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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/NCT01007435
Registration number
NCT01007435
Ethics application status
Date submitted
3/11/2009
Date registered
4/11/2009
Date last updated
26/07/2017
Titles & IDs
Public title
A Study of Tocilizumab as Monotherapy and in Combination With Methotrexate Versus Methotrexate in Patients With Early Moderate to Severe Rheumatoid Arthritis
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Scientific title
A Multi-center, Randomized, Double-blind, Parallel Group Study of the Safety, Disease Remission and Prevention of Structural Joint Damage During Treatment With Tocilizumab (TCZ), as a Monotherapy and in Combination With Methotrexate (MTX), Versus Methotrexate in Patients With Early, Moderate to Severe Rheumatoid Arthritis
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Secondary ID [1]
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2009-012759-12
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Secondary ID [2]
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WA19926
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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 - Placebo to tocilizumab
Treatment: Drugs - Methotrexate
Treatment: Drugs - Placebo to methotrexate
Experimental: (A) Tocilizumab 8 mg/kg + placebo to methotrexate - Patients received tocilizumab 8 mg/kg iv every 4 weeks + placebo to methotrexate orally once a week for 104 weeks.
Experimental: (B) Tocilizumab 8 mg/kg + methotrexate - Patients received tocilizumab 8 mg/kg iv every 4 weeks + methotrexate orally once a week for 104 weeks.
Experimental: (C) Tocilizumab 4 mg/kg + methotrexate - Patients received tocilizumab 4 mg/kg iv every 4 weeks + methotrexate orally once a week for 104 weeks.
Active Comparator: (D) Placebo to tocilizumab + methotrexate - Patients received placebo tocilizumab intravenously (iv) every 4 weeks + methotrexate orally once a week for 104 weeks.
Treatment: Drugs: Tocilizumab
Tocilizumab was supplied in vials.
Treatment: Drugs: Placebo to tocilizumab
Placebo to tocilizumab was supplied in vials.
Treatment: Drugs: Methotrexate
Initially, patients received methotrexate 7.5 mg (3, 2.5 mg tablets) orally once a week. If a patient had swollen or tender joints, the dose was increased to 15 mg and 20 mg weekly, at the Week 4 and Week 8 visits, respectively.
Treatment: Drugs: Placebo to methotrexate
Patients received placebo to methotrexate orally once a week.
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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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Percentage of Participants With a Disease Activity Score 28 (DAS28) Remission Response at Week 24
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Assessment method [1]
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A participant has a DAS28 remission response if their DAS28 < 2.6. 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.
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Timepoint [1]
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Week 24
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Secondary outcome [1]
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Percentage of Participants With a Disease Activity Score 28 (DAS28) Remission Response at Week 52
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Assessment method [1]
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Timepoint [1]
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Week 52
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Secondary outcome [2]
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Percentage of Patients With an Improvement = 20%, 50%, or 70% in American College of Rheumatology (ACR) Score (ACR20/50/70) From Baseline to Weeks 24 and 52
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Assessment method [2]
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Improvement must be seen in tender (68) and swollen (66) joint counts. Joints were assessed and classified as swollen/not swollen and tender/not tender by pressure and joint manipulation. Improvement must also be seen 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 C-reactive protein (CRP), or erythrocyte sedimentation rate if CRP was missing.
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Timepoint [2]
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Baseline to Weeks 24 and 52
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Secondary outcome [3]
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Change From Baseline in Modified Total Sharp Score (mTSS) at Week 52
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Assessment method [3]
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The mTSS is a measure of joint damage and includes measures of joint erosion (JE) and joint space narrowing (JSN). The JE score, using the van der Heijde modification, measures erosion severity in 32 hand joints and 12 foot joints. Each hand joint is scored from 0 to 5 and each foot joint is scored from 0 to 10; the total score ranges from 0 to 280. Each joint is scored according to the surface area involved. A score of 10 indicates extensive loss of bone from more than one-half of the articulating bone; a score of 0 indicates no erosion. The JSN score measures the severity of JSN in 30 hand joints (15 per hand) and 12 foot joints (6 per foot). Each joint, including subluxation, is scored from 0 to 4; the total score ranges from 0 to 168. A higher score indicates more joint space narrowing. The mTSS ranges from 0 to 448 (280+168). A higher mTSS score indicates greater damage. A negative change score indicates improvement.
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Timepoint [3]
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Baseline to Week 52
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Secondary outcome [4]
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Change From Baseline in Modified Sharp Erosion Score at Week 52
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Assessment method [4]
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Timepoint [4]
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Baseline to Week 52
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Secondary outcome [5]
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Change From Baseline in Sharp Joint Space Narrowing Score at Week 52
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Assessment method [5]
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Timepoint [5]
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Baseline to Week 52
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Secondary outcome [6]
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Percentage of Participants With a Major Clinical Response at Week 52
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Assessment method [6]
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A major clinical response is defined as an ACR70 response that is maintained for 6 consecutive months (24 weeks) for any 24-week period between Week 2 and Week 52.
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Timepoint [6]
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Baseline to Week 52
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Secondary outcome [7]
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Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score at Weeks 24 and 52
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Assessment method [7]
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The Stanford HAQ-DI is a patient completed questionnaire specific for rheumatoid arthritis. The HAQ-DI assesses how well the patient is able to perform 8 activities: Dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities. The patient answers 20 questions with 1 of 4 responses with the past week as the time frame: 0=without difficulty, 1=with some difficulty, 2=with much difficulty, and 3=unable to do. The highest score for any question in a category determines the category score. The total score ranges from 0 (no disability) to 3 (completely disabled). A negative change score indicates improvement.
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Timepoint [7]
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Baseline to Weeks 24 and 52
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Secondary outcome [8]
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Change From Baseline in Short Form 36 (SF-36) Physical Component Summary (PCS) Scores at Weeks 24 and 52
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Assessment method [8]
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The SF-36 Health Survey (Version 2) is a standardized questionnaire consisting of 36 questions that measures patient-reported symptoms on 8 dimensions; it is used to assess health-related quality of life (HRQoL). The Physical Component Summary (PCS) score summarizes the subscales Physical Functioning, Role-Physical, Bodily Pain, and General Health. The Mental Component Summary (MCS) score summarizes the subscales Vitality, Social Functioning, Role-Emotional, and Mental Health. Each score was scaled from 0 to 100. A positive change score indicates better HRQoL.
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Timepoint [8]
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Baseline to Weeks 24 and 52
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Eligibility
Key inclusion criteria
- Adult patients = 18 years of age.
- Rheumatoid arthritis of = 2 years duration.
- Disease Activity Score 28 (DAS28) > 3.2.
- Swollen joint count (SJC) = 4 of 66 joints, tender joint count (TJC) = 6 of 68 joints.
- Rheumatoid factor (RF) and/or anti-cyclic citrullinated peptide (anti-CCP) positive
(if RF and anti-CCP negative > 1 erosion required at screening).
- Erythrocyte sedimentation rate (ESR) = 28 mm/h or C-reactive protein (CRP) = 10 mg/L
at screening.
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Minimum age
18
Years
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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
- Previous treatment with tocilizumab.
- Previous treatment with methotrexate or biologic agent.
- Rheumatic autoimmune disease other than rheumatoid arthritis (RA).
- History of or current inflammatory joint disease other than RA.
- Functional class IV as defined by the American College of Rheumatology (ACR)
Classification of Functional Status in RA.
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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 3
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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
31/10/2009
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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
28/01/2014
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Sample size
Target
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Accrual to date
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Final
1162
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,TAS,VIC,WA
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Recruitment hospital [1]
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Royal Prince Alfred Hospital; Rheumatology - Camperdown
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Sunshine Coast Rheumatology Research Unit - Maroochydore
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Queen Elizabeth Hospital; Rheumatology - Woodville
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Menzies Research Institute - Hobart
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Cabrini Medical Centre; Rheumatology - Malvern
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Recruitment hospital [6]
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Worthing Hospital - Murdoch
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Recruitment postcode(s) [1]
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2050 - Camperdown
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4558 - Maroochydore
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5011 - Woodville
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7100 - Hobart
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Recruitment postcode(s) [5]
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3144 - Malvern
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Recruitment postcode(s) [6]
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6150 - Murdoch
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Recruitment outside Australia
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Israel
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Israel
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Israel
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Italy
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Piemonte
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Italy
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Sardegna
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Macedonia, The Former Yugoslav Republic of
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Skopje
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Mexico
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Mexicali
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Mexico
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Mexico
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Mexico
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Hoffmann-La Roche
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Summary
Brief summary
This randomized, double-blind, parallel group study will assess the safety, disease
remission, and prevention of structural joint damage in patients with early moderate to
severe rheumatoid arthritis treated with tocilizumab as monotherapy or in combination with
methotrexate, versus methotrexate alone. Patients will be randomized to receive either (A)
tocilizumab (8 mg/kg iv every 4 weeks) plus placebo, (B) tocilizumab (8 mg/kg iv every 4
weeks) plus methotrexate (7.5-20 mg po weekly), (C) tocilizumab (4 mg/kg iv every 4 weeks)
plus methotrexate (7.5-20 mg po weekly), or (D) placebo plus methotrexate (7.5-20 mg po
weekly). Patients in groups C and D who have not achieved low disease activity at week 52 can
receive tocilizumab 8 mg/kg iv every 4 weeks. Anticipated time on study treatment is 104
weeks.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01007435
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Contacts
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Clinical Trials
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Hoffmann-La Roche
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Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01007435
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