Clinical trial NCT00883753: An Extension to Study MA21573, Evaluating Tocilizumab in Patients With Active Rheumatoid Arthritis and an Inadequate Response to Current Non-Biological DMARDs and/or Anti-tumor Necrosis Factor (TNF) Therapy
Official title: An Extension Phase of the Multi-National Open-Label Study (MA21573) to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Patients With Active Rheumatoid Arthritis on Background Non-biologic DMARDs Who Have an Inadequate Response to Current Non-biologic DMARD and/or Anti-TNF Therapy.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Rheumatoid Arthritis
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2009-04-20
Enrollment: 934
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study was an extension to study MA21573 \[NCT00750880\], which was an open label single arm study to investigate the safety, tolerability and efficacy of tocilizumab monotherapy, or combination therapy with non-biological disease-modifying antirheumatic drugs (DMARDS), in patients with moderate to severe active rheumatoid arthritis. Patients who completed the 24 week core study, and had at least a moderate European League Against Rheumatism (EULAR) response, were eligible to enter this long-term extension study, and received tocilizumab 8 mg/kg intravenous (iv) every 4 weeks. The anticipated time on study treatment was 1-2 years, and the target sample size was \> 500 individuals.


Eligibility criteria: Inclusion Criteria:

- patients who completed the 24-week MA21573 core study, had at least a moderate response based on EULAR definition criteria and no adverse events (AEs), serious adverse events (SAEs) or conditions that led to unacceptable risk of continued treatment.

Exclusion Criteria:

-as for MA21573.

Primary outcomes:
measure: Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: 108 Weeks
Secondary outcomes:
measure: Percentage of Participants With Adverse Events Leading to Withdraw
timeFrame: 108 Weeks
measure: Time to Withdrawal Due to an Adverse Event (AE)
timeFrame: 108 Weeks
measure: Percentage of Participants With Discontinuation of Treatment Due to Any Cause
timeFrame: 108 Weeks
measure: Time to Discontinuation of Tocilizumab Treatment for Any Cause
timeFrame: 108 Weeks
measure: Percentage of Participants With Marked Lipid Abnormalities
timeFrame: 108 Weeks
measure: Percentage of Participants With Adverse Events (AEs) of Special Interest
timeFrame: 108 Weeks
measure: Percentage of Participants With ALT Elevations > 3*ULN
timeFrame: 108 Weeks
measure: Percentage of Participants With AST Elevations > 3*ULN
timeFrame: 108 Weeks
measure: Number of Participants Categorized by Highest Value for ALT (SGPT) During the Study
timeFrame: 108 Weeks
measure: Number of Participants Categorized by Worst Value for AST (SGOT) During the Study
timeFrame: 108 Weeks
measure: Number of Participants Categorized by Worst Value for LDL Cholesterol During the Study
timeFrame: 108 Weeks
measure: Number of Participants Categorized by Worst Value for Total Cholesterol During the Study
timeFrame: 108 Weeks
measure: Number of Participants Categorized by Worst Value for Neutrophil Count During the Study
timeFrame: 108 Weeks
measure: Percentage of Participants With Clinically Meaningful Improvement in Disease Activity Score-28 (DAS28)
timeFrame: Core Baseline, Extension Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108
measure: Percentage of Participants With DAS28 Low Disease Activity
timeFrame: Extension Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108
measure: Percentage of Participants With DAS28 Remission
timeFrame: Extension Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108
measure: Change From Baseline in DAS28
timeFrame: Core Baseline, Extension Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108
measure: Change From Baseline in Tender Joint Count
timeFrame: Core Baseline, Extension Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108
measure: Change From Baseline in Swollen Joint Count
timeFrame: Core Baseline, Extension Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108
measure: Change From Baseline in Patient Assessment of Pain Visual Analog Scale (VAS)
timeFrame: Core Baseline, Extension Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108
measure: Change From Baseline in Patient Global Assessment of Disease Activity VAS
timeFrame: Core Baseline, Extension Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108
measure: Change From Baseline in Physician Global Assessment of Disease Activity VAS
timeFrame: Core Baseline, Extension Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108
measure: Change From Baseline in Erythrocyte Sedimentation Rate (ESR)
timeFrame: Core Baseline, Extension Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108
measure: Change From Baseline in C-Reactive Protein (CRP)
timeFrame: Core Baseline, Extension Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108
measure: Percentage of Participants With American College of Rheumatology 20 (ACR20) Response
timeFrame: Core Baseline, Extension Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108
measure: Percentage of Participants With American College of Rheumatology 50 (ACR50) Response
timeFrame: Core Baseline, Extension Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108
measure: Percentage of Participants With American College of Rheumatology 70 (ACR70) Response
timeFrame: Core Baseline, Extension Weeks 12, 24, 36 ,48, 60, 72, 84, 96, 108
measure: Percentage of Participants With American College of Rheumatology 90 (ACR90) Response
timeFrame: Core Baseline, Extension Weeks 12, 24, 36 ,48, 60, 72, 84, 96, 108
measure: Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Response
timeFrame: Core Baseline, Extension Weeks 12, 24, 36 ,48, 60, 72, 84, 96, 108
measure: Percentage of Participants Achieving Clinical Meaningful Health Assessment Questionnaire Disability Index (HAQ-DI) Response
timeFrame: Core Baseline, Extension Weeks 12, 24, 36 ,48, 60, 72, 84, 96, 108
measure: Percentage of Participants Achieving Health Assessment Questionnaire Disability Index (HAQ-DI) Clinical Remission
timeFrame: Extension Weeks 12, 24, 36 ,48, 60, 72, 84, 96, 108
measure: Change From Baseline in Quality of Life Short Form (SF-36): Physical Component Score
timeFrame: Core Baseline, Extension Weeks 12, 24, 36 ,48, 60, 72, 84, 96, 108
measure: Change From Baseline in Quality of Life Short Form (SF-36):Mental Component Score
timeFrame: Core Baseline, Extension Weeks 12, 24, 36 ,48, 60, 72, 84, 96, 108
measure: Change From Baseline in FACIT-Fatigue Score
timeFrame: Core Baseline, Extension Weeks 12, 24, 36 ,48, 60, 72, 84, 96, 108
Other outcomes:
Locations:
city: Canberra
country: Australia
state: Australian Capital Territory
city: Coffs Harbour
country: Australia
state: New South Wales
city: Kogarah
country: Australia
state: New South Wales
city: Cairns
country: Australia
state: Queensland
city: Adelaide
country: Australia
state: South Australia
city: Fitzroy
country: Australia
state: Victoria
city: Geelong
country: Australia
state: Victoria
city: Melbourne
country: Australia
state: Victoria
city: Edmonton
country: Canada
state: Alberta
city: Lethbridge
country: Canada
state: Alberta
city: Kelowna
country: Canada
state: British Columbia
city: Nanaimo
country: Canada
state: British Columbia
city: Vancouver
country: Canada
state: British Columbia
city: Vancouver
country: Canada
state: British Columbia
city: Quispamsis
country: Canada
state: New Brunswick
city: St John's
country: Canada
state: Newfoundland and Labrador
city: Hamilton
country: Canada
state: Ontario
city: Ottawa
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Windsor
country: Canada
state: Ontario
city: Laval
country: Canada
state: Quebec
city: Montreal
country: Canada
state: Quebec
city: Montreal
country: Canada
state: Quebec
city: Quebec City
country: Canada
state: Quebec
city: Rimouski
country: Canada
state: Quebec
city: Sherbrooke
country: Canada
state: Quebec
city: St-eustache
country: Canada
state: Quebec
city: Trois-rivieres
country: Canada
state: Quebec
city: Saskatoon
country: Canada
state: Saskatchewan
city: Bruntal
country: Czech Republic
city: Ostrava
country: Czech Republic
city: Praha
country: Czech Republic
city: Sokolov
country: Czech Republic
city: Uherske Hradiste
country: Czech Republic
city: Zlin
country: Czech Republic
city: Belfort
country: France
city: Caen
country: France
city: Cahors
country: France
city: Corbeil-essonnes
country: France
city: Dijon
country: France
city: La Rochelle
country: France
city: Lievin
country: France
city: Lomme
country: France
city: Lyon
country: France
city: Lyon
country: France
city: Marseille
country: France
city: Montivilliers
country: France
city: Montpellier
country: France
city: Mulhouse
country: France
city: Paris
country: France
city: Poitiers
country: France
city: Reims
country: France
city: Roubaix
country: France
city: St Brieuc
country: France
city: Strasbourg
country: France
city: Toulouse
country: France
city: Valence
country: France
city: Valenciennes
country: France
city: Heraklion
country: Greece
city: Budapest
country: Hungary
city: Eger
country: Hungary
city: Szeged
country: Hungary
city: Veszprem
country: Hungary
city: Arenzano
country: Italy
city: Legnano
country: Italy
city: Milano
country: Italy
city: Milano
country: Italy
city: Milano
country: Italy
city: Modena
country: Italy
city: Monserrato
country: Italy
city: Novara
country: Italy
city: Palermo
country: Italy
city: Potenza
country: Italy
city: Roma
country: Italy
city: Roma
country: Italy
city: Siena
country: Italy
city: Varese
country: Italy
city: 'S Hertogenbosch
country: Netherlands
city: Alkmaar
country: Netherlands
city: Amsterdam
country: Netherlands
city: Apeldoorn
country: Netherlands
city: Arnhem
country: Netherlands
city: Bergen Op Zoom
country: Netherlands
city: Den Haag
country: Netherlands
city: Den Haag
country: Netherlands
city: Den Helder
country: Netherlands
city: Enschede
country: Netherlands
city: Gouda
country: Netherlands
city: Heerlen
country: Netherlands
city: Hilversum
country: Netherlands
city: Leeuwarden
country: Netherlands
city: Nieuwegein
country: Netherlands
city: Nijmegen
country: Netherlands
city: Roosendaal
country: Netherlands
city: Rotterdam
country: Netherlands
city: Rotterdam
country: Netherlands
city: Schiedam
country: Netherlands
city: Spijkenisse
country: Netherlands
city: Vlissingen
country: Netherlands
city: Krakow
country: Poland
city: Poznan
country: Poland
city: Wroclaw
country: Poland
city: Almada
country: Portugal
city: Coimbra
country: Portugal
city: Lisboa
country: Portugal
city: Lisboa
country: Portugal
city: Porto
country: Portugal
city: Bucharest
country: Romania
city: Bucharest
country: Romania
city: Cluj-napoca
country: Romania
city: Jeddah
country: Saudi Arabia
city: Jeddah
country: Saudi Arabia
city: Jeddah
country: Saudi Arabia
city: Elche
country: Spain
state: Alicante
city: Elda
country: Spain
state: Alicante
city: Sabadell
country: Spain
state: Barcelona
city: Terrassa
country: Spain
state: Barcelona
city: La Coruna
country: Spain
state: La Coruña
city: Las Palmas De Gran Canaria
country: Spain
state: Las Palmas
city: La Laguna
country: Spain
state: Tenerife
city: Alicante
country: Spain
city: Almeria
country: Spain
city: Barcelona
country: Spain
city: Barcelona
country: Spain
city: Barcelona
country: Spain
city: Barcelona
country: Spain
city: Caceres
country: Spain
city: Cordoba
country: Spain
city: Granada
country: Spain
city: Huesca
country: Spain
city: Lugo
country: Spain
city: Madrid
country: Spain
city: Madrid
country: Spain
city: Malaga
country: Spain
city: Salamanca
country: Spain
city: Sevilla
country: Spain
city: Valencia
country: Spain
city: Valencia
country: Spain
city: Barnsley
country: United Kingdom
city: Basingstoke
country: United Kingdom
city: Bournemouth
country: United Kingdom
city: Brighton
country: United Kingdom
city: Burton on Trent
country: United Kingdom
city: Bury St Edmonds
country: United Kingdom
city: Cambridge
country: United Kingdom
city: Cardiff
country: United Kingdom
city: Chelmsford
country: United Kingdom
city: Dudley
country: United Kingdom
city: Eastbourne
country: United Kingdom
city: Gillingham
country: United Kingdom
city: Harrogate
country: United Kingdom
city: Ipswich
country: United Kingdom
city: Liverpool
country: United Kingdom
city: Llantrisant
country: United Kingdom
city: Londonderry
country: United Kingdom
city: London
country: United Kingdom
city: Maidstone
country: United Kingdom
city: Middlesborough
country: United Kingdom
city: Newcastle Upon Tyne
country: United Kingdom
city: Nottingham
country: United Kingdom
city: Reading
country: United Kingdom
city: Salford
country: United Kingdom
city: Sheffield
country: United Kingdom
city: Southport
country: United Kingdom
city: Swindon
country: United Kingdom
city: Torquay
country: United Kingdom
city: Westcliffe-on-sea
country: United Kingdom
city: Wirral
country: United Kingdom
city: Worthing
country: United Kingdom
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: