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An Extension Study of Tocilizumab (Myeloma Receptor Antibody [MRA]) in Patients Completing Treatment in Tocilizumab Core Studies

Sponsor
Hoffmann-La Roche (Industry)
Overall Status
Completed
CT.gov ID
NCT00720798
Collaborator
(none)
2,067
Enrollment
295
Locations
1
Arm
91
Duration (Months)
7
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This single-arm study evaluated the long-term efficacy and safety of tocilizumab in participants who had completed treatment in the tocilizumab core studies (NCT00106522 [Roche protocol WA18062], NCT00106574 [Roche protocol WA18063], and NCT00109408 [Roche protocol WA17824]) of adults with rheumatoid arthritis. Participants received tocilizumab alone or in combination with standard anti-rheumatic treatment.

Condition or Disease Intervention/Treatment Phase
  • Drug: Tocilizumab
  • Drug: Disease-modifying anti-rheumatic drugs
  • Drug: Non-steroidal anti-inflammatory drugs
  • Drug: Oral corticosteroids
 Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
2067 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Long-term Extension Study of Safety During Treatment With Tocilizumab (MRA) in Patients Completing Treatment in MRA Core Studies
Study Start Date :
Sep 1, 2005
Actual Primary Completion Date :
Apr 1, 2013
Actual Study Completion Date :
Apr 1, 2013

Arms and Interventions

Arm Intervention/Treatment
Experimental: Tocilizumab

Participants received tocilizumab 8 mg/kg intravenously every 4 weeks till the end of the study (up to 7 years, 7 months). In addition, participants may have also received disease-modifying anti-rheumatic drugs, non-steroidal anti-inflammatory drugs, and oral corticosteroids at the discretion of the investigator.

Drug: Tocilizumab
For participants weighing > 100 kg, the maximum dose of tocilizumab was 800 mg. Tocilizumab was supplied as a sterile solution in vials.
Other Names:
  • RoActemra
  • Actemra

    • Drug: Disease-modifying anti-rheumatic drugs
    Disease-modifying anti-rheumatic drugs included methotrexate, chloroquine, hydroxychloroquine, parenteral gold, sulfasalazine, azathioprine, and leflunomide. These drugs could be used alone or in combination, except for the combination of methotrexate and leflunomide, which was not allowed.

    Drug: Non-steroidal anti-inflammatory drugs
    Participants could be treated with non-steroidal anti-inflammatory drugs up to the maximum recommended dose throughout the study. The choice and doses of non-steroidal anti-inflammatory drugs were at the discretion of the investigator.

    Drug: Oral corticosteroids
    Oral corticosteroids (≤ 10 mg/day) were permitted during the study.

    Outcome Measures

    Primary Outcome Measures

    1. Percentage of Participants With ≥ 1 Adverse Event [Baseline to the end of the study (up to 7 years, 7 months)]

    Secondary Outcome Measures

    1. Percentage of Participants Who Withdrew From Treatment [Baseline to the end of the study (up to 7 years, 7 months)]

    2. Percentage of Participants With Concomitant Oral Corticosteroid Therapy [Baseline to the end of the study (up to 7 years, 7 months)]

      Concomitant therapy with oral corticosteroids (up 5 to 10 mg daily prednisone or equivalent) was permitted in the study. Reduction of oral corticosteroids was permitted, but not required, if a patient achieved at least a 50% improvement from baseline in both tender joint count and swollen joint count. The data are reported for each 6-month period of the study where a month = 28 days. The last 6-month period is for months 96 through 101. The actually study duration in 28-day months was 98.85 months.

    3. Percentage of Participants Who Changed From Monotherapy to Combination Therapy [Baseline to Week 296]

      Participants who entered this study from study WA17824 on tocilizumab monotherapy, who did not achieve a 50% reduction in tender and swollen joint counts from Baseline of study WA17824, could add methotrexate or another allowable disease-modifying anti-rheumatic drug, according to the investigator's practice and as tolerated by the patient, at any time during this study.

    4. Percentage of Participants With an Improvement of at Least 20%, 50%, 70%, or 90% in the American College of Rheumatology (ACR) Score (ACR20/50/70/90) From Baseline at Weeks 24, 48, 108, 156, 204, and 264 [Baseline to Week 264]

      Improvement must be seen in tender (68 assessed joints) and swollen joint counts (66 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, the left end of the scale "no disease activity" [symptom-free and no arthritis symptoms], right end of the scale "maximum disease activity"); patient assessment of pain in the previous 24 hours on a VAS (left end of the scale "no pain", right end of the scale "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 erythrocyte sedimentation rate.

    5. Percentage of Participants Who Achieved a Major Clinical Response at Weeks 48, 96, 144, 192, and 264 [Baseline to Week 264]

      A major clinical response was defined as maintenance of an improvement of at least 70% in the American College of Rheumatology (ACR) score (ACR70) for at least 24 weeks. Improvement must be seen in tender (68 assessed joints) and swollen joint counts (66 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, the left end of the scale "no disease activity" [symptom-free and no arthritis symptoms], right end of the scale "maximum disease activity"); patient assessment of pain in the previous 24 hours on a VAS (left end of the scale "no pain", right end of the scale "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 erythrocyte sedimentation rate.

    6. Percentage of Participants Who Maintained an Improvement of at Least 20%, 50%, or 70% in the American College of Rheumatology (ACR) Score (ACR20/50/70) Consecutively for 24, 48, 96, and 264 Weeks at Weeks 48, 96, 144, 192, and 264 [Baseline to Week 264]

      Improvement must be seen in tender (68 assessed joints) and swollen joint counts (66 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, the left end of the scale "no disease activity" [symptom-free and no arthritis symptoms], right end of the scale "maximum disease activity"); patient assessment of pain in the previous 24 hours on a VAS (left end of the scale "no pain", right end of the scale "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 erythrocyte sedimentation rate.

    7. Swollen and Tender Joint Count (SJC/TJC) at Baseline and Weeks 24, 48, 108, 156, 204, and 264 [Baseline to Week 264]

      The number of swollen (66 assessed joints) and tender (68 assessed joints) joints was assessed. Joints were physically examined and classified as swollen/not swollen and tender/not tender by pressure and joint manipulation.

    8. Disease Activity and Pain at Baseline and Weeks 24, 48, 108, 156, 204, and 264 [Baseline to Week 264]

      Participant's made a global assessment of their current disease activity on a 100 mm horizontal visual analogue scale (VAS). The left end of the scale indicated "no disease activity" (symptom-free and no arthritis symptoms, score = 0) and the right end indicated "maximum disease activity" (maximum arthritis disease activity, score = 100). The participant's treating physician made a global assessment of the participant's current disease activity on a 100 mm horizontal VAS. The left end of the scale indicated "no disease activity" (symptom-free and no arthritis symptoms, score = 0) and the right end indicated "maximum disease activity" (maximum arthritis disease activity, score = 100). Participant's made an assessment of their current level of pain on a 100 mm horizontal VAS. The left end of the scale indicated "no pain" (score = 0) and the right end of the scale indicated "unbearable pain" (score = 100).

    9. Health Assessment Questionnaire-Disability Index Score at Baseline and Weeks 24, 48, 108, 156, 204, and 264 [Baseline to Week 264]

      The Health Assessment Questionnaire-Disability Index (HAQ-DI), as a measure of functional ability, consists of 30 questions in 8 domains: Dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities. There are 4 possible responses to each question (0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do). A domain score is the highest score in that domain. To calculate the overall score, the patient must have a domain score in at least 6 of the 8 domains. The HAQ-DI score is the sum of the domain scores divided by the number of domains that have a non-missing score and ranges from 0 (best) to 3 (worst). A higher score indicates less ability.

    10. Erythrocyte Sedimentation Rate at Baseline and Weeks 24, 48, 108, 156, 204, and 264 [Baseline to Week 264]

      Erythrocyte sedimentation rate (ESR) was determined locally.

    11. Change in the Disease Activity Score 28 (DAS-28) From Baseline to Weeks 24, 48, 96, and 264 [Baseline to Week 264]

      The DAS28 is a combined index for measuring disease activity in rheumatic arthritis (RA) and includes swollen and tender joint counts, erythrocyte sedimentation rate (ESR), and general health (GH) status. The index is calculated with the following formula: DAS28 = (0.56 × √(TJC28)) + (0.28 × √(SJC28)) + (0.7 × log(ESR)) + (0.014 × GH), where TJC28 = tender joint count and SJC28 = swollen joint count, each on 28 joints. GH = a patient's global assessment of disease activity in the previous 24 hours on a 100 mm visual analog scale (left end = no disease activity [symptom-free and no arthritis symptoms], right end = maximum disease activity [maximum arthritis disease activity]). When ESR equaled 0 mm/hr, it was set to 1 mm/hr. The DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity. A negative change score indicates improvement.

    12. Percentage of Participants Who Were Disease Activity Score 28 (DAS-28) Responders at Weeks 24, 48, 108, 156, 204, and 264 [Baseline to Week 264]

      A DAS-28 responder was defined as someone who met the European League Against Rheumatism [EULAR] criteria of a good or moderate response. A change of the DAS-28 score from Baseline was used to determine EULAR responses of good, moderate, or no response. For a post-baseline score ≤ 3.2, a change from baseline of < -1.2 was a good response, < -0.6 to ≥ -1.2 was a moderate response, and ≥ -0.6 was no response. For a post-baseline score > 3.2 to ≤ 5.1, a change from baseline of < -0.6 was a moderate response and ≥ -0.6 was no response. For a post-baseline score > 5.1, a change from baseline < -1.2 was a moderate response and ≥ -1.2 was no response. A good response could not be achieved for post-baseline scores > 3.2.

    13. Percentage of Participants Who Maintained a Disease Activity Score 28 (DAS-28) Response for 24, 48, 96, 144, and 192 Weeks at Weeks 48, 96, 144, 192, and 264 [Baseline to Week 264]

      A DAS-28 responder was defined as someone who met the European League Against Rheumatism [EULAR] criteria of a good or moderate response. A change of the DAS-28 score from Baseline was used to determine EULAR responses of good, moderate, or no response. For a post-baseline score ≤ 3.2, a change from baseline of < -1.2 was a good response, < -0.6 to ≥ -1.2 was a moderate response, and ≥ -0.6 was no response. For a post-baseline score > 3.2 to ≤ 5.1, a change from baseline of < -0.6 was a moderate response and ≥ -0.6 was no response. For a post-baseline score > 5.1, a change from baseline < -1.2 was a moderate response and ≥ -1.2 was no response. A good response could not be achieved for post-baseline scores > 3.2.

    14. Percentage of Participants With a Clinically Relevant Improvement in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Score at Weeks 24, 36, 48, 108, 156, 204, and 264 [Baseline to Week 264]

      The FACIT-F is a 13-item participant self-report questionnaire that assesses fatigue over the previous 7 days by scoring each item on a 5-point scale (0=Not at all, 1=A little bit, 2=Somewhat, 3=Quite a bit, 4=Very much). An overall FACIT-F score was obtained by summing the scores of all 13 items. The overall score ranged from 0 to 52. A lower score indicates less fatigue. A clinically relevant improvement in the FACIT-F score was defined as a ≥ 5-point increase from Baseline.

    15. Percentage of Participants With a Clinically Relevant Improvement in the Physical and Mental Component Scores of the Short Form 36 (SF-36) Health Survey at Weeks 24, 48, 108, 156, 204, and 264 [Baseline to Week 264]

      The SF-36 Health Survey uses participant-reported symptoms on 8 subscales to assess health-related quality of life (HRQoL). The Physical Component Summary (PCS) score summarizes the subscales Physical Functioning, Role-Physical, Bodily Pain, and General Health. The Mental Component Summary (MCS) score summarizes the subscales Vitality, Social Functioning, Role-Emotional, and Mental Health. Each score was scaled from 0 to 100 with a higher score indicating better HRQoL. A clinically relevant improvement in the Physical and Mental Component Scores of the SF-36 was defined as a ≥ 5-point increase from Baseline.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Patients who have completed participation in 1 of the core studies in adult rheumatoid arthritis.
    Exclusion Criteria:

    • Treatment with any investigational agent since the last administration of study drug in the core studies.

    • Treatment with iv gamma globulin, plasmapheresis, or prosorba column since the last administration of study drug in the core studies.

    • Treatment with an anti-TNF or anti-IL1 agent, a T-cell co-stimulation modulator, or any biologic since the last administration of study drug in the core studies.

    • Immunization with a live/attenuated vaccine since the last administration of study drug in the core studies.

    • Previous treatment with any cell-depleting therapies, including investigational agents.

    • Parenteral, intramuscular, or intra-articular corticosteroids within 6 weeks prior to baseline in this study.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Birmingham Alabama United States 35294-7201
    2 Huntsville Alabama United States 35801
    3 Mesa Arizona United States 85208
    4 Paradise Valley Arizona United States 85253
    5 Peoria Arizona United States 85381
    6 Scottsdale Arizona United States 85251
    7 Scottsdale Arizona United States 85258
    8 Tucson Arizona United States 85723
    9 Tucson Arizona United States 85724
    10 Little Rock Arkansas United States 72205
    11 Anaheim California United States 92801
    12 Long Beach California United States 90806
    13 Long Beach California United States 90808
    14 Los Angeles California United States 90045
    15 Los Angeles California United States 90095
    16 Palm Desert California United States 92260
    17 Palm Springs California United States 92262
    18 Palo Alto California United States 94304
    19 San Diego California United States 92101
    20 San Diego California United States 92108
    21 San Jose California United States 95126
    22 San Leandro California United States 94578
    23 Santa Maria California United States 93454
    24 Torrance California United States 90505
    25 Upland California United States 91786
    26 Colorado Springs Colorado United States 80910
    27 Newark Delaware United States 19713
    28 Aventura Florida United States 33180
    29 Delray Beach Florida United States 33484
    30 Fort Lauderdale Florida United States 33334
    31 Palm Habor Florida United States 34684
    32 Palm Harbor Florida United States 34684
    33 Sarasota Florida United States 34239
    34 Tampa Florida United States 33609
    35 Tampa Florida United States 33614
    36 West Palm Beach Florida United States 33407
    37 Atlanta Georgia United States 30342
    38 Boise Idaho United States 83702
    39 Idaho Falls Idaho United States 83404
    40 Meridian Idaho United States 83642
    41 Morton Grove Illinois United States 60053
    42 Springfield Illinois United States 62704
    43 Vernon Hills Illinois United States 60061
    44 Indianapolis Indiana United States 46202-5149
    45 Cedar Rapids Iowa United States 52401
    46 Des Moines Iowa United States 50322
    47 Bowling Green Kentucky United States 42102
    48 Lexington Kentucky United States 40515
    49 Louisville Kentucky United States 40202
    50 Baton Rouge Louisiana United States 70808
    51 Shreverport Louisiana United States 71103
    52 Slidell Louisiana United States 70458
    53 Portland Maine United States 04102
    54 Frederick Maryland United States 21702
    55 Wheaton Maryland United States 20902
    56 Boston Massachusetts United States 02111
    57 Pittsfield Massachusetts United States 01201
    58 Grand Rapids Michigan United States 49546
    59 Kalamazoo Michigan United States 49048
    60 Lansing Michigan United States 48910
    61 Eagan Minnesota United States 55121
    62 St Cloud Minnesota United States 56303
    63 St. Louis Park Minnesota United States 55426
    64 Flowood Mississippi United States 39232
    65 Tupelo Mississippi United States 38802
    66 Saint Louis Missouri United States 63128
    67 Saint Louis Missouri United States 63131
    68 Springfield Missouri United States 65807
    69 St Louis Missouri United States 63117
    70 St Louis Missouri United States 63141
    71 Billings Montana United States 59107-5100
    72 Lincoln Nebraska United States 68516
    73 Reno Nevada United States 89502
    74 Dover New Hampshire United States 03820
    75 Haddon Heights New Jersey United States 08035
    76 New Brunswick New Jersey United States 08903
    77 Passaic New Jersey United States 07055
    78 Albuquerque New Mexico United States 87131
    79 Albany New York United States 12206
    80 Binghamton New York United States 13905
    81 Great Neck New York United States 11020
    82 New York New York United States 10021
    83 Orchard Park New York United States 14127
    84 Plainview New York United States 11803
    85 Rochester New York United States 14642
    86 Syracuse New York United States 13210
    87 Asheville North Carolina United States 28803
    88 Chapel Hill North Carolina United States 27599-7280
    89 Charlotte North Carolina United States 28210
    90 Durham North Carolina United States 27704
    91 Raleigh North Carolina United States 27609
    92 Bismarck North Dakota United States 58501
    93 Canton Ohio United States 44718
    94 Cincinnati Ohio United States 45219
    95 Cleveland Ohio United States 44109
    96 Dayton Ohio United States 45408
    97 Oklahoma City Oklahoma United States 73103
    98 Oklahoma City Oklahoma United States 73109
    99 Oklahoma City Oklahoma United States 73112
    100 Tulsa Oklahoma United States 74104
    101 Tulsa Oklahoma United States 74135
    102 Eugene Oregon United States 97401
    103 Medford Oregon United States 97504
    104 Allentown Pennsylvania United States 18103
    105 Bethlehem Pennsylvania United States 18015
    106 Danville Pennsylvania United States 17822
    107 Duncansville Pennsylvania United States 16635
    108 Philadelphia Pennsylvania United States 19152
    109 Pittsburgh Pennsylvania United States 15261
    110 Willow Grove Pennsylvania United States 19090
    111 Willow Grove Pennsylvania United States 80045
    112 Wyomissing Pennsylvania United States 19610
    113 Johnston Rhode Island United States 02919
    114 Charleston South Carolina United States 29406
    115 Columbia South Carolina United States 29204
    116 Greenville South Carolina United States 29601
    117 Hickory South Carolina United States 28602
    118 Hixson Tennessee United States 37343
    119 Jackson Tennessee United States 38305
    120 Nashville Tennessee United States 37203
    121 Amarillo Texas United States 79124
    122 Austin Texas United States 78705
    123 Austin Texas United States 78749
    124 Dallas Texas United States 75231-4406
    125 Dallas Texas United States 75231
    126 Houston Texas United States 77074
    127 Mesquite Texas United States 75150
    128 Burlington Vermont United States 05401
    129 Chesapeake Virginia United States 23320
    130 Norfolk Virginia United States 23502
    131 Mountlake Terrace Washington United States 98043
    132 Olympia Washington United States 98502
    133 Seattle Washington United States 98104
    134 Seattle Washington United States 98195
    135 Spokane Washington United States 99204
    136 Tacoma Washington United States 98405
    137 Glendale Wisconsin United States 53217
    138 Lacrosse Wisconsin United States 54601
    139 Buenos Aires Argentina C1015ABO
    140 Buenos Aires Argentina C1428DQG
    141 Florencio Varela Argentina B1878DVB
    142 Rosario Argentina S2000PBJ
    143 Hobart Australia 7000
    144 Malvern Australia 3144
    145 Shenton Park Australia 6008
    146 Sydney Australia 2050
    147 Woolloongabba Australia 4102
    148 Hasselt Belgium 3500
    149 Merksem Belgium 2170
    150 Campinas Brazil 13060-803
    151 Goiania Brazil 74653-050
    152 Rio de Janeiro Brazil 20551030
    153 Calgary Alberta Canada T2V 1P9
    154 Edmonton Alberta Canada T5H 3V9
    155 Victoria British Columbia Canada V8V 3P9
    156 Winnipeg Manitoba Canada R3A 1M3
    157 St John's Newfoundland and Labrador Canada A1A 5E8
    158 Burlington Ontario Canada L7R 1E2
    159 Hamilton Ontario Canada L8N 2B6
    160 Kitchener Ontario Canada N2M 5N6
    161 London Ontario Canada N6A 4V2
    162 Mississauga Ontario Canada L5M 2V8
    163 Ottawa Ontario Canada K1H 1A2
    164 Toronto Ontario Canada M5T 3L9
    165 Montreal Quebec Canada H2L 1S6
    166 Quebec City Quebec Canada G1V 3M7
    167 Sainte-foy Quebec Canada G1W 4R4
    168 Saskatoon Saskatchewan Canada S7N 0W8
    169 Beijing China 100032
    170 Beijing China 100044
    171 Guangzhou China 510630
    172 Hefei Anhui China 230022
    173 Jinan China 250012
    174 Shanghai China 200127
    175 Shanghai China 200433
    176 San Jose Costa Rica 10103
    177 Hradec Kralove Czech Republic 500 05
    178 Praha Czech Republic 128 50
    179 Praha Czech Republic 140 59
    180 Hellerup Denmark 2900
    181 Helsinki Finland 00290
    182 Jyväskylä Finland 40620
    183 Amiens France 80054
    184 Bordeaux France 33076
    185 Boulogne-billancourt France 92104
    186 Brest France 29609
    187 Grenoble France 38042
    188 Le Kremlin-bicetre France 94270
    189 Lille France 59037
    190 Lyon France 69437
    191 Marseille France 13285
    192 Montpellier France 34295
    193 Nantes France 44035
    194 Nice France 06202
    195 Paris France 75181
    196 Paris France 75679
    197 Pierre Benite France 69495
    198 Rennes France 35203
    199 Rouen France 76031
    200 St Priest En Jarez France 42277
    201 Strasbourg France 67098
    202 Toulouse France 31059
    203 Aachen Germany 52064
    204 Berlin Germany 10117
    205 Dresden Germany 01067
    206 Essen Germany 45239
    207 Gommern Germany 39245
    208 Herne Germany 44652
    209 Hildesheim Germany 31134
    210 Köln Germany 50924
    211 München Germany 80335
    212 München Germany 81541
    213 Osnabrück Germany 49074
    214 Sendenhorst Germany 48324
    215 Wiesbaden Germany 65191
    216 Wuerzburg Germany 97080
    217 Hong Kong Hong Kong 852
    218 Tuen Mun Hong Kong 852
    219 Reykjavik Iceland 108
    220 Ashkelon Israel 78306
    221 Haifa Israel 31048
    222 Haifa Israel 34354
    223 Rishon Lezion Israel 70300
    224 Brescia Italy 25123
    225 Genova Italy 16132
    226 Milano Italy 20157
    227 Padova Italy 35128
    228 Pavia Italy 27100
    229 Pisa Italy 56100
    230 Siena Italy 53100
    231 Udine Italy 33100
    232 Kaunas Lithuania 50009
    233 Klaipeda Lithuania 92288
    234 Panevezys Lithuania 35144
    235 Siauliai Lithuania 76231
    236 Vilnius Lithuania LT-08661
    237 Guadalajara Mexico 44340
    238 Guadalajara Mexico 44620
    239 Guadalajara Mexico 45235
    240 Leon Mexico 37000
    241 Mexico City Mexico 06700
    242 Mexico City Mexico 07760
    243 Mexico City Mexico 14050
    244 Tijuana Mexico 22320
    245 Nijmegen Netherlands 6525 GA
    246 Levanger Norway 7600
    247 Lillehammer Norway 2609
    248 Panama City Panama 32400
    249 Lima Peru 11
    250 Lima Peru 13
    251 Lisboa Portugal 1349-019
    252 Ponce Puerto Rico 00716
    253 Moscow Russian Federation 105203
    254 Moscow Russian Federation 115522
    255 Moscow Russian Federation 117049
    256 Ryazan Russian Federation 390026
    257 St Petersburg Russian Federation 190068
    258 St Petersburg Russian Federation 191015
    259 Tula Russian Federation 300053
    260 Belgrade Serbia 11000
    261 Niska Banja Serbia 18250
    262 Ljubljana Slovenia 1000
    263 Maribor Slovenia 2000
    264 Cape Town South Africa 4001
    265 Cape Town South Africa 7500
    266 Diepkloof South Africa 1862
    267 Durban South Africa 4001
    268 Pinelands South Africa 7405
    269 Pretoria South Africa 0002
    270 Radiokop South Africa 2040
    271 Barakaldo Spain 48903
    272 Barcelona Spain 08035
    273 Madrid Spain 28046
    274 Malaga Spain 29010
    275 Pontevedra Spain 36001
    276 Santiago de Compostela Spain 15706
    277 Stockholm Sweden 17176
    278 Umea Sweden 90185
    279 Lausanne Switzerland 1011
    280 Bangkok Thailand 10330
    281 Bangkok Thailand 10400
    282 Chiang Mai Thailand 50200
    283 Basingstoke United Kingdom RG24 9NA
    284 Birmingham United Kingdom B29 6JD
    285 Cannock United Kingdom WS11 5XY
    286 Derby United Kingdom DE1 2QY
    287 Leeds United Kingdom LS7 4SA
    288 London United Kingdom SE1 9RT
    289 Manchester United Kingdom M13 9WL
    290 Manchester United Kingdom M41 5SL
    291 Middlesborough United Kingdom TS4 3BW
    292 Newcastle Upon Tyne United Kingdom NE1 4LP
    293 Oxford United Kingdom OX3 7LD
    294 Southampton United Kingdom SO16 6YD
    295 Stoke-on-trent United Kingdom ST6 7AG

    Sponsors and Collaborators

    • Hoffmann-La Roche

    Investigators

    • Study Director: Clinical Trials, Hoffmann-La Roche

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Hoffmann-La Roche
    ClinicalTrials.gov Identifier:
    NCT00720798
    Other Study ID Numbers:
    • WA18696
    First Posted:
    Jul 23, 2008
    Last Update Posted:
    Sep 30, 2014
    Last Verified:
    Sep 1, 2014
    Additional relevant MeSH terms:
    Arthritis
    Arthritis, Rheumatoid
    Anti-Inflammatory Agents
    Anti-Inflammatory Agents, Non-Steroidal
    Antirheumatic Agents

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group Title Tocilizumab
    Arm/Group Description Participants received tocilizumab 8 mg/kg intravenously every 4 weeks till the end of the study (up to 7 years, 7 months). In addition, participants may have also received disease-modifying anti-rheumatic drugs, non-steroidal anti-inflammatory drugs, and oral corticosteroids at the discretion of the investigator.
    Period Title: Overall Study
    STARTED 2067
    COMPLETED 1311
    NOT COMPLETED 756

    Baseline Characteristics

    Arm/Group Title Tocilizumab
    Arm/Group Description Participants received tocilizumab 8 mg/kg intravenously every 4 weeks till the end of the study (up to 7 years, 7 months). In addition, participants may have also received disease-modifying anti-rheumatic drugs, non-steroidal anti-inflammatory drugs, and oral corticosteroids at the discretion of the investigator.
    Overall Participants 2067
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    52.2
    (12.60)
    Sex: Female, Male (Count of Participants)
    Female
    1689
    81.7%
    Male
    378
    18.3%

    Outcome Measures

    1. Primary Outcome
    Title Percentage of Participants With ≥ 1 Adverse Event
    Description
    Time Frame Baseline to the end of the study (up to 7 years, 7 months)

    Outcome Measure Data

    Analysis Population Description
    All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
    Arm/Group Title Tocilizumab
    Arm/Group Description Participants received tocilizumab 8 mg/kg intravenously every 4 weeks till the end of the study (up to 7 years, 7 months). In addition, participants may have also received disease-modifying anti-rheumatic drugs, non-steroidal anti-inflammatory drugs, and oral corticosteroids at the discretion of the investigator.
    Measure Participants 2067
    Number [Percentage of participants]
    96.3
    4.7%
    2. Secondary Outcome
    Title Percentage of Participants Who Withdrew From Treatment
    Description
    Time Frame Baseline to the end of the study (up to 7 years, 7 months)

    Outcome Measure Data

    Analysis Population Description
    All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
    Arm/Group Title Tocilizumab
    Arm/Group Description Participants received tocilizumab 8 mg/kg intravenously every 4 weeks till the end of the study (up to 7 years, 7 months). In addition, participants may have also received disease-modifying anti-rheumatic drugs, non-steroidal anti-inflammatory drugs, and oral corticosteroids at the discretion of the investigator.
    Measure Participants 2067
    Number [Percentage of participants]
    36.6
    1.8%
    3. Secondary Outcome
    Title Percentage of Participants With Concomitant Oral Corticosteroid Therapy
    Description Concomitant therapy with oral corticosteroids (up 5 to 10 mg daily prednisone or equivalent) was permitted in the study. Reduction of oral corticosteroids was permitted, but not required, if a patient achieved at least a 50% improvement from baseline in both tender joint count and swollen joint count. The data are reported for each 6-month period of the study where a month = 28 days. The last 6-month period is for months 96 through 101. The actually study duration in 28-day months was 98.85 months.
    Time Frame Baseline to the end of the study (up to 7 years, 7 months)

    Outcome Measure Data

    Analysis Population Description
    All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
    Arm/Group Title Tocilizumab
    Arm/Group Description Participants received tocilizumab 8 mg/kg intravenously every 4 weeks till the end of the study (up to 7 years, 7 months). In addition, participants may have also received disease-modifying anti-rheumatic drugs, non-steroidal anti-inflammatory drugs, and oral corticosteroids at the discretion of the investigator.
    Measure Participants 2067
    0 - 6 Months, n = 2067
    55.8
    2.7%
    6 - 12 Months, n = 2041
    55.3
    2.7%
    12 - 18 Months, n = 1944
    54.6
    2.6%
    18 - 24 Months, n = 1832
    54.3
    2.6%
    24 - 30 Months, n = 1753
    53.2
    2.6%
    30 - 36 Months, n = 1677
    52.9
    2.6%
    36 - 42 Months, n = 1620
    51.3
    2.5%
    42 - 48 Months, n = 1568
    50.4
    2.4%
    48 - 54 Months, n = 1516
    50.6
    2.4%
    54 - 60 Months, n = 1475
    50.1
    2.4%
    60 - 66 Months, n = 1423
    49.2
    2.4%
    66 - 72 Months, n = 1342
    48.4
    2.3%
    72 - 78 Months, n = 788
    48.7
    2.4%
    78 - 84 Months, n = 62
    72.6
    3.5%
    84 - 90 Months, n = 34
    79.4
    3.8%
    90 - 96 Months, n = 10
    70.0
    3.4%
    96 - 102 Months, n = 2
    0.0
    0%
    4. Secondary Outcome
    Title Percentage of Participants Who Changed From Monotherapy to Combination Therapy
    Description Participants who entered this study from study WA17824 on tocilizumab monotherapy, who did not achieve a 50% reduction in tender and swollen joint counts from Baseline of study WA17824, could add methotrexate or another allowable disease-modifying anti-rheumatic drug, according to the investigator's practice and as tolerated by the patient, at any time during this study.
    Time Frame Baseline to Week 296

    Outcome Measure Data

    Analysis Population Description
    All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study. Only participants from the core study WA17824 are included in the analysis.
    Arm/Group Title Tocilizumab
    Arm/Group Description Participants received tocilizumab 8 mg/kg intravenously every 4 weeks till the end of the study (up to 7 years, 7 months). In addition, participants may have also received disease-modifying anti-rheumatic drugs, non-steroidal anti-inflammatory drugs, and oral corticosteroids at the discretion of the investigator.
    Measure Participants 243
    Week 8
    1.2
    0.1%
    Week 12
    0.4
    0%
    Week 24
    15.6
    0.8%
    Week 28
    7.0
    0.3%
    Week 32
    2.5
    0.1%
    Week 36
    1.6
    0.1%
    Week 40
    0.4
    0%
    Week 44
    0.4
    0%
    Week 48
    1.6
    0.1%
    Week 52
    0.8
    0%
    Week 54
    0.8
    0%
    Week 64
    1.2
    0.1%
    Week 68
    0.8
    0%
    Week 72
    0.8
    0%
    Week 76
    0.4
    0%
    Week 88
    0.8
    0%
    Week 96
    1.2
    0.1%
    Week 100
    0.8
    0%
    Week 104
    0.4
    0%
    Week 108
    0.4
    0%
    Week 112
    0.4
    0%
    Week 116
    0.4
    0%
    Week 120
    0.4
    0%
    Week 140
    0.4
    0%
    Week 152
    0.8
    0%
    Week 184
    0.4
    0%
    Week 196
    0.4
    0%
    Week 200
    0.8
    0%
    Week 292
    0.4
    0%
    Week 296
    0.8
    0%
    5. Secondary Outcome
    Title Percentage of Participants With an Improvement of at Least 20%, 50%, 70%, or 90% in the American College of Rheumatology (ACR) Score (ACR20/50/70/90) From Baseline at Weeks 24, 48, 108, 156, 204, and 264
    Description Improvement must be seen in tender (68 assessed joints) and swollen joint counts (66 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, the left end of the scale "no disease activity" [symptom-free and no arthritis symptoms], right end of the scale "maximum disease activity"); patient assessment of pain in the previous 24 hours on a VAS (left end of the scale "no pain", right end of the scale "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 erythrocyte sedimentation rate.
    Time Frame Baseline to Week 264

    Outcome Measure Data

    Analysis Population Description
    All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study. Only participants with available data were included in the analysis.
    Arm/Group Title Tocilizumab
    Arm/Group Description Participants received tocilizumab 8 mg/kg intravenously every 4 weeks till the end of the study (up to 7 years, 7 months). In addition, participants may have also received disease-modifying anti-rheumatic drugs, non-steroidal anti-inflammatory drugs, and oral corticosteroids at the discretion of the investigator.
    Measure Participants 2067
    ACR20 Week 24 (n=1966)
    59.5
    2.9%
    ACR20 Week 48 (n=1825)
    66.7
    3.2%
    ACR20 Week 108 (n=1607)
    74.1
    3.6%
    ACR20 Week 156 (n=1512)
    74.3
    3.6%
    ACR20 Week 204 (n=1415)
    77.5
    3.7%
    ACR20 Week 264 (n = 1319)
    78.7
    3.8%
    ACR50 Week 24 (n=1966)
    34.9
    1.7%
    ACR50 Week 48 (n=1825)
    44.4
    2.1%
    ACR50 Week 108 (n=1607)
    52.8
    2.6%
    ACR50 Week 156 (n=1512)
    54.7
    2.6%
    ACR50 Week 204 (n=1415)
    56.5
    2.7%
    ACR50 Week 264 (n= 1319)
    58.8
    2.8%
    ACR70 Week 24 (n=1966)
    17.8
    0.9%
    ACR70 Week 48 (n=1825)
    25.5
    1.2%
    ACR70 Week 108 (n=1607)
    33.2
    1.6%
    ACR70 Week 156 (n=1512)
    35.7
    1.7%
    ACR70 Week 204 (n =1415)
    38.6
    1.9%
    ACR70 Week 264 (n=1319)
    40.5
    2%
    ACR90 Week 24 (n=1966)
    4.3
    0.2%
    ACR90 Week 48 (n=1825
    7.9
    0.4%
    ACR90 Week 108 (n=1607)
    12.1
    0.6%
    ACR90 Week 156 (n=1512)
    14.7
    0.7%
    ACR90 Week 204 (n=1415)
    17.7
    0.9%
    ACR90 Week 264 (n=1319)
    18.1
    0.9%
    6. Secondary Outcome
    Title Percentage of Participants Who Achieved a Major Clinical Response at Weeks 48, 96, 144, 192, and 264
    Description A major clinical response was defined as maintenance of an improvement of at least 70% in the American College of Rheumatology (ACR) score (ACR70) for at least 24 weeks. Improvement must be seen in tender (68 assessed joints) and swollen joint counts (66 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, the left end of the scale "no disease activity" [symptom-free and no arthritis symptoms], right end of the scale "maximum disease activity"); patient assessment of pain in the previous 24 hours on a VAS (left end of the scale "no pain", right end of the scale "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 erythrocyte sedimentation rate.
    Time Frame Baseline to Week 264

    Outcome Measure Data

    Analysis Population Description
    All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study. Only participants with available data were included in the analysis.
    Arm/Group Title Tocilizumab
    Arm/Group Description Participants received tocilizumab 8 mg/kg intravenously every 4 weeks till the end of the study (up to 7 years, 7 months). In addition, participants may have also received disease-modifying anti-rheumatic drugs, non-steroidal anti-inflammatory drugs, and oral corticosteroids at the discretion of the investigator.
    Measure Participants 2067
    Week 48 (n = 1937)
    8.5
    0.4%
    Week 96 (n = 1745)
    16.2
    0.8%
    Week 144 (n = 1615)
    20.9
    1%
    Week 192 (n = 1514)
    22.9
    1.1%
    Week 264 (n = 1358)
    24.9
    1.2%
    7. Secondary Outcome
    Title Percentage of Participants Who Maintained an Improvement of at Least 20%, 50%, or 70% in the American College of Rheumatology (ACR) Score (ACR20/50/70) Consecutively for 24, 48, 96, and 264 Weeks at Weeks 48, 96, 144, 192, and 264
    Description Improvement must be seen in tender (68 assessed joints) and swollen joint counts (66 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, the left end of the scale "no disease activity" [symptom-free and no arthritis symptoms], right end of the scale "maximum disease activity"); patient assessment of pain in the previous 24 hours on a VAS (left end of the scale "no pain", right end of the scale "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 erythrocyte sedimentation rate.
    Time Frame Baseline to Week 264

    Outcome Measure Data

    Analysis Population Description
    All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study. Only participants with available data were included in the analysis.
    Arm/Group Title Tocilizumab
    Arm/Group Description Participants received tocilizumab 8 mg/kg intravenously every 4 weeks till the end of the study (up to 7 years, 7 months). In addition, participants may have also received disease-modifying anti-rheumatic drugs, non-steroidal anti-inflammatory drugs, and oral corticosteroids at the discretion of the investigator.
    Measure Participants 2067
    ACR20 Week 48: Maintained 24 weeks (n=1937)
    41.2
    2%
    ACR20 Week 96: Maintained 24 weeks (n=1745)
    53.0
    2.6%
    ACR20 Week 96: Maintained 48 weeks (n=1745)
    43.0
    2.1%
    ACR20 Week 144: Maintained 24 weeks (n=1615)
    56.3
    2.7%
    ACR20 Week 144: Maintained 48 weeks (n=1615)
    48.7
    2.4%
    ACR20 Week 144: Maintained 96 weeks (n=1615)
    35.6
    1.7%
    ACR20 Week 192: Maintained 24 weeks (n=1514)
    60.0
    2.9%
    ACR20 Week 192: Maintained 48 weeks (n=1514)
    52.3
    2.5%
    ACR20 Week 192: Maintained 96 weeks (n=1514)
    41.3
    2%
    ACR20 Week 192: Maintained 144 weeks (n=1514)
    31.8
    1.5%
    ACR20 Week 264: Maintained 24 weeks (n=1358)
    63.0
    3%
    ACR20 Week 264: Maintained 48 weeks (n=1358)
    54.7
    2.6%
    ACR20 Week 264: Maintained 96 weeks (n=1358)
    46.2
    2.2%
    ACR20 Week 264: Maintained 144 weeks (n=1358)
    38.7
    1.9%
    ACR20 Week 264: Maintained 192 weeks (n=1358)
    32.6
    1.6%
    ACR50 Week 48: Maintained 24 weeks (n=1937)
    20.7
    1%
    ACR50 Week 96: Maintained 24 weeks (n=1745)
    32.0
    1.5%
    ACR50 Week 96: Maintained 48 weeks (n=1745)
    22.8
    1.1%
    ACR50 Week 144: Maintained 24 weeks (n=1615)
    36.9
    1.8%
    ACR50 Week 144: Maintained 48 weeks (n=1615)
    28.4
    1.4%
    ACR50 Week 144: Maintained 96 weeks (n=1615)
    18.1
    0.9%
    ACR50 Week 192: Maintained 24 weeks (n=1514)
    39.8
    1.9%
    ACR50 Week 192: Maintained 48 weeks (n=1514)
    33.0
    1.6%
    ACR50 Week 192: Maintained 96 weeks (n=1514)
    22.7
    1.1%
    ACR50 Week 192: Maintained 144 weeks (n=1514)
    15.9
    0.8%
    ACR50 Week 264: Maintained 24 weeks (n=1358)
    42.3
    2%
    ACR50 Week 264: Maintained 48 weeks (n=1358)
    34.7
    1.7%
    ACR50 Week 264: Maintained 96 weeks (n=1358)
    27.6
    1.3%
    ACR50 Week 264: Maintained 144 weeks (n=1358)
    21.7
    1%
    ACR50 Week 264: Maintained 192 weeks (n=1358)
    16.6
    0.8%
    ACR70 Week 48: Maintained 24 weeks (n=1937)
    8.5
    0.4%
    ACR70 Week 96: Maintained 24 weeks (n=1745)
    16.2
    0.8%
    ACR70 Week 96: Maintained 48 weeks (n=1745)
    11.2
    0.5%
    ACR70 Week 144: Maintained 4 weeks (n=1615)
    20.9
    1%
    ACR70 Week 144: Maintained 48 weeks (n=1615)
    15.0
    0.7%
    ACR70 Week 144: Maintained 96 weeks (n=1615)
    8.7
    0.4%
    ACR70 Week 192: Maintained 24 weeks (n=1514)
    22.9
    1.1%
    ACR70 Week 192: Maintained 48 weeks (n=1514)
    17.6
    0.9%
    ACR70 Week 192: Maintained 96 weeks (n=1514)
    11.4
    0.6%
    ACR70 Week 192: Maintained 144 weeks (n=1514)
    7.3
    0.4%
    ACR70 Week 264: Maintained 24 weeks (n=1358)
    24.9
    1.2%
    ACR70 Week 264: Maintained 48 weeks (n=1358)
    19.7
    1%
    ACR70 Week 264: Maintained 96 weeks (n=1358)
    14.4
    0.7%
    ACR70 Week 264: Maintained 144 weeks (n=1358)
    11.0
    0.5%
    ACR70 Week 264: Maintained 192 weeks (n=1358)
    7.7
    0.4%
    8. Secondary Outcome
    Title Swollen and Tender Joint Count (SJC/TJC) at Baseline and Weeks 24, 48, 108, 156, 204, and 264
    Description The number of swollen (66 assessed joints) and tender (68 assessed joints) joints was assessed. Joints were physically examined and classified as swollen/not swollen and tender/not tender by pressure and joint manipulation.
    Time Frame Baseline to Week 264

    Outcome Measure Data

    Analysis Population Description
    All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study. Only participants with available data were included in the analysis.
    Arm/Group Title Tocilizumab
    Arm/Group Description Participants received tocilizumab 8 mg/kg intravenously every 4 weeks till the end of the study (up to 7 years, 7 months). In addition, participants may have also received disease-modifying anti-rheumatic drugs, non-steroidal anti-inflammatory drugs, and oral corticosteroids at the discretion of the investigator.
    Measure Participants 2067
    Baseline SJC (n = 2047)
    17.4
    (11.96)
    Week 24 SJC (n = 2010)
    8.2
    (9.43)
    Week 48 SJC (n = 1924)
    6.4
    (8.75)
    Week 108 SJC (n = 1692)
    4.2
    (6.69)
    Week 156 SJC (n = 1580)
    4.0
    (7.09)
    Week 204 SJC (n = 1482)
    3.2
    (5.96)
    Week 264 SJC (n = 1352)
    2.9
    (5.85)
    Baseline TJC (n = 2047)
    27.3
    (16.97)
    Week 24 TJC (n = 2010)
    12.8
    (14.10)
    Week 48 TJC (n = 1924)
    10.3
    (12.99)
    Week 108 TJC (n = 1692)
    7.8
    (11.04)
    Week 156 TJC (n = 1580)
    7.2
    (11.03)
    Week 204 TJC (n = 1482)
    6.1
    (9.83)
    Week 264 TJC (n = 1352)
    5.6
    (9.48)
    9. Secondary Outcome
    Title Disease Activity and Pain at Baseline and Weeks 24, 48, 108, 156, 204, and 264
    Description Participant's made a global assessment of their current disease activity on a 100 mm horizontal visual analogue scale (VAS). The left end of the scale indicated "no disease activity" (symptom-free and no arthritis symptoms, score = 0) and the right end indicated "maximum disease activity" (maximum arthritis disease activity, score = 100). The participant's treating physician made a global assessment of the participant's current disease activity on a 100 mm horizontal VAS. The left end of the scale indicated "no disease activity" (symptom-free and no arthritis symptoms, score = 0) and the right end indicated "maximum disease activity" (maximum arthritis disease activity, score = 100). Participant's made an assessment of their current level of pain on a 100 mm horizontal VAS. The left end of the scale indicated "no pain" (score = 0) and the right end of the scale indicated "unbearable pain" (score = 100).
    Time Frame Baseline to Week 264

    Outcome Measure Data

    Analysis Population Description
    All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study. Only participants with available data were included in the analysis.
    Arm/Group Title Tocilizumab
    Arm/Group Description Participants received tocilizumab 8 mg/kg intravenously every 4 weeks till the end of the study (up to 7 years, 7 months). In addition, participants may have also received disease-modifying anti-rheumatic drugs, non-steroidal anti-inflammatory drugs, and oral corticosteroids at the discretion of the investigator.
    Measure Participants 2067
    Participant Disease Activity - Baseline (n=2039)
    60.5
    (25.52)
    Participant Disease Activity - Week 24 (n=1989)
    34.4
    (26.03)
    Participant Disease Activity - Week 48 (n=1840)
    31.7
    (25.25)
    Participant Disease Activity - Week 108 (n=1621)
    29.2
    (24.75)
    Participant Disease Activity - Week 156 (n=1515)
    28.5
    (25.16)
    Participant Disease Activity - Week 204 (n=1427)
    27.4
    (24.72)
    Participant Disease Activity - Week 264 (n=1328)
    27.4
    (25.50)
    Physician Disease Activity - Baseline (n=2043)
    57.3
    (22.04)
    Physician Disease Activity - Week 24 (n=1990)
    26.8
    (20.22)
    Physician Disease Activity - Week 48 (n=1830)
    22.3
    (18.93)
    Physician Disease Activity - Week 108 (n=1619)
    18.6
    (17.59)
    Physician Disease Activity - Week 156 (n=1516)
    17.4
    (17.21)
    Physician Disease Activity - Week 204 (n=1413)
    15.6
    (16.49)
    Physician Disease Activity - Week 264 (n=1330)
    15.1
    (16.51)
    Participant Pain - Baseline (n=2041)
    54.9
    (25.00)
    Participant Pain - Week 24 (n=1991)
    31.0
    (24.56)
    Participant Pain - Week 48 (n=1842)
    28.0
    (23.76)
    Participant Pain - Week 108 (n=1622)
    26.6
    (23.52)
    Participant Pain - Week 156 (n=1517)
    26.2
    (23.90)
    Participant Pain - Week 204 (n=1428)
    25.3
    (23.05)
    Participant Pain - Week 264 (n=1329)
    25.1
    (23.72)
    10. Secondary Outcome
    Title Health Assessment Questionnaire-Disability Index Score at Baseline and Weeks 24, 48, 108, 156, 204, and 264
    Description The Health Assessment Questionnaire-Disability Index (HAQ-DI), as a measure of functional ability, consists of 30 questions in 8 domains: Dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities. There are 4 possible responses to each question (0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do). A domain score is the highest score in that domain. To calculate the overall score, the patient must have a domain score in at least 6 of the 8 domains. The HAQ-DI score is the sum of the domain scores divided by the number of domains that have a non-missing score and ranges from 0 (best) to 3 (worst). A higher score indicates less ability.
    Time Frame Baseline to Week 264

    Outcome Measure Data

    Analysis Population Description
    All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study. Only participants with available data were included in the analysis.
    Arm/Group Title Tocilizumab
    Arm/Group Description Participants received tocilizumab 8 mg/kg intravenously every 4 weeks till the end of the study (up to 7 years, 7 months). In addition, participants may have also received disease-modifying anti-rheumatic drugs, non-steroidal anti-inflammatory drugs, and oral corticosteroids at the discretion of the investigator.
    Measure Participants 2067
    Baseline (n = 2037)
    1.46
    (0.660)
    Week 24 (n = 2008)
    1.04
    (0.692)
    Week 48 (n = 1853)
    0.97
    (0.693)
    Week 108 (n = 1635)
    0.89
    (0.694)
    Week 156 (n = 1529)
    0.87
    (0.689)
    Week 204 (n = 1438)
    0.84
    (0.684)
    Week 264 (n = 1334)
    0.86
    (0.696)
    11. Secondary Outcome
    Title Erythrocyte Sedimentation Rate at Baseline and Weeks 24, 48, 108, 156, 204, and 264
    Description Erythrocyte sedimentation rate (ESR) was determined locally.
    Time Frame Baseline to Week 264

    Outcome Measure Data

    Analysis Population Description
    All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study. Only participants with available data were included in the analysis.
    Arm/Group Title Tocilizumab
    Arm/Group Description Participants received tocilizumab 8 mg/kg intravenously every 4 weeks till the end of the study (up to 7 years, 7 months). In addition, participants may have also received disease-modifying anti-rheumatic drugs, non-steroidal anti-inflammatory drugs, and oral corticosteroids at the discretion of the investigator.
    Measure Participants 2067
    Baseline (n = 2047)
    46.2
    (27.45)
    Week 24 (n = 1992)
    11.3
    (14.97)
    Week 48 (n = 1830)
    10.2
    (13.94)
    Week 108 (n = 1606)
    9.0
    (12.79)
    Week 156 (n = 1509)
    8.9
    (12.44)
    Week 204 (n = 1412)
    8.9
    (12.01)
    Week 264 (n = 1329)
    9.7
    (13.51)
    12. Secondary Outcome
    Title Change in the Disease Activity Score 28 (DAS-28) From Baseline to Weeks 24, 48, 96, and 264
    Description The DAS28 is a combined index for measuring disease activity in rheumatic arthritis (RA) and includes swollen and tender joint counts, erythrocyte sedimentation rate (ESR), and general health (GH) status. The index is calculated with the following formula: DAS28 = (0.56 × √(TJC28)) + (0.28 × √(SJC28)) + (0.7 × log(ESR)) + (0.014 × GH), where TJC28 = tender joint count and SJC28 = swollen joint count, each on 28 joints. GH = a patient's global assessment of disease activity in the previous 24 hours on a 100 mm visual analog scale (left end = no disease activity [symptom-free and no arthritis symptoms], right end = maximum disease activity [maximum arthritis disease activity]). When ESR equaled 0 mm/hr, it was set to 1 mm/hr. The DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity. A negative change score indicates improvement.
    Time Frame Baseline to Week 264

    Outcome Measure Data

    Analysis Population Description
    All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study. Only participants with available data were included in the analysis.
    Arm/Group Title Tocilizumab
    Arm/Group Description Participants received tocilizumab 8 mg/kg intravenously every 4 weeks till the end of the study (up to 7 years, 7 months). In addition, participants may have also received disease-modifying anti-rheumatic drugs, non-steroidal anti-inflammatory drugs, and oral corticosteroids at the discretion of the investigator.
    Measure Participants 2067
    Week 24 (n = 1920)
    -2.82
    (1.559)
    Week 48 (n = 1753)
    -3.20
    (1.644)
    Week 96 (n = 1596)
    -3.46
    (1.715)
    Week 264 (n = 1278)
    -3.73
    (1.742)
    13. Secondary Outcome
    Title Percentage of Participants Who Were Disease Activity Score 28 (DAS-28) Responders at Weeks 24, 48, 108, 156, 204, and 264
    Description A DAS-28 responder was defined as someone who met the European League Against Rheumatism [EULAR] criteria of a good or moderate response. A change of the DAS-28 score from Baseline was used to determine EULAR responses of good, moderate, or no response. For a post-baseline score ≤ 3.2, a change from baseline of < -1.2 was a good response, < -0.6 to ≥ -1.2 was a moderate response, and ≥ -0.6 was no response. For a post-baseline score > 3.2 to ≤ 5.1, a change from baseline of < -0.6 was a moderate response and ≥ -0.6 was no response. For a post-baseline score > 5.1, a change from baseline < -1.2 was a moderate response and ≥ -1.2 was no response. A good response could not be achieved for post-baseline scores > 3.2.
    Time Frame Baseline to Week 264

    Outcome Measure Data

    Analysis Population Description
    All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study. Only participants with available data were included in the analysis.
    Arm/Group Title Tocilizumab
    Arm/Group Description Participants received tocilizumab 8 mg/kg intravenously every 4 weeks till the end of the study (up to 7 years, 7 months). In addition, participants may have also received disease-modifying anti-rheumatic drugs, non-steroidal anti-inflammatory drugs, and oral corticosteroids at the discretion of the investigator.
    Measure Participants 2067
    Week 24 Good (n = 1920)
    43.3
    2.1%
    Week 48 Good (n = 1753)
    51.9
    2.5%
    Week 108 Good (n = 1525)
    61.1
    3%
    Week 156 Good (n = 1441)
    64.7
    3.1%
    Week 204 Good (n = 1358)
    67.8
    3.3%
    Week 264 Good (n = 1278)
    68.8
    3.3%
    Week 24 Moderate (n = 1920)
    45.1
    2.2%
    Week 48 Moderate (n = 1753)
    40.0
    1.9%
    Week 108 Moderate (n = 1525)
    33.2
    1.6%
    Week 156 Moderate (n = 1441)
    28.7
    1.4%
    Week 204 Moderate (n = 1358)
    26.4
    1.3%
    Week 264 Moderate (n = 1278)
    26.1
    1.3%
    14. Secondary Outcome
    Title Percentage of Participants Who Maintained a Disease Activity Score 28 (DAS-28) Response for 24, 48, 96, 144, and 192 Weeks at Weeks 48, 96, 144, 192, and 264
    Description A DAS-28 responder was defined as someone who met the European League Against Rheumatism [EULAR] criteria of a good or moderate response. A change of the DAS-28 score from Baseline was used to determine EULAR responses of good, moderate, or no response. For a post-baseline score ≤ 3.2, a change from baseline of < -1.2 was a good response, < -0.6 to ≥ -1.2 was a moderate response, and ≥ -0.6 was no response. For a post-baseline score > 3.2 to ≤ 5.1, a change from baseline of < -0.6 was a moderate response and ≥ -0.6 was no response. For a post-baseline score > 5.1, a change from baseline < -1.2 was a moderate response and ≥ -1.2 was no response. A good response could not be achieved for post-baseline scores > 3.2.
    Time Frame Baseline to Week 264

    Outcome Measure Data

    Analysis Population Description
    All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study. Only participants with available data were included in the analysis.
    Arm/Group Title Tocilizumab
    Arm/Group Description Participants received tocilizumab 8 mg/kg intravenously every 4 weeks till the end of the study (up to 7 years, 7 months). In addition, participants may have also received disease-modifying anti-rheumatic drugs, non-steroidal anti-inflammatory drugs, and oral corticosteroids at the discretion of the investigator.
    Measure Participants 2067
    Week 48: Maintained response 24 weeks (n=1937)
    67.6
    3.3%
    Week 96: Maintained response 24 weeks (n=1745)
    72.7
    3.5%
    Week 96: Maintained response 48 weeks (n=1745)
    63.4
    3.1%
    Week 144: Maintained response 24 weeks (n=1615)
    73.1
    3.5%
    Week 144: Maintained response 48 weeks (n=1615)
    64.1
    3.1%
    Week 144: Maintained response 96 weeks (n=1615)
    52.9
    2.6%
    Week 192: Maintained response 24 weeks (n=1514)
    73.3
    3.5%
    Week 192: Maintained response 48 weeks (n=1514)
    64.7
    3.1%
    Week 192: Maintained response 96 weeks (n=1514)
    53.6
    2.6%
    Week 192: Maintained response 144 weeks (n=1514)
    45.5
    2.2%
    Week 264: Maintained response 24 weeks (n = 1358)
    76.7
    3.7%
    Week 264: Maintained response 48 weeks (n = 1358)
    68.6
    3.3%
    Week 264: Maintained response 96 weeks (n = 1358)
    56.4
    2.7%
    Week 264: Maintained response 144 weeks (n = 1358)
    48.7
    2.4%
    Week 264: Maintained response 192 weeks (n = 1358)
    42.1
    2%
    15. Secondary Outcome
    Title Percentage of Participants With a Clinically Relevant Improvement in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Score at Weeks 24, 36, 48, 108, 156, 204, and 264
    Description The FACIT-F is a 13-item participant self-report questionnaire that assesses fatigue over the previous 7 days by scoring each item on a 5-point scale (0=Not at all, 1=A little bit, 2=Somewhat, 3=Quite a bit, 4=Very much). An overall FACIT-F score was obtained by summing the scores of all 13 items. The overall score ranged from 0 to 52. A lower score indicates less fatigue. A clinically relevant improvement in the FACIT-F score was defined as a ≥ 5-point increase from Baseline.
    Time Frame Baseline to Week 264

    Outcome Measure Data

    Analysis Population Description
    All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study. Only participants with available data were included in the analysis.
    Arm/Group Title Tocilizumab
    Arm/Group Description Participants received tocilizumab 8 mg/kg intravenously every 4 weeks till the end of the study (up to 7 years, 7 months). In addition, participants may have also received disease-modifying anti-rheumatic drugs, non-steroidal anti-inflammatory drugs, and oral corticosteroids at the discretion of the investigator.
    Measure Participants 2067
    Week 24 (n = 1984)
    59.5
    2.9%
    Week 36 (n = 1839)
    52.5
    2.5%
    Week 48 (n = 1803)
    56.0
    2.7%
    Week 108 (n = 1616)
    56.8
    2.7%
    Week 156 (n = 1513)
    56.3
    2.7%
    Week 204 (n = 1422)
    56.4
    2.7%
    Week 264 (n = 1320)
    61.9
    3%
    16. Secondary Outcome
    Title Percentage of Participants With a Clinically Relevant Improvement in the Physical and Mental Component Scores of the Short Form 36 (SF-36) Health Survey at Weeks 24, 48, 108, 156, 204, and 264
    Description The SF-36 Health Survey uses participant-reported symptoms on 8 subscales to assess health-related quality of life (HRQoL). The Physical Component Summary (PCS) score summarizes the subscales Physical Functioning, Role-Physical, Bodily Pain, and General Health. The Mental Component Summary (MCS) score summarizes the subscales Vitality, Social Functioning, Role-Emotional, and Mental Health. Each score was scaled from 0 to 100 with a higher score indicating better HRQoL. A clinically relevant improvement in the Physical and Mental Component Scores of the SF-36 was defined as a ≥ 5-point increase from Baseline.
    Time Frame Baseline to Week 264

    Outcome Measure Data

    Analysis Population Description
    All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study. Only participants with available data were included in the analysis.
    Arm/Group Title Tocilizumab
    Arm/Group Description Participants received tocilizumab 8 mg/kg intravenously every 4 weeks till the end of the study (up to 7 years, 7 months). In addition, participants may have also received disease-modifying anti-rheumatic drugs, non-steroidal anti-inflammatory drugs, and oral corticosteroids at the discretion of the investigator.
    Measure Participants 2067
    Week 24 Mental Score (n = 1850)
    42.4
    2.1%
    Week 48 Mental Score (n = 1789)
    44.4
    2.1%
    Week 108 Mental Score (n = 1551)
    45.3
    2.2%
    Week 156 Mental Score (n = 1468)
    46.1
    2.2%
    Week 204 Mental Score (n = 1377)
    47.1
    2.3%
    Week 264 Mental Score (n = 1302)
    44.9
    2.2%
    Week 24 Physical Score (n = 1850)
    56.2
    2.7%
    Week 48 Physical Score (n = 1789)
    61.4
    3%
    Week 108 Physical Score (n = 1551)
    63.2
    3.1%
    Week 156 Physical Score (n = 1468)
    62.5
    3%
    Week 204 Physical Score (n = 1377)
    64.1
    3.1%
    Week 264 Physical Score (n = 1302)
    63.7
    3.1%

    Adverse Events

    Time Frame
    Adverse Event Reporting Description All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
    Arm/Group Title Tocilizumab
    Arm/Group Description Participants received tocilizumab 8 mg/kg intravenously every 4 weeks till the end of the study (up to 7 years, 7 months). In addition, participants may have also received disease-modifying anti-rheumatic drugs, non-steroidal anti-inflammatory drugs, and oral corticosteroids at the discretion of the investigator.
    All Cause Mortality
    Tocilizumab
    Affected / at Risk (%) # Events
    Total / (NaN)
    Serious Adverse Events
    Tocilizumab
    Affected / at Risk (%) # Events
    Total 727/2067 (35.2%)
    Blood and lymphatic system disorders
    Anaemia 8/2067 (0.4%)
    Leukopenia 4/2067 (0.2%)
    Thrombocytopenia 3/2067 (0.1%)
    Neutropenia 2/2067 (0.1%)
    Pancytopenia 2/2067 (0.1%)
    Anaemia megaloblastic 1/2067 (0%)
    Disseminated intravascular coagulation 1/2067 (0%)
    Cardiac disorders
    Myocardial infarction 16/2067 (0.8%)
    Atrial fibrillation 13/2067 (0.6%)
    Angina pectoris 9/2067 (0.4%)
    Acute myocardial infarction 8/2067 (0.4%)
    Cardiac failure congestive 6/2067 (0.3%)
    Myocardial ischaemia 6/2067 (0.3%)
    Cardiac failure 5/2067 (0.2%)
    Coronary artery disease 4/2067 (0.2%)
    Arrhythmia 2/2067 (0.1%)
    Atrioventricular block complete 2/2067 (0.1%)
    Coronary artery occlusion 2/2067 (0.1%)
    Coronary artery stenosis 2/2067 (0.1%)
    Tachycardia 2/2067 (0.1%)
    Angina unstable 1/2067 (0%)
    Arteriosclerosis coronary artery 1/2067 (0%)
    Atrial tachycardia 1/2067 (0%)
    Atrioventricular block second degree 1/2067 (0%)
    Bradycardia 1/2067 (0%)
    Cardiac arrest 1/2067 (0%)
    Cardiac failure chronic 1/2067 (0%)
    Congestive cardiomyopathy 1/2067 (0%)
    Diastolic dysfunction 1/2067 (0%)
    Mitral valve incompetence 1/2067 (0%)
    Palpitations 1/2067 (0%)
    Pericardial effusion 1/2067 (0%)
    Sinus bradycardia 1/2067 (0%)
    Stress cardiomyopathy 1/2067 (0%)
    Supraventricular tachycardia 1/2067 (0%)
    Ventricular extrasystoles 1/2067 (0%)
    Ventricular tachycardia 1/2067 (0%)
    Congenital, familial and genetic disorders
    Arnold-chiari malformation 1/2067 (0%)
    Choledochal cyst 1/2067 (0%)
    Ear and labyrinth disorders
    Hypoacusis 1/2067 (0%)
    Sudden hearing loss 1/2067 (0%)
    Vertigo 1/2067 (0%)
    Endocrine disorders
    Goitre 2/2067 (0.1%)
    Thyroid cyst 1/2067 (0%)
    Eye disorders
    Cataract 3/2067 (0.1%)
    Angle closure glaucoma 1/2067 (0%)
    Corneal perforation 1/2067 (0%)
    Retinal artery occlusion 1/2067 (0%)
    Gastrointestinal disorders
    Diverticular perforation 11/2067 (0.5%)
    Abdominal pain 6/2067 (0.3%)
    Gastritis 5/2067 (0.2%)
    Pancreatitis 5/2067 (0.2%)
    Vomiting 4/2067 (0.2%)
    Colitis 3/2067 (0.1%)
    Crohn's disease 3/2067 (0.1%)
    Diarrhoea 3/2067 (0.1%)
    Gastrointestinal haemorrhage 3/2067 (0.1%)
    Irritable bowel syndrome 3/2067 (0.1%)
    Large intestine perforation 3/2067 (0.1%)
    Small intestinal obstruction 3/2067 (0.1%)
    Abdominal pain upper 2/2067 (0.1%)
    Colitis ischaemic 2/2067 (0.1%)
    Diverticulum intestinal haemorrhagic 2/2067 (0.1%)
    Duodenal ulcer haemorrhage 2/2067 (0.1%)
    Gastric ulcer 2/2067 (0.1%)
    Gastric ulcer haemorrhage 2/2067 (0.1%)
    Gastritis erosive 2/2067 (0.1%)
    Haemorrhoids 2/2067 (0.1%)
    Ileus 2/2067 (0.1%)
    Mallory-weiss syndrome 2/2067 (0.1%)
    Abdominal adhesions 1/2067 (0%)
    Abdominal distension 1/2067 (0%)
    Abdominal wall haematoma 1/2067 (0%)
    Anal fissure 1/2067 (0%)
    Ascites 1/2067 (0%)
    Colitis ulcerative 1/2067 (0%)
    Diverticulum 1/2067 (0%)
    Diverticulum intestinal 1/2067 (0%)
    Duodenal ulcer 1/2067 (0%)
    Dyspepsia 1/2067 (0%)
    Enterocutaneous fistula 1/2067 (0%)
    Erosive duodenitis 1/2067 (0%)
    Food poisoning 1/2067 (0%)
    Gastric disorder 1/2067 (0%)
    Gastric perforation 1/2067 (0%)
    Gastrointestinal erosion 1/2067 (0%)
    Gastrointestinal necrosis 1/2067 (0%)
    Gastrooesophageal reflux disease 1/2067 (0%)
    Haemorrhoidal haemorrhage 1/2067 (0%)
    Ileal perforation 1/2067 (0%)
    Inguinal hernia 1/2067 (0%)
    Intestinal ischaemia 1/2067 (0%)
    Intestinal perforation 1/2067 (0%)
    Intussusception 1/2067 (0%)
    Large intestinal ulcer 1/2067 (0%)
    Nausea 1/2067 (0%)
    Oedematous pancreatitis 1/2067 (0%)
    Oesophagitis 1/2067 (0%)
    Pancreatitis acute 1/2067 (0%)
    Peptic ulcer perforation 1/2067 (0%)
    Poor dental condition 1/2067 (0%)
    Rectal haemorrhage 1/2067 (0%)
    Small intestinal perforation 1/2067 (0%)
    Stomatitis haemorrhagic 1/2067 (0%)
    Umbilical hernia 1/2067 (0%)
    Upper gastrointestinal haemorrhage 1/2067 (0%)
    General disorders
    Non-cardiac chest pain 11/2067 (0.5%)
    Device dislocation 6/2067 (0.3%)
    Chest pain 3/2067 (0.1%)
    Multi-organ failure 3/2067 (0.1%)
    Surgical failure 3/2067 (0.1%)
    Death 2/2067 (0.1%)
    Impaired healing 2/2067 (0.1%)
    Cyst 1/2067 (0%)
    Drug withdrawal syndrome 1/2067 (0%)
    Effusion 1/2067 (0%)
    Oedema peripheral 1/2067 (0%)
    Sudden death 1/2067 (0%)
    Systemic inflammatory response syndrome 1/2067 (0%)
    Hepatobiliary disorders
    Cholelithiasis 10/2067 (0.5%)
    Cholecystitis 4/2067 (0.2%)
    Biliary colic 2/2067 (0.1%)
    Cholecystitis acute 2/2067 (0.1%)
    Bile duct stone 1/2067 (0%)
    Cholestasis 1/2067 (0%)
    Hepatic steatosis 1/2067 (0%)
    Ischaemic hepatitis 1/2067 (0%)
    Immune system disorders
    Anaphylactic reaction 2/2067 (0.1%)
    Allergy to arthropod sting 1/2067 (0%)
    Anaphylactic shock 1/2067 (0%)
    Infections and infestations
    Pneumonia 70/2067 (3.4%)
    Cellulitis 57/2067 (2.8%)
    Appendicitis 11/2067 (0.5%)
    Diverticulitis 10/2067 (0.5%)
    Gastroenteritis 10/2067 (0.5%)
    Sepsis 10/2067 (0.5%)
    Urinary tract infection 10/2067 (0.5%)
    Arthritis bacterial 8/2067 (0.4%)
    Bronchitis 7/2067 (0.3%)
    Herpes zoster 7/2067 (0.3%)
    Abscess limb 6/2067 (0.3%)
    Erysipelas 6/2067 (0.3%)
    Septic shock 6/2067 (0.3%)
    Bronchopneumonia 5/2067 (0.2%)
    Postoperative wound infection 5/2067 (0.2%)
    Pyelonephritis 5/2067 (0.2%)
    Infectious pleural effusion 4/2067 (0.2%)
    Peritonitis 4/2067 (0.2%)
    Pulmonary tuberculosis 4/2067 (0.2%)
    Staphylococcal infection 4/2067 (0.2%)
    Wound infection 4/2067 (0.2%)
    Abdominal abscess 3/2067 (0.1%)
    Bursitis infective 3/2067 (0.1%)
    Staphylococcal Clostridium difficile colitis 3/2067 (0.1%)
    Empyema 3/2067 (0.1%)
    Infective exacerbation of chronic obstructive airways disease 3/2067 (0.1%)
    Lung infection 3/2067 (0.1%)
    Necrotising fasciitis 3/2067 (0.1%)
    Osteomyelitis 3/2067 (0.1%)
    Pneumonia pneumococcal 3/2067 (0.1%)
    Pneumonia staphylococcal 3/2067 (0.1%)
    Post procedural infection 3/2067 (0.1%)
    Septic arthritis 3/2067 (0.1%)
    Staphylococcal sinusitis 3/2067 (0.1%)
    Subcutaneous abscess 3/2067 (0.1%)
    Wound infection staphylococcal 3/2067 (0.1%)
    Abdominal wall abscess 2/2067 (0.1%)
    Gastroenteritis viral 2/2067 (0.1%)
    Infective tenosynovitis 2/2067 (0.1%)
    Influenza 2/2067 (0.1%)
    Liver abscess 2/2067 (0.1%)
    Localised infection 2/2067 (0.1%)
    Lower respiratory tract infection 2/2067 (0.1%)
    Pelvic inflammatory disease 2/2067 (0.1%)
    Pericolic abscess 2/2067 (0.1%)
    Peritonitis bacterial 2/2067 (0.1%)
    Pneumonia haemophilus 2/2067 (0.1%)
    Pneumonia streptococcal 2/2067 (0.1%)
    Pulmonary sepsis 2/2067 (0.1%)
    Respiratory tract infection 2/2067 (0.1%)
    Salmonellosis 2/2067 (0.1%)
    Septic arthritis streptococcal 2/2067 (0.1%)
    Sinusitis fungal 2/2067 (0.1%)
    Soft tissue infection 2/2067 (0.1%)
    Staphylococcal abscess 2/2067 (0.1%)
    Tooth infection 2/2067 (0.1%)
    Tuberculous pleurisy 2/2067 (0.1%)
    Upper respiratory tract infection 2/2067 (0.1%)
    Urosepsis 2/2067 (0.1%)
    Viral infection 2/2067 (0.1%)
    Abscess 1/2067 (0%)
    Abscess oral 1/2067 (0%)
    Abscess soft tissue 1/2067 (0%)
    Acquired immunodeficiency syndrome 1/2067 (0%)
    Alcaligenes infection 1/2067 (0%)
    Anal abscess 1/2067 (0%)
    Appendiceal abscess 1/2067 (0%)
    Arthritis infective 1/2067 (0%)
    Bacteraemia 1/2067 (0%)
    Bacterial sepsis 1/2067 (0%)
    Biliary sepsis 1/2067 (0%)
    Breast abscess 1/2067 (0%)
    Bronchitis bacterial 1/2067 (0%)
    Bronchitis viral 1/2067 (0%)
    Bursitis infective 1/2067 (0%)
    Campylobacter gastroenteritis 1/2067 (0%)
    Cellulitis gangrenous 1/2067 (0%)
    Cellulitis staphylococcal 1/2067 (0%)
    Central nervous system infection 1/2067 (0%)
    Chronic tonsillitis 1/2067 (0%)
    Encephalitis viral 1/2067 (0%)
    Endocarditis bacterial 1/2067 (0%)
    Endocarditis enterococcal 1/2067 (0%)
    Enterocolitis infectious 1/2067 (0%)
    Escherichia infection 1/2067 (0%)
    Escherichia sepsis 1/2067 (0%)
    Escherichia urinary tract infection 1/2067 (0%)
    Extradural abscess 1/2067 (0%)
    Fallopian tube abscess 1/2067 (0%)
    Furuncle 1/2067 (0%)
    Gingival infection 1/2067 (0%)
    Haematoma infection 1/2067 (0%)
    Hepatitis B 1/2067 (0%)
    Hepatitis E 1/2067 (0%)
    Herpes zoster ophthalmic 1/2067 (0%)
    Incision site cellulitis 1/2067 (0%)
    Incision site infection 1/2067 (0%)
    Infected bites 1/2067 (0%)
    Infected skin ulcer 1/2067 (0%)
    Infection 1/2067 (0%)
    Keratitis herpetic 1/2067 (0%)
    Klebsiella sepsis 1/2067 (0%)
    Lobar pneumonia 1/2067 (0%)
    Meningitis aseptic 1/2067 (0%)
    Mycobacterium avium complex infection 1/2067 (0%)
    Nasal abscess 1/2067 (0%)
    Neutropenic sepsis 1/2067 (0%)
    Osteomyelitis chronic 1/2067 (0%)
    Paronychia 1/2067 (0%)
    Parotitis 1/2067 (0%)
    Perineal infection 1/2067 (0%)
    Periorbital cellulitis 1/2067 (0%)
    Peritoneal abscess 1/2067 (0%)
    Peritonsillar abscess 1/2067 (0%)
    Pharyngitis streptococcal 1/2067 (0%)
    Pneumococcal sepsis 1/2067 (0%)
    Pneumonia bacterial 1/2067 (0%)
    Pneumonia blastomyces 1/2067 (0%)
    Pneumonia viral 1/2067 (0%)
    Post procedural cellulitis 1/2067 (0%)
    Prostatic abscess 1/2067 (0%)
    Proteus infection 1/2067 (0%)
    Pseudomonal bacteraemia 1/2067 (0%)
    Pseudomonas infection 1/2067 (0%)
    Psoas abscess 1/2067 (0%)
    Pyelonephritis acute 1/2067 (0%)
    Rectal abscess 1/2067 (0%)
    Renal abscess 1/2067 (0%)
    Sialoadenitis 1/2067 (0%)
    Skin infection 1/2067 (0%)
    Staphylococcal sepsis 1/2067 (0%)
    Streptococcal sepsis 1/2067 (0%)
    Systemic candida 1/2067 (0%)
    Tongue abscess 1/2067 (0%)
    Tracheitis 1/2067 (0%)
    Tuberculosis 1/2067 (0%)
    Varicella 1/2067 (0%)
    Viral diarrhoea 1/2067 (0%)
    Wound infection bacterial 1/2067 (0%)
    Injury, poisoning and procedural complications
    Ankle fracture 8/2067 (0.4%)
    Humerus fracture 7/2067 (0.3%)
    Femur fracture 5/2067 (0.2%)
    Pelvic fracture 5/2067 (0.2%)
    Femoral neck fracture 4/2067 (0.2%)
    Joint dislocation 4/2067 (0.2%)
    Upper limb fracture 4/2067 (0.2%)
    Wound dehiscence 4/2067 (0.2%)
    Laceration 3/2067 (0.1%)
    Lower limb fracture 3/2067 (0.1%)
    Spinal compression fracture 3/2067 (0.1%)
    Comminuted fracture 2/2067 (0.1%)
    Foot fracture 2/2067 (0.1%)
    Incisional hernia 2/2067 (0.1%)
    Intentional overdose 2/2067 (0.1%)
    Meniscus injury 2/2067 (0.1%)
    Overdose 2/2067 (0.1%)
    Postoperative ileus 2/2067 (0.1%)
    Postoperative wound complication 2/2067 (0.1%)
    Procedural pain 2/2067 (0.1%)
    Radius fracture 2/2067 (0.1%)
    Seroma 2/2067 (0.1%)
    Thoracic vertebral fracture 2/2067 (0.1%)
    Tibia fracture 2/2067 (0.1%)
    Ulna fracture 2/2067 (0.1%)
    Accidental overdose 1/2067 (0%)
    Bone fragmentation 1/2067 (0%)
    Burns second degree 1/2067 (0%)
    Carotid artery restenosis 1/2067 (0%)
    Cervical vertebral fracture 1/2067 (0%)
    Hip fracture 10/2067 (0.5%)
    Contusion 1/2067 (0%)
    Face injury 1/2067 (0%)
    Fall 1/2067 (0%)
    Fracture displacement 1/2067 (0%)
    Head injury 1/2067 (0%)
    Infusion related reaction 1/2067 (0%)
    Joint injury 1/2067 (0%)
    Lumbar vertebral fracture 1/2067 (0%)
    Multiple fractures 1/2067 (0%)
    Multiple injuries 1/2067 (0%)
    Patella fracture 1/2067 (0%)
    Periprosthetic fracture 1/2067 (0%)
    Post procedural haematoma 1/2067 (0%)
    Post-traumatic pain 1/2067 (0%)
    Pubis fracture 1/2067 (0%)
    Rib fracture 1/2067 (0%)
    Road traffic accident 1/2067 (0%)
    Skull fracture 1/2067 (0%)
    Spinal column injury 1/2067 (0%)
    Spinal cord injury 1/2067 (0%)
    Subcutaneous haematoma 1/2067 (0%)
    Subdural haematoma 1/2067 (0%)
    Synovial rupture 1/2067 (0%)
    Tendon rupture 1/2067 (0%)
    Tracheal haemorrhage 1/2067 (0%)
    Tracheostomy malfunction 1/2067 (0%)
    Wound 1/2067 (0%)
    Investigations
    Hepatic enzyme increased 1/2067 (0%)
    Metabolism and nutrition disorders
    Dehydration 3/2067 (0.1%)
    Diabetes mellitus inadequate control 1/2067 (0%)
    Diabetic ketoacidosis 1/2067 (0%)
    Hypokalaemia 1/2067 (0%)
    Type 1 diabetes mellitus 1/2067 (0%)
    Musculoskeletal and connective tissue disorders
    Osteoarthritis 25/2067 (1.2%)
    Intervertebral disc protrusion 7/2067 (0.3%)
    Foot deformity 5/2067 (0.2%)
    Back pain 4/2067 (0.2%)
    Osteonecrosis 4/2067 (0.2%)
    Rheumatoid arthritis 4/2067 (0.2%)
    Bursitis 3/2067 (0.1%)
    Intervertebral disc degeneration 3/2067 (0.1%)
    Musculoskeletal chest pain 3/2067 (0.1%)
    Osteoporotic fracture 3/2067 (0.1%)
    Spinal column stenosis 3/2067 (0.1%)
    Spinal osteoarthritis 3/2067 (0.1%)
    Arthralgia 2/2067 (0.1%)
    Haemarthrosis 2/2067 (0.1%)
    Synovitis 2/2067 (0.1%)
    Acquired claw toe 1/2067 (0%)
    Arthritis 1/2067 (0%)
    Arthrofibrosis 1/2067 (0%)
    Arthropathy 1/2067 (0%)
    Cervical spinal stenosis 1/2067 (0%)
    Chondrocalcinosis pyrophosphate 1/2067 (0%)
    Dupuytren's contracture 1/2067 (0%)
    Fistula 1/2067 (0%)
    Fracture malunion 1/2067 (0%)
    Joint contracture 1/2067 (0%)
    Joint instability 1/2067 (0%)
    Lumbar spinal stenosis 1/2067 (0%)
    Muscular weakness 1/2067 (0%)
    Musculoskeletal pain 1/2067 (0%)
    Osteitis 1/2067 (0%)
    Patellofemoral pain syndrome 1/2067 (0%)
    Pathological fracture 1/2067 (0%)
    Periarthritis 1/2067 (0%)
    Pseudarthrosis 1/2067 (0%)
    Rotator cuff syndrome 1/2067 (0%)
    Scoliosis 1/2067 (0%)
    Spinal disorder 1/2067 (0%)
    Spondylolisthesis 1/2067 (0%)
    Tendonitis 1/2067 (0%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Basal cell carcinoma 5/2067 (0.2%)
    Invasive ductal breast carcinoma 5/2067 (0.2%)
    Squamous cell carcinoma of skin 5/2067 (0.2%)
    Uterine leiomyoma 4/2067 (0.2%)
    Adenocarcinoma of colon 3/2067 (0.1%)
    Ovarian adenoma 3/2067 (0.1%)
    Prostate cancer 3/2067 (0.1%)
    Breast cancer metastatic 2/2067 (0.1%)
    Carcinoid tumour of the gastrointestinal tract 2/2067 (0.1%)
    Cervix carcinoma stage 0 2/2067 (0.1%)
    Diffuse large b-cell lymphoma 2/2067 (0.1%)
    Lung adenocarcinoma stage II 2/2067 (0.1%)
    Lung adenocarcinoma stage III 2/2067 (0.1%)
    Lung squamous cell carcinoma stage III 2/2067 (0.1%)
    Myelodysplastic syndrome 2/2067 (0.1%)
    Pancreatic carcinoma metastatic 2/2067 (0.1%)
    Small cell lung cancer metastatic 2/2067 (0.1%)
    Acute myeloid leukaemia 1/2067 (0%)
    Adenocarcinoma gastric 1/2067 (0%)
    Astrocytoma malignant 1/2067 (0%)
    Basosquamous carcinoma of skin 1/2067 (0%)
    Benign breast neoplasm 1/2067 (0%)
    Benign neoplasm of thyroid gland 1/2067 (0%)
    Benign renal neoplasm 1/2067 (0%)
    Bladder cancer 1/2067 (0%)
    Bladder transitional cell carcinoma stage 0 1/2067 (0%)
    Bowen's disease 1/2067 (0%)
    Breast cancer 1/2067 (0%)
    Breast cancer stage III 1/2067 (0%)
    Chronic lymphocytic leukaemia 1/2067 (0%)
    Colon adenoma 1/2067 (0%)
    Colon cancer stage I 1/2067 (0%)
    Colon cancer stage II 1/2067 (0%)
    Dermatofibrosarcoma protuberans 1/2067 (0%)
    Endometrial adenocarcinoma 1/2067 (0%)
    Fibrosarcoma 1/2067 (0%)
    Gastrointestinal cancer metastatic 1/2067 (0%)
    Glioblastoma 1/2067 (0%)
    Hepatic neoplasm 1/2067 (0%)
    Intraductal papillary mucinous neoplasm 1/2067 (0%)
    Intraductal proliferative breast lesion 1/2067 (0%)
    Large intestine benign neoplasm 1/2067 (0%)
    Lung adenocarcinoma 1/2067 (0%)
    Lung adenocarcinoma metastatic 1/2067 (0%)
    Lung adenocarcinoma stage I 1/2067 (0%)
    Lung squamous cell carcinoma metastatic 1/2067 (0%)
    Lung squamous cell carcinoma stage I 1/2067 (0%)
    Malignant anorectal neoplasm 1/2067 (0%)
    Malignant melanoma in situ 1/2067 (0%)
    Malignant neoplasm of unknown primary site 1/2067 (0%)
    Meningioma benign 1/2067 (0%)
    Metastases to bone 1/2067 (0%)
    Nasal cavity cancer 1/2067 (0%)
    Non-hodgkin's lymphoma 1/2067 (0%)
    Ocular cancer metastatic 1/2067 (0%)
    Oesophageal carcinoma 1/2067 (0%)
    Ovarian epithelial cancer stage III 1/2067 (0%)
    Ovarian germ cell teratoma benign 1/2067 (0%)
    Post transplant lymphoproliferative disorder 1/2067 (0%)
    Prostate cancer metastatic 1/2067 (0%)
    Prostate cancer stage I 1/2067 (0%)
    Prostate cancer stage II 1/2067 (0%)
    Prostate cancer stage III 1/2067 (0%)
    Sarcoma uterus 1/2067 (0%)
    Spindle cell sarcoma 1/2067 (0%)
    Squamous cell carcinoma of lung 1/2067 (0%)
    Squamous cell carcinoma of pharynx 1/2067 (0%)
    Squamous cell carcinoma of the cervix 1/2067 (0%)
    Squamous cell carcinoma of the tongue 1/2067 (0%)
    Transitional cell carcinoma 1/2067 (0%)
    Uterine cancer 1/2067 (0%)
    Nervous system disorders
    Transient ischaemic attack 9/2067 (0.4%)
    Syncope 6/2067 (0.3%)
    Cerebrovascular accident 5/2067 (0.2%)
    Carotid artery stenosis 4/2067 (0.2%)
    Sciatica 3/2067 (0.1%)
    Cerebral infarction 2/2067 (0.1%)
    Cerebral ischaemia 2/2067 (0.1%)
    Headache 2/2067 (0.1%)
    Intracranial aneurysm 2/2067 (0.1%)
    Ischaemic stroke 2/2067 (0.1%)
    Transient global amnesia 2/2067 (0.1%)
    Viith nerve paralysis 2/2067 (0.1%)
    Aphasia 1/2067 (0%)
    Balance disorder 1/2067 (0%)
    Carotid artery occlusion 1/2067 (0%)
    Cerebral haemorrhage 1/2067 (0%)
    Convulsion 1/2067 (0%)
    Dementia 1/2067 (0%)
    Dizziness 1/2067 (0%)
    Dysarthria 1/2067 (0%)
    Facial neuralgia 1/2067 (0%)
    Grand mal convulsion 1/2067 (0%)
    Haemorrhagic stroke 1/2067 (0%)
    Hypoglycaemic coma 1/2067 (0%)
    Hypoxic-ischaemic encephalopathy 1/2067 (0%)
    Intercostal neuralgia 1/2067 (0%)
    Ischaemic cerebral infarction 1/2067 (0%)
    Lacunar infarction 1/2067 (0%)
    Lumbar radiculopathy 1/2067 (0%)
    Meralgia paraesthetica 1/2067 (0%)
    Migraine 1/2067 (0%)
    Migraine with aura 1/2067 (0%)
    Monoparesis 1/2067 (0%)
    Multiple sclerosis relapse 1/2067 (0%)
    Neuropathy peripheral 1/2067 (0%)
    Normal pressure hydrocephalus 1/2067 (0%)
    Parkinson's disease 1/2067 (0%)
    Perineurial cyst 1/2067 (0%)
    Presyncope 1/2067 (0%)
    Ruptured cerebral aneurysm 1/2067 (0%)
    Spinal claudication 1/2067 (0%)
    Subarachnoid haemorrhage 1/2067 (0%)
    Thalamus haemorrhage 1/2067 (0%)
    Pregnancy, puerperium and perinatal conditions
    Abortion spontaneous 4/2067 (0.2%)
    Pregnancy 1/2067 (0%)
    Psychiatric disorders
    Depression 4/2067 (0.2%)
    Completed suicide 2/2067 (0.1%)
    Mental status changes 2/2067 (0.1%)
    Suicide attempt 2/2067 (0.1%)
    Abnormal behaviour 1/2067 (0%)
    Alcohol abuse 1/2067 (0%)
    Anxiety 1/2067 (0%)
    Bipolar disorder 1/2067 (0%)
    Bipolar I disorder 1/2067 (0%)
    Conversion disorder 1/2067 (0%)
    Drug dependence 1/2067 (0%)
    Schizophrenia, paranoid type 1/2067 (0%)
    Somatoform disorder neurologic 1/2067 (0%)
    Renal and urinary disorders
    Nephrolithiasis 12/2067 (0.6%)
    Renal failure acute 7/2067 (0.3%)
    Calculus ureteric 4/2067 (0.2%)
    Renal failure 3/2067 (0.1%)
    Calculus urinary 2/2067 (0.1%)
    Hydronephrosis 1/2067 (0%)
    Incontinence 1/2067 (0%)
    Mesangioproliferative glomerulonephritis 1/2067 (0%)
    Obstructive uropathy 1/2067 (0%)
    Postrenal failure 1/2067 (0%)
    Renal mass 1/2067 (0%)
    Reproductive system and breast disorders
    Ovarian cyst 4/2067 (0.2%)
    Uterine prolapse 4/2067 (0.2%)
    Menorrhagia 2/2067 (0.1%)
    Adnexa uteri cyst 1/2067 (0%)
    Adnexa uteri mass 1/2067 (0%)
    Cervical dysplasia 1/2067 (0%)
    Cervical polyp 1/2067 (0%)
    Endometrial hyperplasia 1/2067 (0%)
    Endometriosis 1/2067 (0%)
    Fibrocystic breast disease 1/2067 (0%)
    Postmenopausal haemorrhage 1 1/2067 (0%)
    Prostatitis 1/2067 (0%)
    Uterine fibrosis 1/2067 (0%)
    Uterine polyp 1/2067 (0%)
    Respiratory, thoracic and mediastinal disorders
    Pulmonary embolism 15/2067 (0.7%)
    Chronic obstructive pulmonary disease 7/2067 (0.3%)
    Pleural effusion 7/2067 (0.3%)
    Interstitial lung disease 5/2067 (0.2%)
    Respiratory failure 5/2067 (0.2%)
    Acute respiratory distress syndrome 3/2067 (0.1%)
    Asthma 3/2067 (0.1%)
    Rheumatoid lung 3/2067 (0.1%)
    Dyspnoea 2/2067 (0.1%)
    Pneumonia aspiration 2/2067 (0.1%)
    Acute interstitial pneumonitis 1/2067 (0%)
    Alveolitis 1/2067 (0%)
    Bronchiectasis 1/2067 (0%)
    Bronchopleural fistula 1/2067 (0%)
    Bronchopneumopathy 1/2067 (0%)
    Epistaxis 1/2067 (0%)
    Haemoptysis 1/2067 (0%)
    Haemothorax 1/2067 (0%)
    Pleurisy 1/2067 (0%)
    Pneumothorax 1/2067 (0%)
    Pulmonary fibrosis 1/2067 (0%)
    Pulmonary mass 1/2067 (0%)
    Pulmonary oedema 1/2067 (0%)
    Respiratory distress 1/2067 (0%)
    Rhinitis allergic 1/2067 (0%)
    Sleep apnoea syndrome 1/2067 (0%)
    Skin and subcutaneous tissue disorders
    Acute febrile neutrophilic dermatosis 2/2067 (0.1%)
    Leukocytoclastic vasculitis 2/2067 (0.1%)
    Skin ulcer 2/2067 (0.1%)
    Dry gangrene 1/2067 (0%)
    Mucocutaneous rash 1/2067 (0%)
    Surgical and medical procedures
    Removal of internal fixation 1 1/2067 (0%)
    Vascular disorders
    Deep vein thrombosis 14/2067 (0.7%)
    Hypertension 8/2067 (0.4%)
    Aortic aneurysm 4/2067 (0.2%)
    Haematoma 2/2067 (0.1%)
    Hypertensive crisis 2/2067 (0.1%)
    Orthostatic hypotension 2/2067 (0.1%)
    Phlebitis 2/2067 (0.1%)
    Aortic stenosis 1/2067 (0%)
    Arteriosclerosis 1/2067 (0%)
    Arteritis 1/2067 (0%)
    Essential hypertension 1/2067 (0%)
    Hypovolaemic shock 1/2067 (0%)
    Peripheral vascular disorder 1/2067 (0%)
    Post thrombotic syndrome 1/2067 (0%)
    Thrombosed varicose vein 1/2067 (0%)
    Thrombosis 1/2067 (0%)
    Vascular rupture 1/2067 (0%)
    Other (Not Including Serious) Adverse Events
    Tocilizumab
    Affected / at Risk (%) # Events
    Total 1836/2067 (88.8%)
    Gastrointestinal disorders
    Diarrhoea 358/2067 (17.3%)
    Nausea 261/2067 (12.6%)
    Dyspepsia 189/2067 (9.1%)
    Abdominal pain upper 151/2067 (7.3%)
    Gastritis 149/2067 (7.2%)
    Abdominal pain 120/2067 (5.8%)
    Vomiting 114/2067 (5.5%)
    Gastrooesophageal reflux disease 113/2067 (5.5%)
    Constipation 107/2067 (5.2%)
    General disorders
    Oedema peripheral 183/2067 (8.9%)
    Fatigue 128/2067 (6.2%)
    Infections and infestations
    Upper respiratory tract infection 616/2067 (29.8%)
    Nasopharyngitis 495/2067 (23.9%)
    Urinary tract infection 420/2067 (20.3%)
    Bronchitis 405/2067 (19.6%)
    Sinusitis 326/2067 (15.8%)
    Influenza 231/2067 (11.2%)
    Gastroenteritis 213/2067 (10.3%)
    Pharyngitis 180/2067 (8.7%)
    Herpes zoster 129/2067 (6.2%)
    Cellulitis 127/2067 (6.1%)
    Gastroenteritis viral 122/2067 (5.9%)
    Injury, poisoning and procedural complications
    Contusion 149/2067 (7.2%)
    Investigations
    Transaminases increased 136/2067 (6.6%)
    Alanine aminotransferase increased 111/2067 (5.4%)
    Metabolism and nutrition disorders
    Hypercholesterolaemia 170/2067 (8.2%)
    Musculoskeletal and connective tissue disorders
    Rheumatoid arthritis 322/2067 (15.6%)
    Back pain 294/2067 (14.2%)
    Arthralgia 201/2067 (9.7%)
    Osteoarthritis 131/2067 (6.3%)
    Pain in extremity 131/2067 (6.3%)
    Bursitis 117/2067 (5.7%)
    Musculoskeletal pain 113/2067 (5.5%)
    Nervous system disorders
    Headache 289/2067 (14%)
    Dizziness 161/2067 (7.8%)
    Psychiatric disorders
    Insomnia 136/2067 (6.6%)
    Depression 122/2067 (5.9%)
    Respiratory, thoracic and mediastinal disorders
    Cough 199/2067 (9.6%)
    Oropharyngeal pain 115/2067 (5.6%)
    Skin and subcutaneous tissue disorders
    Rash 181/2067 (8.8%)
    Vascular disorders
    Hypertension 411/2067 (19.9%)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.

    Results Point of Contact

    Name/Title Medical Communications
    Organization Hoffmann-La Roche
    Phone 800 821-8590
    Email genentech@druginfo.com
    Responsible Party:
    Hoffmann-La Roche
    ClinicalTrials.gov Identifier:
    NCT00720798
    Other Study ID Numbers:
    • WA18696
    First Posted:
    Jul 23, 2008
    Last Update Posted:
    Sep 30, 2014
    Last Verified:
    Sep 1, 2014