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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)
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
Secondary ID [1] 0 0
ICON 9002/010
Secondary ID [2] 0 0
B3281001
Universal Trial Number (UTN)
Trial acronym
REFLECTIONS
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 - 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
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Maximum Serum Concentration (Cmax) of Rituximab
Timepoint [1] 0 0
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
Primary outcome [2] 0 0
AUC 0-inf of Rituximab
Timepoint [2] 0 0
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
Secondary outcome [1] 0 0
Rituximab AUC From Time 0 to 2 Weeks (AUC 0-2wk)
Timepoint [1] 0 0
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
Secondary outcome [2] 0 0
Rituximab AUC From Time 0 to the Time of the Last Quantifiable Concentration (AUC 0-T)
Timepoint [2] 0 0
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
Secondary outcome [3] 0 0
CD19+ B-cell Count AUC From Time 0 to the Last Measurement at Time T (AUC 0-T,B-cell)
Timepoint [3] 0 0
Baseline and Weeks 2, 3, 5, 9, 13, 17, 21 and 25 (EOT)
Secondary outcome [4] 0 0
Minimum Post-Baseline CD19+ B-cell Count (/uL)
Timepoint [4] 0 0
Baseline and Weeks 2, 3, 5, 9, 13, 17, 21 and 25 (EOT)
Secondary outcome [5] 0 0
Time to Minimum Post-Baseline CD19+ B-cell Count (Weeks)
Timepoint [5] 0 0
Baseline and Weeks 2, 3, 5, 9, 13, 17, 21 and 25 (EOT)
Secondary outcome [6] 0 0
Duration of B-cell Depletion (tB-cell) (Days)
Timepoint [6] 0 0
Baseline and Weeks 2, 3, 5, 9, 13, 17, 21 and 25 (EOT)
Secondary outcome [7] 0 0
Percentage of Participants With CD19+ B-cell Count Recovery
Timepoint [7] 0 0
Baseline and Weeks 2, 3, 5, 9, 13, 17, 21 and 25
Secondary outcome [8] 0 0
Area Under the CD19+ B-cell Count Concentration-time Profile (AUC 0-T, B-cell)
Timepoint [8] 0 0
Baseline and Weeks 2, 3, 5, 9, 13, 17, 21 and 25 (EOT)
Secondary outcome [9] 0 0
Baseline and Change From Baseline in Circulating Immunoglobulin-M (IgM) by Visit (Grams Per Liter (g/L])
Timepoint [9] 0 0
Baseline and Weeks 1, 2, 3, 4, 5, 9, 13, 17, 21 and 25 (EOT)
Secondary outcome [10] 0 0
Percent (%) Change From Baseline in Circulating IgM by Visit (g/L)
Timepoint [10] 0 0
Baseline and Weeks 1, 2, 3, 4, 5, 9, 13, 17, 21 and 25
Secondary outcome [11] 0 0
Percentage of Participants With American College of Rheumatology (ACR) 20% Improvement (ACR20) Response by Visit
Timepoint [11] 0 0
Weeks 3, 5, 9, 13, 17, 21 and 25
Secondary outcome [12] 0 0
Percentage of Participants With ACR 70% Improvement (ACR70) Response by Visit
Timepoint [12] 0 0
Weeks 3, 5, 9, 13, 17, 21 and 25 (EOT)
Secondary outcome [13] 0 0
Percentage of Participants With ACR 50% Improvement (ACR50) Response by Visit
Timepoint [13] 0 0
Weeks 3, 5, 9, 13, 17, 21 and 25
Secondary outcome [14] 0 0
Percentage of Participants by Anti-drug Antibody (ADA) Status
Timepoint [14] 0 0
Days 1 up to Day 169.
Secondary outcome [15] 0 0
Percentage of Participants With Neutralizing Antibody (NAb) in Participants With a Positive ADA by Visit
Timepoint [15] 0 0
Day 1 up to Day 169
Secondary outcome [16] 0 0
Change From Baseline in Disease Activity Score Based on 28-Joint Count and C-Reactive Protein (DAS28-CRP)
Timepoint [16] 0 0
Baseline and Weeks 3, 5, 9, 13, 17, 21 and 25
Secondary outcome [17] 0 0
Percent Change From Baseline in DAS28-CRP by Visit
Timepoint [17] 0 0
Baseline and Weeks 3, 5, 9, 13, 17, 21 and 25
Secondary outcome [18] 0 0
Percentage of Participants With Good European League Against Rheumatism (EULAR) Response Based on Disease Activity Score Based on 28-Joint Count (DAS28) by Visit
Timepoint [18] 0 0
Weeks 3, 5, 9, 13, 17, 21 and 25
Secondary outcome [19] 0 0
Percentage of Participants With Moderate EULAR Response Based on Disease Activity Score Based on DAS28 by Visit
Timepoint [19] 0 0
Weeks 3, 5, 9, 13, 17, 21 and 25
Secondary outcome [20] 0 0
Percentage of Participants With No EULAR Response Based on DAS28 by Visit
Timepoint [20] 0 0
Weeks 3, 5, 9, 13, 17, 21 and 25
Secondary outcome [21] 0 0
Percentage of Participants With Low Disease Activity Score (DAS <=3.2) by Visit
Timepoint [21] 0 0
Weeks 3, 5, 9, 13, 17, 21 and 25
Secondary outcome [22] 0 0
Percentage of Participants With DAS Remission (DAS <2.6) by Visit
Timepoint [22] 0 0
Weeks 3, 5, 9, 13, 17, 21 and 25
Secondary outcome [23] 0 0
Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) by Visit
Timepoint [23] 0 0
Baseline, Week 3, 5, 9, 13, 17, 21 and 25
Secondary outcome [24] 0 0
Percent Change From Baseline in HAQ-DI Score by Visit
Timepoint [24] 0 0
Baseline, Week 3, 5, 9, 13, 17, 21 and 25

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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
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
20/03/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
7/05/2014
Sample size
Target
Accrual to date
Final
220
Recruitment in Australia
Recruitment state(s)
QLD,SA,VIC
Recruitment hospital [1] 0 0
Rheumatology Research Unit - Maroochydore
Recruitment hospital [2] 0 0
The Queen Elizabeth Hospital, Department of Rheumatology - Woodville South
Recruitment hospital [3] 0 0
St. Vincent's Hospital (Melbourne) - Fitzroy
Recruitment postcode(s) [1] 0 0
4558 - Maroochydore
Recruitment postcode(s) [2] 0 0
5011 - Woodville South
Recruitment postcode(s) [3] 0 0
03065 - Fitzroy
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
Florida
Country [7] 0 0
United States of America
State/province [7] 0 0
Illinois
Country [8] 0 0
United States of America
State/province [8] 0 0
Kentucky
Country [9] 0 0
United States of America
State/province [9] 0 0
Maryland
Country [10] 0 0
United States of America
State/province [10] 0 0
Massachusetts
Country [11] 0 0
United States of America
State/province [11] 0 0
Michigan
Country [12] 0 0
United States of America
State/province [12] 0 0
Nevada
Country [13] 0 0
United States of America
State/province [13] 0 0
New Hampshire
Country [14] 0 0
United States of America
State/province [14] 0 0
New York
Country [15] 0 0
United States of America
State/province [15] 0 0
North Carolina
Country [16] 0 0
United States of America
State/province [16] 0 0
Ohio
Country [17] 0 0
United States of America
State/province [17] 0 0
Oklahoma
Country [18] 0 0
United States of America
State/province [18] 0 0
Pennsylvania
Country [19] 0 0
United States of America
State/province [19] 0 0
Tennessee
Country [20] 0 0
United States of America
State/province [20] 0 0
Texas
Country [21] 0 0
Canada
State/province [21] 0 0
Quebec
Country [22] 0 0
Colombia
State/province [22] 0 0
Antioquia
Country [23] 0 0
Colombia
State/province [23] 0 0
Atlantico
Country [24] 0 0
Colombia
State/province [24] 0 0
Atlántico
Country [25] 0 0
Germany
State/province [25] 0 0
Berlin
Country [26] 0 0
Israel
State/province [26] 0 0
Ramat Gan
Country [27] 0 0
Mexico
State/province [27] 0 0
D.f.
Country [28] 0 0
Mexico
State/province [28] 0 0
Jalisco
Country [29] 0 0
Mexico
State/province [29] 0 0
Durango
Country [30] 0 0
Mexico
State/province [30] 0 0
San Luis Potosi
Country [31] 0 0
Russian Federation
State/province [31] 0 0
Novosibirsk Region
Country [32] 0 0
Russian Federation
State/province [32] 0 0
Tatarstan
Country [33] 0 0
Russian Federation
State/province [33] 0 0
Kemerovo
Country [34] 0 0
Russian Federation
State/province [34] 0 0
Nizhny Novgorod
Country [35] 0 0
Russian Federation
State/province [35] 0 0
Saint-Petersburg
Country [36] 0 0
Russian Federation
State/province [36] 0 0
Samara
Country [37] 0 0
Russian Federation
State/province [37] 0 0
St. Petersburg
Country [38] 0 0
Russian Federation
State/province [38] 0 0
Tomsk
Country [39] 0 0
South Africa
State/province [39] 0 0
Cape Town
Country [40] 0 0
South Africa
State/province [40] 0 0
Kwa-zulu Natal
Country [41] 0 0
United Kingdom
State/province [41] 0 0
UK
Country [42] 0 0
United Kingdom
State/province [42] 0 0
Leeds
Country [43] 0 0
United Kingdom
State/province [43] 0 0
London

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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.
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests


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