Clinical trial NCT00720798: An Extension Study of Tocilizumab (Myeloma Receptor Antibody [MRA]) in Patients Completing Treatment in Tocilizumab Core Studies
Official title: Long-term Extension Study of Safety During Treatment With Tocilizumab (MRA) in Patients Completing Treatment in MRA Core Studies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Rheumatoid Arthritis
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2008-07-23
Enrollment: 2067
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This single-arm study evaluated the long-term efficacy and safety of tocilizumab in participants who had completed treatment in the tocilizumab core studies (NCT00106522 \[Roche protocol WA18062\], NCT00106574 \[Roche protocol WA18063\], and NCT00109408 \[Roche protocol WA17824\]) of adults with rheumatoid arthritis. Participants received tocilizumab alone or in combination with standard anti-rheumatic treatment.


Eligibility criteria: Inclusion Criteria:

* Patients who have completed participation in 1 of the core studies in adult rheumatoid arthritis.

Exclusion Criteria:

* Treatment with any investigational agent since the last administration of study drug in the core studies.
* Treatment with iv gamma globulin, plasmapheresis, or prosorba column since the last administration of study drug in the core studies.
* Treatment with an anti-TNF or anti-IL1 agent, a T-cell co-stimulation modulator, or any biologic since the last administration of study drug in the core studies.
* Immunization with a live/attenuated vaccine since the last administration of study drug in the core studies.
* Previous treatment with any cell-depleting therapies, including investigational agents.
* Parenteral, intramuscular, or intra-articular corticosteroids within 6 weeks prior to baseline in this study.

Primary outcomes:
measure: Percentage of Participants With ≥ 1 Adverse Event
timeFrame: Baseline to the end of the study (up to 7 years, 7 months)
Secondary outcomes:
measure: Percentage of Participants Who Withdrew From Treatment
timeFrame: Baseline to the end of the study (up to 7 years, 7 months)
measure: Percentage of Participants With Concomitant Oral Corticosteroid Therapy
timeFrame: Baseline to the end of the study (up to 7 years, 7 months)
measure: Percentage of Participants Who Changed From Monotherapy to Combination Therapy
timeFrame: Baseline to Week 296
measure: Percentage of Participants With an Improvement of at Least 20%, 50%, 70%, or 90% in the American College of Rheumatology (ACR) Score (ACR20/50/70/90) From Baseline at Weeks 24, 48, 108, 156, 204, and 264
timeFrame: Baseline to Week 264
measure: Percentage of Participants Who Achieved a Major Clinical Response at Weeks 48, 96, 144, 192, and 264
timeFrame: Baseline to Week 264
measure: Percentage of Participants Who Maintained an Improvement of at Least 20%, 50%, or 70% in the American College of Rheumatology (ACR) Score (ACR20/50/70) Consecutively for 24, 48, 96, and 264 Weeks at Weeks 48, 96, 144, 192, and 264
timeFrame: Baseline to Week 264
measure: Swollen and Tender Joint Count (SJC/TJC) at Baseline and Weeks 24, 48, 108, 156, 204, and 264
timeFrame: Baseline to Week 264
measure: Disease Activity and Pain at Baseline and Weeks 24, 48, 108, 156, 204, and 264
timeFrame: Baseline to Week 264
measure: Health Assessment Questionnaire-Disability Index Score at Baseline and Weeks 24, 48, 108, 156, 204, and 264
timeFrame: Baseline to Week 264
measure: Erythrocyte Sedimentation Rate at Baseline and Weeks 24, 48, 108, 156, 204, and 264
timeFrame: Baseline to Week 264
measure: Change in the Disease Activity Score 28 (DAS-28) From Baseline to Weeks 24, 48, 96, and 264
timeFrame: Baseline to Week 264
measure: Percentage of Participants Who Were Disease Activity Score 28 (DAS-28) Responders at Weeks 24, 48, 108, 156, 204, and 264
timeFrame: Baseline to Week 264
measure: Percentage of Participants Who Maintained a Disease Activity Score 28 (DAS-28) Response for 24, 48, 96, 144, and 192 Weeks at Weeks 48, 96, 144, 192, and 264
timeFrame: Baseline to Week 264
measure: Percentage of Participants With a Clinically Relevant Improvement in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Score at Weeks 24, 36, 48, 108, 156, 204, and 264
timeFrame: Baseline to Week 264
measure: Percentage of Participants With a Clinically Relevant Improvement in the Physical and Mental Component Scores of the Short Form 36 (SF-36) Health Survey at Weeks 24, 48, 108, 156, 204, and 264
timeFrame: Baseline to Week 264
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Huntsville
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state: Alabama
city: Mesa
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state: Arizona
city: Paradise Valley
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state: Arizona
city: Peoria
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city: Scottsdale
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city: Tucson
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city: Aventura
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state: Georgia
city: Boise
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country: Canada
state: Alberta
city: Edmonton
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state: British Columbia
city: Winnipeg
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state: Manitoba
city: St John's
country: Canada
state: Newfoundland and Labrador
city: Burlington
country: Canada
state: Ontario
city: Hamilton
country: Canada
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city: Kitchener
country: Canada
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city: London
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city: Mississauga
country: Canada
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city: Ottawa
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state: Ontario
city: Montreal
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state: Quebec
city: Quebec City
country: Canada
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city: Sainte-foy
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state: Quebec
city: Saskatoon
country: Canada
state: Saskatchewan
city: Beijing
country: China
city: Beijing
country: China
city: Guangzhou
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city: Jyväskylä
country: Finland
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city: Bordeaux
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country: France
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country: France
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country: France
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country: France
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country: France
city: Lyon
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country: France
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country: France
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country: France
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city: Pierre Benite
country: France
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country: France
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country: France
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country: France
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country: France
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country: France
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country: Germany
city: Berlin
country: Germany
city: Dresden
country: Germany
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country: Germany
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country: Germany
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country: Germany
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country: Germany
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country: Germany
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country: Germany
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country: Germany
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country: Germany
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country: Germany
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country: Germany
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country: Hong Kong
city: Tuen Mun
country: Hong Kong
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country: Iceland
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city: Haifa
country: Israel
city: Haifa
country: Israel
city: Rishon Lezion
country: Israel
city: Brescia
country: Italy
city: Genova
country: Italy
city: Milano
country: Italy
city: Padova
country: Italy
city: Pavia
country: Italy
city: Pisa
country: Italy
city: Siena
country: Italy
city: Udine
country: Italy
city: Kaunas
country: Lithuania
city: Klaipeda
country: Lithuania
city: Panevezys
country: Lithuania
city: Siauliai
country: Lithuania
city: Vilnius
country: Lithuania
city: Guadalajara
country: Mexico
city: Guadalajara
country: Mexico
city: Guadalajara
country: Mexico
city: Leon
country: Mexico
city: Mexico City
country: Mexico
city: Mexico City
country: Mexico
city: Mexico City
country: Mexico
city: Tijuana
country: Mexico
city: Nijmegen
country: Netherlands
city: Levanger
country: Norway
city: Lillehammer
country: Norway
city: Panama City
country: Panama
city: Lima
country: Peru
city: Lima
country: Peru
city: Lisboa
country: Portugal
city: Ponce
country: Puerto Rico
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Ryazan
country: Russian Federation
city: St Petersburg
country: Russian Federation
city: St Petersburg
country: Russian Federation
city: Tula
country: Russian Federation
city: Belgrade
country: Serbia
city: Niska Banja
country: Serbia
city: Ljubljana
country: Slovenia
city: Maribor
country: Slovenia
city: Cape Town
country: South Africa
city: Cape Town
country: South Africa
city: Diepkloof
country: South Africa
city: Durban
country: South Africa
city: Pinelands
country: South Africa
city: Pretoria
country: South Africa
city: Radiokop
country: South Africa
city: Barakaldo
country: Spain
city: Barcelona
country: Spain
city: Madrid
country: Spain
city: Malaga
country: Spain
city: Pontevedra
country: Spain
city: Santiago de Compostela
country: Spain
city: Stockholm
country: Sweden
city: Umea
country: Sweden
city: Lausanne
country: Switzerland
city: Bangkok
country: Thailand
city: Bangkok
country: Thailand
city: Chiang Mai
country: Thailand
city: Basingstoke
country: United Kingdom
city: Birmingham
country: United Kingdom
city: Cannock
country: United Kingdom
city: Derby
country: United Kingdom
city: Leeds
country: United Kingdom
city: London
country: United Kingdom
city: Manchester
country: United Kingdom
city: Manchester
country: United Kingdom
city: Middlesborough
country: United Kingdom
city: Newcastle Upon Tyne
country: United Kingdom
city: Oxford
country: United Kingdom
city: Southampton
country: United Kingdom
city: Stoke-on-trent
country: United Kingdom
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Jones G, Wallace T, McIntosh MJ, Brockwell L, Gomez-Reino JJ, Sebba A. Five-year Efficacy and Safety of Tocilizumab Monotherapy in Patients with Rheumatoid Arthritis Who Were Methotrexate- and Biologic-naive or Free of Methotrexate for 6 Months: the AMBITION Study. J Rheumatol. 2017 Feb;44(2):142-146. doi: 10.3899/jrheum.160287. Epub 2016 Dec 1.