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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/NCT01734993




Registration number
NCT01734993
Ethics application status
Date submitted
19/11/2012
Date registered
28/11/2012
Date last updated
28/11/2016

Titles & IDs
Public title
A Long-Term Extension Study of WA22762 to Evaluate Safety and Efficacy of Subcutaneous Tocilizumab in Participants With Moderate to Severe Rheumatoid Arthritis (RA).
Scientific title
A Multicenter, Open-Label Long-Term Extension Study of WA22762 to Evaluate Safety and Efficacy of Subcutaneous Tocilizumab in Patients With Moderate to Severe Rheumatoid Arthritis
Secondary ID [1] 0 0
ML28544
Universal Trial Number (UTN)
Trial acronym
Linked study record

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Tocilizumab

Experimental: Tocilizumab - Moderate to severe rheumatoid arthritis participants from France, who completed the Week 97 visit of the WA22762 LTE study and considered as responders (defined as having improvement in DAS28 of >1.2 points) will continue tocilizumab treatment within this local LTE study for a maximum of 156 weeks, or until SC TCZ becomes commercially available, whichever occurs first.


Treatment: Drugs: Tocilizumab
Participants will receive TCZ 162 milligrams (mg) SC injection once a week.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Timepoint [1] 0 0
Baseline up to approximately 142 weeks
Primary outcome [2] 0 0
Percentage of Participants With AEs and SAEs Related to TCZ
Timepoint [2] 0 0
Baseline up to approximately 142 weeks
Primary outcome [3] 0 0
Percentage of Participants With Adverse Events of Special Interest (AESIs)
Timepoint [3] 0 0
Baseline up to approximately 142 weeks
Primary outcome [4] 0 0
Percentage of Participants With AESIs Related to TCZ
Timepoint [4] 0 0
Baseline up to approximately 142 weeks
Primary outcome [5] 0 0
Percentage of Participants With AEs Leading to TCZ Discontinuation, Interruption, or Dose Modification
Timepoint [5] 0 0
Baseline up to approximately 142 weeks
Primary outcome [6] 0 0
Percentage of Participants With Clinically Significant Physical Examinations and Vital Signs Abnormalities
Timepoint [6] 0 0
Baseline up to approximately 142 weeks
Primary outcome [7] 0 0
Percentage of Participants With Clinically Significant Laboratory Abnormalities
Timepoint [7] 0 0
Baseline up to approximately 142 weeks
Primary outcome [8] 0 0
Percentage of Participants With Anti-TCZ Antibodies
Timepoint [8] 0 0
Baseline up to approximately 142 weeks
Secondary outcome [1] 0 0
Change From Baseline in Disease Activity Score 28 - Erythrocyte Sedimentation Rate (DAS28-ESR) Score
Timepoint [1] 0 0
Baseline (Day 0), Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, completer last visit (up to Week 120), last visit (up to Week 120), early withdrawal (up to Week 120)
Secondary outcome [2] 0 0
Change From Baseline in Simplified Disease Activity Index (SDAI) Score
Timepoint [2] 0 0
Baseline (Day 0), Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, completer last visit (up to Week 120), last visit (up to Week 120), early withdrawal (up to Week 120)
Secondary outcome [3] 0 0
Change From Baseline in TJC
Timepoint [3] 0 0
Baseline (Day 0), Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, completer last visit (up to Week 120), last visit (up to Week 120), early withdrawal (up to Week 120)
Secondary outcome [4] 0 0
Change From Baseline in SJC
Timepoint [4] 0 0
Baseline (Day 0), Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, completer last visit (up to Week 120), last visit (up to Week 120), early withdrawal (up to Week 120)
Secondary outcome [5] 0 0
Percentage of Participants With Clinical Remission
Timepoint [5] 0 0
Week 48, 108
Secondary outcome [6] 0 0
Percentage of Participants With Concomitant Corticosteroid Discontinuation
Timepoint [6] 0 0
Baseline up to approximately 142 weeks
Secondary outcome [7] 0 0
Percentage of Participants With Concomitant Corticosteroid Dose Reduction
Timepoint [7] 0 0
Baseline up to approximately 142 weeks
Secondary outcome [8] 0 0
Time to Concomitant Corticosteroid Discontinuation
Timepoint [8] 0 0
Baseline up to approximately 142 weeks
Secondary outcome [9] 0 0
Time to Concomitant Corticosteroid Dose Reduction
Timepoint [9] 0 0
Baseline up to approximately 142 weeks
Secondary outcome [10] 0 0
Change From Baseline in PtGA of Disease Activity
Timepoint [10] 0 0
Baseline (Day 0), Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, completer last visit (up to Week 120), last visit (up to Week 120), early withdrawal (up to Week 120)
Secondary outcome [11] 0 0
Change From Baseline in Patient's Assessment of Pain
Timepoint [11] 0 0
Baseline (Day 0), Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, completer last visit (up to Week 120), last visit (up to Week 120), early withdrawal (up to Week 120)
Secondary outcome [12] 0 0
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Total Score
Timepoint [12] 0 0
Baseline (Day 0), Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, completer last visit (up to Week 120), last visit (up to Week 120), early withdrawal (up to Week 120)
Secondary outcome [13] 0 0
Change From Baseline in Physician's Global Assessment of Disease Activity
Timepoint [13] 0 0
Baseline (Day 0), Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, completer last visit (up to Week 120), last visit (up to Week 120), early withdrawal (up to Week 120)
Secondary outcome [14] 0 0
Change From Baseline in ESR
Timepoint [14] 0 0
Baseline (Day 0), Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, completer last visit (up to Week 120), last visit (up to Week 120), early withdrawal (up to Week 120)
Secondary outcome [15] 0 0
Change From Baseline in CRP
Timepoint [15] 0 0
Baseline (Day 0), Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, completer last visit (up to Week 120), last visit (up to Week 120), early withdrawal (up to Week 120)

Eligibility
Key inclusion criteria
- Negative pregnancy test at screening and baseline

- Participants who have completed the 97-week WA22762 LTE study on SC or intravenous
(IV) TCZ and who experienced, at any time during WA22762, clinically significant
improvement in DAS28 (>1.2 points), and based on the investigator's judgment may
continue to benefit from TCZ treatment in this study investigating the SC formulation

- No current or recent adverse events or laboratory findings preventing the use of the
study drug dose of TCZ 162 mg SC at baseline visit

- Receiving treatment on an outpatient basis

- Females of childbearing potential and males with female partners of childbearing
potential must agree to use reliable means of contraception during the study and for
at least 3 months following the last dose of study drug

- Oral corticosteroids and non-steroidal anti-inflammatory drugs (NSAIDS) up to the
recommended dose are permitted if on stable dose regimen for greater than and equal to
(>/=) 4 weeks prior to baseline

- Permitted non-biological disease-modifying anti-rheumatic drugs (DMARDs) are allowed
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Participants who have prematurely withdrawn from the WA22762 LTE study for any reason

- Previous treatment with any cell-depleting therapies, including investigational agents
or approved therapies

- Treatment with an anti-tumor necrosis factor (TNF) or anti-interleukin (IL) 1 agent,
or a T-cell co stimulation modulator since the last administration of study drug in
the WA22762 LTE study

- Immunization with a live/attenuated vaccine since the last administration of study
drug in the WA22762 LTE study

- Diagnosis, since last WA22762 visit (Week 97), of rheumatic autoimmune disease other
than rheumatoid arthritis; secondary Sjörgen's syndrome with RA is permitted

- Diagnosis, since last WA22762 visit (Week 97), of inflammatory joint disease other
than RA

- Uncontrolled disease states, such as asthma or inflammatory bowel disease, where
flares are commonly treated with oral or parenteral corticosteroids

- Evidence of serious uncontrolled concomitant disease

- Known active current or history of recurrent infection

- Primary or secondary immunodeficiency (history of or currently active)

- Body weight >150 kilograms (kg)

- Pregnant or lactating women

- Inadequate hematologic, renal or liver function

- History of alcohol, drug or chemical abuse within 1 year prior to screening

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



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

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/10/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/09/2015
Sample size
Target
Accrual to date
Final
11
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
France
State/province [1] 0 0
Bordeaux
Country [2] 0 0
France
State/province [2] 0 0
Montpellier
Country [3] 0 0
France
State/province [3] 0 0
Nantes
Country [4] 0 0
France
State/province [4] 0 0
Paris
Country [5] 0 0
France
State/province [5] 0 0
Strasbourg
Country [6] 0 0
France
State/province [6] 0 0
Toulouse

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

Ethics approval
Ethics application status

Summary
Brief summary
This multicenter, open-label, single arm, interventional, long-term extension (LTE) study
will evaluate the safety and efficacy of tocilizumab (TCZ, RoActemra/Actemra) in French
participants with moderate to severe RA who have completed the Week 97 visit of WA22762 LTE
study (NCT01194414) (EudraCT Number 2010-018375-22). Participants from France, who completed
the Week 97 visit of the WA22762 LTE study and considered as responders (defined as having
improvement in disease activity score based on 28-joint count [DAS28] of greater than [>] 1.2
points) will continue TCZ treatment within this local LTE study for a maximum of 156 weeks of
subcutaneous (SC) TCZ treatment, or until SC TCZ becomes commercially available, whichever
occurs first.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01734993
Trial related presentations / publications
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

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