A Study to Evaluate Efficacy of Tocilizumab Administered as Monotherapy or in Combination With Methotrexate and/or Other Disease Modifying Antirheumatic Drugs (DMARDs) in Rheumatoid Arthritis (RA) Participants
NCT ID: NCT01941940
Last Updated: 2017-07-11
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
227 participants
INTERVENTIONAL
2013-09-05
2016-07-05
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Tocilizumab
Tocilizumab at a fixed dose of 162 milligrams (mg) will be administered as subcutaneous (SC) injection alone or along with methotrexate and/or other non-biological DMARDs irrespective of body weight, once every week for a total of 52 weeks. After 52-weeks of treatment, at the discretion of the treating physician, participants can continue the study treatment with SC tocilizumab until it becomes commercially available in Italy.
Tocilizumab
Tocilizumab at a fixed dose of 162 mg as SC injection will be administered once every week.
DMARDs
Non-biologic DMARDs according to standard of care, at a stable dose that was initiated at least 4 weeks prior to baseline.
Interventions
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Tocilizumab
Tocilizumab at a fixed dose of 162 mg as SC injection will be administered once every week.
DMARDs
Non-biologic DMARDs according to standard of care, at a stable dose that was initiated at least 4 weeks prior to baseline.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Moderate to severe RA (CDAI at least \[\>/=\] 10 and DAS28 \>/=3.2) at screening
* Tumor necrosis factor inhibitors-inadequate responder (TNF-IR), methotrexate-inadequate responder (MTX-IR), and/or DMARDs-inadequate responder (DMARDs-IR)
* Oral corticosteroids (less than or equal to \[\</=\] 10 mg per day prednisone or equivalent) and non-steroidal anti-inflammatory drugs (NSAIDs; up to the maximum recommended dose) are permitted if on a stable dose regimen for \>/=4 weeks prior to baseline
* Permitted non-biologic DMARDs are allowed if at a stable dose for \>/=4 weeks prior to baseline
* Receiving treatment on an outpatient basis, not including tocilizumab
* Females of childbearing potential and males with female partners of childbearing potential must agree to use a reliable means of contraception for at least 3 months following the last dose of tocilizumab
Exclusion Criteria
* Rheumatic autoimmune disease other than RA; secondary Sjögren's syndrome with RA is permitted
* Functional Class IV as defined by the ACR Classification of Functional Status in RA
* Diagnosis of juvenile idiopathic arthritis or juvenile RA and/or RA before the age of 16
* Prior history of or current inflammatory joint disease other than RA
* Exposure to tocilizumab (either intravenous \[IV\] or SC) at any time prior to baseline
* Treatment with any investigational agent within 4 weeks (or 5 half-lives of the investigational drug, whichever is longer) of screening
* Previous treatment with any cell-depleting therapies
* Intra-articular or parenteral corticosteroids within 4 weeks prior to baseline
* History of severe allergic or anaphylactic reactions to human, humanized, or murine monoclonal antibodies
* Evidence of serious uncontrolled concomitant cardiovascular, nervous system, pulmonary, renal, hepatic, endocrine (including uncontrolled diabetes mellitus), or gastrointestinal disease
* Known active current or history of recurrent bacterial, viral, fungal, mycobacterial, or other infections
* Any major episode of infection requiring hospitalization or treatment with IV antibiotics within 4 weeks of screening or oral antibiotics within 2 weeks of screening
* Active tuberculosis (TB) requiring treatment within the previous 3 years
* Positive for hepatitis B surface antigen or hepatitis C antibody
* Primary or secondary immunodeficiency (history of or currently active)
* Evidence of active malignant disease, malignancies diagnosed within the previous 10 years (except for basal and squamous cell carcinoma of the skin or carcinoma in situ of the cervix uteri that has been excised and cured), or breast cancer diagnosed within the previous 20 years
* Pregnant or breast feeding women
* Neuropathies or other conditions that might interfere with pain evaluation
18 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Uni Degli Studi Di L Aquila; Cattedra Di Reumatologia - Dept. Di Medicina Interna E San
Coppito, Abruzzo, Italy
P. O. Spirito Santo - Asl Pescara; U.O. Complessa Di Reumatologia
Pescara, Abruzzo, Italy
Ospedale Regionale Umberto Parini; Reparto Endocrinologia e Diabetologia - Amb. Reumatologia
Aosta, Aosta Valley, Italy
Azienda Ospedaliera Policlinico; Servizio Reumatologia
Bari, Apulia, Italy
ASL Lecce- Presidio Ospedaliero di Casarano-Servizio di Reumatologia ed Osteoporosi
Casarano (LE), Apulia, Italy
Ospedali Riuniti di Foggia; Dipartimento Medicina Interna Reumatologia
Foggia, Apulia, Italy
Ospedali Riuniti Di Foggia; Struttura Di Reumatologia
Foggia, Apulia, Italy
Azienda Ospedaliera Bianchi Melacrino Morelli; Unità Operativa di Reumatologia
Reggio Calabria, Calabria, Italy
Az. Ospedaliera S. Giuseppe Moscati; Dip. Med. Gen. Struttura Semplice Reumatologia
Avellino, Campania, Italy
Azienda Ospedaliera Rummo; Divisione Di Reumatologia
Benevento, Campania, Italy
Azienda Ospedaliera A. Cardarelli; Medicina III - Divisione di Reumatologia
Napoli, Campania, Italy
Policlinico Universitario-II Università di Napoli; Reumatologia
Napoli, Campania, Italy
Osp Riuniti S.Giovanni di Dio e Ruggi d'Aragona; Rep. Medicina Interna
Salerno, Campania, Italy
Irccs Fondazione Salvatore Maugeri-Istituto Scientifico Di Telese;U.O. Riabilitazione Reumatologica
Telese Terme, Campania, Italy
A.O.U Policlinico S. Orsola Malpighi di Bologna U.O di Medicina Interna Borghi - Pad.2
Bologna, Emilia-Romagna, Italy
A.O. Universitaria Policlinico Di Modena; Reumatologia
Modena, Emilia-Romagna, Italy
Arcispedale Santa Maria Nuova; Reumatologia
Reggio Emilia, Emilia-Romagna, Italy
Policlinico Univ. Uni Degli Sudi Di Udine; Clinica Di Reumatologia
Udine, Friuli Venezia Giulia, Italy
Policlinico Campus Bio-Medico Di Trigoria; Medicina Clinica E Reumatologia
Rome, Lazio, Italy
Policlinico Tor Vergata; Divisione Di Reumatologia
Rome, Lazio, Italy
Ospedale S.Pietro Fatebenefratelli; Divisione di Reumatologia
Rome, Lazio, Italy
Ospedale La Colletta; Reparto Di Reumatologia
Arenzano, Liguria, Italy
Università Degli Studi Di Genova - Dimi; Reumatologia
Genoa, Liguria, Italy
Ospedale San Paolo; Divisione di Reumatologia
Savona, Liguria, Italy
Asst Papa Giovanni XXIII; Dh Reumatologia
Bergamo, Lombardy, Italy
Ospedale Civile "La Memoria" Di Gavardo;Immunoematologia Trasfusionale-Allergologia E Reumatologia
Gavardo, Lombardy, Italy
Ospedale Di Magenta Fornaroli; U.O. Di Reumatologia
Magenta, Lombardy, Italy
Asst Centro Specialistico Ortopedico Traumato-Logico Gaetano Pini/Cto; Divisione Di Reumatologia
Milan, Lombardy, Italy
Ospedale Maggiore Policlinico; Unità Operativa Complessa di Allergologia e Immunologia Clinica
Milan, Lombardy, Italy
ASST FATEBENEFRATELLI SACCO; Reumatologia (Sacco)
Milan, Lombardy, Italy
Asst Grande Ospedale Metropolitano Niguarda; Reumatologia
Milan, Lombardy, Italy
ASST DI MONZA; Reumatologia (Medicina I)
Monza, Lombardy, Italy
Irccs Policlinico San Matteo; Reumatologia Adulti
Pavia, Lombardy, Italy
ASST DI VIMERCATE; Medicina Generale
Vimercate, Lombardy, Italy
Azienda Ospedaliera Maggiore Della Carita; Day Hospital Immunologia
Novara, Piedmont, Italy
Azienda Ospedaliera San Giovanni Battista; Reparto Reumatologia
Turin, Piedmont, Italy
Ordine Mauriziano Ospedale Umberto I; Centro Di Reumatologia
Turin, Piedmont, Italy
A.O. Universitaria Policlinico Monserrato Di Cagliari; Reumatologia I
Cagliari, Sardinia, Italy
Azienda Ospedaliero Universitaria di Sassari; UOC Reumatologia
Sassari, Sardinia, Italy
Ospedale Vittorio Emanuele Ii; U.O. Reumatologia Clinica Medica Condorelli
Catania, Sicily, Italy
Azienda Osped. Univ. Policlinico G. Martino; Centro Prevenzione E Cura Osteoporosi
Messina, Sicily, Italy
Arnas Ospedale Civico; Medicina Interna II
Palermo, Sicily, Italy
Ospedale Regionale Torrette; SOD Clinica Medica del Dipartimento di Medicina Interna e Specialisti
Ancona, The Marches, Italy
Ospedale Murri - Universita Politecnica Delle Marche; Clinica Reumatologica Ii
Iesi, The Marches, Italy
Ospedale Careggi Villa Monnatessa ; Sezione Di Reumatologia
Florence, Tuscany, Italy
Az. Osp. Pisana Ospedale S. Chiara; U.O. Di Reumatologia
Pisa, Tuscany, Italy
Osp S. Maria Misericordia Dip. Medicina Clinica Sperimentale Cattedra Reumatologia
Perugia, Umbria, Italy
Azienda Ospedaliera Universitaria Borgo Trento; Dipartimento di Medicina Sezione di Reumatologia
Verona, Veneto, Italy
Policlinico G.B. Rossi; Divisione Immunologia Clinica Sperimentale Medicina B
Verona, Veneto, Italy
Countries
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References
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Choy E, Caporali R, Xavier R, Fautrel B, Sanmarti R, Bao M, Devenport J, Petho-Schramm A. Effects of concomitant glucocorticoids in TOZURA, a common-framework study programme of subcutaneous tocilizumab in rheumatoid arthritis. Rheumatology (Oxford). 2019 Jun 1;58(6):1056-1064. doi: 10.1093/rheumatology/key393.
Choy E, Caporali R, Xavier R, Fautrel B, Sanmarti R, Bao M, Bernasconi C, Petho-Schramm A. Subcutaneous tocilizumab in rheumatoid arthritis: findings from the common-framework phase 4 study programme TOZURA conducted in 22 countries. Rheumatology (Oxford). 2018 Mar 1;57(3):499-507. doi: 10.1093/rheumatology/kex443.
Other Identifiers
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2013-001569-17
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
ML28699
Identifier Type: -
Identifier Source: org_study_id
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