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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00750880




Registration number
NCT00750880
Ethics application status
Date submitted
10/09/2008
Date registered
11/09/2008
Date last updated
22/07/2015

Titles & IDs
Public title
An Exploratory Study of Tocilizumab in Patients With Active Rheumatoid Arthritis (RA) and an Inadequate Response to Current Non-Biologic DMARDs and/or Anti-TNF Therapy.
Scientific title
International Multi-Center Open Label Study 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 or Anti-TNF Therapy.
Secondary ID [1] 0 0
2008-000587-17
Secondary ID [2] 0 0
MA21573
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Rheumatoid Arthritis 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Osteoarthritis
Inflammatory and Immune System 0 0 0 0
Rheumatoid arthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - tocilizumab [RoActemra/Actemra]

Experimental: 1 -


Treatment: Drugs: tocilizumab [RoActemra/Actemra]
8mg/kg iv (60 minute infusion)
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants With Adverse Events (AEs): Overall Summary
Timepoint [1] 0 0
Weeks 4, 8, 12, 16, 20, and 24
Secondary outcome [1] 0 0
Percentage of Participants Who Achieved Low Disease Activity or Remission Based on Disease Activity Score Based on 28-Joints Count (DAS28) by Visit
Timepoint [1] 0 0
Baseline, Weeks 4, 8, 12, 16, 20, and 24
Secondary outcome [2] 0 0
Time to Low Disease Activity or Remission Based on DAS28 - Number of Participants With an Event
Timepoint [2] 0 0
Baseline, Weeks 4, 8, 12, 16, 20, and 24
Secondary outcome [3] 0 0
Time to Low Disease Activity and Remission Based on DAS28 Score - Time to Event
Timepoint [3] 0 0
Baseline,Weeks 4, 8, 12, 16, 20, and 24
Secondary outcome [4] 0 0
Percentage of Participants Achieving a Response by European League Against Rheumatism (EULAR) Response Category and Visit
Timepoint [4] 0 0
Weeks 4, 8, 12, 16, 20, and 24
Secondary outcome [5] 0 0
DAS28 Scores by Visit
Timepoint [5] 0 0
Baseline, Weeks 4, 8, 12, 16, 20, and 24
Secondary outcome [6] 0 0
Percentage of Participants Achieving an American College of Rheumatology 20 Percent (%), 50%, 70%, or 90% Improvement (ACR20/ACR50/ACR70/ACR90) by Visit
Timepoint [6] 0 0
Weeks 4, 8, 12, 16, 20, and 24
Secondary outcome [7] 0 0
Time to Achieve ACR20, ACR50, ACR70 and ACR90 Response - Number of Participants With an Event
Timepoint [7] 0 0
Weeks 4, 8, 12, 16, 20, and 24
Secondary outcome [8] 0 0
Time to Achieve ACR20, ACR50, ACR70 and ACR90 Response
Timepoint [8] 0 0
Weeks 4, 8, 12, 16, 20, and 24
Secondary outcome [9] 0 0
Swollen Joint Count by Visit
Timepoint [9] 0 0
Baseline, Weeks 4, 8, 12, 16, 20, and 24
Secondary outcome [10] 0 0
Tender Joint Count by Visit
Timepoint [10] 0 0
Baseline, Weeks 4, 8, 12, 16, 20, and 24
Secondary outcome [11] 0 0
Patient's Global Assessment of Disease Activity by Visit
Timepoint [11] 0 0
Baseline, Weeks 4, 8, 12, 16, 20, and 24
Secondary outcome [12] 0 0
Physician's Global Assessment of Disease Activity by Visit
Timepoint [12] 0 0
Baseline, Weeks 4, 8, 12, 16, 20, and 24
Secondary outcome [13] 0 0
Patient's Global Assessment of Pain by Visit
Timepoint [13] 0 0
Baseline, Weeks 4, 8, 12, 16, 20, and 24
Secondary outcome [14] 0 0
C-Reactive Protein by Visit
Timepoint [14] 0 0
Baseline, Weeks 4, 8, 12, 16, 20, and 24
Secondary outcome [15] 0 0
Erythrocyte Sedimentation Rate by Visit
Timepoint [15] 0 0
Baseline, Weeks 4, 8, 12, 16, 20, and 24
Secondary outcome [16] 0 0
HAQ-DI Scores by Visit
Timepoint [16] 0 0
Baseline, Weeks 4, 8, 12, 16, 20, and 24
Secondary outcome [17] 0 0
Short Form-36 (SF-36) Physical Functioning Domain Scores by Visit
Timepoint [17] 0 0
Baseline, Weeks 4, 8, 12, 16, 20, and 24
Secondary outcome [18] 0 0
Percentage of Participants With HAQ-DI Clinical Remission and Clinically Meaningful Improvement By Visit
Timepoint [18] 0 0
Baseline, Weeks 4, 8, 12, 16, 20, and 24
Secondary outcome [19] 0 0
Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) Score by Visit
Timepoint [19] 0 0
Baseline, Weeks 4, 8, 12, 16, 20, and 24

Eligibility
Key inclusion criteria
* male and non-pregnant or nursing female patients >=18 years of age;
* body weight <=150kg;
* moderate to severe active RA (DAS28 >=3.2) of >=6 months duration;
* on >=1 non-biologic DMARDs at a stable dose for a period of >= 8 weeks prior to start of treatment;
* inadequate clinical response to a stable dose of non-biologic DMARD or anti-TNF therapy;
* if receiving oral corticosteroids, the dose must have been stable for at least 25 of 28 days prior to start of treatment.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months following enrollment;
* rheumatic autoimmune disease other than RA;
* prior history of, or current inflammatory joint disease other than RA;
* functional class IV as defined by the ACR Classification of Functional Status in RA.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/09/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/07/2011
Sample size
Target
Accrual to date
Final
1681
Recruitment in Australia
Recruitment state(s)
ACT,NSW,SA,VIC
Recruitment hospital [1] 0 0
- Canberra
Recruitment hospital [2] 0 0
- Coffs Harbour
Recruitment hospital [3] 0 0
- Kogarah
Recruitment hospital [4] 0 0
- Parramatta Park
Recruitment hospital [5] 0 0
- Adelaide
Recruitment hospital [6] 0 0
- Fitzroy
Recruitment hospital [7] 0 0
- Geelong
Recruitment hospital [8] 0 0
- Melbourne
Recruitment postcode(s) [1] 0 0
2601 - Canberra
Recruitment postcode(s) [2] 0 0
2450 - Coffs Harbour
Recruitment postcode(s) [3] 0 0
2217 - Kogarah
Recruitment postcode(s) [4] 0 0
4870 - Parramatta Park
Recruitment postcode(s) [5] 0 0
5041 - Adelaide
Recruitment postcode(s) [6] 0 0
3065 - Fitzroy
Recruitment postcode(s) [7] 0 0
3220 - Geelong
Recruitment postcode(s) [8] 0 0
3168 - Melbourne
Recruitment outside Australia
Country [1] 0 0
Austria
State/province [1] 0 0
Graz-Eggenberg
Country [2] 0 0
Austria
State/province [2] 0 0
Graz
Country [3] 0 0
Austria
State/province [3] 0 0
Innsbruck
Country [4] 0 0
Austria
State/province [4] 0 0
Linz
Country [5] 0 0
Austria
State/province [5] 0 0
Salzburg
Country [6] 0 0
Austria
State/province [6] 0 0
Stockerau
Country [7] 0 0
Austria
State/province [7] 0 0
Wien
Country [8] 0 0
Belgium
State/province [8] 0 0
Aalst
Country [9] 0 0
Belgium
State/province [9] 0 0
Bruxelles
Country [10] 0 0
Belgium
State/province [10] 0 0
Edegem
Country [11] 0 0
Belgium
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Gent
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Belgium
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Hasselt
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Belgium
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Heusy
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Belgium
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Leuven
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Belgium
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Liege
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Belgium
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Merksem
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Belgium
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Montignies S/ Sambre
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Belgium
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Westmalle
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State/province [19] 0 0
Alberta
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British Columbia
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Canada
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New Brunswick
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Canada
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Newfoundland and Labrador
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Ontario
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Quebec
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Basingstoke
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Brighton
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Harrogate
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Ipswich
Country [205] 0 0
United Kingdom
State/province [205] 0 0
Liverpool
Country [206] 0 0
United Kingdom
State/province [206] 0 0
Llantrisant
Country [207] 0 0
United Kingdom
State/province [207] 0 0
Londonderry
Country [208] 0 0
United Kingdom
State/province [208] 0 0
London
Country [209] 0 0
United Kingdom
State/province [209] 0 0
Maidstone
Country [210] 0 0
United Kingdom
State/province [210] 0 0
Middlesborough
Country [211] 0 0
United Kingdom
State/province [211] 0 0
Newcastle upon Tyne
Country [212] 0 0
United Kingdom
State/province [212] 0 0
Nottingham
Country [213] 0 0
United Kingdom
State/province [213] 0 0
Reading
Country [214] 0 0
United Kingdom
State/province [214] 0 0
Salford
Country [215] 0 0
United Kingdom
State/province [215] 0 0
Sheffield
Country [216] 0 0
United Kingdom
State/province [216] 0 0
Southport
Country [217] 0 0
United Kingdom
State/province [217] 0 0
Swindon
Country [218] 0 0
United Kingdom
State/province [218] 0 0
Torquay
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United Kingdom
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Westcliffe-on-sea
Country [220] 0 0
United Kingdom
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Wirral
Country [221] 0 0
United Kingdom
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Worthing

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Hoffmann-La Roche
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This open-label, single arm study will investigate the safety, tolerability and efficacy of tocilizumab monotherapy, or combination therapy with non-biologic disease modifying antirheumatic drugs (DMARDs), in patients with severe active RA. Patients will receive tocilizumab 8mg/kg iv as a 60 minute infusion every 4 weeks for a total of 6 infusions. The anticipated time on study treatment is 3-12 months, and the target sample size is \>500 individuals.
Trial website
https://clinicaltrials.gov/study/NCT00750880
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Trials
Address 0 0
Hoffmann-La Roche
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00750880