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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
Date last updated
29/01/2019

Titles & IDs
Public title
Rheumatoid Arthritis Extension Trial For Subjects Who Have Participated In Other PF-05280586 Trials (REFLECTIONS B328-04)
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
Secondary ID [1] 0 0
ICON 9002/0101
Secondary ID [2] 0 0
B3281004
Universal Trial Number (UTN)
Trial acronym
Linked study record

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: 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
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants by Anti-Drug Antibody (ADA) Status Using Anti-PF-05280586 Antibody Assay
Timepoint [1] 0 0
Course 1 (C1) Overall, Course 2 (C2) Overall, Course 3 (C3) Overall, and All Courses Overall.
Primary outcome [2] 0 0
Percentage of Participants by ADA Status Using Anti-Rituximab Antibody Assay
Timepoint [2] 0 0
Course 1 Overall, Course 2 Overall, Course 3 Overall, and All Courses Overall.
Primary outcome [3] 0 0
Percentage of Participants by Neutralizing Antibody (Nab) Status in Participants With a Positive ADA Using Anti-PF-05280586 NAb Assay
Timepoint [3] 0 0
Weeks 1, 3, 13, and 25 (Course 1, Course 2, and Course 3).
Primary outcome [4] 0 0
Percentage of Participants by Nab Status in Participants With a Positive ADA Using Anti-PF-05280586 NAb Assay Using Anti-Rituximab NAb Assay
Timepoint [4] 0 0
Weeks 1, 3, 13, and 25 (Course 1, Course 2, and Course 3).
Primary outcome [5] 0 0
Mean Rituximab Serum Trough Concentrations
Timepoint [5] 0 0
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).
Primary outcome [6] 0 0
Cluster of Differentiation 19 (CD19+) B Cell Count
Timepoint [6] 0 0
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.
Primary outcome [7] 0 0
Circulating Immunoglobulin G (IgG) Concentrations
Timepoint [7] 0 0
Screening, Week 25 (Course 1), and Weeks 1 and 25 (Course 2 and Course 3).
Primary outcome [8] 0 0
Circulating Immunoglobulin M (IgM) Concentrations
Timepoint [8] 0 0
Screening, Week 25 (Course 1), and Weeks 1 and 25 (Course 2 and Course 3).
Primary outcome [9] 0 0
Circulating Rheumatoid Factor (RF) Concentrations
Timepoint [9] 0 0
Week 1 and 25 (Course 1, Course 2, and Course 3).
Primary outcome [10] 0 0
Anti-Cyclic Citrullinated Peptide (Anti-CCP) and Complement
Timepoint [10] 0 0
Week 1 and 25 (Course 1, Course 2, and Course 3).
Primary outcome [11] 0 0
Mean Change From Initial Study Baseline in Disease Activity Score (DAS28)-C-Reactive Protein (CRP) - by the End of Course 1
Timepoint [11] 0 0
Baseline B3281001, Week 1, 6, 13, and 25 (Course 1).
Primary outcome [12] 0 0
Mean Change From Initial Study Baseline in Disease Activity Score (DAS28)-C-Reactive Protein (CRP) - by the End of Course 2
Timepoint [12] 0 0
Baseline B3281001, Week 1, 6, 13, and 25 (Course 1 and Course 2).
Primary outcome [13] 0 0
Mean Change From Initial Study Baseline in Disease Activity Score (DAS28)-C-Reactive Protein (CRP) - by the End of Course 3
Timepoint [13] 0 0
Baseline B3281001, Week 1, 6, 13, and 25 (Course 1 and Course 2), and Week 1, 13, and 25 (Course 3).
Primary outcome [14] 0 0
Percentage of Participants With Good European League Against Rheumatism (EULAR) Response Based on DAS28 - by the End of Course 1
Timepoint [14] 0 0
Week 1, 6, 13, and 25 (Course 1).
Primary outcome [15] 0 0
Percentage of Participants With Good European League Against Rheumatism (EULAR) Response Based on DAS28 - by the End of Course 2
Timepoint [15] 0 0
Week 1, 6, 13, and 25 (Course 1 and Course 2).
Primary outcome [16] 0 0
Percentage of Participants With Good European League Against Rheumatism (EULAR) Response Based on DAS28 - by the End of Course 3
Timepoint [16] 0 0
Week 1, 6, 13, and 25 (Course 1 and Course 2) and Week 1, 13, and 25 (Course 3).
Primary outcome [17] 0 0
Percentage of Participants With Low Disease Activity State (LDAS) (=3.2) - by the End of Course 1
Timepoint [17] 0 0
Week 1, 6, 13, and 25 (Course 1).
Primary outcome [18] 0 0
Percentage of Participants With Low Disease Activity State (LDAS) (=3.2) - by the End of Course 2
Timepoint [18] 0 0
Week 1, 6, 13, and 25 (Course 1 and Course 2).
Primary outcome [19] 0 0
Percentage of Participants With Low Disease Activity State (LDAS) (=3.2) - by the End of Course 3
Timepoint [19] 0 0
Week 1, 6, 13, and 25 (Course 1 and Course 2), and Week 1, 13, and 25 (Course 3).
Primary outcome [20] 0 0
Percentage of Participants With DAS Remission (DAS28-CRP Less Than [<] 2.6) - by the End of Course 1
Timepoint [20] 0 0
Week 1, 6, 13, and 25 (Course 1).
Primary outcome [21] 0 0
Percentage of Participants With DAS Remission (DAS28-CRP Less Than [<] 2.6) - by the End of Course 2
Timepoint [21] 0 0
Week 1, 6, 13, and 25 (Course 1 and Course 2).
Primary outcome [22] 0 0
Percentage of Participants With DAS Remission (DAS28-CRP Less Than [<] 2.6) - by the End of Course 3
Timepoint [22] 0 0
Week 1, 6, 13, and 25 (Course 1 and Course 2), and Week 1, 13, and 25 (Course 3).
Primary outcome [23] 0 0
Percentage of Participants With American College of Rheumatology (ACR) 20% Improvement (ACR20) Response - by the End of Course 1
Timepoint [23] 0 0
Week 1, 6, 13, and 25 (Course 1).
Primary outcome [24] 0 0
Percentage of Participants With American College of Rheumatology (ACR) 20% Improvement (ACR20) Response - by the End of Course 2
Timepoint [24] 0 0
Week 1, 6, 13, and 25 (Course 1 and Course 2).
Primary outcome [25] 0 0
Percentage of Participants With American College of Rheumatology (ACR) 20% Improvement (ACR20) Response - by the End of Course 3
Timepoint [25] 0 0
Week 1, 6, 13, and 25 (Course 1 and Course 2), and Week 1, 13, and 25 (Course 3).
Primary outcome [26] 0 0
Percentage of Participants With American College of Rheumatology (ACR) 50% Improvement (ACR50) Response - by the End of Course 1
Timepoint [26] 0 0
Week 1, 6, 13, and 25 (Course 1).
Primary outcome [27] 0 0
Percentage of Participants With American College of Rheumatology (ACR) 50% Improvement (ACR50) Response - by the End of Course 2
Timepoint [27] 0 0
Week 1, 6, 13, and 25 (Course 1 and Course 2).
Primary outcome [28] 0 0
Percentage of Participants With American College of Rheumatology (ACR) 50% Improvement (ACR50) Response - by the End of Course 3
Timepoint [28] 0 0
Week 1, 6, 13, and 25 (Course 1 and Course 2), and Week 1, 13, and 25 (Course 3).
Primary outcome [29] 0 0
Percentage of Participants With American College of Rheumatology (ACR) 70% Improvement (ACR70) Response - by the End of Course 1
Timepoint [29] 0 0
Week 1, 6, 13, and 25 (Course 1).
Primary outcome [30] 0 0
Percentage of Participants With American College of Rheumatology (ACR) 70% Improvement (ACR70) Response - by the End of Course 2
Timepoint [30] 0 0
Week 1, 6, 13, and 25 (Course 1 and Course 2).
Primary outcome [31] 0 0
Percentage of Participants With American College of Rheumatology (ACR) 70% Improvement (ACR70) Response - by the End of Course 3
Timepoint [31] 0 0
Week 1, 6, 13, and 25 (Course 1 and Course 2), and Week 1, 13, and 25 (Course 3).
Primary outcome [32] 0 0
Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Tender/Painful Joint Count - by the End of Course 1
Timepoint [32] 0 0
Screening, Week 1, 6, 13, and 25 (Course 1).
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
Timepoint [33] 0 0
Screening, Week 1, 6, 13, and 25 (Course 1 and Course 2).
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
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).
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
Timepoint [35] 0 0
Screening, Week 1, 6, 13, and 25 (Course 1).
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
Timepoint [36] 0 0
Screening, Week 1, 6, 13, and 25 (Course 1 and Course 2).
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
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).
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
Timepoint [38] 0 0
Week 1, 6, 13, and 25 (Course 1).
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
Timepoint [39] 0 0
Week 1, 6, 13, and 25 (Course 1 and Course 2).
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
Timepoint [40] 0 0
Week 1, 6, 13, and 25 (Course 1 and Course 2), and Week 1, 13, and 25 (Course 3).
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
Timepoint [41] 0 0
Week 1, 6, 13, and 25 (Course 1).
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
Timepoint [42] 0 0
Week 1, 6, 13, and 25 (Course 1 and Course 2).
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
Timepoint [43] 0 0
Week 1, 6, 13, and 25 (Course 1 and Course 2), and Week 1, 13, and 25 (Course 3).
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
Timepoint [44] 0 0
Week 1, 6, 13, and 25 (Course 1).
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
Timepoint [45] 0 0
Week 1, 6, 13, and 25 (Course 1 and Course 2).
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
Timepoint [46] 0 0
Week 1, 6, 13, and 25 (Course 1 and Course 2), and Week 1, 13, and 25 (Course 3).
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
Timepoint [47] 0 0
Week 1, 6, 13, and 25 (Course 1).
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
Timepoint [48] 0 0
Week 1, 6, 13, and 25 (Course 1 and Course 2).
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
Timepoint [49] 0 0
Week 1, 6, 13, and 25 (Course 1 and Course 2), and Week 1, 13, and 25 (Course 3).
Primary outcome [50] 0 0
Outcome Measure Using HAQ-DI - by the End of Course 1
Timepoint [50] 0 0
Week 1, 6, 13, and 25 (Course 1).
Primary outcome [51] 0 0
Outcome Measure Using HAQ-DI - by the End of Course 2
Timepoint [51] 0 0
Week 1, 6, 13, and 25 (Course 1 and Course 2).
Primary outcome [52] 0 0
Outcome Measure Using HAQ-DI - by the End of Course 3
Timepoint [52] 0 0
Week 1, 6, 13, and 25 (Course 1 and Course 2), and Week 1, 13, and 25 (Course 3).

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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
16/08/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
14/03/2016
Sample size
Target
Accrual to date
Final
185
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
Rheumatology Research Unit - Maroochydore
Recruitment postcode(s) [1] 0 0
4558 - Maroochydore
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
Arkansas
Country [4] 0 0
United States of America
State/province [4] 0 0
California
Country [5] 0 0
United States of America
State/province [5] 0 0
Connecticut
Country [6] 0 0
United States of America
State/province [6] 0 0
Delaware
Country [7] 0 0
United States of America
State/province [7] 0 0
Florida
Country [8] 0 0
United States of America
State/province [8] 0 0
Illinois
Country [9] 0 0
United States of America
State/province [9] 0 0
Indiana
Country [10] 0 0
United States of America
State/province [10] 0 0
Kentucky
Country [11] 0 0
United States of America
State/province [11] 0 0
Maryland
Country [12] 0 0
United States of America
State/province [12] 0 0
Massachusetts
Country [13] 0 0
United States of America
State/province [13] 0 0
Michigan
Country [14] 0 0
United States of America
State/province [14] 0 0
Nevada
Country [15] 0 0
United States of America
State/province [15] 0 0
New Hampshire
Country [16] 0 0
United States of America
State/province [16] 0 0
New York
Country [17] 0 0
United States of America
State/province [17] 0 0
North Carolina
Country [18] 0 0
United States of America
State/province [18] 0 0
Ohio
Country [19] 0 0
United States of America
State/province [19] 0 0
Oklahoma
Country [20] 0 0
United States of America
State/province [20] 0 0
Pennsylvania
Country [21] 0 0
United States of America
State/province [21] 0 0
Tennessee
Country [22] 0 0
United States of America
State/province [22] 0 0
Texas
Country [23] 0 0
Canada
State/province [23] 0 0
Quebec
Country [24] 0 0
Colombia
State/province [24] 0 0
Antioquia
Country [25] 0 0
Colombia
State/province [25] 0 0
Atlantico
Country [26] 0 0
Germany
State/province [26] 0 0
Berlin
Country [27] 0 0
Israel
State/province [27] 0 0
Tel Hashomer
Country [28] 0 0
Mexico
State/province [28] 0 0
Distrito Federal
Country [29] 0 0
Mexico
State/province [29] 0 0
Jalisco
Country [30] 0 0
Mexico
State/province [30] 0 0
San Luis Potosi
Country [31] 0 0
Russian Federation
State/province [31] 0 0
Republic OF Tatarstan
Country [32] 0 0
Russian Federation
State/province [32] 0 0
Kemerovo
Country [33] 0 0
Russian Federation
State/province [33] 0 0
Novosibirsk
Country [34] 0 0
Russian Federation
State/province [34] 0 0
Samara
Country [35] 0 0
Russian Federation
State/province [35] 0 0
St Petersburg
Country [36] 0 0
Russian Federation
State/province [36] 0 0
St. Petersburg
Country [37] 0 0
South Africa
State/province [37] 0 0
Cape Town
Country [38] 0 0
South Africa
State/province [38] 0 0
KwaZulu Natal
Country [39] 0 0
United Kingdom
State/province [39] 0 0
Leeds

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Pfizer
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/study/NCT01643928
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.
Public notes

Contacts
Principal investigator
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Pfizer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01643928