Clinical trial NCT01643928: Rheumatoid Arthritis Extension Trial For Subjects Who Have Participated In Other PF-05280586 Trials (REFLECTIONS B328-04)
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rheumatoid Arthritis
Keywords: extension trial
rheumatoid arthritis
rituximab
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2012-07-18
Enrollment: 185
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

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.

Primary outcomes:
measure: Percentage of Participants by Anti-Drug Antibody (ADA) Status Using Anti-PF-05280586 Antibody Assay
timeFrame: Course 1 (C1) Overall, Course 2 (C2) Overall, Course 3 (C3) Overall, and All Courses Overall.
measure: Percentage of Participants by ADA Status Using Anti-Rituximab Antibody Assay
timeFrame: Course 1 Overall, Course 2 Overall, Course 3 Overall, and All Courses Overall.
measure: Percentage of Participants by Neutralizing Antibody (Nab) Status in Participants With a Positive ADA Using Anti-PF-05280586 NAb Assay
timeFrame: Weeks 1, 3, 13, and 25 (Course 1, Course 2, and Course 3).
measure: Percentage of Participants by Nab Status in Participants With a Positive ADA Using Anti-PF-05280586 NAb Assay Using Anti-Rituximab NAb Assay
timeFrame: Weeks 1, 3, 13, and 25 (Course 1, Course 2, and Course 3).
measure: Mean Rituximab Serum Trough Concentrations
timeFrame: 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).
measure: Cluster of Differentiation 19 (CD19+) B Cell Count
timeFrame: 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.
measure: Circulating Immunoglobulin G (IgG) Concentrations
timeFrame: Screening, Week 25 (Course 1), and Weeks 1 and 25 (Course 2 and Course 3).
measure: Circulating Immunoglobulin M (IgM) Concentrations
timeFrame: Screening, Week 25 (Course 1), and Weeks 1 and 25 (Course 2 and Course 3).
measure: Circulating Rheumatoid Factor (RF) Concentrations
timeFrame: Week 1 and 25 (Course 1, Course 2, and Course 3).
measure: Anti-Cyclic Citrullinated Peptide (Anti-CCP) and Complement
timeFrame: Week 1 and 25 (Course 1, Course 2, and Course 3).
measure: Mean Change From Initial Study Baseline in Disease Activity Score (DAS28)-C-Reactive Protein (CRP) - by the End of Course 1
timeFrame: Baseline B3281001, Week 1, 6, 13, and 25 (Course 1).
measure: Mean Change From Initial Study Baseline in Disease Activity Score (DAS28)-C-Reactive Protein (CRP) - by the End of Course 2
timeFrame: Baseline B3281001, Week 1, 6, 13, and 25 (Course 1 and Course 2).
measure: Mean Change From Initial Study Baseline in Disease Activity Score (DAS28)-C-Reactive Protein (CRP) - by the End of Course 3
timeFrame: Baseline B3281001, Week 1, 6, 13, and 25 (Course 1 and Course 2), and Week 1, 13, and 25 (Course 3).
measure: Percentage of Participants With Good European League Against Rheumatism (EULAR) Response Based on DAS28 - by the End of Course 1
timeFrame: Week 1, 6, 13, and 25 (Course 1).
measure: Percentage of Participants With Good European League Against Rheumatism (EULAR) Response Based on DAS28 - by the End of Course 2
timeFrame: Week 1, 6, 13, and 25 (Course 1 and Course 2).
measure: Percentage of Participants With Good European League Against Rheumatism (EULAR) Response Based on DAS28 - by the End of Course 3
timeFrame: Week 1, 6, 13, and 25 (Course 1 and Course 2) and Week 1, 13, and 25 (Course 3).
measure: Percentage of Participants With Low Disease Activity State (LDAS) (≤3.2) - by the End of Course 1
timeFrame: Week 1, 6, 13, and 25 (Course 1).
measure: Percentage of Participants With Low Disease Activity State (LDAS) (≤3.2) - by the End of Course 2
timeFrame: Week 1, 6, 13, and 25 (Course 1 and Course 2).
measure: Percentage of Participants With Low Disease Activity State (LDAS) (≤3.2) - by the End of Course 3
timeFrame: Week 1, 6, 13, and 25 (Course 1 and Course 2), and Week 1, 13, and 25 (Course 3).
measure: Percentage of Participants With DAS Remission (DAS28-CRP Less Than [<] 2.6) - by the End of Course 1
timeFrame: Week 1, 6, 13, and 25 (Course 1).
measure: Percentage of Participants With DAS Remission (DAS28-CRP Less Than [<] 2.6) - by the End of Course 2
timeFrame: Week 1, 6, 13, and 25 (Course 1 and Course 2).
measure: Percentage of Participants With DAS Remission (DAS28-CRP Less Than [<] 2.6) - by the End of Course 3
timeFrame: Week 1, 6, 13, and 25 (Course 1 and Course 2), and Week 1, 13, and 25 (Course 3).
measure: Percentage of Participants With American College of Rheumatology (ACR) 20% Improvement (ACR20) Response - by the End of Course 1
timeFrame: Week 1, 6, 13, and 25 (Course 1).
measure: Percentage of Participants With American College of Rheumatology (ACR) 20% Improvement (ACR20) Response - by the End of Course 2
timeFrame: Week 1, 6, 13, and 25 (Course 1 and Course 2).
measure: Percentage of Participants With American College of Rheumatology (ACR) 20% Improvement (ACR20) Response - by the End of Course 3
timeFrame: Week 1, 6, 13, and 25 (Course 1 and Course 2), and Week 1, 13, and 25 (Course 3).
measure: Percentage of Participants With American College of Rheumatology (ACR) 50% Improvement (ACR50) Response - by the End of Course 1
timeFrame: Week 1, 6, 13, and 25 (Course 1).
measure: Percentage of Participants With American College of Rheumatology (ACR) 50% Improvement (ACR50) Response - by the End of Course 2
timeFrame: Week 1, 6, 13, and 25 (Course 1 and Course 2).
measure: Percentage of Participants With American College of Rheumatology (ACR) 50% Improvement (ACR50) Response - by the End of Course 3
timeFrame: Week 1, 6, 13, and 25 (Course 1 and Course 2), and Week 1, 13, and 25 (Course 3).
measure: Percentage of Participants With American College of Rheumatology (ACR) 70% Improvement (ACR70) Response - by the End of Course 1
timeFrame: Week 1, 6, 13, and 25 (Course 1).
measure: Percentage of Participants With American College of Rheumatology (ACR) 70% Improvement (ACR70) Response - by the End of Course 2
timeFrame: Week 1, 6, 13, and 25 (Course 1 and Course 2).
measure: Percentage of Participants With American College of Rheumatology (ACR) 70% Improvement (ACR70) Response - by the End of Course 3
timeFrame: Week 1, 6, 13, and 25 (Course 1 and Course 2), and Week 1, 13, and 25 (Course 3).
measure: Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Tender/Painful Joint Count - by the End of Course 1
timeFrame: Screening, Week 1, 6, 13, and 25 (Course 1).
measure: Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Tender/Painful Joint Count - by the End of Course 2
timeFrame: Screening, Week 1, 6, 13, and 25 (Course 1 and Course 2).
measure: Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Tender/Painful Joint Count - by the End of Course 3
timeFrame: Screening, Week 1, 6, 13, and 25 (Course 1 and Course 2), and Screening, Week 1, 13, and 25 (Course 3).
measure: Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Swollen Joint Count - by the End of Course 1
timeFrame: Screening, Week 1, 6, 13, and 25 (Course 1).
measure: Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Swollen Joint Count - by the End of Course 2
timeFrame: Screening, Week 1, 6, 13, and 25 (Course 1 and Course 2).
measure: Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Swollen Joint Count - by the End of Course 3
timeFrame: Screening, Week 1, 6, 13, and 25 (Course 1 and Course 2), and Screening, Week 1, 13, and 25 (Course 3).
measure: 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
timeFrame: Week 1, 6, 13, and 25 (Course 1).
measure: 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
timeFrame: Week 1, 6, 13, and 25 (Course 1 and Course 2).
measure: 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
timeFrame: Week 1, 6, 13, and 25 (Course 1 and Course 2), and Week 1, 13, and 25 (Course 3).
measure: 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
timeFrame: Week 1, 6, 13, and 25 (Course 1).
measure: 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
timeFrame: Week 1, 6, 13, and 25 (Course 1 and Course 2).
measure: 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
timeFrame: Week 1, 6, 13, and 25 (Course 1 and Course 2), and Week 1, 13, and 25 (Course 3).
measure: 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
timeFrame: Week 1, 6, 13, and 25 (Course 1).
measure: 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
timeFrame: Week 1, 6, 13, and 25 (Course 1 and Course 2).
measure: 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
timeFrame: Week 1, 6, 13, and 25 (Course 1 and Course 2), and Week 1, 13, and 25 (Course 3).
measure: 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
timeFrame: Week 1, 6, 13, and 25 (Course 1).
measure: 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
timeFrame: Week 1, 6, 13, and 25 (Course 1 and Course 2).
measure: 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
timeFrame: Week 1, 6, 13, and 25 (Course 1 and Course 2), and Week 1, 13, and 25 (Course 3).
measure: Outcome Measure Using HAQ-DI - by the End of Course 1
timeFrame: Week 1, 6, 13, and 25 (Course 1).
measure: Outcome Measure Using HAQ-DI - by the End of Course 2
timeFrame: Week 1, 6, 13, and 25 (Course 1 and Course 2).
measure: Outcome Measure Using HAQ-DI - by the End of Course 3
timeFrame: Week 1, 6, 13, and 25 (Course 1 and Course 2), and Week 1, 13, and 25 (Course 3).
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Huntsville
country: United States
facility: Rheumatology Associates of North Alabama, PC
state: Alabama
city: Gilbert
country: United States
facility: Arthrocare, Arthritiscare & Research, PC
state: Arizona
city: Hot Springs
country: United States
facility: CHI St. Vincent Medical Group Hot Springs
state: Arkansas
city: Los Angeles
country: United States
facility: UCLA Clinical & Translational Research Center
state: California
city: Los Angeles
country: United States
facility: UCLA David Geffen School of Medicine
state: California
city: Palm Desert
country: United States
facility: Desert Medical Advances
state: California
city: Trumbull
country: United States
facility: New England Research Associates, LLC
state: Connecticut
city: Newark
country: United States
facility: QPS Labs
state: Delaware
city: Tampa
country: United States
facility: University of South Florida - College of Medicine Carol and Frank Morsani Center
state: Florida
city: Maywood
country: United States
facility: Loyola University Medical Center
state: Illinois
city: Morton Grove
country: United States
facility: Illnois Bone & Joint Institute
state: Illinois
city: Indianapolis
country: United States
facility: Covance Central Laboratory Services
state: Indiana
city: Lexington
country: United States
facility: Bluegrass Community Research, Inc.
state: Kentucky
city: Cumberland
country: United States
facility: Klein & Associates, M.D., P.A.
state: Maryland
city: Worcester
country: United States
facility: Clinical Pharmacology Study Group
state: Massachusetts
city: Battle Creek
country: United States
facility: Bronson Internal Medicine and Rheumatology
state: Michigan
city: Lansing
country: United States
facility: Justus J. Fiechtner, MD, PC
state: Michigan
city: Las Vegas
country: United States
facility: University of Nevada School of Medicine
state: Nevada
city: Lebanon
country: United States
facility: Dartmouth - Hitchcock Medical Center
state: New Hampshire
city: Great Neck
country: United States
facility: North Shore-LIJ Health System - Division of Rheumatology and Allergy-Clinical
state: New York
city: Hickory
country: United States
facility: PMG Research of Hickory LLC
state: North Carolina
city: Hickory
country: United States
facility: PMG Research of Hickory, LLC
state: North Carolina
city: Cincinnati
country: United States
facility: Cincinnati Rheumatic Disease Study Group
state: Ohio
city: Oklahoma City
country: United States
facility: Health Research of Oklahoma
state: Oklahoma
city: Duncansville
country: United States
facility: Altoona Center for Clinical Research
state: Pennsylvania
city: Philadelphia
country: United States
facility: The Arthritis Group
state: Pennsylvania
city: Wyomissing
country: United States
facility: Clinical Research Center of Reading, LLC
state: Pennsylvania
city: Hixson
country: United States
facility: Arthritis Associates, PLLC
state: Tennessee
city: Jackson
country: United States
facility: Arthritis Clinic
state: Tennessee
city: Jackson
country: United States
facility: West Tennessee Research Institute
state: Tennessee
city: Dallas
country: United States
facility: Metroplex Clinical Research Center
state: Texas
city: Houston
country: United States
facility: Apocell, Inc
state: Texas
city: Mesquite
country: United States
facility: Southwest Rheumatology Research, LLC
state: Texas
city: Maroochydore
country: Australia
facility: Rheumatology Research Unit
state: Queensland
city: Rimouski
country: Canada
facility: Clinique Medicale du Phare (ECG Only)
state: Quebec
city: Rimouski
country: Canada
facility: Centre de Rhumatologie de l'Est du Quebec
state: Quebec
city: Quebec
country: Canada
facility: Pharmacie Matte et Petit
city: Quebec
country: Canada
facility: Centre de Recherche Saint-Louis
city: Medellin
country: Colombia
facility: IPS Rodrigo Botero S.A.S.
state: Antioquia
city: Medellin
country: Colombia
facility: Rodrigo Botero S.A.S.
state: Antioquia
city: Medellín
country: Colombia
facility: Clínica Medellín S.A. Sede Centro
state: Antioquia
city: Medellín
country: Colombia
facility: Mix Supplier S.A.
state: Antioquia
city: Barranquilla
country: Colombia
facility: Centro de Reumatologia y Ortopedia
state: Atlantico
city: Barranquilla
country: Colombia
facility: Clinica de La Costa Ltda.
state: Atlantico
city: Barranquilla
country: Colombia
facility: Congregación de las Hermanas Franciscanas Misioneras de María Auxiliadora-Clinica La Asuncion
state: Atlantico
city: Barranquilla
country: Colombia
facility: IPS Centro Integral de Reumatologia del Caribe, CIRCARIBE S.A.S.
state: Atlantico
city: Barranquilla
country: Colombia
facility: IPS Centro Integral De Reumatologia del Caribe, CIRCARIBE S.A.S
state: Atlantico
city: Barranquilla
country: Colombia
facility: Organizacion Clinica General Del Norte S.A.
state: Atlantico
city: Berlin
country: Germany
facility: Schlosspark-Klinik GmbH, Internal Medicine II
city: Tel Hashomer
country: Israel
facility: The Chaim Sheba Medical Center
city: Mexico City
country: Mexico
facility: C.T. Scanner de Mexico, S.A. de C.V. (CT ONLY)
state: Distrito Federal
city: Mexico City
country: Mexico
facility: CLIDITER, S.A de C.V.
state: Distrito Federal
city: Mexico City
country: Mexico
facility: Hospital Angeles Clinica Londres
state: Distrito Federal
city: Guadalajara
country: Mexico
facility: Hospital Bernardette (Emergencies)
state: Jalisco
city: Guadalajara
country: Mexico
facility: Private Office
state: Jalisco
city: San Luis Potosi
country: Mexico
facility: Hospital Angeles, Centro Medico del Potosi
city: San Luis Potosi
country: Mexico
facility: Centro de Alta Especialidad en Reumatologia e Investigacion del Potosi, S.C.
city: Kazan
country: Russian Federation
facility: LLC Scientific and Research Medical Complex "Your Health"
state: Republic OF Tatarstan
city: Kemerovo
country: Russian Federation
facility: State Institution of Healthcare "Regional Clinical Hospital for Wars' Veterans"
city: Novosibirsk
country: Russian Federation
facility: LLC Consulting and Diagnostic Rheumatological Center "Healthy Joints"
city: Samara
country: Russian Federation
facility: State Budget Institution of Healthcare "Samara Regional Clinical Hospital named after V.D. Seredavin
city: Samara
country: Russian Federation
facility: State Institution of Healthcare "Samara Regional Clinical Hospital named after V.D. Seredavin"
city: St Petersburg
country: Russian Federation
facility: AVA-PETER Ltd.
city: St Petersburg
country: Russian Federation
facility: Local Ethics Committee of LLC AVA-PETER
city: St. Petersburg
country: Russian Federation
facility: St. Petersburg State Healthcare Institution "Clinical Rheumatology Hospital 25"
city: St. Petersburg
country: Russian Federation
facility: "AVA-PETER" Ltd - Affiliate Address
city: St. Petersburg
country: Russian Federation
facility: Laboratory of LLC AVA-PETER
city: Cape Town
country: South Africa
facility: Panorama Medical Centre - Room 136
city: KwaZulu Natal
country: South Africa
facility: Dr. Jan Fourie Medical Centre
city: Leeds
country: United Kingdom
facility: Division of Rheumatic & Musculoskeletal Diseases
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: 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.