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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/NCT01668966
Registration number
NCT01668966
Ethics application status
Date submitted
16/08/2012
Date registered
20/08/2012
Date last updated
13/05/2019
Titles & IDs
Public title
A Long Term Extension Study of WA19926 (NCT01007435) of Tocilizumab (RoActemra/Actemra) in Participants With Early, Moderate to Severe Rheumatoid Arthritis (RA)
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Scientific title
A Multicenter, Open-Label, Single Arm, Long Term Extension Study of WA19926 to Describe Safety During Treatment With Tocilizumab in Patients With Early, Moderate to Severe Rheumatoid Arthritis
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Secondary ID [1]
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ML28080
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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
Experimental: Tocilizumab - Participants will receive tocilizumab 8 milligrams per kilogram (mg/kg) intravenously (IV) every 4 weeks for up to 104 weeks.
Treatment: Drugs: Tocilizumab
Participants will receive tocilizumab 8 mg/kg IV every 4 weeks for up to 104 weeks.
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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 Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
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Assessment method [1]
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An adverse event (AE) is any unfavorable or unintended sign (including an abnormal laboratory finding), symptom or disease temporarily associated with use of study drug, regardless of its relation to study drug. A TEAE is an AE that occurs only once treatment has started. An SAE can be a) fatal, b) life-threatening, c) requires/prolongs hospitalization, d) results in persistent/significant incapacity/disability, e) results in congenital anomaly/birth defect or f) is considered as a significant medical event by the investigator.
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Timepoint [1]
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Baseline up to approximately 104 weeks
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Primary outcome [2]
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Percentage of Participants With TEAEs of Special Interest
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Assessment method [2]
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An AE is any unfavorable or unintended sign (including an abnormal laboratory finding), symptom or disease temporarily associated with use of study drug, regardless of its relation to study drug. A TEAE is an AE that occurs only once treatment has started. Nine categories of AE of special interest are identified for tocilizumab which includes a) serious/medically significant infections, b) myocardial infarction/acute coronary syndrome, c) gastrointestinal perforations, d) malignancies, e) anaphylaxis/hypersensitivity reactions, f) demyelinating disorders, g) stroke, h) serious and/or medically significant bleeding events, and i) serious/medically significant hepatic events. Data reported is an average of the nine categories.
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Timepoint [2]
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Baseline up to approximately 104 weeks
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Primary outcome [3]
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Percentage of Participants With TEAEs Leading to Change in Dose or Study Drug Discontinuation
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Assessment method [3]
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An AE is any unfavorable or unintended sign (including an abnormal laboratory finding), symptom or disease temporarily associated with use of study drug, regardless of its relation to study drug. A TEAE is an AE that occurs only once treatment has started.
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Timepoint [3]
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Baseline up to approximately 104 weeks
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Secondary outcome [1]
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Change From Baseline (CFB) in Disease Activity Score 28 Using Erythrocyte Sedimentation Rate (DAS28-ESR) at Specified Time Points
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Assessment method [1]
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The DAS28-ESR is a combined index for measuring disease activity in rheumatoid arthritis (RA). The index includes swollen joint counts (SJC) and tender joint counts (TJC), both scored 0-28 (higher scores indicate higher disease activity), as well as acute phase response (APR) determined as erythrocyte sedimentation rate (ESR) in millimeters per hour (mm/hr), and general health (GH) (patient global assessment of disease activity [PGA] using visual analog scale [VAS], range 1-100 millimeters [mm]) (higher scores indicate higher disease activity). DAS28-ESR is calculated according to the following formula: DAS28-ESR equals (=) [0.56 multiplied by (*) the square root (v) of TJC] plus (+) [0.28 * v of SJC] + (0.70 * the natural logarithm [ln] ESR in mm/h) + (0.014*GH in mm VAS). DAS28-ESR scale is transformed and ranges from 0 to 10. A negative CFB indicated improvement.
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Timepoint [1]
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Baseline, Weeks 12, 24, 36, 48, 56, 68, 80, 92, 104, early withdrawal (up to 104 weeks), follow-up 1 (8 weeks after the last visit or discontinuation; 112 weeks), follow-up 2 (16 weeks after the last visit or discontinuation; 120 weeks)
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Secondary outcome [2]
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CFB in Simplified Disease Activity Index (SDAI) Score at Specified Time Points
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Assessment method [2]
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The SDAI is a combined index for measuring disease activity. SDAI is the sum of TJC and SJC, both scored 0-28 (higher scores indicate higher disease activity), physician global assessment (PhGA) and PGA of disease activity, both scored 0 to 10 centimeters (cm) as assessed by VAS, and C-reactive protein level (CRP) in milligrams per deciliter (mg/dL) where normal is less than (<) 1 mg/dL. SDAI is calculated according to the following formula: SDAI = TJC + SJC + PhGA + PGA + CRP. SDAI ranges from 0 to 86. A negative CFB indicated improvement.
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Timepoint [2]
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Baseline, Weeks 12, 24, 36, 48, 56, 68, 80, 92, 104, early withdrawal (up to 104 weeks), follow-up 1 (8 weeks after the last visit or discontinuation; 112 weeks), follow-up 2 (16 weeks after the last visit or discontinuation; 120 weeks)
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Secondary outcome [3]
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CFB in Swollen Joint Count (SJC) at Specified Time Points
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Assessment method [3]
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For SJC, a total of 66 joints are assessed. The presence of a swollen joint is scored as 1 and absence as 0. Total score is calculated by adding the scores, which ranges from 0 (best possible score or no swollen joint) to 66 (worse possible score or all swollen joints). Lower scores indicated no swollen joint and higher scores indicated worsening swollen joints.
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Timepoint [3]
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Baseline, Weeks 12, 24, 36, 48, 56, 68, 80, 92, 104, follow-up 1 (8 weeks after the last visit or discontinuation; 112 weeks), follow-up 2 (16 weeks after the last visit or discontinuation; 120 weeks)
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Secondary outcome [4]
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CFB in Tender Joint Count (TJC) at Specified Time Points
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Assessment method [4]
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The number of tender joints is recorded on the joint assessment form, no tenderness = 0, tenderness = 1, for 68 joints and joints were classified as tender/not tender giving a total possible tender joint count score of 0 to 68.
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Timepoint [4]
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Baseline, Weeks 12, 24, 36, 48, 56, 68, 80, 92, 104, early withdrawal (up to 104 weeks), follow-up 1 (8 weeks after the last visit or discontinuation; 112 weeks), follow-up 2 (16 weeks after the last visit or discontinuation; 120 weeks)
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Secondary outcome [5]
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Percentage of Participants Reaching Clinical Remission (DAS28-ESR Score Less Than [<] 2.6 and/or SDAI Score Less Than or Equal to [</=] 3.3) Among Participants for Whom Tocilizumab Treatment Was Discontinued
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Assessment method [5]
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Remission: DAS28-ESR score <2.6 and SDAI score </=3.3. DAS28-ESR index included SJC and TJC, both scored 0-28, as well as APR determined as ESR in mm/hr, and GH (ranges 1-100 mm; higher scores=higher disease activity). DAS28=(0.56*vTJC)+(0.28*vSJC) +(0.70*ln ESR) +(0.014*GH). DAS28-ESR scale is transformed and ranges from 0 to 10. Negative CFB indicated improvement. DAS28 >2.6 (clinical remission); DAS28 2.6 to 3.2 (low disease activity); DAS28 >3.2 to 5.1 = moderate to high disease activity. SDAI is sum of TJC and SJC (both scored 0-28), PhGA and PGA of disease activity (both scored 0 to 10 cm as assessed by VAS, higher scores=higher disease activity), and CRP in mg/dL where normal is <1 mg/dL. SDAI=TJC + SJC + PhGA + PGA + CRP. SDAI ranged from 0 to 86. A negative CFB indicated improvement. SDAI <=3.3 (clinical remission), >3.4 to 11 (low disease activity) >11 to 26 (moderate disease activity), and >26 = (high/severe disease activity).
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Timepoint [5]
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Baseline up to approximately 104 weeks
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Secondary outcome [6]
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Time to RA Crisis Among Participants Who Discontinued After Clinical Remission
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Assessment method [6]
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RA crisis is any worsening of participant disease acitivity that, in the opinion of the investigator, required intensified treatment other than supportive therapy, and may have included restart of the treatment with the study drug. Time to RA crisis is defined as the period of remission without drug until the RA crisis documentation.
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Timepoint [6]
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Baseline up to approximately 104 weeks
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Secondary outcome [7]
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CFB in PGA of Disease Activity Using VAS Score at Specified Time Points
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Assessment method [7]
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PGA of disease activity is assessed on a 0 to 100 mm horizontal VAS by the participant. The left-hand extreme of the line equals 0 mm, and is described as "no disease activity" (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm, as "maximum disease activity" (maximum arthritis disease activity). A negative CFB indicated improvement.
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Timepoint [7]
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Baseline, Weeks 12, 24, 36, 48, 56, 68, 80, 92, 104, early withdrawal (up to 104 weeks), follow-up 1 (8 weeks after the last visit or discontinuation; 112 weeks), follow-up 2 (16 weeks after the last visit or discontinuation; 120 weeks)
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Secondary outcome [8]
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CFB in PGA of Pain Using VAS Score at Specified Time Points
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Assessment method [8]
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PGA of pain is assessed on a 0 to 100 mm horizontal VAS. The left-hand extreme of the line equals 0 mm, and is described as "no pain" and the right-hand extreme equals 100 mm, and is described as "unbearable pain". A negative change indicated improvement.
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Timepoint [8]
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Baseline, Weeks 12, 24, 36, 48, 56, 68, 80, 92, 104, early withdrawal (up to 104 weeks), follow-up 1 (8 weeks after the last visit or discontinuation; 112 weeks), follow-up 2 (16 weeks after the last visit or discontinuation; 120 weeks)
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Secondary outcome [9]
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CFB in PhGA of Disease Activity Using VAS Score at Specified Time Points
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Assessment method [9]
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PhGA of disease activity is assessed on a 0 to 100 mm horizontal VAS by the physician. The left-hand extreme of the line equals 0 mm, and is described as "no disease activity" (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm as "maximum disease activity" (maximum arthritis disease activity).
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Timepoint [9]
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Baseline, Weeks 12, 24, 36, 48, 56, 68, 80, 92, 104, early withdrawal (up to 104 weeks), follow-up 1 (8 weeks after the last visit or discontinuation; 112 weeks), follow-up 2 (16 weeks after the last visit or discontinuation; 120 weeks)
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Secondary outcome [10]
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CFB in Health Assessment Questionnaire-Disease Index (HAQ-DI) Score at Specified Time Points
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Assessment method [10]
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HAQ-DI is a self-reported participant questionnaire specific for RA. It consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip; common daily activities. Each domain has at least 2 component questions. There are 4 possible responses for each component 0=without any difficulty 1=with some difficulty 2=with much difficulty 3=unable to do. Total score for HAQ-DI is the sum of all questions and ranges from 0 = without any difficulty to 60 = unable to do. A negative CFB indicates improvement.
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Timepoint [10]
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Baseline, Weeks 12, 24, 36, 48, 56, 68, 80, 92, 104, early withdrawal (up to 104 weeks), follow-up 1 (8 weeks after the last visit or discontinuation; 112 weeks), follow-up 2 (16 weeks after the last visit or discontinuation; 120 weeks)
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Eligibility
Key inclusion criteria
- Participants who completed their last WA19926 (NCT01649804) core study visit (Week
104) and who may benefit from study drug treatment according to the Investigator's
assessment
- No current or recent adverse event or laboratory finding preventing the use of
tocilizumab 8 mg/kg at baseline visit
- Women of childbearing potential must agree to use highly reliable contraception during
the treatment period
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Minimum age
18
Months
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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
- Pregnant or breastfeeding females
- Participants who have withdrawn prematurely from the WA19926 (NCT01649804) core study
for any reason
- Treatment with any investigational agent or cell-depleting therapies since the last
administration of study drug in WA19926 (NCT01649804)
- Treatment with an anti-tumor necrosis factor (TNF) or anti-interleukin (IL) 1 agent,
or a T-cell costimulation modulator since the last administration of study drug in
WA19926 (NCT01649804)
- Immunization with a live/attenuated vaccine since the last administration of study
drug in WA19926 (NCT01649804)
- Diagnosis since last WA19926 (NCT01649804) visit (Week 104) of rheumatic autoimmune
disease other than RA
- Diagnosis since last WA19926 (NCT01649804) visit (Week 104) of inflammatory joint
disease other than RA
- History of severe allergic or anaphylactic reactions to humanized or murine monoclonal
antibodies, including tocilizumab and its excipients
- Evidence of severe uncontrolled concomitant disease or disorder
- Known active infections or history of recurrent infections
- Active tuberculosis requiring treatment in the previous 3 years
- History of alcohol, drug or chemical abuse since inclusion in the WA19926
(NCT01649804) study
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Study design
Purpose of the study
Treatment
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Allocation to intervention
N/A
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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
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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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
9/12/2013
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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
11/05/2016
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Sample size
Target
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Accrual to date
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Final
23
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
Country [1]
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Brazil
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State/province [1]
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GO
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Country [2]
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Brazil
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State/province [2]
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MG
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Country [3]
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Brazil
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State/province [3]
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PR
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Country [4]
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Brazil
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State/province [4]
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RS
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Country [5]
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Brazil
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State/province [5]
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SP
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Hoffmann-La Roche
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
This open-label, single arm, multicenter long-term extension study of WA19926 (NCT01007435)
will evaluate the safety and efficacy of tocilizumab in participants with early, moderate to
severe RA who have completed the 104-week WA19926 (NCT01007435) core study. Eligible
participants will be those who are expected to benefit from the study medicine based on the
investigator's discretion.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01668966
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Trial related presentations / publications
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Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed
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Contacts
Principal investigator
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Clinical Trials
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Address
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Hoffmann-La Roche
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01668966
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