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

• ClinicalTrials.gov Identifier: NCT00720798
• Recruitment Status: Completed
• First Posted: July 23, 2008
• Results First Posted: September 30, 2014
• Last Update Posted: September 30, 2014
• Sponsor: Hoffmann-La Roche
• Information provided by (Responsible Party): Hoffmann-La Roche

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
Rheumatoid Arthritis	Drug: Tocilizumab; Drug: Disease-modifying anti-rheumatic drugs; Drug: Non-steroidal anti-inflammatory drugs; Drug: Oral corticosteroids	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• 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: September 2005
• Actual Primary Completion Date: April 2013
• Actual Study Completion Date: April 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 [ Time Frame: Baseline to the end of the study (up to 7 years, 7 months) ]

Secondary Outcome Measures :

1. Percentage of Participants Who Withdrew From Treatment [ Time Frame: Baseline to the end of the study (up to 7 years, 7 months) ]
2. Percentage of Participants With Concomitant Oral Corticosteroid Therapy [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

United States, Alabama

Birmingham, Alabama, United States, 35294-7201

Huntsville, Alabama, United States, 35801

United States, Arizona

Mesa, Arizona, United States, 85208

Paradise Valley, Arizona, United States, 85253

Peoria, Arizona, United States, 85381

Scottsdale, Arizona, United States, 85251

Scottsdale, Arizona, United States, 85258

Tucson, Arizona, United States, 85723

Tucson, Arizona, United States, 85724

United States, Arkansas

Little Rock, Arkansas, United States, 72205

United States, California

Anaheim, California, United States, 92801

Long Beach, California, United States, 90806

Long Beach, California, United States, 90808

Los Angeles, California, United States, 90045

Los Angeles, California, United States, 90095

Palm Desert, California, United States, 92260

Palm Springs, California, United States, 92262

Palo Alto, California, United States, 94304

San Diego, California, United States, 92101

San Diego, California, United States, 92108

San Jose, California, United States, 95126

San Leandro, California, United States, 94578

Santa Maria, California, United States, 93454

Torrance, California, United States, 90505

Upland, California, United States, 91786

United States, Colorado

Colorado Springs, Colorado, United States, 80910

United States, Delaware

Newark, Delaware, United States, 19713

United States, Florida

Aventura, Florida, United States, 33180

Delray Beach, Florida, United States, 33484

Fort Lauderdale, Florida, United States, 33334

Palm Habor, Florida, United States, 34684

Palm Harbor, Florida, United States, 34684

Sarasota, Florida, United States, 34239

Tampa, Florida, United States, 33609

Tampa, Florida, United States, 33614

West Palm Beach, Florida, United States, 33407

United States, Georgia

Atlanta, Georgia, United States, 30342

United States, Idaho

Boise, Idaho, United States, 83702

Idaho Falls, Idaho, United States, 83404

Meridian, Idaho, United States, 83642

United States, Illinois

Morton Grove, Illinois, United States, 60053

Springfield, Illinois, United States, 62704

Vernon Hills, Illinois, United States, 60061

United States, Indiana

Indianapolis, Indiana, United States, 46202-5149

United States, Iowa

Cedar Rapids, Iowa, United States, 52401

Des Moines, Iowa, United States, 50322

United States, Kentucky

Bowling Green, Kentucky, United States, 42102

Lexington, Kentucky, United States, 40515

Louisville, Kentucky, United States, 40202

United States, Louisiana

Baton Rouge, Louisiana, United States, 70808

Shreverport, Louisiana, United States, 71103

Slidell, Louisiana, United States, 70458

United States, Maine

Portland, Maine, United States, 04102

United States, Maryland

Frederick, Maryland, United States, 21702

Wheaton, Maryland, United States, 20902

United States, Massachusetts

Boston, Massachusetts, United States, 02111

Pittsfield, Massachusetts, United States, 01201

United States, Michigan

Grand Rapids, Michigan, United States, 49546

Kalamazoo, Michigan, United States, 49048

Lansing, Michigan, United States, 48910

United States, Minnesota

Eagan, Minnesota, United States, 55121

St Cloud, Minnesota, United States, 56303

St. Louis Park, Minnesota, United States, 55426

United States, Mississippi

Flowood, Mississippi, United States, 39232

Tupelo, Mississippi, United States, 38802

United States, Missouri

Saint Louis, Missouri, United States, 63128

Saint Louis, Missouri, United States, 63131

Springfield, Missouri, United States, 65807

St Louis, Missouri, United States, 63117

St Louis, Missouri, United States, 63141

United States, Montana

Billings, Montana, United States, 59107-5100

United States, Nebraska

Lincoln, Nebraska, United States, 68516

United States, Nevada

Reno, Nevada, United States, 89502

United States, New Hampshire

Dover, New Hampshire, United States, 03820

United States, New Jersey

Haddon Heights, New Jersey, United States, 08035

New Brunswick, New Jersey, United States, 08903

Passaic, New Jersey, United States, 07055

United States, New Mexico

Albuquerque, New Mexico, United States, 87131

United States, New York

Albany, New York, United States, 12206

Binghamton, New York, United States, 13905

Great Neck, New York, United States, 11020

New York, New York, United States, 10021

Orchard Park, New York, United States, 14127

Plainview, New York, United States, 11803

Rochester, New York, United States, 14642

Syracuse, New York, United States, 13210

United States, North Carolina

Asheville, North Carolina, United States, 28803

Chapel Hill, North Carolina, United States, 27599-7280

Charlotte, North Carolina, United States, 28210

Durham, North Carolina, United States, 27704

Raleigh, North Carolina, United States, 27609

United States, North Dakota

Bismarck, North Dakota, United States, 58501

United States, Ohio

Canton, Ohio, United States, 44718

Cincinnati, Ohio, United States, 45219

Cleveland, Ohio, United States, 44109

Dayton, Ohio, United States, 45408

United States, Oklahoma

Oklahoma City, Oklahoma, United States, 73103

Oklahoma City, Oklahoma, United States, 73109

Oklahoma City, Oklahoma, United States, 73112

Tulsa, Oklahoma, United States, 74104

Tulsa, Oklahoma, United States, 74135

United States, Oregon

Eugene, Oregon, United States, 97401

Medford, Oregon, United States, 97504

United States, Pennsylvania

Allentown, Pennsylvania, United States, 18103

Bethlehem, Pennsylvania, United States, 18015

Danville, Pennsylvania, United States, 17822

Duncansville, Pennsylvania, United States, 16635

Philadelphia, Pennsylvania, United States, 19152

Pittsburgh, Pennsylvania, United States, 15261

Willow Grove, Pennsylvania, United States, 19090

Willow Grove, Pennsylvania, United States, 80045

Wyomissing, Pennsylvania, United States, 19610

United States, Rhode Island

Johnston, Rhode Island, United States, 02919

United States, South Carolina

Charleston, South Carolina, United States, 29406

Columbia, South Carolina, United States, 29204

Greenville, South Carolina, United States, 29601

Hickory, South Carolina, United States, 28602

United States, Tennessee

Hixson, Tennessee, United States, 37343

Jackson, Tennessee, United States, 38305

Nashville, Tennessee, United States, 37203

United States, Texas

Amarillo, Texas, United States, 79124

Austin, Texas, United States, 78705

Austin, Texas, United States, 78749

Dallas, Texas, United States, 75231-4406

Dallas, Texas, United States, 75231

Houston, Texas, United States, 77074

Mesquite, Texas, United States, 75150

United States, Vermont

Burlington, Vermont, United States, 05401

United States, Virginia

Chesapeake, Virginia, United States, 23320

Norfolk, Virginia, United States, 23502

United States, Washington

Mountlake Terrace, Washington, United States, 98043

Olympia, Washington, United States, 98502

Seattle, Washington, United States, 98104

Seattle, Washington, United States, 98195

Spokane, Washington, United States, 99204

Tacoma, Washington, United States, 98405

United States, Wisconsin

Glendale, Wisconsin, United States, 53217

Lacrosse, Wisconsin, United States, 54601

Argentina

Buenos Aires, Argentina, C1015ABO

Buenos Aires, Argentina, C1428DQG

Florencio Varela, Argentina, B1878DVB

Rosario, Argentina, S2000PBJ

Australia

Hobart, Australia, 7000

Malvern, Australia, 3144

Shenton Park, Australia, 6008

Sydney, Australia, 2050

Woolloongabba, Australia, 4102

Belgium

Hasselt, Belgium, 3500

Merksem, Belgium, 2170

Brazil

Campinas, Brazil, 13060-803

Goiania, Brazil, 74653-050

Rio de Janeiro, Brazil, 20551030

Canada, Alberta

Calgary, Alberta, Canada, T2V 1P9

Edmonton, Alberta, Canada, T5H 3V9

Canada, British Columbia

Victoria, British Columbia, Canada, V8V 3P9

Canada, Manitoba

Winnipeg, Manitoba, Canada, R3A 1M3

Canada, Newfoundland and Labrador

St John's, Newfoundland and Labrador, Canada, A1A 5E8

Canada, Ontario

Burlington, Ontario, Canada, L7R 1E2

Hamilton, Ontario, Canada, L8N 2B6

Kitchener, Ontario, Canada, N2M 5N6

London, Ontario, Canada, N6A 4V2

Mississauga, Ontario, Canada, L5M 2V8

Ottawa, Ontario, Canada, K1H 1A2

Toronto, Ontario, Canada, M5T 3L9

Canada, Quebec

Montreal, Quebec, Canada, H2L 1S6

Quebec City, Quebec, Canada, G1V 3M7

Sainte-foy, Quebec, Canada, G1W 4R4

Canada, Saskatchewan

Saskatoon, Saskatchewan, Canada, S7N 0W8

China

Beijing, China, 100032

Beijing, China, 100044

Guangzhou, China, 510630

Hefei Anhui, China, 230022

Jinan, China, 250012

Shanghai, China, 200127

Shanghai, China, 200433

Costa Rica

San Jose, Costa Rica, 10103

Czech Republic

Hradec Kralove, Czech Republic, 500 05

Praha, Czech Republic, 128 50

Praha, Czech Republic, 140 59

Denmark

Hellerup, Denmark, 2900

Finland

Helsinki, Finland, 00290

Jyväskylä, Finland, 40620

France

Amiens, France, 80054

Bordeaux, France, 33076

Boulogne-billancourt, France, 92104

Brest, France, 29609

Grenoble, France, 38042

Le Kremlin-bicetre, France, 94270

Lille, France, 59037

Lyon, France, 69437

Marseille, France, 13285

Montpellier, France, 34295

Nantes, France, 44035

Nice, France, 06202

Paris, France, 75181

Paris, France, 75679

Pierre Benite, France, 69495

Rennes, France, 35203

Rouen, France, 76031

St Priest En Jarez, France, 42277

Strasbourg, France, 67098

Toulouse, France, 31059

Germany

Aachen, Germany, 52064

Berlin, Germany, 10117

Dresden, Germany, 01067

Essen, Germany, 45239

Gommern, Germany, 39245

Herne, Germany, 44652

Hildesheim, Germany, 31134

Köln, Germany, 50924

München, Germany, 80335

München, Germany, 81541

Osnabrück, Germany, 49074

Sendenhorst, Germany, 48324

Wiesbaden, Germany, 65191

Wuerzburg, Germany, 97080

Hong Kong

Hong Kong, Hong Kong, 852

Tuen Mun, Hong Kong, 852

Iceland

Reykjavik, Iceland, 108

Israel

Ashkelon, Israel, 78306

Haifa, Israel, 31048

Haifa, Israel, 34354

Rishon Lezion, Israel, 70300

Italy

Brescia, Italy, 25123

Genova, Italy, 16132

Milano, Italy, 20157

Padova, Italy, 35128

Pavia, Italy, 27100

Pisa, Italy, 56100

Siena, Italy, 53100

Udine, Italy, 33100

Lithuania

Kaunas, Lithuania, 50009

Klaipeda, Lithuania, 92288

Panevezys, Lithuania, 35144

Siauliai, Lithuania, 76231

Vilnius, Lithuania, LT-08661

Mexico

Guadalajara, Mexico, 44340

Guadalajara, Mexico, 44620

Guadalajara, Mexico, 45235

Leon, Mexico, 37000

Mexico City, Mexico, 06700

Mexico City, Mexico, 07760

Mexico City, Mexico, 14050

Tijuana, Mexico, 22320

Netherlands

Nijmegen, Netherlands, 6525 GA

Norway

Levanger, Norway, 7600

Lillehammer, Norway, 2609

Panama

Panama City, Panama, 32400

Peru

Lima, Peru, 11

Lima, Peru, 13

Portugal

Lisboa, Portugal, 1349-019

Puerto Rico

Ponce, Puerto Rico, 00716

Russian Federation

Moscow, Russian Federation, 105203

Moscow, Russian Federation, 115522

Moscow, Russian Federation, 117049

Ryazan, Russian Federation, 390026

St Petersburg, Russian Federation, 190068

St Petersburg, Russian Federation, 191015

Tula, Russian Federation, 300053

Serbia

Belgrade, Serbia, 11000

Niska Banja, Serbia, 18250

Slovenia

Ljubljana, Slovenia, 1000

Maribor, Slovenia, 2000

South Africa

Cape Town, South Africa, 4001

Cape Town, South Africa, 7500

Diepkloof, South Africa, 1862

Durban, South Africa, 4001

Pinelands, South Africa, 7405

Pretoria, South Africa, 0002

Radiokop, South Africa, 2040

Spain

Barakaldo, Spain, 48903

Barcelona, Spain, 08035

Madrid, Spain, 28046

Malaga, Spain, 29010

Pontevedra, Spain, 36001

Santiago de Compostela, Spain, 15706

Sweden

Stockholm, Sweden, 17176

Umea, Sweden, 90185

Switzerland

Lausanne, Switzerland, 1011

Thailand

Bangkok, Thailand, 10330

Bangkok, Thailand, 10400

Chiang Mai, Thailand, 50200

United Kingdom

Basingstoke, United Kingdom, RG24 9NA

Birmingham, United Kingdom, B29 6JD

Cannock, United Kingdom, WS11 5XY

Derby, United Kingdom, DE1 2QY

Leeds, United Kingdom, LS7 4SA

London, United Kingdom, SE1 9RT

Manchester, United Kingdom, M13 9WL

Manchester, United Kingdom, M41 5SL

Middlesborough, United Kingdom, TS4 3BW

Newcastle Upon Tyne, United Kingdom, NE1 4LP

Oxford, United Kingdom, OX3 7LD

Southampton, United Kingdom, SO16 6YD

Stoke-on-trent, United Kingdom, ST6 7AG

Sponsors and Collaborators

Hoffmann-La Roche

Investigators

• Study Director: Clinical Trials; Hoffmann-La Roche

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Jones G, Wallace T, McIntosh MJ, Brockwell L, Gomez-Reino JJ, Sebba A. Five-year Efficacy and Safety of Tocilizumab Monotherapy in Patients with Rheumatoid Arthritis Who Were Methotrexate- and Biologic-naive or Free of Methotrexate for 6 Months: the AMBITION Study. J Rheumatol. 2017 Feb;44(2):142-146. doi: 10.3899/jrheum.160287. Epub 2016 Dec 1.

• Responsible Party: Hoffmann-La Roche
• ClinicalTrials.gov Identifier: NCT00720798
• Other Study ID Numbers: WA18696
• First Posted: July 23, 2008
• Results First Posted: September 30, 2014
• Last Update Posted: September 30, 2014
• Last Verified: September 2014

Additional relevant MeSH terms:

Arthritis; Arthritis, Rheumatoid; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Anti-Inflammatory Agents; Anti-Inflammatory Agents, Non-Steroidal; Antirheumatic Agents; Analgesics, Non-Narcotic; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs