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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT01526057
Registration number
NCT01526057
Ethics application status
Date submitted
1/02/2012
Date registered
3/02/2012
Titles & IDs
Public title
A Pharmacokinetic/Pharmacodynamic Study Comparing PF-05280586 To Rituximab In Subjects With Active Rheumatoid Arthritis With An Inadequate Response To TNF Inhibitors (REFLECTIONS B328-01)
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Scientific title
A RANDOMIZED, DOUBLE-BLIND, STUDY COMPARING THE PHARMACOKINETICS AND PHARMACODYNAMICS, AND ASSESSING THE SAFETY OF PF-05280586 AND RITUXIMAB IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS ON A BACKGROUND OF METHOTREXATE WHO HAVE HAD AN INADEQUATE RESPONSE TO ONE OR MORE TNF ANTAGONIST THERAPIES
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Secondary ID [1]
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ICON 9002/010
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Secondary ID [2]
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0
B3281001
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Universal Trial Number (UTN)
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Trial acronym
REFLECTIONS
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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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0
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Condition category
Condition code
Musculoskeletal
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0
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0
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Osteoarthritis
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Inflammatory and Immune System
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0
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0
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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: Other - PF-05280586
Treatment: Other - MabThera
Treatment: Other - Rituxan
Experimental: A - PF-05280586 -
Active comparator: B - Rituximab EU -
Active comparator: C- Rituximab-US -
Treatment: Other: PF-05280586
1000 mg, IV on days 1 and 15
Treatment: Other: MabThera
1000 mg, IV on days 1 and 15
Treatment: Other: Rituxan
1000 mg, IV on days 1 and 15
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Intervention code [1]
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Treatment: Other
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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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Maximum Serum Concentration (Cmax) of Rituximab
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Assessment method [1]
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Cmax is the peak serum concentration of study drug (rituximab) after a dose has been administered.
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Timepoint [1]
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Predose (Day 1) and 3, 4.25 (immediately before 1st infusion end), 72, 168, 335 (Day 15 within 1.5 hours before 2nd infusion), 337.5, 339.25 (Day 15 immediately before 2nd infusion end), 408, 504, 672, 1344, and 2016 hours after start of 1st infusion
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Primary outcome [2]
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AUC 0-inf of Rituximab
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Assessment method [2]
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The AUC 0-inf refers to the concentration in serum of the drug over time. It represents the total drug exposure over time, from time 0 (the point of drug administration) extrapolated to infinity.
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Timepoint [2]
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Predose (Day 1) and 3, 4.25 (immediately before 1st infusion end), 72, 168, 335 (Day 15 within 1.5 hours before 2nd infusion), 337.5, 339.25 (Day 15 immediately before 2nd infusion end), 408, 504, 672, 1344, and 2016 hours after start of 1st infusion
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Secondary outcome [1]
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Rituximab AUC From Time 0 to 2 Weeks (AUC 0-2wk)
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Assessment method [1]
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The AUC 0-2wk refers to the concentration in serum of the drug over time. It represents the total drug exposure over time, from time 0 (the point of drug administration) to 2 weeks after drug administration.
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Timepoint [1]
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Predose (Day 1) and 3, 4.25 (immediately before 1st infusion end), 72, 168, 335 (Day 15 within 1.5 hours before 2nd infusion), 337.5, 339.25 (Day 15 immediately before 2nd infusion end), 408, 504, 672, 1344, and 2016 hours after start of 1st infusion
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Secondary outcome [2]
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Rituximab AUC From Time 0 to the Time of the Last Quantifiable Concentration (AUC 0-T)
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Assessment method [2]
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The AUC 0-T refers to the concentration in serum of the drug over time. It represents the total drug exposure over time, from time 0 (the point of drug administration) to the last measured concentration at time T.
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Timepoint [2]
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Predose (Day 1) and 3, 4.25 (immediately before 1st infusion end), 72, 168, 335 (Day 15 within 1.5 hours before 2nd infusion), 337.5, 339.25 (Day 15 immediately before 2nd infusion end), 408, 504, 672, 1344, and 2016 hours after start of 1st infusion
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Secondary outcome [3]
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CD19+ B-cell Count AUC From Time 0 to the Last Measurement at Time T (AUC 0-T,B-cell)
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Assessment method [3]
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The AUC 0-T,B-cell refers to the concentration in serum of B-cells. It represents the total B-cells over time from time 0 (the point of drug administration) to the last measurement taken at time T.
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Timepoint [3]
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Baseline and Weeks 2, 3, 5, 9, 13, 17, 21 and 25 (EOT)
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Secondary outcome [4]
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Minimum Post-Baseline CD19+ B-cell Count (/uL)
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Assessment method [4]
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The lowest CD19+ B-cell count measured in a participant's blood post-baseline.
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Timepoint [4]
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Baseline and Weeks 2, 3, 5, 9, 13, 17, 21 and 25 (EOT)
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Secondary outcome [5]
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Time to Minimum Post-Baseline CD19+ B-cell Count (Weeks)
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Assessment method [5]
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The amount of time in weeks from baseline to the lowest observed CD19+ B-cell count.
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Timepoint [5]
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Baseline and Weeks 2, 3, 5, 9, 13, 17, 21 and 25 (EOT)
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Secondary outcome [6]
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Duration of B-cell Depletion (tB-cell) (Days)
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Assessment method [6]
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The tB-cell is defined as the time interval over which the B-cell count was \<0.3 cells/uL or the detection limit.
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Timepoint [6]
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Baseline and Weeks 2, 3, 5, 9, 13, 17, 21 and 25 (EOT)
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Secondary outcome [7]
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Percentage of Participants With CD19+ B-cell Count Recovery
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Assessment method [7]
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The percentage of participants with CD19+ B-cell counts which fell to \<50% of Baseline value during treatment and which recovered to =50% of Baseline value at End of Treatment.
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Timepoint [7]
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Baseline and Weeks 2, 3, 5, 9, 13, 17, 21 and 25
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Secondary outcome [8]
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Area Under the CD19+ B-cell Count Concentration-time Profile (AUC 0-T, B-cell)
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Assessment method [8]
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The AUC 0-T, B-cell refers to the CD19+ B-cell count over time. It represents the total B-cells over time, from time 0 (the point of drug administration) to the last measured count at time T.
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Timepoint [8]
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Baseline and Weeks 2, 3, 5, 9, 13, 17, 21 and 25 (EOT)
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Secondary outcome [9]
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Baseline and Change From Baseline in Circulating Immunoglobulin-M (IgM) by Visit (Grams Per Liter (g/L])
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Assessment method [9]
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The level of IgM in serum at Baseline and the change from Baseline at each subsequent visit.
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Timepoint [9]
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Baseline and Weeks 1, 2, 3, 4, 5, 9, 13, 17, 21 and 25 (EOT)
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Secondary outcome [10]
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Percent (%) Change From Baseline in Circulating IgM by Visit (g/L)
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Assessment method [10]
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The percentage change from Baseline in circulating IgM by visit.
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Timepoint [10]
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Baseline and Weeks 1, 2, 3, 4, 5, 9, 13, 17, 21 and 25
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Secondary outcome [11]
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Percentage of Participants With American College of Rheumatology (ACR) 20% Improvement (ACR20) Response by Visit
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Assessment method [11]
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ACR20 response: greater than or equal to (=)20% improvement in tender joint count; =20% improvement in swollen joint count; and =20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire \[HAQ\]); and C-Reactive Protein (CRP).
Non-responder imputation categorized participants as having a non-response if they did not have data available at a visit due to missing data or study discontinuation. Participants who rolled over to the extension study were not included in the non-responder imputation from that point on.
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Timepoint [11]
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Weeks 3, 5, 9, 13, 17, 21 and 25
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Secondary outcome [12]
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Percentage of Participants With ACR 70% Improvement (ACR70) Response by Visit
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Assessment method [12]
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ACR70 response: =70% improvement in tender joint count; =70% improvement in swollen joint count; and =70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.
Non-responder imputation categorized participants as having a non-response if they did not have data available at a visit due to missing data or study discontinuation. Participantss who rolled over to the extension study were not included in the non-responder imputation from that point on.
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Timepoint [12]
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Weeks 3, 5, 9, 13, 17, 21 and 25 (EOT)
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Secondary outcome [13]
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Percentage of Participants With ACR 50% Improvement (ACR50) Response by Visit
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Assessment method [13]
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ACR50 response: =50% improvement in tender joint count; =50% improvement in swollen joint count; and =50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.
Non-responder imputation categorized participants as having a non-response if they did not have data available at a visit due to missing data or study discontinuation. Participants who rolled over to the extension study were not included in the non-responder imputation from that point on.
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Timepoint [13]
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Weeks 3, 5, 9, 13, 17, 21 and 25
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Secondary outcome [14]
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Percentage of Participants by Anti-drug Antibody (ADA) Status
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Assessment method [14]
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Presence of anti-rituximab antibodies in blood. Participants with a positive antibody status at any time during the study were defined as having overall positive antibody status; participants with a negative antibody status throughout the study were defined as having overall negative antibody status.
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Timepoint [14]
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Days 1 up to Day 169.
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Secondary outcome [15]
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Percentage of Participants With Neutralizing Antibody (NAb) in Participants With a Positive ADA by Visit
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Assessment method [15]
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Timepoint [15]
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Day 1 up to Day 169
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Secondary outcome [16]
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Change From Baseline in Disease Activity Score Based on 28-Joint Count and C-Reactive Protein (DAS28-CRP)
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Assessment method [16]
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DAS28-CRP was calculated from the swollen joint count and tender joint count using the 28 joints count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-CRP less than or equal to (=)3.2 implied low disease activity, DAS28-CRP greater than (\>)3.2 to =5.1 implied moderate to high disease activity, and DAS28-CRP less than (\<)2.6 implied remission.
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Timepoint [16]
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Baseline and Weeks 3, 5, 9, 13, 17, 21 and 25
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Secondary outcome [17]
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Percent Change From Baseline in DAS28-CRP by Visit
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Assessment method [17]
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DAS28-CRP was calculated from the swollen joint count and tender joint count using the 28 joints count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-CRP less than or equal to (=)3.2 implied low disease activity, DAS28-CRP greater than (\>)3.2 to =5.1 implied moderate to high disease activity, and DAS28-CRP less than (\<)2.6 implied remission.
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Timepoint [17]
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Baseline and Weeks 3, 5, 9, 13, 17, 21 and 25
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Secondary outcome [18]
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Percentage of Participants With Good European League Against Rheumatism (EULAR) Response Based on Disease Activity Score Based on 28-Joint Count (DAS28) by Visit
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Assessment method [18]
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The DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders: change from baseline \>1.2 with DAS28 =3.2; moderate responders: change from baseline \>1.2 with DAS28 \>3.2 to =5.1 or change from baseline \>0.6 to =1.2 with DAS28 =5.1; non-responders: change from baseline =0.6, or change from baseline \>0.6 and =1.2 with DAS28 \>5.1.
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Timepoint [18]
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Weeks 3, 5, 9, 13, 17, 21 and 25
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Secondary outcome [19]
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Percentage of Participants With Moderate EULAR Response Based on Disease Activity Score Based on DAS28 by Visit
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Assessment method [19]
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The DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders: change from baseline \>1.2 with DAS28 =3.2; moderate responders: change from baseline \>1.2 with DAS28 \>3.2 to =5.1 or change from baseline \>0.6 to =1.2 with DAS28 =5.1; non-responders: change from baseline =0.6, or change from baseline \>0.6 and =1.2 with DAS28 \>5.1.
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Timepoint [19]
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Weeks 3, 5, 9, 13, 17, 21 and 25
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Secondary outcome [20]
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Percentage of Participants With No EULAR Response Based on DAS28 by Visit
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Assessment method [20]
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The DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders: change from baseline \>1.2 with DAS28 =3.2; moderate responders: change from baseline \>1.2 with DAS28 \>3.2 to =5.1 or change from baseline \>0.6 to =1.2 with DAS28 =5.1; non-responders: change from baseline =0.6, or change from baseline \>0.6 and =1.2 with DAS28 \>5.1.
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Timepoint [20]
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Weeks 3, 5, 9, 13, 17, 21 and 25
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Secondary outcome [21]
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Percentage of Participants With Low Disease Activity Score (DAS <=3.2) by Visit
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Assessment method [21]
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DAS28-CRP was calculated from the swollen joint count and tender joint count using the 28 joints count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-CRP =3.2 implied low disease activity. p-value of 9999 indicates p-value is not applicable.
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Timepoint [21]
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Weeks 3, 5, 9, 13, 17, 21 and 25
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Secondary outcome [22]
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Percentage of Participants With DAS Remission (DAS <2.6) by Visit
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Assessment method [22]
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DAS28-CRP was calculated from the swollen joint count and tender joint count using the 28 joints count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-CRP \<2.6 implied remission. p-value of 9999 indicates p-value is not applicable.
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Timepoint [22]
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Weeks 3, 5, 9, 13, 17, 21 and 25
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Secondary outcome [23]
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Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) by Visit
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Assessment method [23]
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HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.
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Timepoint [23]
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Baseline, Week 3, 5, 9, 13, 17, 21 and 25
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Secondary outcome [24]
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Percent Change From Baseline in HAQ-DI Score by Visit
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Assessment method [24]
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HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.
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Timepoint [24]
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0
Baseline, Week 3, 5, 9, 13, 17, 21 and 25
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Eligibility
Key inclusion criteria
* Confirmed diagnosis of rheumatoid arthritis
* Meets Class I, II or III of the ACR 1991 Revised Criteria
* RA seropositivity
* Stable dose of methotrexate
* Inadequate response to TNF inhibitors
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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
* Any prior treatment with lymphocyte depleting therapies
* History of active TB infection
* Known or screen test positive for specific viruses or indicators of viral infection
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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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
Blinded (masking used)
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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
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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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
20/03/2012
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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
7/05/2014
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Sample size
Target
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Accrual to date
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Final
220
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Recruitment in Australia
Recruitment state(s)
QLD,SA,VIC
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Recruitment hospital [1]
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0
Rheumatology Research Unit - Maroochydore
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Recruitment hospital [2]
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0
The Queen Elizabeth Hospital, Department of Rheumatology - Woodville South
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Recruitment hospital [3]
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0
St. Vincent's Hospital (Melbourne) - Fitzroy
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Recruitment postcode(s) [1]
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0
4558 - Maroochydore
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Recruitment postcode(s) [2]
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0
5011 - Woodville South
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Recruitment postcode(s) [3]
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0
03065 - Fitzroy
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Recruitment outside Australia
Country [1]
0
0
United States of America
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State/province [1]
0
0
Alabama
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Country [2]
0
0
United States of America
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State/province [2]
0
0
Arizona
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Country [3]
0
0
United States of America
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State/province [3]
0
0
Arkansas
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Country [4]
0
0
United States of America
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State/province [4]
0
0
California
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Country [5]
0
0
United States of America
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State/province [5]
0
0
Connecticut
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Country [6]
0
0
United States of America
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State/province [6]
0
0
Florida
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Country [7]
0
0
United States of America
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State/province [7]
0
0
Illinois
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Country [8]
0
0
United States of America
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State/province [8]
0
0
Kentucky
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Country [9]
0
0
United States of America
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State/province [9]
0
0
Maryland
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Country [10]
0
0
United States of America
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State/province [10]
0
0
Massachusetts
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Country [11]
0
0
United States of America
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State/province [11]
0
0
Michigan
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Country [12]
0
0
United States of America
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State/province [12]
0
0
Nevada
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Country [13]
0
0
United States of America
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State/province [13]
0
0
New Hampshire
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Country [14]
0
0
United States of America
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State/province [14]
0
0
New York
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Country [15]
0
0
United States of America
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State/province [15]
0
0
North Carolina
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Country [16]
0
0
United States of America
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State/province [16]
0
0
Ohio
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Country [17]
0
0
United States of America
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State/province [17]
0
0
Oklahoma
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Country [18]
0
0
United States of America
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State/province [18]
0
0
Pennsylvania
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Country [19]
0
0
United States of America
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State/province [19]
0
0
Tennessee
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Country [20]
0
0
United States of America
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State/province [20]
0
0
Texas
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Country [21]
0
0
Canada
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State/province [21]
0
0
Quebec
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Country [22]
0
0
Colombia
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State/province [22]
0
0
Antioquia
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Country [23]
0
0
Colombia
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State/province [23]
0
0
Atlantico
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Country [24]
0
0
Colombia
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State/province [24]
0
0
Atlántico
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Country [25]
0
0
Germany
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State/province [25]
0
0
Berlin
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Country [26]
0
0
Israel
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State/province [26]
0
0
Ramat Gan
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Country [27]
0
0
Mexico
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State/province [27]
0
0
D.f.
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Country [28]
0
0
Mexico
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State/province [28]
0
0
Jalisco
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Country [29]
0
0
Mexico
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State/province [29]
0
0
Durango
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Country [30]
0
0
Mexico
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State/province [30]
0
0
San Luis Potosi
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Country [31]
0
0
Russian Federation
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State/province [31]
0
0
Novosibirsk Region
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Country [32]
0
0
Russian Federation
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State/province [32]
0
0
Tatarstan
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Country [33]
0
0
Russian Federation
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State/province [33]
0
0
Kemerovo
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Country [34]
0
0
Russian Federation
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State/province [34]
0
0
Nizhny Novgorod
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Country [35]
0
0
Russian Federation
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State/province [35]
0
0
Saint-Petersburg
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Country [36]
0
0
Russian Federation
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State/province [36]
0
0
Samara
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Country [37]
0
0
Russian Federation
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State/province [37]
0
0
St. Petersburg
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Country [38]
0
0
Russian Federation
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State/province [38]
0
0
Tomsk
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Country [39]
0
0
South Africa
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State/province [39]
0
0
Cape Town
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Country [40]
0
0
South Africa
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State/province [40]
0
0
Kwa-zulu Natal
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Country [41]
0
0
United Kingdom
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State/province [41]
0
0
UK
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Country [42]
0
0
United Kingdom
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State/province [42]
0
0
Leeds
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Country [43]
0
0
United Kingdom
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State/province [43]
0
0
London
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Pfizer
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Address
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Country
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Ethics approval
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Summary
Brief summary
In this study, patients with moderate to severe rheumatoid arthritis who are being treated with methotrexate will receive 2 intravenous treatments with either PF-05280586 or Rituxan (Rituximab) or MabThera (Rituximab). During the course of the study, the effects of the drugs will be assessed by sampling the levels of drug in the blood, blood cell counts, and by comparing these levels among the different treatments. Safety, tolerability and immunologic response also will be evaluated throughout.
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Trial website
https://clinicaltrials.gov/study/NCT01526057
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Trial related presentations / publications
Williams JH, Hutmacher MM, Zierhut ML, Becker JC, Gumbiner B, Spencer-Green G, Melia LA, Liao KH, Suster M, Yin D, Li R, Meng X. Comparative assessment of clinical response in patients with rheumatoid arthritis between PF-05280586, a proposed rituximab biosimilar, and rituximab. Br J Clin Pharmacol. 2016 Dec;82(6):1568-1579. doi: 10.1111/bcp.13094. Epub 2016 Sep 22.
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Public notes
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Contacts
Principal investigator
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Pfizer CT.gov Call Center
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Pfizer
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
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When will data be available (start and end dates)?
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Available to whom?
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Available for what types of analyses?
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How or where can data be obtained?
IPD available at link: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests
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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/NCT01526057