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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT01119859
Registration number
NCT01119859
Ethics application status
Date submitted
1/04/2010
Date registered
10/05/2010
Date last updated
11/02/2013
Titles & IDs
Public title
A Study of Tocilizumab (RoActemra/Actemra) Versus Adalimumab in Patients With Rheumatoid Arthritis
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Scientific title
A Multi-center, Randomized, Blinded, Parallel-group Study of the Reduction of Signs and Symptoms During Monotherapy Treatment With Tocilizumab 8 mg/kg Intravenously Versus Adalimumab 40 mg Subcutaneously in Patients With Rheumatoid Arthritis
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Secondary ID [1]
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2009-015845-21
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Secondary ID [2]
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WA19924
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Rheumatoid Arthritis
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Condition category
Condition code
Musculoskeletal
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Osteoarthritis
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Inflammatory and Immune System
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Rheumatoid arthritis
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Tocilizumab
Treatment: Drugs - Adalimumab
Treatment: Drugs - Placebo to tocilizumab
Treatment: Drugs - Placebo to adalimumab
Experimental: Tocilizumab 8 mg/kg - Patients received 6 infusions of tocilizumab 8 mg/kg intravenously every 4 weeks and 12 injections of placebo to adalimumab subcutaneously every 2 weeks.
Active Comparator: Adalimumab 40 mg - Patients received 12 injections of adalimumab 40 mg subcutaneously every 2 weeks and 6 infusions of placebo to tocilizumab intravenously every 4 weeks.
Treatment: Drugs: Tocilizumab
The maximum dose was 800 mg for patients weighing more than 100 kg. Tocilizumab was infused into an arm vein over a 1-hour period.
Treatment: Drugs: Adalimumab
Treatment: Drugs: Placebo to tocilizumab
Treatment: Drugs: Placebo to adalimumab
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Change From Baseline to Week 24 in the Disease Activity Score 28 (DAS28)
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Assessment method [1]
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The DAS28 is a combined index for measuring disease activity in rheumatic arthritis (RA) and includes swollen and tender joint counts, erythrocyte sedimentation rate (ESR), and general health (GH) status. The index is calculated with the following formula: DAS28 = (0.56 × v(TJC28)) + (0.28 × v(SJC28)) + (0.7 × log(ESR)) + (0.014 × GH), where TJC28 = tender joint count and SJC28 = swollen joint count, each on 28 joints. GH = a patient's global assessment of disease activity in the previous 24 hours on a 100 mm visual analog scale (left end = no disease activity [symptom-free and no arthritis symptoms], right end = maximum disease activity [maximum arthritis disease activity]). When ESR equaled 0 mm/hr, it was set to 1 mm/hr. The DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity. A negative change score indicates improvement. The analysis was adjusted for stratification factors of duration of RA (= 2 years and > 2 years) and region (US and non-US).
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Timepoint [1]
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Baseline to Week 24
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Secondary outcome [1]
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Percentage of Patients With a Remission Response (Disease Activity Score 28 [DAS28] < 2.6) at Week 24
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Assessment method [1]
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The percentage of patients who achieved remission of their rheumatic arthritis at Week 24, as measured by a DAS28 score < 2.6, is reported.
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Timepoint [1]
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Week 24
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Secondary outcome [2]
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Percentage of Patients With Low Disease Activity (Disease Activity Score 28 [DAS28] = 3.2) at Week 24
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Assessment method [2]
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The percentage of patients who had low rheumatic arthritis disease activity at Week 24, as measured by a DAS28 score of 3.2 or less, is reported.
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Timepoint [2]
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Week 24
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Secondary outcome [3]
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Percentage of Patients With an Improvement of at Least 20%, 50%, or 70% in American College of Rheumatology (ACR) Score (ACR20/50/70) From Baseline at Week 24
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Assessment method [3]
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Improvement must be seen in tender and swollen joint counts (28 assessed joints) and in at least 3 of the following 5 parameters: Separate patient and physician assessments of patient disease activity in the previous 24 hours on a visual analog scale (VAS, the extreme left end of the line "no disease activity" [symptom-free and no arthritis symptoms] and the extreme right end "maximum disease activity"; patient assessment of pain in previous the 24 hours on a VAS (extreme left end of the line "no pain" and the extreme right end "unbearable pain"); Health Assessment Questionnaire-Disability Index (20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities, 0=without difficulty to 3=unable to do); and erythrocyte sedimentation rate.
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Timepoint [3]
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Baseline to Week 24
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Secondary outcome [4]
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Percentage of Patients With a European League Against Rheumatism (EULAR) Good Response at Week 24
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Assessment method [4]
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Change of the Disease Activity Score 28 score from baseline was used to determine EULAR responses of good, moderate, or no response. For a post-baseline score = 3.2, a change from baseline of < -1.2 was a good response, < -0.6 to = -1.2 was a moderate response, and = -0.6 was no response. For a post-baseline score > 3.2 to = 5.1, a change from baseline of < -0.6 was a moderate response and = -0.6 was no response. For a post-baseline score > 5.1, a change from baseline < -1.2 was a moderate response and = -1.2 was no response. A good response could not be achieved for post-baseline scores > 3.2.
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Timepoint [4]
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Baseline to Week 24
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Secondary outcome [5]
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Percentage of Patients With a European League Against Rheumatism (EULAR) Good or Moderate Response at Week 24
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Assessment method [5]
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Change of the Disease Activity Score 28 score from baseline was used to determine EULAR responses of good, moderate, or no response. For a post-baseline score = 3.2, a change from baseline of < -1.2 was a good response, < -0.6 to = -1.2 was a moderate response, and = -0.6 was no response. For a post-baseline score > 3.2 to = 5.1, a change from baseline of < -0.6 was a moderate response and = -0.6 was no response. For a post-baseline score > 5.1, a change from baseline < -1.2 was a moderate response and = -1.2 was no response. A good response could not be achieved for post-baseline scores > 3.2.
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Timepoint [5]
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Baseline to Week 24
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Eligibility
Key inclusion criteria
- Adult patients, = 18 years of age.
- Rheumatoid arthritis of > 6 months duration.
- Intolerant of methotrexate or continued treatment with methotrexate is considered
inappropriate.
- All disease-modifying anti-rheumatic drugs (DMARD) are to be withdrawn prior to
receiving study drug.
- Weight = 150 kg.
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Minimum age
18
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Major surgery (including joint surgery) within 12 weeks prior to baseline or planned
major surgery within 6 months after baseline.
- History of or current inflammatory joint disease other than rheumatoid arthritis (RA).
- Treatment with a biologic agent at any time prior to baseline.
- Intra-articular or parenteral corticosteroids = 4 weeks prior to baseline.
- Active current infection or history of recurrent bacterial, viral, fungal or
mycobacterial infection.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 4
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/05/2010
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/01/2012
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Sample size
Target
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Accrual to date
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Final
326
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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- Maroochydore
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Recruitment hospital [2]
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- Sydney
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Recruitment postcode(s) [1]
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4558 - Maroochydore
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Recruitment postcode(s) [2]
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2050 - Sydney
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Recruitment outside Australia
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Poole
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Funding & Sponsors
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Commercial sector/Industry
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Name
Hoffmann-La Roche
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Ethics approval
Ethics application status
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Summary
Brief summary
This randomized, blinded, parallel arm study evaluated the efficacy and safety of tocilizumab
(RoActemra/Actemra) versus adalimumab as monotherapy in patients with rheumatoid arthritis
who are intolerant of methotrexate or where continued treatment with methotrexate was
considered inappropriate. Patients were randomized to receive either tocilizumab 8 mg/kg
intravenously (iv) every 4 weeks plus placebo subcutaneously (sc) every 2 weeks, or
adalimumab 40 mg sc every 2 weeks plus placebo iv every 4 weeks. Treatment was anticipated to
last 24 weeks. With regard to the blind, the study nurse was unblinded due to the nature of
the treatment administration, but the investigator and the patient remained blinded.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01119859
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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Hoffmann-La Roche
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01119859
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