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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
Scientific title
Long-term Extension Study of Safety During Treatment With Tocilizumab (MRA) in Patients Completing Treatment in MRA Core Studies
Secondary ID [1] 0 0
WA18696
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Rheumatoid Arthritis 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Osteoarthritis
Inflammatory and Immune System 0 0 0 0
Rheumatoid arthritis

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants With = 1 Adverse Event
Assessment method [1] 0 0
Timepoint [1] 0 0
Baseline to the end of the study (up to 7 years, 7 months)
Secondary outcome [1] 0 0
Percentage of Participants Who Withdrew From Treatment
Assessment method [1] 0 0
Timepoint [1] 0 0
Baseline to the end of the study (up to 7 years, 7 months)
Secondary outcome [2] 0 0
Percentage of Participants With Concomitant Oral Corticosteroid Therapy
Assessment method [2] 0 0
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.
Timepoint [2] 0 0
Baseline to the end of the study (up to 7 years, 7 months)
Secondary outcome [3] 0 0
Percentage of Participants Who Changed From Monotherapy to Combination Therapy
Assessment method [3] 0 0
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.
Timepoint [3] 0 0
Baseline to Week 296
Secondary outcome [4] 0 0
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
Assessment method [4] 0 0
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.
Timepoint [4] 0 0
Baseline to Week 264
Secondary outcome [5] 0 0
Percentage of Participants Who Achieved a Major Clinical Response at Weeks 48, 96, 144, 192, and 264
Assessment method [5] 0 0
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.
Timepoint [5] 0 0
Baseline to Week 264
Secondary outcome [6] 0 0
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
Assessment method [6] 0 0
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.
Timepoint [6] 0 0
Baseline to Week 264
Secondary outcome [7] 0 0
Swollen and Tender Joint Count (SJC/TJC) at Baseline and Weeks 24, 48, 108, 156, 204, and 264
Assessment method [7] 0 0
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.
Timepoint [7] 0 0
Baseline to Week 264
Secondary outcome [8] 0 0
Disease Activity and Pain at Baseline and Weeks 24, 48, 108, 156, 204, and 264
Assessment method [8] 0 0
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).
Timepoint [8] 0 0
Baseline to Week 264
Secondary outcome [9] 0 0
Health Assessment Questionnaire-Disability Index Score at Baseline and Weeks 24, 48, 108, 156, 204, and 264
Assessment method [9] 0 0
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.
Timepoint [9] 0 0
Baseline to Week 264
Secondary outcome [10] 0 0
Erythrocyte Sedimentation Rate at Baseline and Weeks 24, 48, 108, 156, 204, and 264
Assessment method [10] 0 0
Erythrocyte sedimentation rate (ESR) was determined locally.
Timepoint [10] 0 0
Baseline to Week 264
Secondary outcome [11] 0 0
Change in the Disease Activity Score 28 (DAS-28) From Baseline to Weeks 24, 48, 96, and 264
Assessment method [11] 0 0
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.
Timepoint [11] 0 0
Baseline to Week 264
Secondary outcome [12] 0 0
Percentage of Participants Who Were Disease Activity Score 28 (DAS-28) Responders at Weeks 24, 48, 108, 156, 204, and 264
Assessment method [12] 0 0
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.
Timepoint [12] 0 0
Baseline to Week 264
Secondary outcome [13] 0 0
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
Assessment method [13] 0 0
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.
Timepoint [13] 0 0
Baseline to Week 264
Secondary outcome [14] 0 0
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
Assessment method [14] 0 0
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.
Timepoint [14] 0 0
Baseline to Week 264
Secondary outcome [15] 0 0
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
Assessment method [15] 0 0
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.
Timepoint [15] 0 0
Baseline to Week 264

Eligibility
Key inclusion criteria
* Patients who have completed participation in 1 of the core studies in adult rheumatoid arthritis.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/09/2005
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/04/2013
Sample size
Target
Accrual to date
Final
2067
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- Hobart
Recruitment hospital [2] 0 0
- Malvern
Recruitment hospital [3] 0 0
- Shenton Park
Recruitment hospital [4] 0 0
- Sydney
Recruitment hospital [5] 0 0
- Woolloongabba
Recruitment postcode(s) [1] 0 0
7000 - Hobart
Recruitment postcode(s) [2] 0 0
3144 - Malvern
Recruitment postcode(s) [3] 0 0
6008 - Shenton Park
Recruitment postcode(s) [4] 0 0
2050 - Sydney
Recruitment postcode(s) [5] 0 0
4102 - Woolloongabba
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
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Arkansas
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United States of America
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California
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Colorado
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Delaware
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United States of America
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Florida
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United States of America
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Georgia
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United States of America
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Idaho
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United States of America
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Illinois
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Indiana
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Iowa
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Kentucky
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Louisiana
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Maine
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Maryland
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Massachusetts
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Michigan
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Minnesota
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Mississippi
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Missouri
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Montana
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Nebraska
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Nevada
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New Hampshire
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New Jersey
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New Mexico
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New York
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North Carolina
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North Dakota
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Ohio
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Oregon
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Rhode Island
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South Carolina
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Tennessee
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Texas
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Vermont
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Washington
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Wisconsin
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Argentina
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Buenos Aires
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Florencio Varela
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Rosario
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Hasselt
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Merksem
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Campinas
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Goiania
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Hradec Kralove
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Praha
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Helsinki
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Amiens
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Brest
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Pierre Benite
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Rennes
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Rouen
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St Priest En Jarez
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Strasbourg
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Toulouse
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Aachen
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Berlin
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Dresden
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Germany
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Essen
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Gommern
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Germany
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Herne
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Germany
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Hildesheim
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Germany
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Köln
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Germany
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München
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Germany
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Osnabrück
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Germany
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Sendenhorst
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Germany
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Wiesbaden
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Germany
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Wuerzburg
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Hong Kong
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Hong Kong
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Hong Kong
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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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Israel
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Rishon Lezion
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Italy
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Brescia
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Italy
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Genova
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Italy
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Milano
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Italy
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Padova
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Italy
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Pavia
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Italy
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Pisa
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Italy
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Siena
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Italy
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Udine
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Lithuania
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Kaunas
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Lithuania
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Klaipeda
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Lithuania
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Panevezys
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Lithuania
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Siauliai
Country [119] 0 0
Lithuania
State/province [119] 0 0
Vilnius
Country [120] 0 0
Mexico
State/province [120] 0 0
Guadalajara
Country [121] 0 0
Mexico
State/province [121] 0 0
Leon
Country [122] 0 0
Mexico
State/province [122] 0 0
Mexico City
Country [123] 0 0
Mexico
State/province [123] 0 0
Tijuana
Country [124] 0 0
Netherlands
State/province [124] 0 0
Nijmegen
Country [125] 0 0
Norway
State/province [125] 0 0
Levanger
Country [126] 0 0
Norway
State/province [126] 0 0
Lillehammer
Country [127] 0 0
Panama
State/province [127] 0 0
Panama City
Country [128] 0 0
Peru
State/province [128] 0 0
Lima
Country [129] 0 0
Portugal
State/province [129] 0 0
Lisboa
Country [130] 0 0
Puerto Rico
State/province [130] 0 0
Ponce
Country [131] 0 0
Russian Federation
State/province [131] 0 0
Moscow
Country [132] 0 0
Russian Federation
State/province [132] 0 0
Ryazan
Country [133] 0 0
Russian Federation
State/province [133] 0 0
St Petersburg
Country [134] 0 0
Russian Federation
State/province [134] 0 0
Tula
Country [135] 0 0
Serbia
State/province [135] 0 0
Belgrade
Country [136] 0 0
Serbia
State/province [136] 0 0
Niska Banja
Country [137] 0 0
Slovenia
State/province [137] 0 0
Ljubljana
Country [138] 0 0
Slovenia
State/province [138] 0 0
Maribor
Country [139] 0 0
South Africa
State/province [139] 0 0
Cape Town
Country [140] 0 0
South Africa
State/province [140] 0 0
Diepkloof
Country [141] 0 0
South Africa
State/province [141] 0 0
Durban
Country [142] 0 0
South Africa
State/province [142] 0 0
Pinelands
Country [143] 0 0
South Africa
State/province [143] 0 0
Pretoria
Country [144] 0 0
South Africa
State/province [144] 0 0
Radiokop
Country [145] 0 0
Spain
State/province [145] 0 0
Barakaldo
Country [146] 0 0
Spain
State/province [146] 0 0
Barcelona
Country [147] 0 0
Spain
State/province [147] 0 0
Madrid
Country [148] 0 0
Spain
State/province [148] 0 0
Malaga
Country [149] 0 0
Spain
State/province [149] 0 0
Pontevedra
Country [150] 0 0
Spain
State/province [150] 0 0
Santiago de Compostela
Country [151] 0 0
Sweden
State/province [151] 0 0
Stockholm
Country [152] 0 0
Sweden
State/province [152] 0 0
Umea
Country [153] 0 0
Switzerland
State/province [153] 0 0
Lausanne
Country [154] 0 0
Thailand
State/province [154] 0 0
Bangkok
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Thailand
State/province [155] 0 0
Chiang Mai
Country [156] 0 0
United Kingdom
State/province [156] 0 0
Basingstoke
Country [157] 0 0
United Kingdom
State/province [157] 0 0
Birmingham
Country [158] 0 0
United Kingdom
State/province [158] 0 0
Cannock
Country [159] 0 0
United Kingdom
State/province [159] 0 0
Derby
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United Kingdom
State/province [160] 0 0
Leeds
Country [161] 0 0
United Kingdom
State/province [161] 0 0
London
Country [162] 0 0
United Kingdom
State/province [162] 0 0
Manchester
Country [163] 0 0
United Kingdom
State/province [163] 0 0
Middlesborough
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United Kingdom
State/province [164] 0 0
Newcastle Upon Tyne
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United Kingdom
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Oxford
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Southampton
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United Kingdom
State/province [167] 0 0
Stoke-on-trent

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Hoffmann-La Roche
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Trials
Address 0 0
Hoffmann-La Roche
Country 0 0
Phone 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT00720798