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

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.

Study Overview

• Status: Completed
• Conditions: Rheumatoid Arthritis
• Intervention / Treatment: Drug: tocilizumab SC; Drug: placebo to tocilizumab IV; Drug: Disease-modifying antirheumatic drugs (DMARDs); Drug: tocilizumab IV; Drug: placebo to tocilizumab SC

• Study Type: Interventional
• Enrollment (Actual): 1262
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, C1015ABO
  • Buenos Aires, Argentina, C1428DQG
  • Buenos Aires, Argentina, B1878DVB
  • Rosario, Argentina, S2000PBJ
• Australia
  • Adelaide, Australia, 5041
  • Adelaide, Australia, 5011
  • Clayton, Australia, 3168
  • Geelong, Australia, 3220
  • Hobart, Australia, 7000
  • Malvern East, Australia, 3145
  • Maroochydore, Australia, 4558
  • New Lambton, Australia, 2305
• Brazil
  • Curitiba, Brazil, 80060-240
  • Goiania, Brazil, 74110010
  • Juiz de Fora, Brazil, 36010-570
  • Porto Alegre, Brazil, 90035-903
  • Porto Alegre, Brazil, 90610-000
  • Sao Paulo, Brazil, 04039-000
  • Sao Paulo, Brazil, 4037003
  • São Paulo, Brazil, 05403-000
• Bulgaria
  • Sofia, Bulgaria, 1784
  • Sofia, Bulgaria, 1606
  • Sofia, Bulgaria, 1612
• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T5H 3V9
  • British Columbia
    • Kelowna, British Columbia, Canada, V1Y 3G8
    • Vancouver, British Columbia, Canada, V5Z 1L7
  • Newfoundland and Labrador
    • St John's, Newfoundland and Labrador, Canada, A1A 5E8
    • St John's, Newfoundland and Labrador, Canada, A1C 5B8
  • Ontario
    • Hamilton, Ontario, Canada, L8N 1Y2
    • Hamilton, Ontario, Canada, L8N 2B6
    • Kitchener, Ontario, Canada, N2M 5N6
    • Ottawa, Ontario, Canada, K1Y 4G2
    • St. Catharines, Ontario, Canada, L2N 7E4
    • Windsor, Ontario, Canada, N8X 5A6
  • Quebec
    • Montreal, Quebec, Canada, H2L 1S6
    • Quebec City, Quebec, Canada, G1V 3M7
    • Rimouski, Quebec, Canada, G5L 3W1
    • Sainte-foy, Quebec, Canada, G1W 4R4
    • Trois-rivieres, Quebec, Canada, G8Z 1Y2
  • Saskatchewan
    • Saskatoon, Saskatchewan, Canada, S7K 0H6
• Colombia
  • Barranquilla, Colombia
  • Bogota, Colombia
  • Bogotá, Colombia
• France
  • Bordeaux, France, 33076
  • Le Mans, France, 72037
  • Marseille, France, 13285
  • Montpellier, France, 34295
  • Nantes, France, 44035
  • Paris, France, 75679
  • Strasbourg, France, 67098
  • Toulouse, France, 31059
• Germany
  • Bad Bramstedt, Germany, 24576
  • Berlin, Germany, 10117
  • Berlin, Germany, 14059
  • Dresden, Germany, 01067
  • Essen, Germany, 45239
  • Freiburg, Germany, 79106
  • Gommern, Germany, 39245
  • Heidelberg, Germany, 69120
  • Herne, Germany, 44652
  • Hildesheim, Germany, 31134
  • Köln, Germany, 50924
  • Ludwigshafen, Germany, 67063
  • Osnabrück, Germany, 49074
  • Ratingen, Germany, 40882
  • Rostock, Germany, 18059
  • Würzburg, Germany, 97080
• Guatemala
  • Guatemala City, Guatemala, 01015
  • Guatemala City, Guatemala, 01010
• Hong Kong
  • Hong Kong, Hong Kong
  • Hong Kong, Hong Kong, 852
• Italy
  • Arenzano, Italy, 16011
  • Bergamo, Italy, 24128
  • Catania, Italy, 95124
  • Cona (ferrara), Italy, 44124
  • Genova, Italy, 16132
  • Napoli, Italy, 80131
  • Pavia, Italy, 27100
  • Pisa, Italy, 56100
  • Potenza, Italy, 85100
  • Reggio Emilia, Italy, 42100
  • Udine, Italy, 33100
  • Varese, Italy, 21100
• Lithuania
  • Klaipeda, Lithuania, 92288
  • Siauliai, Lithuania, 76231
  • Vilnius, Lithuania, LT-08661
• Mexico
  • Culiacan, Mexico, 80000
  • Guadalajara, Mexico, 44690
  • Guadalajara, Mexico, 44629
  • Leon, Mexico, 37000
  • Merida, Mexico, 97000
  • Mexico Ctiy, Mexico, 07760
  • Miexico City, Mexico, 06700
  • Morelia, Mexico, 58070
  • Obregon, Mexico, 85000
  • Queretaro, Mexico, 76178
  • Saltillo, Mexico, 25000
  • Torreon, Mexico, 27000
• New Zealand
  • Auckland, New Zealand, 2025
  • Hamilton, New Zealand, 3240
  • Tauranga, New Zealand, 3112
  • Wellington, New Zealand, 6035
• Peru
  • Lima, Peru, Lima 41
  • Lima, Peru, LIMA 14
  • Lima 01, Peru, 01
• Philippines
  • Cebu, Philippines, 6000
  • Manila, Philippines, 1000
  • Quezon, Philippines, 1102
• Poland
  • Bialystok, Poland, 15-351
  • Lublin, Poland, 20-954
  • Poznan, Poland, 60-218
  • Warszawa, Poland, 01-157
• Puerto Rico
  • Ponce, Puerto Rico, 00716
• Romania
  • Bucharest, Romania, 020475
  • Bucharest, Romania, 011172
  • Bucuresti, Romania, 020983
  • Iasi, Romania, 700661
• Russian Federation
  • Moscow, Russian Federation, 115522
  • Moscow, Russian Federation, 119991
  • Novosibirsk, Russian Federation, 630117
  • Novosibirsk, Russian Federation, 630099
  • Ryazan, Russian Federation, 390026
  • St Petersburg, Russian Federation, 190068
  • Ulyanovsk, Russian Federation, 432600
  • Yaroslavl, Russian Federation, 150030
  • Yaroslavl, Russian Federation, 150062
• Singapore
  • Singapore, Singapore, 119074
• South Africa
  • Cape Town, South Africa, 7500
  • Durban, South Africa, 4001
  • Parktown, South Africa, 2000
  • Port Elizabeth, South Africa, 6045
  • Stellenbosch, South Africa, 7600
• Spain
  • Barakaldo, Spain, 48903
  • Bilbao, Spain, 48013
  • La Coruna, Spain, 15006
  • La Laguna, Spain, 38320
  • Madrid, Spain, 28046
  • Madrid, Spain, 28007
  • Malaga, Spain, 29010
  • Merida, Spain, 97500
  • Santander, Spain, 39008
  • Santiago de Compostela, Spain, 15706
  • Sevilla, Spain, 41009
  • Torrelavega, Spain, 39300
  • Valencia, Spain, 46009
• Thailand
  • Bangkok, Thailand, 10400
  • Bangkok, Thailand, 10700
  • Chiang Mai, Thailand, 50200
  • Khon Kaen, Thailand, 40002
• United Kingdom
  • Cambridge, United Kingdom, CB2 2QQ
  • Cannock, United Kingdom, WS11 5XY
  • Coventry, United Kingdom, CV2 2DX
  • Eastbourne, United Kingdom, BN21 2UD
  • Exeter, United Kingdom, EX2 5DW
  • Harrogate, United Kingdom, HG2 7SX
  • Ipswich, United Kingdom, IP4 5PD
  • London, United Kingdom, E11 1NR
  • Middlesborough, United Kingdom, TS4 3BW
  • Newcastle Upon Tyne, United Kingdom, NE7 7DN
  • Northampton, United Kingdom, NN1 5BD
  • Nottingham, United Kingdom, NG7 2UH
  • Westcliffe-on-sea, United Kingdom, SS0 0RY
  • Wirral, United Kingdom, CH49 5PE
• United States
  • Alabama
    • Huntsville, Alabama, United States, 35801
    • Tuscaloosa, Alabama, United States, 35406
  • Arizona
    • Tucson, Arizona, United States, 85704
    • Tucson, Arizona, United States, 85712
  • California
    • Long Beach, California, United States, 90806
    • Los Angeles, California, United States, 90048
    • Upland, California, United States, 91786
    • Van Nuys, California, United States, 91405
  • Colorado
    • Denver, Colorado, United States, 80230-7127
  • Connecticut
    • Bridgeport, Connecticut, United States, 06606
  • Florida
    • Delray Beach, Florida, United States, 33484
    • Miami, Florida, United States, 33133
    • Ocala, Florida, United States, 34474
    • Orlando, Florida, United States, 32806
    • Palm Harbor, Florida, United States, 34684
    • Pinellas Park, Florida, United States, 33782
    • South Miami, Florida, United States, 33143
    • Tampa, Florida, United States, 33614
  • Idaho
    • Coeur D'alene, Idaho, United States, 83814
  • Illinois
    • Morton Grove, Illinois, United States, 60053
  • Kansas
    • Wichita, Kansas, United States, 67208
  • Louisiana
    • Monroe, Louisiana, United States, 71203
  • Michigan
    • Petoskey, Michigan, United States, 49770
    • St. Claire Shores, Michigan, United States, 48081
  • Minnesota
    • Eagan, Minnesota, United States, 55121
  • Missouri
    • Florissant, Missouri, United States, 63031
    • Saint Louis, Missouri, United States, 63117
    • Saint Louis, Missouri, United States, 63131
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03756
  • New Jersey
    • Clifton, New Jersey, United States, 07012
    • Manalapan, New Jersey, United States, 07726
    • Voorhees, New Jersey, United States, 08043
  • New Mexico
    • Albuquerque, New Mexico, United States, 87102
  • New York
    • Albany, New York, United States, 12206
    • Binghamton, New York, United States, 13905
    • Orchard Park, New York, United States, 14127
  • North Carolina
    • Asheville, North Carolina, United States, 28803
    • Raleigh, North Carolina, United States, 27609
    • Wilmington, North Carolina, United States, 28401
  • Ohio
    • Cincinnati, Ohio, United States, 45219
    • Toledo, Ohio, United States, 43623
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73103
    • Tulsa, Oklahoma, United States, 74135
  • Pennsylvania
    • Bethlehem, Pennsylvania, United States, 18015
  • South Carolina
    • Charleston, South Carolina, United States, 29406
    • Charleston, South Carolina, United States, 29407
  • Tennessee
    • Knoxville, Tennessee, United States, 37909
    • Memphis, Tennessee, United States, 38119
  • Texas
    • Houston, Texas, United States, 77004
    • San Antonio, Texas, United States, 78217
  • Washington
    • Olympia, Washington, United States, 98502
    • Seattle, Washington, United States, 98122
    • Spokane, Washington, United States, 99204
    • Wenatchee, Washington, United States, 98801

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

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 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Tocilizumab SC; Participants 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.	Drug: tocilizumab SC; 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.; Other Names: RoActemra/Actemra; Drug: placebo to tocilizumab IV; 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.; Drug: Disease-modifying antirheumatic drugs (DMARDs); stable dose as prescribed
EXPERIMENTAL: Tocilizumab IV; Participants 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.	Drug: Disease-modifying antirheumatic drugs (DMARDs); stable dose as prescribed; Drug: tocilizumab IV; Tocilizumab supplied in vials as a sterile solution for 8 mg/kg intravenous infusion every 4 weeks.; Other Names: RoActemra/Actemra; Drug: placebo to tocilizumab SC; 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.
EXPERIMENTAL: Tocilizumab SC Then Tocilizumab IV; Participants 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.	Drug: tocilizumab SC; 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.; Other Names: RoActemra/Actemra; Drug: placebo to tocilizumab IV; 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.; Drug: Disease-modifying antirheumatic drugs (DMARDs); stable dose as prescribed; Drug: tocilizumab IV; Tocilizumab supplied in vials as a sterile solution for 8 mg/kg intravenous infusion every 4 weeks.; Other Names: RoActemra/Actemra
EXPERIMENTAL: Tocilizumab IV Then Tocilizumab SC; Participants 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.	Drug: tocilizumab SC; 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.; Other Names: RoActemra/Actemra; Drug: Disease-modifying antirheumatic drugs (DMARDs); stable dose as prescribed; Drug: tocilizumab IV; Tocilizumab supplied in vials as a sterile solution for 8 mg/kg intravenous infusion every 4 weeks.; Other Names: RoActemra/Actemra; Drug: placebo to tocilizumab SC; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Achieving an American College of Rheumatology Criteria (ACR50) Response at Week 24	ACR50 response is defined as a ≥ 50% 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 or Erythrocyte Sedimentation Rate).	Baseline, 24 weeks
Percentage of Participants Achieving an American College of Rheumatology Criteria (ACR70) Response at Week 24	ACR70 response is defined as a ≥ 70% 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 or Erythrocyte Sedimentation Rate).	Baseline, 24 weeks
Percentage of Participants With Disease Activity Score 28 (DAS28) Remission at Week 24	The DAS28 (ESR) score is a measure of the subject's disease activity. It is calculated using the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity VAS where left side of the line 0=no disease activity to right side of the line 100=extreme disease activity and ESR. DAS28-(ESR) total scores range from 0 - 10. Remission is defined as achieving a DAS28-ESR score of less than 2.6.	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	The Stanford Health Assessment Questionnaire disability index (HAQ-DI) is a participant completed questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip and common daily activities. Each domain has at least two component questions. There are four possible responses for each component ranging from 0(without any difficulty) to 4 (unable to do).HAQ-DI=sum of worst scores in each domain divided by the number of domains answered. A decrease indicates improvement.	Baseline, 24 Weeks
Percentage of Participants Who Withdrew Because of Lack of Therapeutic Response at Week 24	The percentage of participants who withdrew from the study because they were not responding to treatment with the study drug.	24 Weeks
Percentage of Participants With American College of Rheumatology Criteria (ACR20, ACR50, ACR70) at Week 97	ACR20, ACR50 and ACR70: ≥20%, ≥50% and ≥70% reduction from baseline for both TJC68 and SJC66, as well as for 3 of 5 additional ACR variables: Patient's Assessment of Pain in last 24 hours using a Visual Analog Scale (VAS) (0=no pain and 100=unbearable pain); Patient's and Physician's Global Assessment of Disease Activity in last 24 hours using a VAS (0=no disease activity and100=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 CRP or ESR). CRP was used for calculation of ACR. If missing, ESR was used. LOCF was used for missing joint counts, no imputation for other ACR components.	Week 97
Percentage of Participants With Disease Activity Score 28 (DAS28) Remission at Week 97	The DAS28 (ESR) score is a measure of the subject's disease activity. It is calculated using the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity VAS where left side of the line 0=no disease activity to right side of the line 100=extreme disease activity and ESR. DAS28-(ESR) total scores range from 0 - 10. Remission is defined as achieving a DAS28-ESR score of less than 2.6. LOCF used for tender and swollen joint counts, no imputation used for ESR and Patient's Global Assessment of Disease Activity VAS.	Week 97
Percentage of Participants Achieving a Decrease of ≥0.3 in the Health Assessment Questionnaire-Disability Index (HAQ-DI) From Baseline to Week 97	The Stanford Health Assessment Questionnaire disability index (HAQ-DI) is a patient completed questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip and common daily activities. Each domain has at least two component questions. There are four possible responses for each component ranging from 0(without any difficulty) to 4 (unable to do).HAQ-DI=sum of worst scores in each domain divided by the number of domains answered. A decrease indicates improvement. No imputation of missing scores was made other than for missing baseline scores, for which last score prior to baseline will be carried forward. For participants who prematurely withdrew, data collected at withdrawal visit was used and data thereafter is missing.	Baseline, Week 97
Percentage of Participants Who Withdrew Because of Lack of Therapeutic Response at Week 97	The percentage of participants who withdrew from the study because they were not responding to treatment with the study drug.	Week 97
Area Under the Serum Concentration Curve of Tocilizumab After First SC Injection or IV Infusion		Week 0: at 6 hours (hr), 24 hr, 48 hr, 96 hr, 120 hr and 168 hr after first dose
Area Under the Serum Concentration Curve of Tocilizumab at Steady State for SC and IV Treatment		Week 20: at 6 hours (hr), 24 hr, 48 hr, 96 hr, 120 hr and 168 hr after dose.
Minimum Serum Concentration (Cmin) of Tocilizumab		Week 0, Week 20: at 6 hours (hr), 24 hr, 48 hr, 96 hr, 120 hr and 168 hr after dose
Maximum Serum Concentration (Cmax) of Tocilizumab		Week 0, Week 20: at 6 hours (hr), 24 hr, 48 hr, 96 hr, 120 hr and 168 hr after dose
Time to Maximum Serum Concentration (Tmax) of Tocilizumab		Week 0, Week 20: at 6 hours (hr), 24 hr, 48 hr, 96 hr, 120 hr and 168 hr after dose
Change From Baseline in Serum Interleukin-6 (IL-6) Concentration at Week 25		Baseline, Week 25
Change From Baseline in Serum Soluble Interleukin-6 Receptor (sIL-6R) Concentration at Week 97		Baseline, Week 97
Percentage of Participants Who Developed Antibodies To Tocilizumab at Week 97		Week 97

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: September 1, 2010
• Primary Completion (ACTUAL): January 1, 2012
• Study Completion (ACTUAL): August 1, 2013

Study Registration Dates

• First Submitted: September 1, 2010
• First Submitted That Met QC Criteria: September 1, 2010
• First Posted (ESTIMATE): September 3, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): June 20, 2016
• Last Update Submitted That Met QC Criteria: May 11, 2016
• Last Verified: September 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Arthritis, Rheumatoid; Antirheumatic Agents
• Other Study ID Numbers: WA22762; 2010-018375-22