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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT01643928
Registration number
NCT01643928
Ethics application status
Date submitted
6/07/2012
Date registered
18/07/2012
Titles & IDs
Public title
Rheumatoid Arthritis Extension Trial For Subjects Who Have Participated In Other PF-05280586 Trials (REFLECTIONS B328-04)
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Scientific title
EXTENSION STUDY EVALUATING TREATMENT WITH PF-05280586 VERSUS RITUXIMAB IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS WHO HAVE PARTICIPATED IN OTHER PF-05280586 CLINICAL TRIALS
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Secondary ID [1]
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ICON 9002/0101
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Secondary ID [2]
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B3281004
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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: Other - Rituximab-Pfizer (PF-05280586) x 3 courses
Treatment: Other - Rituximab-EU+ Rituximab-Pfizer x 2 Courses
Treatment: Other - Rituximab-US + Rituximab-Pfizer x 2 Courses
Experimental: Rituximab-Pfizer -
Active comparator: Rituximab-EU+Rituximab-Pfizer - Subjects will receive Rituximab-EU x 1 course followed by Rituximab-Pfizer x 2 courses.
Active comparator: Rituximab-US+Rituximab-Pfizer - Subjects will receive Rituximab-US x 1 course followed by Rituximab-Pfizer x 2 courses.
Treatment: Other: Rituximab-Pfizer (PF-05280586) x 3 courses
1000 mg intravenous infusion \[IV\] on Days 1 and 15 of each 24 week treatment course for up to 3 treatment courses
Treatment: Other: Rituximab-EU+ Rituximab-Pfizer x 2 Courses
Subjects will receive Rituximab-EU x 1 course followed by Rituximab-Pfizer x 2 courses. 1000 mg IV infusion of Rituximab-EU on Days 1 and 15 of a 24 week treatment course followed by 1000 mg IV infusion of PF-05280586 on Days 1 and 15 of each 24 week course for up to 2 additional treatment courses
Treatment: Other: Rituximab-US + Rituximab-Pfizer x 2 Courses
Subjects will receive Rituximab-US x 1 course followed by Rituximab-Pfizer x 2 courses. 1000 mg IV infusion of Rituximab-US on Days 1 and 15 of a 24 week treatment course followed by 1000 mg IV infusion of PF-05280586 on Days 1 and 15 of each 24 week course for up to 2 additional treatment courses
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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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Percentage of Participants by Anti-Drug Antibody (ADA) Status Using Anti-PF-05280586 Antibody Assay
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Assessment method [1]
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Serum samples were collected to determine the presence of ADA using two validated assays, one specific for PF-05280586 and one specific for the licensed drug products. For participants assigned to PF-05280586 in Study B3281001, blood samples were screened for ADA using the assay specific to PF-05280586; if the blood samples were confirmed to be positive (+ve) for ADA against PF-05280586, the samples were also analyzed using the assay specific for the licensed drug products to assess cross-reactivity of the ADA. For participants assigned to the licensed products in Study B3281001, blood samples were screened for ADA using both assays in order to assess any product-specific ADA and/or cross-reactivity for the transition from the licensed products to PF-05280586.
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Timepoint [1]
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Course 1 (C1) Overall, Course 2 (C2) Overall, Course 3 (C3) Overall, and All Courses Overall.
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Primary outcome [2]
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Percentage of Participants by ADA Status Using Anti-Rituximab Antibody Assay
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Assessment method [2]
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Serum samples were collected to determine the presence of ADA using two validated assays, one specific for PF-05280586 and one specific for the licensed drug products. For participants assigned to PF-05280586 in Study B3281001, blood samples were screened for ADA using the assay specific to PF-05280586; if the blood samples were confirmed to be positive for ADA against PF-05280586, the samples were also analyzed using the assay specific for the licensed drug products to assess cross-reactivity of the ADA. For participants assigned to the licensed products in Study B3281001, blood samples were screened for ADA using both assays in order to assess any product-specific ADA and/or cross-reactivity for the transition from the licensed products to PF-05280586.
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Timepoint [2]
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Course 1 Overall, Course 2 Overall, Course 3 Overall, and All Courses Overall.
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Primary outcome [3]
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Percentage of Participants by Neutralizing Antibody (Nab) Status in Participants With a Positive ADA Using Anti-PF-05280586 NAb Assay
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Assessment method [3]
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Blood samples that were confirmed as positive for ADA were further evaluated for Nab using validated assays - None of the ADA samples tested positive for NAb.
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Timepoint [3]
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Weeks 1, 3, 13, and 25 (Course 1, Course 2, and Course 3).
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Primary outcome [4]
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Percentage of Participants by Nab Status in Participants With a Positive ADA Using Anti-PF-05280586 NAb Assay Using Anti-Rituximab NAb Assay
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Assessment method [4]
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Blood samples that were confirmed as positive for ADA were further evaluated for Nab using validated assays. - None of the ADA samples tested positive for NAb.
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Timepoint [4]
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Weeks 1, 3, 13, and 25 (Course 1, Course 2, and Course 3).
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Primary outcome [5]
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Mean Rituximab Serum Trough Concentrations
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Assessment method [5]
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Serum samples for determination of drug concentrations were collected pre-dose concurrent with ADA sample collection. Drug concentrations in the samples were determined using a validated assay.
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Timepoint [5]
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Weeks 1, 3, 13, and 25 (Course 1, Course 2, and Course 3), Follow up Months 3, 6, 9, and 12. Course 3/Week 25 is End of Treatment (EOT).
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Primary outcome [6]
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Cluster of Differentiation 19 (CD19+) B Cell Count
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Assessment method [6]
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Blood samples were assayed for CD19+ B-cell counts using laser scanning cytometry.
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Timepoint [6]
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Weeks 1, 6, 13, and 25 (Course 1 and Course 2), Weeks 1, 13, 25 (Course 3), and Follow up Months 3, 6, and 9.
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Primary outcome [7]
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Circulating Immunoglobulin G (IgG) Concentrations
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Assessment method [7]
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Blood samples for immunoglobulin assessments were obtained to determine IgG levels in serum.
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Timepoint [7]
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Screening, Week 25 (Course 1), and Weeks 1 and 25 (Course 2 and Course 3).
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Primary outcome [8]
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Circulating Immunoglobulin M (IgM) Concentrations
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Assessment method [8]
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Blood samples for immunoglobulin assessments were obtained to determine IgM levels in serum.
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Timepoint [8]
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Screening, Week 25 (Course 1), and Weeks 1 and 25 (Course 2 and Course 3).
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Primary outcome [9]
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Circulating Rheumatoid Factor (RF) Concentrations
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Assessment method [9]
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RF is the auto-antibody directed against IgG. Blood samples were obtained to determine RF levels in serum.
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Timepoint [9]
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Week 1 and 25 (Course 1, Course 2, and Course 3).
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Primary outcome [10]
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Anti-Cyclic Citrullinated Peptide (Anti-CCP) and Complement
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Assessment method [10]
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Blood samples were obtained to determine anti-CCP and compliment levels in serum.
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Timepoint [10]
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Week 1 and 25 (Course 1, Course 2, and Course 3).
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Primary outcome [11]
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Mean Change From Initial Study Baseline in Disease Activity Score (DAS28)-C-Reactive Protein (CRP) - by the End of Course 1
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Assessment method [11]
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The disease activity score (DAS) assessment is a continuous composite measure derived using differential weighting given to the following 4 components: tender/painful joint count (28 joints), swollen joint count (28 joints), CRP and patient's global assessment of arthritis Visual Analog Scale (VAS). The formula for calculation of DAS28-CRP from these 4 components is DAS28-CRP equals (=) 0.56 square root (sqrt) (DAS 28 tender joint count) + 0.28 sqrt (DAS 28 swollen joint count) + 0.36 natural log \[ln\] (CRP \[milligrams per liter, mg/L\] +1) + 0.014 (global assessment of health \[GH\]) + 0.96. Total score range: 0 to 9.4, higher score indicated more disease activity.
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Timepoint [11]
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Baseline B3281001, Week 1, 6, 13, and 25 (Course 1).
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Primary outcome [12]
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Mean Change From Initial Study Baseline in Disease Activity Score (DAS28)-C-Reactive Protein (CRP) - by the End of Course 2
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Assessment method [12]
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The disease activity score (DAS) assessment is a continuous composite measure derived using differential weighting given to the following 4 components: tender/painful joint count (28 joints), swollen joint count (28 joints), CRP and patient's global assessment of arthritis Visual Analog Scale (VAS). The formula for calculation of DAS28-CRP from these 4 components is DAS28-CRP equals (=) 0.56 square root (sqrt) (DAS 28 tender joint count) + 0.28 sqrt (DAS 28 swollen joint count) + 0.36 natural log \[ln\] (CRP \[milligrams per liter, mg/L\] +1) + 0.014 (global assessment of health \[GH\]) + 0.96. Total score range: 0 to 9.4, higher score indicated more disease activity.
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Timepoint [12]
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Baseline B3281001, Week 1, 6, 13, and 25 (Course 1 and Course 2).
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Primary outcome [13]
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Mean Change From Initial Study Baseline in Disease Activity Score (DAS28)-C-Reactive Protein (CRP) - by the End of Course 3
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Assessment method [13]
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0
The disease activity score (DAS) assessment is a continuous composite measure derived using differential weighting given to the following 4 components: tender/painful joint count (28 joints), swollen joint count (28 joints), CRP and patient's global assessment of arthritis Visual Analog Scale (VAS). The formula for calculation of DAS28-CRP from these 4 components is DAS28-CRP equals (=) 0.56 square root (sqrt) (DAS 28 tender joint count) + 0.28 sqrt (DAS 28 swollen joint count) + 0.36 natural log \[ln\] (CRP \[milligrams per liter, mg/L\] +1) + 0.014 (global assessment of health \[GH\]) + 0.96. Total score range: 0 to 9.4, higher score indicated more disease activity.
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Timepoint [13]
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Baseline B3281001, Week 1, 6, 13, and 25 (Course 1 and Course 2), and Week 1, 13, and 25 (Course 3).
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Primary outcome [14]
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Percentage of Participants With Good European League Against Rheumatism (EULAR) Response Based on DAS28 - by the End of Course 1
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Assessment method [14]
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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 had a change from baseline greater than (\>) 1.2 with present DAS28 less than or equal to (=) 3.2; moderate responders had a change from baseline \>0.6 and =1.2 with present DAS28 =3.2 or change from baseline \>0.6 with present DAS28 \>3.2 and =5.1 or change from baseline \>1.2 with present DAS28 \>5.1; non-responders had a change from baseline =0.6 with present DAS28 =5.1 or change from baseline =1.2 with present DAS28 \>5.1.
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Timepoint [14]
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Week 1, 6, 13, and 25 (Course 1).
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Primary outcome [15]
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Percentage of Participants With Good European League Against Rheumatism (EULAR) Response Based on DAS28 - by the End of Course 2
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Assessment method [15]
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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 had a change from baseline greater than (\>) 1.2 with present DAS28 less than or equal to (=) 3.2; moderate responders had a change from baseline \>0.6 and =1.2 with present DAS28 =3.2 or change from baseline \>0.6 with present DAS28 \>3.2 and =5.1 or change from baseline \>1.2 with present DAS28 \>5.1; non-responders had a change from baseline =0.6 with present DAS28 =5.1 or change from baseline =1.2 with present DAS28 \>5.1.
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Timepoint [15]
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0
Week 1, 6, 13, and 25 (Course 1 and Course 2).
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Primary outcome [16]
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Percentage of Participants With Good European League Against Rheumatism (EULAR) Response Based on DAS28 - by the End of Course 3
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Assessment method [16]
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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 had a change from baseline greater than (\>) 1.2 with present DAS28 less than or equal to (=) 3.2; moderate responders had a change from baseline \>0.6 and =1.2 with present DAS28 =3.2 or change from baseline \>0.6 with present DAS28 \>3.2 and =5.1 or change from baseline \>1.2 with present DAS28 \>5.1; non-responders had a change from baseline =0.6 with present DAS28 =5.1 or change from baseline =1.2 with present DAS28 \>5.1.
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Timepoint [16]
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Week 1, 6, 13, and 25 (Course 1 and Course 2) and Week 1, 13, and 25 (Course 3).
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Primary outcome [17]
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Percentage of Participants With Low Disease Activity State (LDAS) (=3.2) - by the End of Course 1
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Assessment method [17]
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The DAS assessment is a continuous composite measure derived using differential weighting given to the following 4 components: tender/painful joint count (28 joints), swollen joint count (28 joints), CRP and patient's global assessment of arthritis VAS. The formula for calculation of DAS28-CRP from these 4 components is DAS28-CRP = 0.56 sqrt (DAS 28 tender joint count) + 0.28 sqrt (DAS 28 swollen joint count) + 0.36 (ln CRP \[mg/L\] +1) + 0.014 (GH) + 0.96. Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-CRP =3.2 implied low disease activity.
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Timepoint [17]
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Week 1, 6, 13, and 25 (Course 1).
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Primary outcome [18]
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Percentage of Participants With Low Disease Activity State (LDAS) (=3.2) - by the End of Course 2
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Assessment method [18]
0
0
The DAS assessment is a continuous composite measure derived using differential weighting given to the following 4 components: tender/painful joint count (28 joints), swollen joint count (28 joints), CRP and patient's global assessment of arthritis VAS. The formula for calculation of DAS28-CRP from these 4 components is DAS28-CRP = 0.56 sqrt (DAS 28 tender joint count) + 0.28 sqrt (DAS 28 swollen joint count) + 0.36 (ln CRP \[mg/L\] +1) + 0.014 (GH) + 0.96. Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-CRP =3.2 implied low disease activity.
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Timepoint [18]
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Week 1, 6, 13, and 25 (Course 1 and Course 2).
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Primary outcome [19]
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Percentage of Participants With Low Disease Activity State (LDAS) (=3.2) - by the End of Course 3
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Assessment method [19]
0
0
The DAS assessment is a continuous composite measure derived using differential weighting given to the following 4 components: tender/painful joint count (28 joints), swollen joint count (28 joints), CRP and patient's global assessment of arthritis VAS. The formula for calculation of DAS28-CRP from these 4 components is DAS28-CRP = 0.56 sqrt (DAS 28 tender joint count) + 0.28 sqrt (DAS 28 swollen joint count) + 0.36 (ln CRP \[mg/L\] +1) + 0.014 (GH) + 0.96. Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-CRP =3.2 implied low disease activity.
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Timepoint [19]
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0
Week 1, 6, 13, and 25 (Course 1 and Course 2), and Week 1, 13, and 25 (Course 3).
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Primary outcome [20]
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Percentage of Participants With DAS Remission (DAS28-CRP Less Than [<] 2.6) - by the End of Course 1
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Assessment method [20]
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The DAS assessment is a continuous composite measure derived using differential weighting given to the following 4 components: tender/painful joint count (28 joints), swollen joint count (28 joints), CRP and patient's global assessment of arthritis VAS. The formula for calculation of DAS28-CRP from these 4 components is DAS28-CRP = 0.56 sqrt (DAS 28 tender joint count) + 0.28 sqrt (DAS 28 swollen joint count) + 0.36 (ln CRP \[mg/L\] +1) + 0.014 (GH) + 0.96. Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-CRP \<2.6 implied remission.
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Timepoint [20]
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Week 1, 6, 13, and 25 (Course 1).
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Primary outcome [21]
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Percentage of Participants With DAS Remission (DAS28-CRP Less Than [<] 2.6) - by the End of Course 2
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Assessment method [21]
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0
The DAS assessment is a continuous composite measure derived using differential weighting given to the following 4 components: tender/painful joint count (28 joints), swollen joint count (28 joints), CRP and patient's global assessment of arthritis VAS. The formula for calculation of DAS28-CRP from these 4 components is DAS28-CRP = 0.56 sqrt (DAS 28 tender joint count) + 0.28 sqrt (DAS 28 swollen joint count) + 0.36 (ln CRP \[mg/L\] +1) + 0.014 (GH) + 0.96. Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-CRP \<2.6 implied remission.
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Timepoint [21]
0
0
Week 1, 6, 13, and 25 (Course 1 and Course 2).
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Primary outcome [22]
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0
Percentage of Participants With DAS Remission (DAS28-CRP Less Than [<] 2.6) - by the End of Course 3
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Assessment method [22]
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0
The DAS assessment is a continuous composite measure derived using differential weighting given to the following 4 components: tender/painful joint count (28 joints), swollen joint count (28 joints), CRP and patient's global assessment of arthritis VAS. The formula for calculation of DAS28-CRP from these 4 components is DAS28-CRP = 0.56 sqrt (DAS 28 tender joint count) + 0.28 sqrt (DAS 28 swollen joint count) + 0.36 (ln CRP \[mg/L\] +1) + 0.014 (GH) + 0.96. Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-CRP \<2.6 implied remission.
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Timepoint [22]
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0
Week 1, 6, 13, and 25 (Course 1 and Course 2), and Week 1, 13, and 25 (Course 3).
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Primary outcome [23]
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Percentage of Participants With American College of Rheumatology (ACR) 20% Improvement (ACR20) Response - by the End of Course 1
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Assessment method [23]
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ACR20 response: = 20 percent (%) improvement in tender/painful joint count; = 20% improvement in swollen joint count; and = 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of arthritis pain; participant global assessment of arthritis; physician global assessment of arthritis; self-assessed disability (disability index of the Health Assessment Questionnaire \[HAQ\]); and CRP.
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Timepoint [23]
0
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Week 1, 6, 13, and 25 (Course 1).
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Primary outcome [24]
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Percentage of Participants With American College of Rheumatology (ACR) 20% Improvement (ACR20) Response - by the End of Course 2
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Assessment method [24]
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ACR20 response: = 20 percent (%) improvement in tender/painful joint count; = 20% improvement in swollen joint count; and = 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of arthritis pain; participant global assessment of arthritis; physician global assessment of arthritis; self-assessed disability (disability index of the Health Assessment Questionnaire \[HAQ\]); and CRP.
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Timepoint [24]
0
0
Week 1, 6, 13, and 25 (Course 1 and Course 2).
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Primary outcome [25]
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0
Percentage of Participants With American College of Rheumatology (ACR) 20% Improvement (ACR20) Response - by the End of Course 3
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Assessment method [25]
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ACR20 response: = 20 percent (%) improvement in tender/painful joint count; = 20% improvement in swollen joint count; and = 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of arthritis pain; participant global assessment of arthritis; physician global assessment of arthritis; self-assessed disability (disability index of the Health Assessment Questionnaire \[HAQ\]); and CRP.
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Timepoint [25]
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0
Week 1, 6, 13, and 25 (Course 1 and Course 2), and Week 1, 13, and 25 (Course 3).
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Primary outcome [26]
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Percentage of Participants With American College of Rheumatology (ACR) 50% Improvement (ACR50) Response - by the End of Course 1
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Assessment method [26]
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ACR50 response: =50% improvement in tender/painful joint count; =50% improvement in swollen joint count; and =50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of arthritis pain; participant global assessment of arthritis; physician global assessment of arthritis; self-assessed disability (disability index of the HAQ); and CRP.
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Timepoint [26]
0
0
Week 1, 6, 13, and 25 (Course 1).
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Primary outcome [27]
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0
Percentage of Participants With American College of Rheumatology (ACR) 50% Improvement (ACR50) Response - by the End of Course 2
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Assessment method [27]
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0
ACR50 response: =50% improvement in tender/painful joint count; =50% improvement in swollen joint count; and =50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of arthritis pain; participant global assessment of arthritis; physician global assessment of arthritis; self-assessed disability (disability index of the HAQ); and CRP.
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Timepoint [27]
0
0
Week 1, 6, 13, and 25 (Course 1 and Course 2).
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Primary outcome [28]
0
0
Percentage of Participants With American College of Rheumatology (ACR) 50% Improvement (ACR50) Response - by the End of Course 3
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Assessment method [28]
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0
ACR50 response: =50% improvement in tender/painful joint count; =50% improvement in swollen joint count; and =50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of arthritis pain; participant global assessment of arthritis; physician global assessment of arthritis; self-assessed disability (disability index of the HAQ); and CRP.
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Timepoint [28]
0
0
Week 1, 6, 13, and 25 (Course 1 and Course 2), and Week 1, 13, and 25 (Course 3).
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Primary outcome [29]
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0
Percentage of Participants With American College of Rheumatology (ACR) 70% Improvement (ACR70) Response - by the End of Course 1
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Assessment method [29]
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0
ACR70 response: =70% improvement in tender/painful joint count; =70% improvement in swollen joint count; and =70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of arthritis pain; participant global assessment of arthritis; physician global assessment of arthritis; self-assessed disability (disability index of the HAQ); and CRP.
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Timepoint [29]
0
0
Week 1, 6, 13, and 25 (Course 1).
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Primary outcome [30]
0
0
Percentage of Participants With American College of Rheumatology (ACR) 70% Improvement (ACR70) Response - by the End of Course 2
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Assessment method [30]
0
0
ACR70 response: =70% improvement in tender/painful joint count; =70% improvement in swollen joint count; and =70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of arthritis pain; participant global assessment of arthritis; physician global assessment of arthritis; self-assessed disability (disability index of the HAQ); and CRP.
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Timepoint [30]
0
0
Week 1, 6, 13, and 25 (Course 1 and Course 2).
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Primary outcome [31]
0
0
Percentage of Participants With American College of Rheumatology (ACR) 70% Improvement (ACR70) Response - by the End of Course 3
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Assessment method [31]
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0
ACR70 response: =70% improvement in tender/painful joint count; =70% improvement in swollen joint count; and =70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of arthritis pain; participant global assessment of arthritis; physician global assessment of arthritis; self-assessed disability (disability index of the HAQ); and CRP.
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Timepoint [31]
0
0
Week 1, 6, 13, and 25 (Course 1 and Course 2), and Week 1, 13, and 25 (Course 3).
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Primary outcome [32]
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0
Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Tender/Painful Joint Count - by the End of Course 1
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Assessment method [32]
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0
Sixty-eight joints were assessed by a blinded joint assessor to determine the number of joints that were considered tender or painful. For consistency, a single assessor was preferred to perform all evaluations across the study for an individual participant. The response to pressure/motion on each joint was assessed using the following scale: Present/Absent/Not Done/Not Applicable (to be used for artificial or missing joints). Artificial joints were not be assessed.
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Timepoint [32]
0
0
Screening, Week 1, 6, 13, and 25 (Course 1).
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Primary outcome [33]
0
0
Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Tender/Painful Joint Count - by the End of Course 2
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Assessment method [33]
0
0
Sixty-eight joints were assessed by a blinded joint assessor to determine the number of joints that were considered tender or painful. For consistency, a single assessor was preferred to perform all evaluations across the study for an individual participant. The response to pressure/motion on each joint was assessed using the following scale: Present/Absent/Not Done/Not Applicable (to be used for artificial or missing joints). Artificial joints were not be assessed.
Query!
Timepoint [33]
0
0
Screening, Week 1, 6, 13, and 25 (Course 1 and Course 2).
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Primary outcome [34]
0
0
Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Tender/Painful Joint Count - by the End of Course 3
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Assessment method [34]
0
0
Sixty-eight joints were assessed by a blinded joint assessor to determine the number of joints that were considered tender or painful. For consistency, a single assessor was preferred to perform all evaluations across the study for an individual participant. The response to pressure/motion on each joint was assessed using the following scale: Present/Absent/Not Done/Not Applicable (to be used for artificial or missing joints). Artificial joints were not be assessed.
Query!
Timepoint [34]
0
0
Screening, Week 1, 6, 13, and 25 (Course 1 and Course 2), and Screening, Week 1, 13, and 25 (Course 3).
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Primary outcome [35]
0
0
Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Swollen Joint Count - by the End of Course 1
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Assessment method [35]
0
0
Sixty-six joints were assessed by a blinded joint assessor for swelling. For consistency, a single assessor was preferred to perform all evaluations across the study for an individual participant. The response was assessed using the following scale: Present/Absent/Not Done/Not Applicable (to be used for artificial or missing joints). Artificial joints were not be assessed.
Query!
Timepoint [35]
0
0
Screening, Week 1, 6, 13, and 25 (Course 1).
Query!
Primary outcome [36]
0
0
Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Swollen Joint Count - by the End of Course 2
Query!
Assessment method [36]
0
0
Sixty-six joints were assessed by a blinded joint assessor for swelling. For consistency, a single assessor was preferred to perform all evaluations across the study for an individual participant. The response was assessed using the following scale: Present/Absent/Not Done/Not Applicable (to be used for artificial or missing joints). Artificial joints were not be assessed.
Query!
Timepoint [36]
0
0
Screening, Week 1, 6, 13, and 25 (Course 1 and Course 2).
Query!
Primary outcome [37]
0
0
Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Swollen Joint Count - by the End of Course 3
Query!
Assessment method [37]
0
0
Sixty-six joints were assessed by a blinded joint assessor for swelling. For consistency, a single assessor was preferred to perform all evaluations across the study for an individual participant. The response was assessed using the following scale: Present/Absent/Not Done/Not Applicable (to be used for artificial or missing joints). Artificial joints were not be assessed.
Query!
Timepoint [37]
0
0
Screening, Week 1, 6, 13, and 25 (Course 1 and Course 2), and Screening, Week 1, 13, and 25 (Course 3).
Query!
Primary outcome [38]
0
0
Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Assessment of Arthritis Pain - by the End of Course 1
Query!
Assessment method [38]
0
0
Participants assessed the severity of their arthritis pain using a 100 millimeter (mm) VAS by placing a mark on the scale between 0 (no pain) and 100 (most severe pain), which corresponded to the magnitude of their pain.
Query!
Timepoint [38]
0
0
Week 1, 6, 13, and 25 (Course 1).
Query!
Primary outcome [39]
0
0
Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Assessment of Arthritis Pain - by the End of Course 2
Query!
Assessment method [39]
0
0
Participants assessed the severity of their arthritis pain using a 100 millimeter (mm) VAS by placing a mark on the scale between 0 (no pain) and 100 (most severe pain), which corresponded to the magnitude of their pain.
Query!
Timepoint [39]
0
0
Week 1, 6, 13, and 25 (Course 1 and Course 2).
Query!
Primary outcome [40]
0
0
Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Assessment of Arthritis Pain - by the End of Course 3
Query!
Assessment method [40]
0
0
Participants assessed the severity of their arthritis pain using a 100 millimeter (mm) VAS by placing a mark on the scale between 0 (no pain) and 100 (most severe pain), which corresponded to the magnitude of their pain.
Query!
Timepoint [40]
0
0
Week 1, 6, 13, and 25 (Course 1 and Course 2), and Week 1, 13, and 25 (Course 3).
Query!
Primary outcome [41]
0
0
Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Global Assessment of Arthritis - by the End of Course 1
Query!
Assessment method [41]
0
0
Participants were asked the following question, "Considering all the ways your arthritis affects you, how are you feeling today?" Their response was recorded using a 100 mm VAS between 0 (very well) and 100 (very poor).
Query!
Timepoint [41]
0
0
Week 1, 6, 13, and 25 (Course 1).
Query!
Primary outcome [42]
0
0
Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Global Assessment of Arthritis - by the End of Course 2
Query!
Assessment method [42]
0
0
Participants were asked the following question, "Considering all the ways your arthritis affects you, how are you feeling today?" Their response was recorded using a 100 mm VAS between 0 (very well) and 100 (very poor).
Query!
Timepoint [42]
0
0
Week 1, 6, 13, and 25 (Course 1 and Course 2).
Query!
Primary outcome [43]
0
0
Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Global Assessment of Arthritis - by the End of Course 3
Query!
Assessment method [43]
0
0
Participants were asked the following question, "Considering all the ways your arthritis affects you, how are you feeling today?" Their response was recorded using a 100 mm VAS between 0 (very well) and 100 (very poor).
Query!
Timepoint [43]
0
0
Week 1, 6, 13, and 25 (Course 1 and Course 2), and Week 1, 13, and 25 (Course 3).
Query!
Primary outcome [44]
0
0
Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Physician's Global Assessment of Arthritis - by the End of Course 1
Query!
Assessment method [44]
0
0
The investigator assessed how the participant's overall arthritis appeared at the time of the visit. This evaluation was based on the participant's disease signs, functional capacity and physical examination, and was independent of the Patient's Global Assessment of Arthritis. The investigator's response was recorded using a 100 mm VAS by placing a mark on the scale between 0 (very good) and 100 (very poor).
Query!
Timepoint [44]
0
0
Week 1, 6, 13, and 25 (Course 1).
Query!
Primary outcome [45]
0
0
Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Physician's Global Assessment of Arthritis - by the End of Course 2
Query!
Assessment method [45]
0
0
The investigator assessed how the participant's overall arthritis appeared at the time of the visit. This evaluation was based on the participant's disease signs, functional capacity and physical examination, and was independent of the Patient's Global Assessment of Arthritis. The investigator's response was recorded using a 100 mm VAS by placing a mark on the scale between 0 (very good) and 100 (very poor).
Query!
Timepoint [45]
0
0
Week 1, 6, 13, and 25 (Course 1 and Course 2).
Query!
Primary outcome [46]
0
0
Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Physician's Global Assessment of Arthritis - by the End of Course 3
Query!
Assessment method [46]
0
0
The investigator assessed how the participant's overall arthritis appeared at the time of the visit. This evaluation was based on the participant's disease signs, functional capacity and physical examination, and was independent of the Patient's Global Assessment of Arthritis. The investigator's response was recorded using a 100 mm VAS by placing a mark on the scale between 0 (very good) and 100 (very poor).
Query!
Timepoint [46]
0
0
Week 1, 6, 13, and 25 (Course 1 and Course 2), and Week 1, 13, and 25 (Course 3).
Query!
Primary outcome [47]
0
0
Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Health Assessment Questionnaire - Disability Index (HAQ-DI) - by the End of Course 1
Query!
Assessment method [47]
0
0
HAQ-DI assessed the degree of difficulty participants experienced in 8 daily living activity domains during a week: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and other activities. Each activity category consisted of 2-3 items. Each question's difficulty was scored from 0-3 (0=no difficulty, 1=some difficulty, 2=much difficulty, 3=unable to do). Activities requiring assistance (from people or assistive devices) were adjusted to =2 to denote more limited functional status. The questionnaire was to be completed by the participant prior to any procedures during the visit, if possible.
Overall HAQ-DI score was computed as the sum of domain scores divided by the number of domains answered, providing a score from 0-3. Low scores denoted improvement of disability/lower degree of domain difficulty.
Primary outcomes reported post baseline mean percent (%) changes in HAQ-DI score. Post baseline values are reported on the % change from initial study Baseline scale.
Query!
Timepoint [47]
0
0
Week 1, 6, 13, and 25 (Course 1).
Query!
Primary outcome [48]
0
0
Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Health Assessment Questionnaire - Disability Index (HAQ-DI) - by the End of Course 2
Query!
Assessment method [48]
0
0
HAQ-DI assessed the degree of difficulty participants experienced in 8 daily living activity domains during a week: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and other activities. Each activity category consisted of 2-3 items. Each question's difficulty was scored from 0-3 (0=no difficulty, 1=some difficulty, 2=much difficulty, 3=unable to do). Activities requiring assistance (from people or assistive devices) were adjusted to =2 to denote more limited functional status. The questionnaire was to be completed by the participant prior to any procedures during the visit, if possible.
Overall HAQ-DI score was computed as the sum of domain scores divided by the number of domains answered, providing a score from 0-3. Low scores denoted improvement of disability/lower degree of domain difficulty.
Primary outcomes reported post baseline mean percent (%) changes in HAQ-DI score. Post baseline values are reported on the % change from initial study Baseline scale.
Query!
Timepoint [48]
0
0
Week 1, 6, 13, and 25 (Course 1 and Course 2).
Query!
Primary outcome [49]
0
0
Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Health Assessment Questionnaire - Disability Index (HAQ-DI) - by the End of Course 3
Query!
Assessment method [49]
0
0
HAQ-DI assessed the degree of difficulty participants experienced in 8 daily living activity domains during a week: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and other activities. Each activity category consisted of 2-3 items. Each question's difficulty was scored from 0-3 (0=no difficulty, 1=some difficulty, 2=much difficulty, 3=unable to do). Activities requiring assistance (from people or assistive devices) were adjusted to =2 to denote more limited functional status. The questionnaire was to be completed by the participant prior to any procedures during the visit, if possible.
Overall HAQ-DI score was computed as the sum of domain scores divided by the number of domains answered, providing a score from 0-3. Low scores denoted improvement of disability/lower degree of domain difficulty.
Primary outcomes reported post baseline mean percent (%) changes in HAQ-DI score. Post baseline values are reported on the % change from initial study Baseline scale.
Query!
Timepoint [49]
0
0
Week 1, 6, 13, and 25 (Course 1 and Course 2), and Week 1, 13, and 25 (Course 3).
Query!
Primary outcome [50]
0
0
Outcome Measure Using HAQ-DI - by the End of Course 1
Query!
Assessment method [50]
0
0
HAQ-DI assessed the degree of difficulty participants experienced in 8 daily living activity domains during a week: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and other activities. Each activity category consisted of 2-3 items. Each question's difficulty was scored from 0-3 (0=no difficulty, 1=some difficulty, 2=much difficulty, 3=unable to do). Activities requiring assistance (from people or assistive devices) were adjusted to =2 to denote more limited functional status. The questionnaire was to be completed by the participant prior to any procedures during the visit, if possible.
Overall HAQ-DI score was computed as the sum of domain scores divided by the number of domains answered, providing a score from 0-3. Low scores denoted improvement of disability/lower degree of domain difficulty.
Primary outcome reported in the table is mean HAQ-DI score at each time point, and it is on the scale of HAQ-DI score with the range from 0 to 3.
Query!
Timepoint [50]
0
0
Week 1, 6, 13, and 25 (Course 1).
Query!
Primary outcome [51]
0
0
Outcome Measure Using HAQ-DI - by the End of Course 2
Query!
Assessment method [51]
0
0
HAQ-DI assessed the degree of difficulty participants experienced in 8 daily living activity domains during a week: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and other activities. Each activity category consisted of 2-3 items. Each question's difficulty was scored from 0-3 (0=no difficulty, 1=some difficulty, 2=much difficulty, 3=unable to do). Activities requiring assistance (from people or assistive devices) were adjusted to =2 to denote more limited functional status. The questionnaire was to be completed by the participant prior to any procedures during the visit, if possible.
Overall HAQ-DI score was computed as the sum of domain scores divided by the number of domains answered, providing a score from 0-3. Low scores denoted improvement of disability/lower degree of domain difficulty.
Primary outcome reported in the table is mean HAQ-DI score at each time point, and it is on the scale of HAQ-DI score with the range from 0 to 3.
Query!
Timepoint [51]
0
0
Week 1, 6, 13, and 25 (Course 1 and Course 2).
Query!
Primary outcome [52]
0
0
Outcome Measure Using HAQ-DI - by the End of Course 3
Query!
Assessment method [52]
0
0
HAQ-DI assessed the degree of difficulty participants experienced in 8 daily living activity domains during a week: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and other activities. Each activity category consisted of 2-3 items. Each question's difficulty was scored from 0-3 (0=no difficulty, 1=some difficulty, 2=much difficulty, 3=unable to do). Activities requiring assistance (from people or assistive devices) were adjusted to =2 to denote more limited functional status. The questionnaire was to be completed by the participant prior to any procedures during the visit, if possible.
Overall HAQ-DI score was computed as the sum of domain scores divided by the number of domains answered, providing a score from 0-3. Low scores denoted improvement of disability/lower degree of domain difficulty.
Primary outcome reported in the table is mean HAQ-DI score at each time point, and it is on the scale of HAQ-DI score with the range from 0 to 3.
Query!
Timepoint [52]
0
0
Week 1, 6, 13, and 25 (Course 1 and Course 2), and Week 1, 13, and 25 (Course 3).
Query!
Eligibility
Key inclusion criteria
* Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
* Participated for a minimum of 16 weeks after the initiation of the last course of treatment in a previous rheumatoid arthritis study in the rituximab-Pfizer program within the past 2 months.
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
* Investigational site staff members or relatives of those site staff members or subjects who are Pfizer employees directly involved in the conduct of the study.
* Initiated treatment with investigational agents or other biologics (including Rituxan and MabThera) since participating in a previous rheumatoid arthritis study in the rituximab-Pfizer program.
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people receiving the treatment/s
The people assessing the outcomes
The people analysing the results/data
Query!
Query!
Query!
Query!
Intervention assignment
Query!
Other design features
Query!
Phase
NA
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
16/08/2012
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
14/03/2016
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
185
Query!
Recruitment in Australia
Recruitment state(s)
QLD
Query!
Recruitment hospital [1]
0
0
Rheumatology Research Unit - Maroochydore
Query!
Recruitment postcode(s) [1]
0
0
4558 - Maroochydore
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Alabama
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Arizona
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
Arkansas
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
California
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Connecticut
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Delaware
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Florida
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Illinois
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Indiana
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
Kentucky
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
Maryland
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
Massachusetts
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
Michigan
Query!
Country [14]
0
0
United States of America
Query!
State/province [14]
0
0
Nevada
Query!
Country [15]
0
0
United States of America
Query!
State/province [15]
0
0
New Hampshire
Query!
Country [16]
0
0
United States of America
Query!
State/province [16]
0
0
New York
Query!
Country [17]
0
0
United States of America
Query!
State/province [17]
0
0
North Carolina
Query!
Country [18]
0
0
United States of America
Query!
State/province [18]
0
0
Ohio
Query!
Country [19]
0
0
United States of America
Query!
State/province [19]
0
0
Oklahoma
Query!
Country [20]
0
0
United States of America
Query!
State/province [20]
0
0
Pennsylvania
Query!
Country [21]
0
0
United States of America
Query!
State/province [21]
0
0
Tennessee
Query!
Country [22]
0
0
United States of America
Query!
State/province [22]
0
0
Texas
Query!
Country [23]
0
0
Canada
Query!
State/province [23]
0
0
Quebec
Query!
Country [24]
0
0
Colombia
Query!
State/province [24]
0
0
Antioquia
Query!
Country [25]
0
0
Colombia
Query!
State/province [25]
0
0
Atlantico
Query!
Country [26]
0
0
Germany
Query!
State/province [26]
0
0
Berlin
Query!
Country [27]
0
0
Israel
Query!
State/province [27]
0
0
Tel Hashomer
Query!
Country [28]
0
0
Mexico
Query!
State/province [28]
0
0
Distrito Federal
Query!
Country [29]
0
0
Mexico
Query!
State/province [29]
0
0
Jalisco
Query!
Country [30]
0
0
Mexico
Query!
State/province [30]
0
0
San Luis Potosi
Query!
Country [31]
0
0
Russian Federation
Query!
State/province [31]
0
0
Republic OF Tatarstan
Query!
Country [32]
0
0
Russian Federation
Query!
State/province [32]
0
0
Kemerovo
Query!
Country [33]
0
0
Russian Federation
Query!
State/province [33]
0
0
Novosibirsk
Query!
Country [34]
0
0
Russian Federation
Query!
State/province [34]
0
0
Samara
Query!
Country [35]
0
0
Russian Federation
Query!
State/province [35]
0
0
St Petersburg
Query!
Country [36]
0
0
Russian Federation
Query!
State/province [36]
0
0
St. Petersburg
Query!
Country [37]
0
0
South Africa
Query!
State/province [37]
0
0
Cape Town
Query!
Country [38]
0
0
South Africa
Query!
State/province [38]
0
0
KwaZulu Natal
Query!
Country [39]
0
0
United Kingdom
Query!
State/province [39]
0
0
Leeds
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Query!
Name
Pfizer
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
This extension study will evaluate the safety (including immunogenicity) of treatment with rituximab-Pfizer, as well as the safety and immunogenicity after transitioning from rituximab-US or rituximab-EU to rituximab-Pfizer. This study will provide continued treatment access to subjects with active rheumatoid arthritis who have participated for at least 16 weeks in other studies in the rituximab Pfizer program.
Query!
Trial website
https://clinicaltrials.gov/study/NCT01643928
Query!
Trial related presentations / publications
Cohen SB, Burgos-Vargas R, Emery P, Jin B, Cronenberger C, Vazquez-Abad MD. Extension Study of PF-05280586, a Potential Rituximab Biosimilar, Versus Rituximab in Subjects With Active Rheumatoid Arthritis. Arthritis Care Res (Hoboken). 2018 Nov;70(11):1598-1606. doi: 10.1002/acr.23586.
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Public notes
Query!
Contacts
Principal investigator
Name
0
0
Pfizer CT.gov Call Center
Query!
Address
0
0
Pfizer
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
Query!
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.
Query!
When will data be available (start and end dates)?
Query!
Available to whom?
Query!
Available for what types of analyses?
Query!
How or where can data be obtained?
IPD available at link: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests
Query!
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/NCT01643928