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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00720798
Registration number
NCT00720798
Ethics application status
Date submitted
22/07/2008
Date registered
23/07/2008
Date last updated
30/09/2014
Titles & IDs
Public title
An Extension Study of Tocilizumab (Myeloma Receptor Antibody [MRA]) in Patients Completing Treatment in Tocilizumab Core Studies
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Scientific title
Long-term Extension Study of Safety During Treatment With Tocilizumab (MRA) in Patients Completing Treatment in MRA Core Studies
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Secondary ID [1]
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WA18696
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Rheumatoid Arthritis
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Condition category
Condition code
Musculoskeletal
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Osteoarthritis
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Inflammatory and Immune System
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Rheumatoid arthritis
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Tocilizumab
Treatment: Drugs - Disease-modifying anti-rheumatic drugs
Treatment: Drugs - Non-steroidal anti-inflammatory drugs
Treatment: Drugs - Oral corticosteroids
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.
Treatment: Drugs: Tocilizumab
For participants weighing > 100 kg, the maximum dose of tocilizumab was 800 mg. Tocilizumab was supplied as a sterile solution in vials.
Treatment: Drugs: 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.
Treatment: Drugs: 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.
Treatment: Drugs: Oral corticosteroids
Oral corticosteroids (= 10 mg/day) were permitted during the study.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percentage of Participants With = 1 Adverse Event
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Assessment method [1]
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Timepoint [1]
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Baseline to the end of the study (up to 7 years, 7 months)
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Secondary outcome [1]
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Percentage of Participants Who Withdrew From Treatment
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Assessment method [1]
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Timepoint [1]
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Baseline to the end of the study (up to 7 years, 7 months)
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Secondary outcome [2]
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Percentage of Participants With Concomitant Oral Corticosteroid Therapy
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Assessment method [2]
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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.
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Timepoint [2]
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Baseline to the end of the study (up to 7 years, 7 months)
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Secondary outcome [3]
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Percentage of Participants Who Changed From Monotherapy to Combination Therapy
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Assessment method [3]
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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.
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Timepoint [3]
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Baseline to Week 296
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Secondary outcome [4]
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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
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Assessment method [4]
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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.
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Timepoint [4]
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Baseline to Week 264
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Secondary outcome [5]
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Percentage of Participants Who Achieved a Major Clinical Response at Weeks 48, 96, 144, 192, and 264
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Assessment method [5]
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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.
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Timepoint [5]
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Baseline to Week 264
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Secondary outcome [6]
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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
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Assessment method [6]
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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.
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Timepoint [6]
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Baseline to Week 264
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Secondary outcome [7]
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Swollen and Tender Joint Count (SJC/TJC) at Baseline and Weeks 24, 48, 108, 156, 204, and 264
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Assessment method [7]
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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.
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Timepoint [7]
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Baseline to Week 264
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Secondary outcome [8]
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Disease Activity and Pain at Baseline and Weeks 24, 48, 108, 156, 204, and 264
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Assessment method [8]
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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).
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Timepoint [8]
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Baseline to Week 264
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Secondary outcome [9]
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Health Assessment Questionnaire-Disability Index Score at Baseline and Weeks 24, 48, 108, 156, 204, and 264
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Assessment method [9]
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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.
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Timepoint [9]
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Baseline to Week 264
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Secondary outcome [10]
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Erythrocyte Sedimentation Rate at Baseline and Weeks 24, 48, 108, 156, 204, and 264
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Assessment method [10]
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Erythrocyte sedimentation rate (ESR) was determined locally.
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Timepoint [10]
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Baseline to Week 264
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Secondary outcome [11]
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Change in the Disease Activity Score 28 (DAS-28) From Baseline to Weeks 24, 48, 96, and 264
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Assessment method [11]
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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 × v(TJC28)) + (0.28 × v(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.
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Timepoint [11]
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Baseline to Week 264
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Secondary outcome [12]
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Percentage of Participants Who Were Disease Activity Score 28 (DAS-28) Responders at Weeks 24, 48, 108, 156, 204, and 264
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Assessment method [12]
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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.
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Timepoint [12]
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Baseline to Week 264
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Secondary outcome [13]
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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
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Assessment method [13]
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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.
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Timepoint [13]
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Baseline to Week 264
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Secondary outcome [14]
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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
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Assessment method [14]
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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.
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Timepoint [14]
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Baseline to Week 264
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Secondary outcome [15]
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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
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Assessment method [15]
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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.
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Timepoint [15]
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Baseline to Week 264
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Eligibility
Key inclusion criteria
- Patients who have completed participation in 1 of the core studies in adult rheumatoid
arthritis.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
N/A
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/09/2005
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/04/2013
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Sample size
Target
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Accrual to date
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Final
2067
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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- Hobart
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Recruitment hospital [2]
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- Malvern
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Recruitment hospital [3]
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- Shenton Park
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Recruitment hospital [4]
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- Sydney
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Recruitment hospital [5]
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- Woolloongabba
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Recruitment postcode(s) [1]
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7000 - Hobart
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Recruitment postcode(s) [2]
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3144 - Malvern
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Recruitment postcode(s) [3]
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6008 - Shenton Park
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Recruitment postcode(s) [4]
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2050 - Sydney
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Recruitment postcode(s) [5]
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4102 - Woolloongabba
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Recruitment outside Australia
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United States of America
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Alabama
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Colorado
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Delaware
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Illinois
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Kentucky
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Louisiana
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Maine
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Argentina
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Buenos Aires
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Argentina
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Hasselt
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Merksem
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Brazil
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Campinas
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Brazil
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Goiania
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Brazil
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Rio de Janeiro
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Alberta
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Canada
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Canada
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Manitoba
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Canada
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Newfoundland and Labrador
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Canada
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Ontario
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Canada
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China
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Beijing
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China
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Guangzhou
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China
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Hefei Anhui
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China
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Jinan
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China
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Shanghai
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San Jose
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Hradec Kralove
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Czech Republic
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Praha
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Denmark
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Hellerup
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Finland
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Helsinki
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Finland
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Jyväskylä
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France
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Amiens
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France
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Bordeaux
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France
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Boulogne-billancourt
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France
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Brest
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France
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Grenoble
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France
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Le Kremlin-bicetre
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France
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Lille
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France
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Lyon
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France
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Marseille
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France
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Montpellier
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France
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Nantes
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France
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Nice
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France
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Paris
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Country [82]
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France
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Pierre Benite
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France
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Rennes
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France
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Rouen
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France
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St Priest En Jarez
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France
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Strasbourg
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France
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Toulouse
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Aachen
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Germany
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Berlin
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Germany
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Dresden
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Germany
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Essen
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Germany
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Gommern
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Germany
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Herne
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Country [94]
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Germany
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Hildesheim
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Country [95]
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Germany
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Köln
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Country [96]
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Germany
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München
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Country [97]
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Germany
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Osnabrück
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Country [98]
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Germany
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Sendenhorst
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Country [99]
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Germany
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Wiesbaden
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Country [100]
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Germany
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Wuerzburg
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Country [101]
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Hong Kong
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Hong Kong
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Country [102]
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Hong Kong
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State/province [102]
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Tuen Mun
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Iceland
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Reykjavik
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Israel
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Ashkelon
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Israel
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Haifa
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Country [106]
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Israel
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Rishon Lezion
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Country [107]
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Italy
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Brescia
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Country [108]
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Italy
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Genova
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Country [109]
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Italy
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Milano
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Country [110]
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Italy
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Padova
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Country [111]
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Italy
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Pavia
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Country [112]
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Italy
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Pisa
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Country [113]
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Italy
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Siena
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Country [114]
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Italy
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Udine
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Country [115]
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Lithuania
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Kaunas
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Country [116]
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Lithuania
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Klaipeda
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Lithuania
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Panevezys
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Country [118]
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Lithuania
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Siauliai
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Lithuania
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Vilnius
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Country [120]
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Mexico
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Guadalajara
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Mexico
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Leon
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Mexico
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Mexico City
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Mexico
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Tijuana
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Country [124]
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Netherlands
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Nijmegen
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Country [125]
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Norway
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Levanger
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Norway
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Lillehammer
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Country [127]
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Panama
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Country [128]
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Peru
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Lima
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Country [129]
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Portugal
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Lisboa
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Puerto Rico
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Ponce
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Country [131]
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Russian Federation
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Moscow
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Country [132]
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Russian Federation
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Ryazan
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Country [133]
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Russian Federation
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St Petersburg
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Country [134]
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Russian Federation
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Tula
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Country [135]
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Serbia
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Belgrade
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Serbia
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Niska Banja
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Slovenia
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Ljubljana
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Country [138]
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Slovenia
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Maribor
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Country [139]
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Cape Town
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South Africa
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Diepkloof
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South Africa
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Durban
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Country [142]
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South Africa
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Pinelands
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Country [143]
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South Africa
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Pretoria
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South Africa
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Spain
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Malaga
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Spain
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Pontevedra
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Spain
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Stockholm
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Umea
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Lausanne
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Bangkok
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Thailand
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United Kingdom
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Basingstoke
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Birmingham
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Cannock
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United Kingdom
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Derby
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United Kingdom
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Leeds
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London
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United Kingdom
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Middlesborough
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United Kingdom
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Oxford
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United Kingdom
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Southampton
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United Kingdom
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Stoke-on-trent
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Hoffmann-La Roche
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Address
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Ethics approval
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Summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00720798
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Public notes
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Contacts
Principal investigator
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Clinical Trials
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Hoffmann-La Roche
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Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00720798
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