Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT01209702
Registration number
NCT01209702
Ethics application status
Date submitted
24/09/2010
Date registered
27/09/2010
Date last updated
11/02/2013
Titles & IDs
Public title
A Study of RoActemra/Actemra (Tocilizumab) in Patients With Ankylosing Spondylitis Who Have Failed Treatment With NSAIDs
Query!
Scientific title
A Ph II/III Seamless, Multi-center, Randomized, Double-blind, Placebo-controlled Study of the Reduction in Signs and Symptoms and Inhibition of Structural Damage During Treatment With Tocilizumab Versus Placebo in Patients With Ankylosing Spondylitis Who Have Failed Non-steroidal Anti-inflammatory Drugs and Are naïve to TNF Antagonist Therapy NSAIDs
Query!
Secondary ID [1]
0
0
2009-017443-34
Query!
Secondary ID [2]
0
0
NA22823
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Spondylitis, Ankylosing
0
0
Query!
Condition category
Condition code
Inflammatory and Immune System
0
0
0
0
Query!
Other inflammatory or immune system disorders
Query!
Musculoskeletal
0
0
0
0
Query!
Other muscular and skeletal disorders
Query!
Inflammatory and Immune System
0
0
0
0
Query!
Rheumatoid arthritis
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Treatment: Other - tocilizumab
Treatment: Drugs - Placebo
Placebo comparator: Part 1: Placebo - Participants received intravenous infusions of placebo once every 4 weeks until Week 12. Following the Week 12 visit, participants who completed Part 1 of the study received open-label 8 mg/kg tocilizumab through Week 208.
Experimental: Part 1: Tocilizumab - Participants received intravenous infusions of 8 mg/kg tocilizumab once every 4 weeks until Week 12. Following the Week 12 visit, participants who completed Part 1 of the study received open-label 8 mg/kg tocilizumab through Week 208.
Placebo comparator: Part 2: Placebo - Participants received intravenous infusions of placebo once every 4 weeks until Week 24. Participants who did not attain an ASsessment in Ankylosing Spondylitis-20 (ASAS20) response at Week 16 were, at the investigator's discretion, eligible to receive open-label escape therapy consisting of 8 mg/kg tocilizumab. After Week 24, participants were to receive open-label treatment with 8 mg/kg tocilizumab every 4 weeks until Week 104. At the completion of Week 104, all Part 2 participants were to receive tocilizumab 8 mg/kg in the common open-label extension phase, however the study was terminated prior to any participants reaching this stage.
Experimental: Part 2: Tocilizumab 4 mg/kg - Participants received intravenous infusions of 4 mg/kg tocilizumab once every 4 weeks until Week 24. Participants who did not attain an ASAS20 response at Week 16 were, at the investigator's discretion, eligible to receive open-label escape therapy consisting of 8 mg/kg tocilizumab. After Week 24, participants were to receive open-label treatment with 8 mg/kg tocilizumab every 4 weeks until Week 104. At the completion of Week 104, all Part 2 participants were to receive tocilizumab 8 mg/kg in the common open-label extension phase, however the study was terminated prior to any participants reaching this stage.
Experimental: Part 2: Tocilizumab 8 mg/kg - Participants received intravenous infusions of 8 mg/kg tocilizumab once every 4 weeks until Week 24. Participants who did not attain an ASAS20 response at Week 16 were, at the investigator's discretion, eligible to receive open-label escape therapy consisting of 8 mg/kg tocilizumab. After Week 24, participants were to receive open-label treatment with 8 mg/kg tocilizumab every 4 weeks until Week 104. At the completion of Week 104, all Part 2 participants were to receive tocilizumab 8 mg/kg in the common open-label extension phase, however the study was terminated prior to any participants reaching this stage.
Treatment: Other: tocilizumab
Administered intravenously (iv) every 4 weeks
Treatment: Drugs: Placebo
Placebo to tocilizumab administered intravenously every 4 weeks
Query!
Intervention code [1]
0
0
Treatment: Other
Query!
Intervention code [2]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Part 1: Percentage of Participants Achieving a 20% Improvement in Assessment in Ankylosing Spondylitis (ASAS20) at Week 12
Query!
Assessment method [1]
0
0
ASAS is composed of four domains. To achieve an ASAS20 response required improvement of =20% and = 1 unit (10 mm) in at least 3 domains and no worsening of = 20 % and = 1 unit (10 mm) in the remaining domain.
* The patient's global assessment of current disease status, measured on a 100 mm visual analog scale (VAS), from symptom-free / no AS symptoms (0) to maximum AS disease severity (100).
* The patient's overall assessment of the severity of spinal pain based on responses to 2 questions assessed on a 100 mm VAS, from no pain (0) to most severe pain (100). The spinal pain score is the mean of these 2 questions.
* The function component was measured by the Bath Ankylosing Spondylitis Functional Index (BASFI). The patient provides self-assessment of 10 questions on a 100 mm VAS. The BASFI score is the mean of these values.
* The inflammation component of the ASAS was determined by the mean of questions 5 and 6 of the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI).
Query!
Timepoint [1]
0
0
Baseline and Week 12
Query!
Primary outcome [2]
0
0
Part 2: Percentage of Participants Achieving a 20% Improvement in Assessment in Ankylosing Spondylitis (ASAS20) at Week 12
Query!
Assessment method [2]
0
0
ASAS is composed of four domains. To achieve an ASAS20 response required improvement of =20% and = 1 unit (10 mm) in at least 3 domains and no worsening of = 20 % and = 1 unit (10 mm) in the remaining domain.
* The patient's global assessment of current disease status, measured on a 100 mm visual analog scale (VAS), from symptom-free / no AS symptoms (0) to maximum AS disease severity (100).
* The patient's overall assessment of the severity of spinal pain based on responses to 2 questions assessed on a 100 mm VAS, from no pain (0) to most severe pain (100). The spinal pain score is the mean of these 2 questions.
* The function component was measured by the Bath Ankylosing Spondylitis Functional Index (BASFI). The patient provides self-assessment of 10 questions on a 100 mm VAS. The BASFI score is the mean of these values.
* The inflammation component of the ASAS was determined by the mean of questions 5 and 6 of the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI).
Query!
Timepoint [2]
0
0
Baseline and Week 12
Query!
Secondary outcome [1]
0
0
Part 2: Percentage of Participants Achieving a 20% Improvement in Assessment in Ankylosing Spondylitis (ASAS20) at Week 24
Query!
Assessment method [1]
0
0
ASAS is composed of four domains. To achieve an ASAS20 response required improvement of =20% and = 1 unit (10 mm) in at least 3 domains and no worsening of = 20 % and = 1 unit (10 mm) in the remaining domain.
* The patient's global assessment of current disease status, measured on a 100 mm visual analog scale (VAS), from symptom-free / no AS symptoms (0) to maximum AS disease severity (100).
* The patient's overall assessment of the severity of spinal pain based on responses to 2 questions assessed on a 100 mm VAS, from no pain (0) to most severe pain (100). The spinal pain score is the mean of these 2 questions.
* The function component was measured by the Bath Ankylosing Spondylitis Functional Index (BASFI). The patient provides self-assessment of 10 questions on a 100 mm VAS. The BASFI score is the mean of these values.
* The inflammation component of the ASAS was determined by the mean of questions 5 and 6 of the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI).
Query!
Timepoint [1]
0
0
Baseline and Week 24
Query!
Secondary outcome [2]
0
0
Percentage of Participants Who Achieved a Value <2 in Each of the 4 ASAS Parameters at Week 12
Query!
Assessment method [2]
0
0
Assessment in Ankylosing Spondylitis (ASAS) is composed of four domains.
* The patient's global assessment of current disease status, measured on a 100 mm visual analog scale (VAS), from symptom-free / no AS symptoms (0) to maximum AS disease severity (100).
* The patient's overall assessment of the severity of spinal pain based on responses to 2 questions assessed on a 100 mm VAS, from no pain (0) to most severe pain (100). The spinal pain score is the mean of these 2 questions.
* The function component was measured by the Bath Ankylosing Spondylitis Functional Index (BASFI), the mean of 10 self-assessment questions on a 100 mm VAS.
* The inflammation component of the ASAS was determined by the mean of questions 5 and 6 of the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI).
Each of the above 4 domains are measured on a scale from 0-100 mm, but reported on a 0-10 cm scale. A score of less than 2 units (20 mm) in each domain is defined as partial remission.
Query!
Timepoint [2]
0
0
Week 12
Query!
Secondary outcome [3]
0
0
Percentage of Participants Achieving a 40% Improvement in Assessment in Ankylosing Spondylitis (ASAS40) at Week 12
Query!
Assessment method [3]
0
0
ASAS is composed of four domains. To achieve an ASAS40 response required improvement of =40% and = 2 units (20 mm) in at least 3 domains and no worsening at all in the remaining domain.
* The patient's global assessment of current disease status, measured on a 100 mm visual analog scale (VAS), from symptom-free / no AS symptoms (0) to maximum AS disease severity (100).
* The patient's overall assessment of the severity of spinal pain based on responses to 2 questions assessed on a 100 mm VAS, from no pain (0) to most severe pain (100). The spinal pain score is the mean of these 2 questions.
* The function component was measured by the Bath Ankylosing Spondylitis Functional Index (BASFI). The patient provides self-assessment of 10 questions on a 100 mm VAS. The BASFI score is the mean of these values.
* The inflammation component of the ASAS was determined by the mean of questions 5 and 6 of the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI).
Query!
Timepoint [3]
0
0
Baseline and Week 12
Query!
Secondary outcome [4]
0
0
Part 2: Percentage of Participants Achieving a 40% Improvement in Assessment in Ankylosing Spondylitis (ASAS40) at Week 24
Query!
Assessment method [4]
0
0
ASAS is composed of four domains. To achieve an ASAS40 response required improvement of =40% and = 2 units (20 mm) in at least 3 domains and no worsening at all in the remaining domain.
* The patient's global assessment of current disease status, measured on a 100 mm visual analog scale (VAS), from symptom-free / no AS symptoms (0) to maximum AS disease severity (100).
* The patient's overall assessment of the severity of spinal pain based on responses to 2 questions assessed on a 100 mm VAS, from no pain (0) to most severe pain (100). The spinal pain score is the mean of these 2 questions.
* The function component was measured by the Bath Ankylosing Spondylitis Functional Index (BASFI). The patient provides self-assessment of 10 questions on a 100 mm VAS. The BASFI score is the mean of these values.
* The inflammation component of the ASAS was determined by the mean of questions 5 and 6 of the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI).
Query!
Timepoint [4]
0
0
Baseline and Week 24
Query!
Secondary outcome [5]
0
0
Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
Query!
Assessment method [5]
0
0
The BASDAI is a patient-administered assessment of 6 parameters specific to AS. The following parameters were assessed on a 100-mm horizontal visual analogue: fatigue, spinal pain, peripheral arthritis, enthesitis, intensity of morning stiffness, and duration of morning stiffness. For questions 1 to 5, the left-hand extreme of the line (0) represents "none" (symptom-free) and the right-hand extreme (100) represents "very severe" (maximum severity). For question 6, a time axis was used, with the left-hand extreme of the line representing "0 hours" and the right-hand extreme representing "2 or more hours". The BASDAI score was calculated as follows:
BASDAI = \[Q1 + Q2 + Q3 + Q4 + (Q5 + Q6)/2\]/5. The total score is tabulated on a scale from 0 (best) to 10 cm (worst).
Query!
Timepoint [5]
0
0
Baseline and Week 12
Query!
Secondary outcome [6]
0
0
Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI)
Query!
Assessment method [6]
0
0
The Bath Ankylosing Spondylitis Functional Index (BASFI) is an assessment of function in AS patients. The participant provides their assessment of their ability to perform 10 activities on a 100 mm horizontal visual analog scale (VAS) ranging from 0 (easy) to 100 (impossible). The BASFI score is the mean of these values and is tabulated on a 0 (best) to 10 (worst) cm scale.
Query!
Timepoint [6]
0
0
Baseline and Week 12
Query!
Secondary outcome [7]
0
0
Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI)
Query!
Assessment method [7]
0
0
The Bath Ankylosing Spondylitis Metrology Index linear function is a combined index of 5 clinical measurements (performed by the Joint Assessor) which reflect axial mobility in the AS patient. The measurements to assess mobility are:
1. Tragus-to-wall;
2. Modified Schober (lumbar flexion);
3. Cervical rotation;
4. Lateral spinal flexion;
5. Intermalleolar distance.
The BASMI linear result is the average of the 5 assessments and ranges from 0 to 10. The higher the BASMI score the more severe the patient's limitation of movement due to their AS.
Query!
Timepoint [7]
0
0
Baseline and Week 12
Query!
Secondary outcome [8]
0
0
Change From Baseline in C-Reactive Protein
Query!
Assessment method [8]
0
0
Levels of C-reactive protein (CRP) were measured from blood samples taken at Baseline and at Week 12.
Query!
Timepoint [8]
0
0
Baseline and Week 12
Query!
Secondary outcome [9]
0
0
Part 2: Area Under the Plasma Concentration Versus Time Curve of Tocilizumab
Query!
Assessment method [9]
0
0
Area under the plasma concentration versus time curve (AUC) of tocilizumab at steady state after 12 weeks of treatment.
Query!
Timepoint [9]
0
0
Week 12, pre-dose and at the end of infusion, on the 2nd and 7th day of Week 12, 14 days post-dose (Week 14) and 28 days post-dose (pre-dose of Week 16 infusion).
Query!
Secondary outcome [10]
0
0
Part 2: Peak Plasma Concentration of Tocilizumab
Query!
Assessment method [10]
0
0
The peak plasma concentration (Cmax) of tocilizumab at steady state after 12 weeks of treatment.
Query!
Timepoint [10]
0
0
Week 12, pre-dose and at the end of infusion, on the 2nd and 7th day of Week 12, 14 days post-dose (Week 14) and 28 days post-dose (pre-dose of Week 16 infusion).
Query!
Secondary outcome [11]
0
0
Part 2: Elimination Half-life of Tocilizumab
Query!
Assessment method [11]
0
0
Elimination half-life of tocilizumab at steady state after 12 weeks of treatment.
Query!
Timepoint [11]
0
0
Week 12, pre-dose and at the end of infusion, on the 2nd and 7th day of Week 12, 14 days post-dose (Week 14) and 28 days post-dose (pre-dose of Week 16 infusion).
Query!
Secondary outcome [12]
0
0
Part 2: Clearance of Tocilizumab
Query!
Assessment method [12]
0
0
Clearance of tocilizumab at steady state after 12 weeks of treatment.
Query!
Timepoint [12]
0
0
Week 12, pre-dose and at the end of infusion, on the 2nd and 7th day of Week 12, 14 days post-dose (Week 14) and 28 days post-dose (pre-dose of Week 16 infusion).
Query!
Secondary outcome [13]
0
0
Part 2: Volume of Distribution of Tocilizumab
Query!
Assessment method [13]
0
0
Volume of distribution of tocilizumab at steady state after 12 weeks of treatment.
Query!
Timepoint [13]
0
0
Week 12, pre-dose and at the end of infusion, on the 2nd and 7th day of Week 12, 14 days post-dose (Week 14) and 28 days post-dose (pre-dose of Week 16 infusion).
Query!
Secondary outcome [14]
0
0
Change From Baseline in the Level of Interleukin-6
Query!
Assessment method [14]
0
0
Interleukin-6 levels were measured from blood samples taken pre-dose at Baseline and after 12 weeks of treatment.
The analysis was not performed for participants in Part 2 due to premature study termination.
Query!
Timepoint [14]
0
0
Baseline and Week 12
Query!
Secondary outcome [15]
0
0
Change From Baseline in Level of Soluble Interleukin-6 Receptor
Query!
Assessment method [15]
0
0
Soluble Interleukin-6 receptor levels were measured from blood samples taken pre-dose at Baseline and after 12 weeks of treatment.
The analysis was not performed for participants in Part 2 due to premature study termination.
Query!
Timepoint [15]
0
0
Baseline and Week 12
Query!
Secondary outcome [16]
0
0
Number of Participants With Anti-tocilizumab Antibodies
Query!
Assessment method [16]
0
0
A positive anti-tocilizumab antibody result was defined as a negative assay result at Baseline and a positive post-baseline screening assay with positive confirmation or neutralizing assay at the same visit.
Query!
Timepoint [16]
0
0
From Baseline until end of study (a maximum treatment duration of 40 weeks).
Query!
Secondary outcome [17]
0
0
Part 2: Radiographic Change According to the Modified Stoke Ankylosing Spondylitis Spinal Score (mSASSS)
Query!
Assessment method [17]
0
0
Radiographs were to be assessed using the modified Stoke Ankylosing Spondylitis Spinal Score (mSASSS). The mSASSS is a four-point scoring system for lateral radiographs of the lumbar and cervical spine and has been shown to reliably track disease progression over time, where:
* 0 = No abnormality;
* 1 = Erosion, sclerosis, or squaring;
* 2 = Syndesmophyte;
* 3 = Total bony bridging at each site.
Query!
Timepoint [17]
0
0
Baseline and Week 104
Query!
Secondary outcome [18]
0
0
Part 2: Percentage of Participants With a Reduction of Magnetic Resonance Imaging (MRI) Proven Spinal Inflammation
Query!
Assessment method [18]
0
0
Magentic resonance imaging of the axial skeleton was to be performed at Baseline and Week 24. MRI scans will be evaluated using the ankylosing spondylitis spinal MRI activity (ASspiMRI-a) score, grading activity (0-6) per vertebral unit in 23 units.
Query!
Timepoint [18]
0
0
Baseline and Week 24
Query!
Secondary outcome [19]
0
0
Part 1: The Number of Participants With Adverse Events
Query!
Assessment method [19]
0
0
A serious adverse event (AE) is any event that is fatal, life-threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant or requires intervention to prevent one or other of the outcomes listed above. The intensity of each AE was graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 4.02. A severe AE was any event of Grade 4 (life-threatening consequences; urgent intervention indicated) or 5 (death related to AE).
Query!
Timepoint [19]
0
0
Up to 40 weeks
Query!
Eligibility
Key inclusion criteria
Inclusion Criteria
* Adult patients, = 18 years of age
* Ankylosing Spondylitis as defined by the modified New York criteria for = 3 months prior to baseline
* Active disease at screening and baseline (Bath Ankylosing Spondylitis Disease Activity Index [BASDAI] =4.0, spinal pain visual analog scale [VAS] =40)
* Inadequate response or intolerant to 1 or more previous non-steroidal anti-inflammatory drugs (NSAIDs)
* Traditional disease-modifying anti-rheumatic drugs (DMARDs) must be withdrawn for at least 4 weeks prior to baseline (methotrexate, sulfasalazine and hydroxychloroquine or chloroquine may be allowed if at stable dose for at least 4 weeks prior to baseline)
* Oral corticosteroids (= 10 mg/day prednisone or equivalent) and NSAIDs/COX-2 inhibitors must be at stable dose for at least 4 weeks prior to baseline
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
* Major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months after randomization
* Total ankylosis of spine (as determined by investigator)
* Inflammatory rheumatic disease other than ankylosing spondylitis
* Active, acute uveitis at baseline
* Treatment with tumor necrosis factor (TNF) antagonist therapy at any time prior to baseline
* Intra-articular or tendon injections or parenteral corticosteroids within 4 weeks prior to screening
* History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies
* Active current or history of recurrent bacterial, viral, fungal, mycobacterial or other infection
* History of or currently active primary or secondary immunodeficiency
* Body weight > 150 kg
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Stopped early
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
1/09/2010
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
1/12/2011
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
306
Query!
Recruitment in Australia
Recruitment state(s)
Query!
Recruitment hospital [1]
0
0
- Adelaide
Query!
Recruitment hospital [2]
0
0
- Heidelberg
Query!
Recruitment hospital [3]
0
0
- Hobart
Query!
Recruitment hospital [4]
0
0
- Malvern East
Query!
Recruitment hospital [5]
0
0
- Maroochydore
Query!
Recruitment hospital [6]
0
0
- Sydney
Query!
Recruitment hospital [7]
0
0
- Woodville
Query!
Recruitment postcode(s) [1]
0
0
5041 - Adelaide
Query!
Recruitment postcode(s) [2]
0
0
3084 - Heidelberg
Query!
Recruitment postcode(s) [3]
0
0
7000 - Hobart
Query!
Recruitment postcode(s) [4]
0
0
3145 - Malvern East
Query!
Recruitment postcode(s) [5]
0
0
4558 - Maroochydore
Query!
Recruitment postcode(s) [6]
0
0
2050 - Sydney
Query!
Recruitment postcode(s) [7]
0
0
5011 - Woodville
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
California
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Florida
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
Georgia
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Idaho
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Kansas
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Maryland
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Michigan
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
North Carolina
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Pennsylvania
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
South Carolina
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
Texas
Query!
Country [12]
0
0
Belgium
Query!
State/province [12]
0
0
Bruxelles
Query!
Country [13]
0
0
Belgium
Query!
State/province [13]
0
0
Kortrijk
Query!
Country [14]
0
0
Belgium
Query!
State/province [14]
0
0
Liege
Query!
Country [15]
0
0
Belgium
Query!
State/province [15]
0
0
Yvoir
Query!
Country [16]
0
0
Brazil
Query!
State/province [16]
0
0
Cuiabá
Query!
Country [17]
0
0
Brazil
Query!
State/province [17]
0
0
Goiania
Query!
Country [18]
0
0
Brazil
Query!
State/province [18]
0
0
Sao Paulo
Query!
Country [19]
0
0
Brazil
Query!
State/province [19]
0
0
São Paulo
Query!
Country [20]
0
0
Bulgaria
Query!
State/province [20]
0
0
Plovdiv
Query!
Country [21]
0
0
Bulgaria
Query!
State/province [21]
0
0
Ruse
Query!
Country [22]
0
0
Bulgaria
Query!
State/province [22]
0
0
Sevlievo
Query!
Country [23]
0
0
Bulgaria
Query!
State/province [23]
0
0
Sofia
Query!
Country [24]
0
0
Canada
Query!
State/province [24]
0
0
Alberta
Query!
Country [25]
0
0
Canada
Query!
State/province [25]
0
0
Manitoba
Query!
Country [26]
0
0
Canada
Query!
State/province [26]
0
0
Newfoundland and Labrador
Query!
Country [27]
0
0
Canada
Query!
State/province [27]
0
0
Ontario
Query!
Country [28]
0
0
Canada
Query!
State/province [28]
0
0
Quebec
Query!
Country [29]
0
0
Czech Republic
Query!
State/province [29]
0
0
Bruntal
Query!
Country [30]
0
0
Czech Republic
Query!
State/province [30]
0
0
Hlucin
Query!
Country [31]
0
0
Czech Republic
Query!
State/province [31]
0
0
Olomouc
Query!
Country [32]
0
0
Czech Republic
Query!
State/province [32]
0
0
Prague
Query!
Country [33]
0
0
Czech Republic
Query!
State/province [33]
0
0
Praha 11
Query!
Country [34]
0
0
Czech Republic
Query!
State/province [34]
0
0
Praha 4 Nusle
Query!
Country [35]
0
0
Czech Republic
Query!
State/province [35]
0
0
Praha 4
Query!
Country [36]
0
0
Czech Republic
Query!
State/province [36]
0
0
Sokolov
Query!
Country [37]
0
0
Czech Republic
Query!
State/province [37]
0
0
Uherske Hradiste
Query!
Country [38]
0
0
Czech Republic
Query!
State/province [38]
0
0
Zlin
Query!
Country [39]
0
0
France
Query!
State/province [39]
0
0
Besancon
Query!
Country [40]
0
0
France
Query!
State/province [40]
0
0
Boulogne-billancourt
Query!
Country [41]
0
0
France
Query!
State/province [41]
0
0
Creteil
Query!
Country [42]
0
0
France
Query!
State/province [42]
0
0
Grenoble
Query!
Country [43]
0
0
France
Query!
State/province [43]
0
0
Montpellier
Query!
Country [44]
0
0
France
Query!
State/province [44]
0
0
Paris
Query!
Country [45]
0
0
France
Query!
State/province [45]
0
0
Strasbourg
Query!
Country [46]
0
0
France
Query!
State/province [46]
0
0
Toulouse
Query!
Country [47]
0
0
Germany
Query!
State/province [47]
0
0
Berlin
Query!
Country [48]
0
0
Germany
Query!
State/province [48]
0
0
Gommern
Query!
Country [49]
0
0
Germany
Query!
State/province [49]
0
0
Hannover
Query!
Country [50]
0
0
Germany
Query!
State/province [50]
0
0
Köln
Query!
Country [51]
0
0
Germany
Query!
State/province [51]
0
0
Würzburg
Query!
Country [52]
0
0
India
Query!
State/province [52]
0
0
Ahmedabad
Query!
Country [53]
0
0
India
Query!
State/province [53]
0
0
Bangalore
Query!
Country [54]
0
0
India
Query!
State/province [54]
0
0
Hyderabad
Query!
Country [55]
0
0
India
Query!
State/province [55]
0
0
Jaipur
Query!
Country [56]
0
0
India
Query!
State/province [56]
0
0
New Delhi
Query!
Country [57]
0
0
India
Query!
State/province [57]
0
0
Secunderabad
Query!
Country [58]
0
0
Italy
Query!
State/province [58]
0
0
Ferrara
Query!
Country [59]
0
0
Italy
Query!
State/province [59]
0
0
Firenze
Query!
Country [60]
0
0
Italy
Query!
State/province [60]
0
0
Monserrato
Query!
Country [61]
0
0
Italy
Query!
State/province [61]
0
0
Prato
Query!
Country [62]
0
0
Italy
Query!
State/province [62]
0
0
Reggio Emilia
Query!
Country [63]
0
0
Italy
Query!
State/province [63]
0
0
Roma
Query!
Country [64]
0
0
Italy
Query!
State/province [64]
0
0
Siena
Query!
Country [65]
0
0
Lithuania
Query!
State/province [65]
0
0
Kaunas
Query!
Country [66]
0
0
Lithuania
Query!
State/province [66]
0
0
Klaipeda
Query!
Country [67]
0
0
Lithuania
Query!
State/province [67]
0
0
Vilnius
Query!
Country [68]
0
0
Poland
Query!
State/province [68]
0
0
Bydgoszcz
Query!
Country [69]
0
0
Poland
Query!
State/province [69]
0
0
Krakow
Query!
Country [70]
0
0
Poland
Query!
State/province [70]
0
0
Lublin
Query!
Country [71]
0
0
Poland
Query!
State/province [71]
0
0
Poznan
Query!
Country [72]
0
0
Poland
Query!
State/province [72]
0
0
Torun
Query!
Country [73]
0
0
Poland
Query!
State/province [73]
0
0
Warszawa
Query!
Country [74]
0
0
Poland
Query!
State/province [74]
0
0
Wroclaw
Query!
Country [75]
0
0
Russian Federation
Query!
State/province [75]
0
0
Kazan
Query!
Country [76]
0
0
Russian Federation
Query!
State/province [76]
0
0
Moscow
Query!
Country [77]
0
0
Russian Federation
Query!
State/province [77]
0
0
Voronezh
Query!
Country [78]
0
0
Russian Federation
Query!
State/province [78]
0
0
Yaroslavl
Query!
Country [79]
0
0
Slovakia
Query!
State/province [79]
0
0
Kosice
Query!
Country [80]
0
0
Slovakia
Query!
State/province [80]
0
0
Piestany
Query!
Country [81]
0
0
South Africa
Query!
State/province [81]
0
0
Cape Town
Query!
Country [82]
0
0
South Africa
Query!
State/province [82]
0
0
Durban
Query!
Country [83]
0
0
South Africa
Query!
State/province [83]
0
0
Pretoria
Query!
Country [84]
0
0
South Africa
Query!
State/province [84]
0
0
Stellenbosch
Query!
Country [85]
0
0
Spain
Query!
State/province [85]
0
0
Barcelona
Query!
Country [86]
0
0
Spain
Query!
State/province [86]
0
0
Córdoba
Query!
Country [87]
0
0
Spain
Query!
State/province [87]
0
0
La Coruna
Query!
Country [88]
0
0
Spain
Query!
State/province [88]
0
0
Lugo
Query!
Country [89]
0
0
Spain
Query!
State/province [89]
0
0
Madrid
Query!
Country [90]
0
0
Spain
Query!
State/province [90]
0
0
Oviedo
Query!
Country [91]
0
0
Spain
Query!
State/province [91]
0
0
Sabadell
Query!
Country [92]
0
0
United Kingdom
Query!
State/province [92]
0
0
Basingstoke
Query!
Country [93]
0
0
United Kingdom
Query!
State/province [93]
0
0
Bath
Query!
Country [94]
0
0
United Kingdom
Query!
State/province [94]
0
0
Cannock
Query!
Country [95]
0
0
United Kingdom
Query!
State/province [95]
0
0
Greenock
Query!
Country [96]
0
0
United Kingdom
Query!
State/province [96]
0
0
Leeds
Query!
Country [97]
0
0
United Kingdom
Query!
State/province [97]
0
0
London
Query!
Country [98]
0
0
United Kingdom
Query!
State/province [98]
0
0
Salford
Query!
Country [99]
0
0
United Kingdom
Query!
State/province [99]
0
0
Stoke-on-trent
Query!
Country [100]
0
0
United Kingdom
Query!
State/province [100]
0
0
Wigan
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Query!
Name
Hoffmann-La Roche
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
This randomized, double-blind, placebo-controlled study will evaluate the safety and efficacy of RoActemra/Actemra (tocilizumab) in patients with ankylosing spondylitis (AS) who have failed treatment with non-steroidal anti-inflammatory drugs and are naïve to tumor necrsos factor (TNF) antagonist therapy. In Part 1 of the study, patients will be randomized to receive either RoActemra/Actemra 8 mg/kg intravenously (IV) or placebo every 4 weeks for 12 weeks. In Part 2, patients will be randomized to receive RoActemra at either 8 mg/kg or 4 mg/kg IV or placebo every 4 weeks for 24 weeks. The double-blind treatment period will be followed by open-label treatment with RoActemra/Actemra 8 mg/kg iv every 4 weeks until Week 208 for all patients. Anticipated time on study treatment is 208 weeks.
Query!
Trial website
https://clinicaltrials.gov/study/NCT01209702
Query!
Trial related presentations / publications
Sieper J, Porter-Brown B, Thompson L, Harari O, Dougados M. Assessment of short-term symptomatic efficacy of tocilizumab in ankylosing spondylitis: results of randomised, placebo-controlled trials. Ann Rheum Dis. 2014 Jan;73(1):95-100. doi: 10.1136/annrheumdis-2013-203559. Epub 2013 Jun 13.
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Clinical Trials
Query!
Address
0
0
Hoffmann-La Roche
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT01209702
Download to PDF