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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00720798
First received: July 22, 2008
Last updated: September 26, 2014
Last verified: September 2014
  Purpose

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

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Percentage of Participants With ≥ 1 Adverse Event [ Time Frame: Baseline to the end of the study (up to 7 years, 7 months) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Percentage of Participants Who Withdrew From Treatment [ Time Frame: Baseline to the end of the study (up to 7 years, 7 months) ] [ Designated as safety issue: No ]
  • Percentage of Participants With Concomitant Oral Corticosteroid Therapy [ Time Frame: Baseline to the end of the study (up to 7 years, 7 months) ] [ Designated as safety issue: No ]

    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.


  • Percentage of Participants Who Changed From Monotherapy to Combination Therapy [ Time Frame: Baseline to Week 296 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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.

  • Percentage of Participants Who Achieved a Major Clinical Response at Weeks 48, 96, 144, 192, and 264 [ Time Frame: Baseline to Week 264 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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.

  • Swollen and Tender Joint Count (SJC/TJC) at Baseline and Weeks 24, 48, 108, 156, 204, and 264 [ Time Frame: Baseline to Week 264 ] [ Designated as safety issue: No ]
    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.

  • Disease Activity and Pain at Baseline and Weeks 24, 48, 108, 156, 204, and 264 [ Time Frame: Baseline to Week 264 ] [ Designated as safety issue: No ]
    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).

  • Health Assessment Questionnaire-Disability Index Score at Baseline and Weeks 24, 48, 108, 156, 204, and 264 [ Time Frame: Baseline to Week 264 ] [ Designated as safety issue: No ]
    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.

  • Erythrocyte Sedimentation Rate at Baseline and Weeks 24, 48, 108, 156, 204, and 264 [ Time Frame: Baseline to Week 264 ] [ Designated as safety issue: No ]
    Erythrocyte sedimentation rate (ESR) was determined locally.

  • Change in the Disease Activity Score 28 (DAS-28) From Baseline to Weeks 24, 48, 96, and 264 [ Time Frame: Baseline to Week 264 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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.


Enrollment: 2067
Study Start Date: September 2005
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00720798

  Hide Study 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, 85258
Scottsdale, Arizona, United States, 85251
Tucson, Arizona, United States, 85724
Tucson, Arizona, United States, 85723
United States, Arkansas
Little Rock, Arkansas, United States, 72205
United States, California
Anaheim, California, United States, 92801
Long Beach, California, United States, 90808
Long Beach, California, United States, 90806
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, 33614
Tampa, Florida, United States, 33609
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, 63131
Saint Louis, Missouri, United States, 63128
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, 73112
Oklahoma City, Oklahoma, United States, 73109
Oklahoma City, Oklahoma, United States, 73103
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, 80045
Willow Grove, Pennsylvania, United States, 19090
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, C1428DQG
Buenos Aires, Argentina, C1015ABO
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, 100044
Beijing, China, 100032
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, 140 59
Praha, Czech Republic, 128 50
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, 75679
Paris, France, 75181
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, 34354
Haifa, Israel, 31048
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, 07760
Mexico City, Mexico, 06700
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, 117049
Moscow, Russian Federation, 115522
Ryazan, Russian Federation, 390026
St Petersburg, Russian Federation, 191015
St Petersburg, Russian Federation, 190068
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

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00720798     History of Changes
Other Study ID Numbers: WA18696
Study First Received: July 22, 2008
Results First Received: June 10, 2014
Last Updated: September 26, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Arthritis, Rheumatoid
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Anti-Inflammatory Agents
Antirheumatic Agents
Anti-Inflammatory Agents, Non-Steroidal
Therapeutic Uses
Pharmacologic Actions
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 02, 2014