4 3BW, United Kingdom
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Newcastle upon Tyne, NE7 7DN, United Kingdom
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Northampton, NN1 5BD, United Kingdom
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Nottingham, NG7 2UH, United Kingdom
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Westcliffe-on-sea, SS0 0RY, United Kingdom
Related Publications (1)
Burmester GR, Rubbert-Roth A, Cantagrel A, Hall S, Leszczynski P, Feldman D, Rangaraj MJ, Roane G, Ludivico C, Bao M, Rowell L, Davies C, Mysler EF. Efficacy and safety of subcutaneous tocilizumab versus intravenous tocilizumab in combination with traditional DMARDs in patients with RA at week 97 (SUMMACTA). Ann Rheum Dis. 2016 Jan;75(1):68-74. doi: 10.1136/annrheumdis-2015-207281. Epub 2015 Jun 8.
PMID: 26056119DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Communications
- Organization
- Hoffman-LaRoche
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 1, 2010
First Posted
September 3, 2010
Study Start
September 1, 2010
Primary Completion
January 1, 2012
Study Completion
August 1, 2013
Last Updated
June 20, 2016
Results First Posted
February 12, 2013
Record last verified: 2013-09