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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00095147




Registration number
NCT00095147
Ethics application status
Date submitted
1/11/2004
Date registered
2/11/2004
Date last updated
24/03/2015

Titles & IDs
Public title
Abatacept and Infliximab in Combination With Methotrexate in Subjects With Rheumatoid Arthritis
Scientific title
A Phase IIIB, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Comparative Study of Abatacept or Infliximab in Combination With Methotrexate in Controlling Disease Activity in Subjects With Rheumatoid Arthritis Having an Inadequate Clinical Response to Methotrexate
Secondary ID [1] 0 0
IM101-043
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 - Abatacept (ABA) + Methotrexate (MTX), double-blind (DB)
Treatment: Drugs - Infliximab (INF) + MTX, DB
Treatment: Drugs - Placebo (PLA) + MTX, DB
Treatment: Drugs - PLA + MTX switched to ABA+ MTX, DB
Treatment: Drugs - ABA, open-label (OL)

Active comparator: Abatacept (ABA) + Methotrexate (MTX) (double-blind [DB]) - Days 1-365

Active comparator: Infliximab + MTX (DB) - Days 1-365

Placebo comparator: Placebo + MTX (DB) - Days 1-197

Experimental: Placebo + MTX switched to abatacept + MTX (DB) - Participants received placebo plus methotrexate for days 1-197, and abatacept plus methotrexate for days 198-365

Experimental: Abatacept (open-label) - Days 365 to 729 All participants receive Active Drug


Treatment: Drugs: Abatacept (ABA) + Methotrexate (MTX), double-blind (DB)
Abatacept, intravenous (IV) Solution, Infusion, Depends on participant weight, Monthly, 12 months.

Treatment: Drugs: Infliximab (INF) + MTX, DB
Infliximab, IV Solution, Infusion, Depends on participant weight, Every 2 Months, 12 months.

Treatment: Drugs: Placebo (PLA) + MTX, DB
Placebo, IV Solution, Infusion, Depends on participant weight, Monthly, 6 months.

Treatment: Drugs: PLA + MTX switched to ABA+ MTX, DB
Placebo=IV Solution, Infusion, Depends on participant weight, Monthly, 6 months. Abatacept=IV Solution, Infusion, Depends on participant weight, Monthly, 6 months

Treatment: Drugs: ABA, open-label (OL)
Abatacept, IV solution, Infusion. Depends on participant weight, Monthly, 12+ months
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
DB; Adjusted Mean Change From Baseline to Day 197 in Disease Activity Score (DAS) 28 Score (Erythrocyte Sedimentation Rate [ESR]) For ABA Versus PLA (Last Observation Carried Forward [LOCF] Analysis)
Timepoint [1] 0 0
Baseline (Day 1), 6 months (Day 197)
Primary outcome [2] 0 0
OL; Number of Participants With Death, Serious Adverse Events (SAEs), Related SAEs, SAEs Leading to Discontinuation, Adverse Events (AEs), Related AEs, and AEs Leading to Discontinuation
Timepoint [2] 0 0
From beginning of OL (Day 366) through end of OL (range from 1.9 months to 42.3 months)
Primary outcome [3] 0 0
OL; Number of Participants With AEs of Special Interest
Timepoint [3] 0 0
From beginning of OL (Day 366) through end of OL (range from 1.9 months to 42.3 months)
Primary outcome [4] 0 0
OL; Number of Participants With Select Hematologic Laboratory Abnormalities
Timepoint [4] 0 0
From Day 366 through end of OL (range from 1.9 months to 42.3 months)
Primary outcome [5] 0 0
OL; Number of Participants With Select Blood Chemistry Laboratory Abnormalities
Timepoint [5] 0 0
From Day 366 through end of OL (range from 1.9 months to 42.3 months)
Primary outcome [6] 0 0
OL; Mean Change From Baseline to Day 365 in Hemoglobin, Total Protein, and Albumin
Timepoint [6] 0 0
Baseline (Day 1), Day 365
Primary outcome [7] 0 0
OL; Mean Change From Baseline to Day 365 in Platelets
Timepoint [7] 0 0
Baseline (Day 1), Day 365
Primary outcome [8] 0 0
OL; Mean Change From Baseline to Day 365 in Hematocrit
Timepoint [8] 0 0
Baseline (Day 1), Day 365
Primary outcome [9] 0 0
OL; Mean Change From Baseline to Day 365 in White Blood Cells
Timepoint [9] 0 0
Baseline (Day 1), Day 365
Primary outcome [10] 0 0
OL; Mean Change From Baseline to Day 365 in Erythrocytes
Timepoint [10] 0 0
Baseline (Day 1), Day 365
Primary outcome [11] 0 0
OL; Mean Change From Baseline to Day 365 in Electrolytes
Timepoint [11] 0 0
Baseline (Day 1), Day 365
Primary outcome [12] 0 0
OL; Mean Change From Baseline to Day 365 in Bilirubin, Blood Urea Nitrogen, Creatinine, Calcium, Phosphorous, Serum Glucose, Fasting Serum Glucose, and Uric Acid
Timepoint [12] 0 0
Baseline (Day 1), Day 365
Primary outcome [13] 0 0
OL; Mean Change From Baseline to Day 365 in Alanine Aminotransferase, Aspartate Aminotransferase, G-Glutamyl Transferase, and Alkaline Phosphatase
Timepoint [13] 0 0
Baseline (Day 1), Day 365
Primary outcome [14] 0 0
OL; Mean Change From Baseline to Day 729 in Hemoglobin, Total Protein, and Albumin
Timepoint [14] 0 0
Baseline (Day 1), Day 729
Primary outcome [15] 0 0
OL; Mean Change From Baseline to Day 729 in Platelets
Timepoint [15] 0 0
Baseline (Day 1), Day 729
Primary outcome [16] 0 0
OL; Mean Change From Baseline to Day 729 in Hematocrit
Timepoint [16] 0 0
Baseline (Day 1), Day 729
Primary outcome [17] 0 0
OL; Mean Change From Baseline to Day 729 in White Blood Cells
Timepoint [17] 0 0
Baseline (Day 1), Day 729
Primary outcome [18] 0 0
OL; Mean Change From Baseline to Day 729 in Erythrocytes
Timepoint [18] 0 0
Baseline (Day 1), Day 729
Primary outcome [19] 0 0
OL; Mean Change From Baseline to Day 729 in Electrolytes
Timepoint [19] 0 0
Baseline (Day 1), Day 729
Primary outcome [20] 0 0
OL; Mean Change From Baseline to Day 729 in Bilirubin, Blood Urea Nitrogen, Creatinine, Calcium, Phosphorous, Serum Glucose, Fasting Serum Glucose, and Uric Acid
Timepoint [20] 0 0
Baseline (Day 1), Day 729
Primary outcome [21] 0 0
OL; Mean Change From Baseline to Day 729 in Alanine Aminotransferase, Aspartate Aminotransferase, G-Glutamyl Transferase, and Alkaline Phosphatase
Timepoint [21] 0 0
Baseline (Day 1), Day 729
Primary outcome [22] 0 0
OL; Mean Change From Baseline to Day 1121 in Hemoglobin, Total Protein, and Albumin
Timepoint [22] 0 0
Baseline (Day 1), Day 1121
Primary outcome [23] 0 0
OL; Mean Change From Baseline to Day 1121 in Platelets
Timepoint [23] 0 0
Baseline (Day 1), Day 1121
Primary outcome [24] 0 0
OL; Mean Change From Baseline to Day 1121 in Hematocrit
Timepoint [24] 0 0
Baseline (Day 1), Day 1121
Primary outcome [25] 0 0
OL; Mean Change From Baseline to Day 1121 in White Blood Cells
Timepoint [25] 0 0
Baseline (Day 1), Day 1121
Primary outcome [26] 0 0
OL; Mean Change From Baseline to Day 1121 in Erythrocytes
Timepoint [26] 0 0
Baseline (Day 1), Day 1121
Primary outcome [27] 0 0
OL; Mean Change From Baseline to Day 1121 in Electrolytes
Timepoint [27] 0 0
Baseline (Day 1), Day 1121
Primary outcome [28] 0 0
OL; Mean Change From Baseline to Day 1121 in Bilirubin, Blood Urea Nitrogen, Creatinine, Calcium, Phosphorous, Serum Glucose, Fasting Serum Glucose, and Uric Acid
Timepoint [28] 0 0
Baseline (Day 1), Day 1121
Primary outcome [29] 0 0
OL; Mean Change From Baseline to Day 1121 in Alanine Aminotransferase, Aspartate Aminotransferase, G-Glutamyl Transferase, and Alkaline Phosphatase
Timepoint [29] 0 0
Baseline (Day 1), Day 1121
Primary outcome [30] 0 0
OL; Mean Change From Baseline to Day 1513 in Hemoglobin, Total Protein, and Albumin
Timepoint [30] 0 0
Baseline (Day 1), Day 1513
Primary outcome [31] 0 0
OL; Mean Change From Baseline to Day 1513 in Platelets
Timepoint [31] 0 0
Baseline (Day 1), Day 1513
Primary outcome [32] 0 0
OL; Mean Change From Baseline to Day 1513 in Hematocrit
Timepoint [32] 0 0
Baseline (Day 1), Day 1513
Primary outcome [33] 0 0
OL; Mean Change From Baseline to Day 1513 in White Blood Cells
Timepoint [33] 0 0
Baseline (Day 1), Day 1513
Primary outcome [34] 0 0
OL; Mean Change From Baseline to Day 1513 in Erythrocytes
Timepoint [34] 0 0
Baseline (Day 1), Day 1513
Primary outcome [35] 0 0
OL; Mean Change From Baseline to Day 1513 in Electrolytes
Timepoint [35] 0 0
Baseline (Day 1), Day 1513
Primary outcome [36] 0 0
OL; Mean Change From Baseline to Day 1513 in Bilirubin, Blood Urea Nitrogen, Creatinine, Calcium, Phosphorous, Serum Glucose, Fasting Serum Glucose, and Uric Acid
Timepoint [36] 0 0
Baseline (Day 1), Day 1513
Primary outcome [37] 0 0
OL; Mean Change From Baseline to Day 1513 in Alanine Aminotransferase, Aspartate Aminotransferase, G-Glutamyl Transferase, and Alkaline Phosphatase
Timepoint [37] 0 0
Baseline (Day 1), Day 1513
Primary outcome [38] 0 0
OL; Mean Systolic (SBP) and Diastolic (DBP) Blood Pressure During Open Label Period
Timepoint [38] 0 0
Days 365, 729, 1121, and 1513
Primary outcome [39] 0 0
OL; Mean Heart Rate (HR) During Open Label Period
Timepoint [39] 0 0
Days 365, 729, 1121, and 1513
Primary outcome [40] 0 0
OL; Mean Temperature (T) During Open Label Period
Timepoint [40] 0 0
Days 365, 729, 1121, and 1513
Secondary outcome [1] 0 0
DB; Adjusted Mean Change From Baseline to Day 197 in DAS 28 Score (ESR) For INF Versus PLA (LOCF Analysis)
Timepoint [1] 0 0
Baseline (Day 1), 6 months (Day 197)
Secondary outcome [2] 0 0
DB; DAS 28 (ESR) Area Under The Curve (AUC) Over 12 Months For ABA Versus INF
Timepoint [2] 0 0
From Day 1 through Day 365 (12 months)
Secondary outcome [3] 0 0
DB; Percentage of Participants With Clinically Meaningful Health Assessment Questionnaire-Disability Index (HAQ-DI) Response at Day 197
Timepoint [3] 0 0
DB Day 197
Secondary outcome [4] 0 0
DB; Percentage of Participants With Clinically Meaningful Health Assessment Questionnaire-Disability Index (HAQ-DI) Response at Day 365
Timepoint [4] 0 0
DB Day 365
Secondary outcome [5] 0 0
DB; Adjusted Mean Change From Baseline to Day 197 in HAQ-DI (LOCF Analysis)
Timepoint [5] 0 0
Baseline (Day 1), 6 months (Day 197)
Secondary outcome [6] 0 0
DB; Adjusted Mean Change From Baseline to Day 365 in HAQ-DI (LOCF Analysis)
Timepoint [6] 0 0
Baseline (Day 1), 12 months (Day 365)
Secondary outcome [7] 0 0
DB; Adjusted Mean Change From Baseline to Day 197 in SF-36 Physical Component Summary (PCS) and Mental Component Summary (MCS)
Timepoint [7] 0 0
Baseline (Day 1), 6 months (Day 197)
Secondary outcome [8] 0 0
DB; Adjusted Mean Change From Baseline to Day 365 in SF-36 Physical Component Summary (PCS) and Mental Component Summary (MCS)
Timepoint [8] 0 0
Baseline (Day 1), 12 months (Day 365)
Secondary outcome [9] 0 0
DB; Percentage of Participants With Good, Moderate, or No Response According to European League Against Rheumatism (EULAR) at Day 365
Timepoint [9] 0 0
DB Day 365
Secondary outcome [10] 0 0
DB; Percentage of Participants With American College of Rheumatology (ACR) Responses at Day 197
Timepoint [10] 0 0
DB Day 197
Secondary outcome [11] 0 0
DB; Percentage of Participants With American College of Rheumatology (ACR) Responses at Day 365
Timepoint [11] 0 0
DB Day 365
Secondary outcome [12] 0 0
DB; Number of Participants With Death, Serious Adverse Events (SAEs), Related SAEs, SAEs Leading to Discontinuation, AEs, Related AEs, and AEs Leading to Discontinuation From Day 1 Through Day 197
Timepoint [12] 0 0
From Baseline (Day 1) through Day 197, and up to 56 days after last dose if occurring on-study
Secondary outcome [13] 0 0
DB; Number of Participants With AEs of Special Interest From Day 1 Through Day 197
Timepoint [13] 0 0
From Baseline (Day 1) through Day 197, and up to 56 days after last dose if occurring on-study
Secondary outcome [14] 0 0
DB; Number of Participants With Death, Serious Adverse Events (SAEs), Related SAEs, SAEs Leading to Discontinuation, AEs, Related AEs, and AEs Leading to Discontinuation From Day 1 Through Day 365
Timepoint [14] 0 0
From Baseline (Day 1) through Day 365, and up to 56 days after last dose if occurring on-study
Secondary outcome [15] 0 0
DB; Number of Participants With Death, Serious Adverse Events (SAEs), Related SAEs, SAEs Leading to Discontinuation, AEs, Related AEs, and AEs Leading to Discontinuation From Day 198 Through Day 365 in Participants Receiving Placebo Switched to Abatacept
Timepoint [15] 0 0
From Day 198 through Day 365, and up to 56 days after last dose if occurring on-study
Secondary outcome [16] 0 0
DB; Number of Participants With AEs of Special Interest From Day 1 Through Day 365
Timepoint [16] 0 0
From Baseline (Day 1) through Day 365, and up to 56 days after last dose if occurring on-study
Secondary outcome [17] 0 0
DB; Number of Participants With AEs of Special Interest From Day 198 Through Day 365 in Participants Receiving Placebo Switched to Abatacept
Timepoint [17] 0 0
From Day 198 through Day 365, and up to 56 days after last dose if occurring on-study
Secondary outcome [18] 0 0
DB; Number of Participants With Significant Changes in Mean Systolic and Diastolic Blood Pressure During Days 1 Through 197 and Days 1 Through 365
Timepoint [18] 0 0
From Baseline (Day 1) through Day 197, or Day 1 through Day 365, and up to 56 days after last dose if occurring on-study
Secondary outcome [19] 0 0
DB; Number of Participants With Significant Changes in Mean Heart Rate During Days 1 Through 197 and Days 1 Through 365
Timepoint [19] 0 0
From Baseline (Day 1) through Day 197, or Day 1 through Day 365, and up to 56 days after last dose if occurring on-study
Secondary outcome [20] 0 0
DB; Number of Participants With Significant Changes in Mean Temperature During Days 1 Through 197 and Days 1 Through 365
Timepoint [20] 0 0
From Baseline (Day 1) through Day 197, and up to 56 days after last dose if occurring on-study
Secondary outcome [21] 0 0
DB; Number of Participants With Select Hematologic and Blood Chemistry Laboratory Abnormalities on Days 1 Through 197
Timepoint [21] 0 0
From Baseline (Day 1) through Day 197, and up to 56 days after last dose if occurring on-study
Secondary outcome [22] 0 0
DB; Number of Participants With Select Hematologic and Blood Chemistry Laboratory Abnormalities on Days 1 Through 365
Timepoint [22] 0 0
From Baseline (Day 1) through Day 365, and up to 56 days after last dose if occurring on-study
Secondary outcome [23] 0 0
DB; Number of Participants With Anti-Abatacept Antibodies From Day 1 Through Day 365 (Electrochemiluminescent [ECL] Immunoassay)
Timepoint [23] 0 0
Day 1 through day 365
Secondary outcome [24] 0 0
DB; Percentage of Participants With Antibodies Against Infliximab (Human Anti-chimeric Antibody [HACA]) From Day 1 Through Day 365
Timepoint [24] 0 0
Day 1 through day 365
Secondary outcome [25] 0 0
OL; Mean Change From Baseline Over Time in DAS 28 (ESR) Score
Timepoint [25] 0 0
Baseline (Day 1), Day 365, Day 533, Day 729
Secondary outcome [26] 0 0
OL; Percentage of Participants With DAS28 (ESR) Remission and Low Disease Activity (LDAS) Over Time
Timepoint [26] 0 0
Baseline (Day 1), Day 365, Day 533, Day 729
Secondary outcome [27] 0 0
OL; Percentage of Participants With Good, Moderate, or No Response According to European League Against Rheumatism (EULAR) Over Time
Timepoint [27] 0 0
DB Days 365, 533, and 729
Secondary outcome [28] 0 0
OL; Percentage of Participants With American College of Rheumatology (ACR) Responses Over Time
Timepoint [28] 0 0
DB Day 197, Day 365, Day 533, Day 729
Secondary outcome [29] 0 0
OL; Percentage of Participants Who Achieved Major Clinical Response
Timepoint [29] 0 0
Defined from the date of achieving ACR 70 response to 6 months post response
Secondary outcome [30] 0 0
OL; Percentage of Participants With Clinically Meaningful Health Assessment Questionnaire-Disability Index (HAQ-DI) Response Over Time
Timepoint [30] 0 0
OL Days 197, 253, 281, 309, 337, 365, 449, 533, 617, and 729
Secondary outcome [31] 0 0
OL; Adjusted Mean Change From Baseline to Day 729 in HAQ-DI
Timepoint [31] 0 0
Day 1 (Baseline), Day 729

Eligibility
Key inclusion criteria
* Diagnosis of Rheumatoid Arthritis
* At least 3 months prior treatment with Methotrexate (MTX)
* At least 10 swollen joints and 12 tender joints and C-Reactive Protein of at least 1 mg/dl
* Washout required for other disease modifying anti-rheumatic drugs (DMARDS)
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* participants who have failed more than 3 DMARDs
* participants previously treated with an approved biologic drug
* History of cancer in the last 5 years
* Severe or recurrent bacterial infection
* Any previous or current medical conditions that are contraindications to the use of TNF blocking agents
* Women of Child Bearing Potential

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
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
1/02/2005
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/07/2009
Sample size
Target
Accrual to date
Final
431
Recruitment in Australia
Recruitment state(s)
QLD,VIC,WA
Recruitment hospital [1] 0 0
Local Institution - Cairns
Recruitment hospital [2] 0 0
Local Institution - Cotton Tree
Recruitment hospital [3] 0 0
Local Institution - Clayton
Recruitment hospital [4] 0 0
Local Institution - Heidelberg
Recruitment hospital [5] 0 0
Local Institution - Malvern
Recruitment hospital [6] 0 0
Local Institution - Parkville
Recruitment hospital [7] 0 0
Local Institution - Perth
Recruitment postcode(s) [1] 0 0
- Cairns
Recruitment postcode(s) [2] 0 0
- Cotton Tree
Recruitment postcode(s) [3] 0 0
- Clayton
Recruitment postcode(s) [4] 0 0
- Heidelberg
Recruitment postcode(s) [5] 0 0
- Malvern
Recruitment postcode(s) [6] 0 0
- Parkville
Recruitment postcode(s) [7] 0 0
- Perth
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
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Indiana
Country [5] 0 0
United States of America
State/province [5] 0 0
Louisiana
Country [6] 0 0
United States of America
State/province [6] 0 0
Massachusetts
Country [7] 0 0
United States of America
State/province [7] 0 0
Mississippi
Country [8] 0 0
United States of America
State/province [8] 0 0
New York
Country [9] 0 0
United States of America
State/province [9] 0 0
North Carolina
Country [10] 0 0
United States of America
State/province [10] 0 0
Ohio
Country [11] 0 0
United States of America
State/province [11] 0 0
Oklahoma
Country [12] 0 0
United States of America
State/province [12] 0 0
Pennsylvania
Country [13] 0 0
United States of America
State/province [13] 0 0
Texas
Country [14] 0 0
Argentina
State/province [14] 0 0
Buenos Aires
Country [15] 0 0
Argentina
State/province [15] 0 0
Cordoba
Country [16] 0 0
Argentina
State/province [16] 0 0
Tucuman
Country [17] 0 0
Brazil
State/province [17] 0 0
Parana
Country [18] 0 0
Brazil
State/province [18] 0 0
Pernambuco
Country [19] 0 0
Brazil
State/province [19] 0 0
Rio Grande Do Sul
Country [20] 0 0
Brazil
State/province [20] 0 0
Rio De Janeiro
Country [21] 0 0
Brazil
State/province [21] 0 0
Sao Paulo
Country [22] 0 0
Canada
State/province [22] 0 0
Alberta
Country [23] 0 0
Canada
State/province [23] 0 0
Manitoba
Country [24] 0 0
Canada
State/province [24] 0 0
Newfoundland and Labrador
Country [25] 0 0
Canada
State/province [25] 0 0
Ontario
Country [26] 0 0
Canada
State/province [26] 0 0
Quebec
Country [27] 0 0
Canada
State/province [27] 0 0
Saskatchewan
Country [28] 0 0
Canada
State/province [28] 0 0
Kitchener
Country [29] 0 0
Czech Republic
State/province [29] 0 0
Prague 2
Country [30] 0 0
Denmark
State/province [30] 0 0
Copenhagen
Country [31] 0 0
Korea, Republic of
State/province [31] 0 0
Seoul
Country [32] 0 0
Mexico
State/province [32] 0 0
Baja California
Country [33] 0 0
Mexico
State/province [33] 0 0
Distrito Federal
Country [34] 0 0
Mexico
State/province [34] 0 0
Guanajuato
Country [35] 0 0
Mexico
State/province [35] 0 0
Jalisco
Country [36] 0 0
Mexico
State/province [36] 0 0
Nuevo Leon
Country [37] 0 0
Mexico
State/province [37] 0 0
San Luis Potosi
Country [38] 0 0
Peru
State/province [38] 0 0
Lima
Country [39] 0 0
Poland
State/province [39] 0 0
Poznan
Country [40] 0 0
Poland
State/province [40] 0 0
Sopot
Country [41] 0 0
Poland
State/province [41] 0 0
Warszawa
Country [42] 0 0
Puerto Rico
State/province [42] 0 0
Rio Piedras
Country [43] 0 0
Russian Federation
State/province [43] 0 0
Moscow
Country [44] 0 0
South Africa
State/province [44] 0 0
Gauteng
Country [45] 0 0
South Africa
State/province [45] 0 0
Kwa Zulu Natal
Country [46] 0 0
South Africa
State/province [46] 0 0
Western Cape
Country [47] 0 0
Spain
State/province [47] 0 0
A Coruna
Country [48] 0 0
Spain
State/province [48] 0 0
Barcelona
Country [49] 0 0
Spain
State/province [49] 0 0
Cordoba
Country [50] 0 0
Spain
State/province [50] 0 0
Madrid
Country [51] 0 0
Sweden
State/province [51] 0 0
Falun
Country [52] 0 0
Sweden
State/province [52] 0 0
Linkoping
Country [53] 0 0
Sweden
State/province [53] 0 0
Lund
Country [54] 0 0
Sweden
State/province [54] 0 0
Stockholm
Country [55] 0 0
Sweden
State/province [55] 0 0
Uppsala
Country [56] 0 0
Switzerland
State/province [56] 0 0
Bern
Country [57] 0 0
Switzerland
State/province [57] 0 0
St. Gallen

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Bristol-Myers Squibb
Address
Country

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Bristol-Myers Squibb
Address 0 0
Bristol-Myers Squibb
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 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/NCT00095147