Questa pagina è stata tradotta automaticamente e l'accuratezza della traduzione non è garantita. Si prega di fare riferimento al Versione inglese per un testo di partenza.

Rheumatoid Arthritis Extension Trial For Subjects Who Have Participated In Other PF-05280586 Trials (REFLECTIONS B328-04)

8 gennaio 2019 aggiornato da: Pfizer

EXTENSION STUDY EVALUATING TREATMENT WITH PF-05280586 VERSUS RITUXIMAB IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS WHO HAVE PARTICIPATED IN OTHER PF-05280586 CLINICAL TRIALS

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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Effettivo)

185

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Australia
    • Queensland
      • Maroochydore, Queensland, Australia, 4558
        • Rheumatology Research Unit
  • Canada
      • Quebec, Canada, G1W 4R4
        • Centre de Recherche Saint-Louis
      • Quebec, Canada, G1V 3M7
        • Pharmacie Matte et Petit
    • Quebec
      • Rimouski, Quebec, Canada, G5L 8W1
        • Centre de Rhumatologie de l'Est du Quebec
      • Rimouski, Quebec, Canada, G5L 1J5
        • Clinique Medicale du Phare (ECG Only)
  • Colombia
    • Antioquia
      • Medellin, Antioquia, Colombia
        • Rodrigo Botero S.A.S.
      • Medellin, Antioquia, Colombia
        • IPS Rodrigo Botero S.A.S.
      • Medellín, Antioquia, Colombia
        • Clínica Medellín S.A. Sede Centro
      • Medellín, Antioquia, Colombia
        • Mix Supplier S.A.
    • Atlantico
      • Barranquilla, Atlantico, Colombia
        • Centro de Reumatologia y Ortopedia
      • Barranquilla, Atlantico, Colombia
        • Clínica de la costa Ltda.
      • Barranquilla, Atlantico, Colombia
        • Congregación de las Hermanas Franciscanas Misioneras de María Auxiliadora-Clinica La Asuncion
      • Barranquilla, Atlantico, Colombia
        • IPS Centro Integral de Reumatologia del Caribe, CIRCARIBE S.A.S.
      • Barranquilla, Atlantico, Colombia
        • IPS Centro Integral De Reumatologia del Caribe, CIRCARIBE S.A.S
      • Barranquilla, Atlantico, Colombia
        • Organizacion Clinica General del Norte S.A.
  • Federazione Russa
      • Kemerovo, Federazione Russa, 650000
        • State Institution of Healthcare "Regional Clinical Hospital for Wars' Veterans"
      • Novosibirsk, Federazione Russa, 630099
        • LLC Consulting and Diagnostic Rheumatological Center "Healthy Joints"
      • Samara, Federazione Russa, 443095
        • State Budget Institution of Healthcare "Samara Regional Clinical Hospital named after V.D. Seredavin
      • Samara, Federazione Russa, 443095
        • State Institution of Healthcare "Samara Regional Clinical Hospital named after V.D. Seredavin"
      • St Petersburg, Federazione Russa, 191014
        • AVA-PETER Ltd.
      • St Petersburg, Federazione Russa, 191025
        • Local Ethics Committee of LLC AVA-PETER
      • St. Petersburg, Federazione Russa, 190068
        • St. Petersburg State Healthcare Institution "Clinical Rheumatology Hospital 25"
      • St. Petersburg, Federazione Russa, 191014
        • "AVA-PETER" Ltd - Affiliate Address
      • St. Petersburg, Federazione Russa
        • Laboratory of LLC AVA-PETER
    • Republic OF Tatarstan
      • Kazan, Republic OF Tatarstan, Federazione Russa, 420103
        • LLC Scientific and Research Medical Complex "Your Health"
  • Germania
      • Berlin, Germania, 14059
        • Schlosspark-Klinik GmbH, Internal Medicine II
  • Israele
      • Tel Hashomer, Israele, 5262000
        • The Chaim Sheba Medical Center
  • Messico
      • San Luis Potosi, Messico, 78213
        • Centro de Alta Especialidad en Reumatologia e Investigacion del Potosi, S.C.
      • San Luis Potosi, Messico, 78200
        • Hospital Angeles, Centro Medico del Potosi
    • Distrito Federal
      • Mexico City, Distrito Federal, Messico, 06700
        • C.T. Scanner de Mexico, S.A. de C.V. (CT ONLY)
      • Mexico City, Distrito Federal, Messico, 06700
        • CLIDITER, S.A de C.V.
      • Mexico City, Distrito Federal, Messico, 06700
        • Hospital Angeles Clinica Londres
    • Jalisco
      • Guadalajara, Jalisco, Messico, 44650
        • Private Office
      • Guadalajara, Jalisco, Messico, 44200
        • Hospital Bernardette (Emergencies)
  • Regno Unito
      • Leeds, Regno Unito, LS7 1NR
        • Division of Rheumatic & Musculoskeletal Diseases
  • Stati Uniti
    • Alabama
      • Birmingham, Alabama, Stati Uniti, 35294
        • University of Alabama at Birmingham
      • Huntsville, Alabama, Stati Uniti, 35801
        • Rheumatology Associates of North Alabama, PC
    • Arizona
      • Gilbert, Arizona, Stati Uniti, 85234
        • Arthrocare, Arthritiscare & Research, PC
    • Arkansas
      • Hot Springs, Arkansas, Stati Uniti, 71913
        • CHI St. Vincent Medical Group Hot Springs
    • California
      • Los Angeles, California, Stati Uniti, 90095
        • UCLA David Geffen School of Medicine
      • Los Angeles, California, Stati Uniti, 90095
        • UCLA Clinical & Translational Research Center
      • Palm Desert, California, Stati Uniti, 92260
        • Desert Medical Advances
    • Connecticut
      • Trumbull, Connecticut, Stati Uniti, 06611
        • New England Research Associates, LLC
    • Delaware
      • Newark, Delaware, Stati Uniti, 19711
        • QPS Labs
    • Florida
      • Tampa, Florida, Stati Uniti, 33612
        • University of South Florida - College of Medicine Carol and Frank Morsani Center
    • Illinois
      • Maywood, Illinois, Stati Uniti, 60153
        • Loyola University Medical Center
      • Morton Grove, Illinois, Stati Uniti, 60053
        • Illnois Bone & Joint Institute
    • Indiana
      • Indianapolis, Indiana, Stati Uniti, 46214
        • Covance Central Laboratory Services
    • Kentucky
      • Lexington, Kentucky, Stati Uniti, 40504
        • Bluegrass Community Research, Inc.
    • Maryland
      • Cumberland, Maryland, Stati Uniti, 21502
        • Klein & Associates, M.D., P.A.
    • Massachusetts
      • Worcester, Massachusetts, Stati Uniti, 01605
        • Clinical Pharmacology Study Group
    • Michigan
      • Battle Creek, Michigan, Stati Uniti, 49015
        • Bronson Internal Medicine and Rheumatology
      • Lansing, Michigan, Stati Uniti, 48910
        • Justus J. Fiechtner, MD, PC
    • Nevada
      • Las Vegas, Nevada, Stati Uniti, 89102
        • University of Nevada School of Medicine
    • New Hampshire
      • Lebanon, New Hampshire, Stati Uniti, 03756
        • Dartmouth - Hitchcock Medical Center
    • New York
      • Great Neck, New York, Stati Uniti, 11021
        • North Shore-LIJ Health System - Division of Rheumatology and Allergy-Clinical
    • North Carolina
      • Hickory, North Carolina, Stati Uniti, 28602
        • PMG Research of Hickory LLC
      • Hickory, North Carolina, Stati Uniti, 28602
        • PMG Research of Hickory, LLC
    • Ohio
      • Cincinnati, Ohio, Stati Uniti, 45219
        • Cincinnati Rheumatic Disease Study Group
    • Oklahoma
      • Oklahoma City, Oklahoma, Stati Uniti, 73103
        • Health Research of Oklahoma
    • Pennsylvania
      • Duncansville, Pennsylvania, Stati Uniti, 16635
        • Altoona Center For Clinical Research
      • Philadelphia, Pennsylvania, Stati Uniti, 19152
        • The Arthritis Group
      • Wyomissing, Pennsylvania, Stati Uniti, 19610
        • Clinical Research Center of Reading, LLC
    • Tennessee
      • Hixson, Tennessee, Stati Uniti, 37343
        • Arthritis Associates, PLLC
      • Jackson, Tennessee, Stati Uniti, 38305
        • Arthritis Clinic
      • Jackson, Tennessee, Stati Uniti, 38305
        • West Tennessee Research Institute
    • Texas
      • Dallas, Texas, Stati Uniti, 75231
        • Metroplex Clinical Research Center
      • Houston, Texas, Stati Uniti, 77054
        • Apocell, Inc
      • Mesquite, Texas, Stati Uniti, 75150
        • SouthWest Rheumatology Research, LLC
  • Sud Africa
      • Cape Town, Sud Africa, 7500
        • Panorama Medical Centre - Room 136
      • KwaZulu Natal, Sud Africa, 3000
        • Dr. Jan Fourie Medical Centre

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Mascheramento: Triplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Rituximab-Pfizer
Biologico: 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
Comparatore attivo: Rituximab-EU+Rituximab-Pfizer
Subjects will receive Rituximab-EU x 1 course followed by Rituximab-Pfizer x 2 courses.
Biologico: 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
Comparatore attivo: Rituximab-US+Rituximab-Pfizer
Subjects will receive Rituximab-US x 1 course followed by Rituximab-Pfizer x 2 courses.
Biologico: 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

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Percentage of Participants by Anti-Drug Antibody (ADA) Status Using Anti-PF-05280586 Antibody Assay
Lasso di tempo: Course 1 (C1) Overall, Course 2 (C2) Overall, Course 3 (C3) Overall, and All Courses Overall.
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.
Course 1 (C1) Overall, Course 2 (C2) Overall, Course 3 (C3) Overall, and All Courses Overall.
Percentage of Participants by ADA Status Using Anti-Rituximab Antibody Assay
Lasso di tempo: Course 1 Overall, Course 2 Overall, Course 3 Overall, and All Courses Overall.
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.
Course 1 Overall, Course 2 Overall, Course 3 Overall, and All Courses Overall.
Percentage of Participants by Neutralizing Antibody (Nab) Status in Participants With a Positive ADA Using Anti-PF-05280586 NAb Assay
Lasso di tempo: Weeks 1, 3, 13, and 25 (Course 1, Course 2, and Course 3).
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.
Weeks 1, 3, 13, and 25 (Course 1, Course 2, and Course 3).
Percentage of Participants by Nab Status in Participants With a Positive ADA Using Anti-PF-05280586 NAb Assay Using Anti-Rituximab NAb Assay
Lasso di tempo: Weeks 1, 3, 13, and 25 (Course 1, Course 2, and Course 3).
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.
Weeks 1, 3, 13, and 25 (Course 1, Course 2, and Course 3).
Mean Rituximab Serum Trough Concentrations
Lasso di tempo: 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).
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.
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).
Cluster of Differentiation 19 (CD19+) B Cell Count
Lasso di tempo: 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.
Blood samples were assayed for CD19+ B-cell counts using laser scanning cytometry.
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.
Circulating Immunoglobulin G (IgG) Concentrations
Lasso di tempo: Screening, Week 25 (Course 1), and Weeks 1 and 25 (Course 2 and Course 3).
Blood samples for immunoglobulin assessments were obtained to determine IgG levels in serum.
Screening, Week 25 (Course 1), and Weeks 1 and 25 (Course 2 and Course 3).
Circulating Immunoglobulin M (IgM) Concentrations
Lasso di tempo: Screening, Week 25 (Course 1), and Weeks 1 and 25 (Course 2 and Course 3).
Blood samples for immunoglobulin assessments were obtained to determine IgM levels in serum.
Screening, Week 25 (Course 1), and Weeks 1 and 25 (Course 2 and Course 3).
Circulating Rheumatoid Factor (RF) Concentrations
Lasso di tempo: Week 1 and 25 (Course 1, Course 2, and Course 3).
RF is the auto-antibody directed against IgG. Blood samples were obtained to determine RF levels in serum.
Week 1 and 25 (Course 1, Course 2, and Course 3).
Anti-Cyclic Citrullinated Peptide (Anti-CCP) and Complement
Lasso di tempo: Week 1 and 25 (Course 1, Course 2, and Course 3).
Blood samples were obtained to determine anti-CCP and compliment levels in serum.
Week 1 and 25 (Course 1, Course 2, and Course 3).
Mean Change From Initial Study Baseline in Disease Activity Score (DAS28)-C-Reactive Protein (CRP) - by the End of Course 1
Lasso di tempo: Baseline B3281001, Week 1, 6, 13, and 25 (Course 1).
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.
Baseline B3281001, Week 1, 6, 13, and 25 (Course 1).
Mean Change From Initial Study Baseline in Disease Activity Score (DAS28)-C-Reactive Protein (CRP) - by the End of Course 2
Lasso di tempo: Baseline B3281001, Week 1, 6, 13, and 25 (Course 1 and Course 2).
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.
Baseline B3281001, Week 1, 6, 13, and 25 (Course 1 and Course 2).
Mean Change From Initial Study Baseline in Disease Activity Score (DAS28)-C-Reactive Protein (CRP) - by the End of Course 3
Lasso di tempo: Baseline B3281001, Week 1, 6, 13, and 25 (Course 1 and Course 2), and Week 1, 13, and 25 (Course 3).
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.
Baseline B3281001, Week 1, 6, 13, and 25 (Course 1 and Course 2), and Week 1, 13, and 25 (Course 3).
Percentage of Participants With Good European League Against Rheumatism (EULAR) Response Based on DAS28 - by the End of Course 1
Lasso di tempo: Week 1, 6, 13, and 25 (Course 1).
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.
Week 1, 6, 13, and 25 (Course 1).
Percentage of Participants With Good European League Against Rheumatism (EULAR) Response Based on DAS28 - by the End of Course 2
Lasso di tempo: Week 1, 6, 13, and 25 (Course 1 and Course 2).
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.
Week 1, 6, 13, and 25 (Course 1 and Course 2).
Percentage of Participants With Good European League Against Rheumatism (EULAR) Response Based on DAS28 - by the End of Course 3
Lasso di tempo: Week 1, 6, 13, and 25 (Course 1 and Course 2) and Week 1, 13, and 25 (Course 3).
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.
Week 1, 6, 13, and 25 (Course 1 and Course 2) and Week 1, 13, and 25 (Course 3).
Percentage of Participants With Low Disease Activity State (LDAS) (≤3.2) - by the End of Course 1
Lasso di tempo: Week 1, 6, 13, and 25 (Course 1).
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.
Week 1, 6, 13, and 25 (Course 1).
Percentage of Participants With Low Disease Activity State (LDAS) (≤3.2) - by the End of Course 2
Lasso di tempo: Week 1, 6, 13, and 25 (Course 1 and Course 2).
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.
Week 1, 6, 13, and 25 (Course 1 and Course 2).
Percentage of Participants With Low Disease Activity State (LDAS) (≤3.2) - by the End of Course 3
Lasso di tempo: Week 1, 6, 13, and 25 (Course 1 and Course 2), and Week 1, 13, and 25 (Course 3).
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.
Week 1, 6, 13, and 25 (Course 1 and Course 2), and Week 1, 13, and 25 (Course 3).
Percentage of Participants With DAS Remission (DAS28-CRP Less Than [<] 2.6) - by the End of Course 1
Lasso di tempo: Week 1, 6, 13, and 25 (Course 1).
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.
Week 1, 6, 13, and 25 (Course 1).
Percentage of Participants With DAS Remission (DAS28-CRP Less Than [<] 2.6) - by the End of Course 2
Lasso di tempo: Week 1, 6, 13, and 25 (Course 1 and Course 2).
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.
Week 1, 6, 13, and 25 (Course 1 and Course 2).
Percentage of Participants With DAS Remission (DAS28-CRP Less Than [<] 2.6) - by the End of Course 3
Lasso di tempo: Week 1, 6, 13, and 25 (Course 1 and Course 2), and Week 1, 13, and 25 (Course 3).
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.
Week 1, 6, 13, and 25 (Course 1 and Course 2), and Week 1, 13, and 25 (Course 3).
Percentage of Participants With American College of Rheumatology (ACR) 20% Improvement (ACR20) Response - by the End of Course 1
Lasso di tempo: Week 1, 6, 13, and 25 (Course 1).
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.
Week 1, 6, 13, and 25 (Course 1).
Percentage of Participants With American College of Rheumatology (ACR) 20% Improvement (ACR20) Response - by the End of Course 2
Lasso di tempo: Week 1, 6, 13, and 25 (Course 1 and Course 2).
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.
Week 1, 6, 13, and 25 (Course 1 and Course 2).
Percentage of Participants With American College of Rheumatology (ACR) 20% Improvement (ACR20) Response - by the End of Course 3
Lasso di tempo: Week 1, 6, 13, and 25 (Course 1 and Course 2), and Week 1, 13, and 25 (Course 3).
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.
Week 1, 6, 13, and 25 (Course 1 and Course 2), and Week 1, 13, and 25 (Course 3).
Percentage of Participants With American College of Rheumatology (ACR) 50% Improvement (ACR50) Response - by the End of Course 1
Lasso di tempo: Week 1, 6, 13, and 25 (Course 1).
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.
Week 1, 6, 13, and 25 (Course 1).
Percentage of Participants With American College of Rheumatology (ACR) 50% Improvement (ACR50) Response - by the End of Course 2
Lasso di tempo: Week 1, 6, 13, and 25 (Course 1 and Course 2).
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.
Week 1, 6, 13, and 25 (Course 1 and Course 2).
Percentage of Participants With American College of Rheumatology (ACR) 50% Improvement (ACR50) Response - by the End of Course 3
Lasso di tempo: Week 1, 6, 13, and 25 (Course 1 and Course 2), and Week 1, 13, and 25 (Course 3).
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.
Week 1, 6, 13, and 25 (Course 1 and Course 2), and Week 1, 13, and 25 (Course 3).
Percentage of Participants With American College of Rheumatology (ACR) 70% Improvement (ACR70) Response - by the End of Course 1
Lasso di tempo: Week 1, 6, 13, and 25 (Course 1).
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.
Week 1, 6, 13, and 25 (Course 1).
Percentage of Participants With American College of Rheumatology (ACR) 70% Improvement (ACR70) Response - by the End of Course 2
Lasso di tempo: Week 1, 6, 13, and 25 (Course 1 and Course 2).
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.
Week 1, 6, 13, and 25 (Course 1 and Course 2).
Percentage of Participants With American College of Rheumatology (ACR) 70% Improvement (ACR70) Response - by the End of Course 3
Lasso di tempo: Week 1, 6, 13, and 25 (Course 1 and Course 2), and Week 1, 13, and 25 (Course 3).
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.
Week 1, 6, 13, and 25 (Course 1 and Course 2), and Week 1, 13, and 25 (Course 3).
Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Tender/Painful Joint Count - by the End of Course 1
Lasso di tempo: Screening, Week 1, 6, 13, and 25 (Course 1).
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.
Screening, Week 1, 6, 13, and 25 (Course 1).
Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Tender/Painful Joint Count - by the End of Course 2
Lasso di tempo: Screening, Week 1, 6, 13, and 25 (Course 1 and Course 2).
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.
Screening, Week 1, 6, 13, and 25 (Course 1 and Course 2).
Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Tender/Painful Joint Count - by the End of Course 3
Lasso di tempo: Screening, Week 1, 6, 13, and 25 (Course 1 and Course 2), and Screening, Week 1, 13, and 25 (Course 3).
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.
Screening, Week 1, 6, 13, and 25 (Course 1 and Course 2), and Screening, Week 1, 13, and 25 (Course 3).
Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Swollen Joint Count - by the End of Course 1
Lasso di tempo: Screening, Week 1, 6, 13, and 25 (Course 1).
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.
Screening, Week 1, 6, 13, and 25 (Course 1).
Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Swollen Joint Count - by the End of Course 2
Lasso di tempo: Screening, Week 1, 6, 13, and 25 (Course 1 and Course 2).
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.
Screening, Week 1, 6, 13, and 25 (Course 1 and Course 2).
Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Swollen Joint Count - by the End of Course 3
Lasso di tempo: Screening, Week 1, 6, 13, and 25 (Course 1 and Course 2), and Screening, Week 1, 13, and 25 (Course 3).
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.
Screening, Week 1, 6, 13, and 25 (Course 1 and Course 2), and Screening, Week 1, 13, and 25 (Course 3).
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
Lasso di tempo: Week 1, 6, 13, and 25 (Course 1).
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.
Week 1, 6, 13, and 25 (Course 1).
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
Lasso di tempo: Week 1, 6, 13, and 25 (Course 1 and Course 2).
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.
Week 1, 6, 13, and 25 (Course 1 and Course 2).
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
Lasso di tempo: Week 1, 6, 13, and 25 (Course 1 and Course 2), and Week 1, 13, and 25 (Course 3).
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.
Week 1, 6, 13, and 25 (Course 1 and Course 2), and Week 1, 13, and 25 (Course 3).
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
Lasso di tempo: Week 1, 6, 13, and 25 (Course 1).
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).
Week 1, 6, 13, and 25 (Course 1).
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
Lasso di tempo: Week 1, 6, 13, and 25 (Course 1 and Course 2).
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).
Week 1, 6, 13, and 25 (Course 1 and Course 2).
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
Lasso di tempo: Week 1, 6, 13, and 25 (Course 1 and Course 2), and Week 1, 13, and 25 (Course 3).
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).
Week 1, 6, 13, and 25 (Course 1 and Course 2), and Week 1, 13, and 25 (Course 3).
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
Lasso di tempo: Week 1, 6, 13, and 25 (Course 1).
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).
Week 1, 6, 13, and 25 (Course 1).
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
Lasso di tempo: Week 1, 6, 13, and 25 (Course 1 and Course 2).
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).
Week 1, 6, 13, and 25 (Course 1 and Course 2).
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
Lasso di tempo: Week 1, 6, 13, and 25 (Course 1 and Course 2), and Week 1, 13, and 25 (Course 3).
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).
Week 1, 6, 13, and 25 (Course 1 and Course 2), and Week 1, 13, and 25 (Course 3).
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
Lasso di tempo: Week 1, 6, 13, and 25 (Course 1).

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.
Week 1, 6, 13, and 25 (Course 1).
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
Lasso di tempo: Week 1, 6, 13, and 25 (Course 1 and Course 2).

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.
Week 1, 6, 13, and 25 (Course 1 and Course 2).
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
Lasso di tempo: Week 1, 6, 13, and 25 (Course 1 and Course 2), and Week 1, 13, and 25 (Course 3).

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.
Week 1, 6, 13, and 25 (Course 1 and Course 2), and Week 1, 13, and 25 (Course 3).
Outcome Measure Using HAQ-DI - by the End of Course 1
Lasso di tempo: Week 1, 6, 13, and 25 (Course 1).

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.
Week 1, 6, 13, and 25 (Course 1).
Outcome Measure Using HAQ-DI - by the End of Course 2
Lasso di tempo: Week 1, 6, 13, and 25 (Course 1 and Course 2).

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.
Week 1, 6, 13, and 25 (Course 1 and Course 2).
Outcome Measure Using HAQ-DI - by the End of Course 3
Lasso di tempo: Week 1, 6, 13, and 25 (Course 1 and Course 2), and Week 1, 13, and 25 (Course 3).

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.
Week 1, 6, 13, and 25 (Course 1 and Course 2), and Week 1, 13, and 25 (Course 3).

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Pfizer

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Collegamenti utili

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

16 agosto 2012

Completamento primario (Effettivo)

14 marzo 2016

Completamento dello studio (Effettivo)

14 marzo 2016

Date di iscrizione allo studio

Primo inviato

6 luglio 2012

Primo inviato che soddisfa i criteri di controllo qualità

16 luglio 2012

Primo Inserito (Stima)

18 luglio 2012

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

29 gennaio 2019

Ultimo aggiornamento inviato che soddisfa i criteri QC

8 gennaio 2019

Ultimo verificato

1 gennaio 2019

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • B3281004
  • ICON 9002/0101
  • 2012-003223-38 (Numero EudraCT)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Descrizione del piano IPD

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.

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

Prove cliniche su Rituximab-Pfizer (PF-05280586) x 3 courses

Cerca prove simili

Sponsor e collaboratori

Condizioni mediche

Interventi farmacologici

CROs by country

CROs in Madagascar

Condizioni

Malattie rare

Interventi farmacologici

Supplementi dietetici

Sponsor / Collaboratori

Sedi

Sottoscrivi