Trial Review

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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/NCT01665430




Registration number
NCT01665430
Ethics application status
Date submitted
13/08/2012
Date registered
15/08/2012
Date last updated
8/02/2018

Titles & IDs
Public title
A Long-Term Extension Study to WA19926 (NCT01007435) of Tocilizumab in Participants With Early, Moderate to Severe Rheumatoid Arthritis
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
Secondary ID [1] 0 0
2012-000172-42
Secondary ID [2] 0 0
ML28175
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 - Participants will receive tocilizumab 8 milligrams per kilogram (mg/kg) intravenous infusion every 4 weeks up to 104 weeks.


Treatment: Drugs: Tocilizumab
Tocilizumab will be administered at 8 mg/kg intravenous infusion every 4 weeks, up to 104 weeks.
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), AEs of Special Interest and Serious Adverse Events (SAEs)
Timepoint [1] 0 0
Baseline up to 112 weeks
Secondary outcome [1] 0 0
Change From Baseline in Disease Activity Index 28 Erythrocyte Sedimentation Rate (DAS28-ESR) Score
Timepoint [1] 0 0
Baseline, Weeks 12, 24, 36, 48, 56, 68, 80, 92, at end of study visit (Week 104), at early withdrawal (up to Week 104)
Secondary outcome [2] 0 0
Change From Baseline in Total Tender Joint Counts (28 Joints)
Timepoint [2] 0 0
Baseline, Weeks 12, 24, 36, 48, 56, 68, 80, 92, at end of study visit (Week 104), at early withdrawal (up to Week 104)
Secondary outcome [3] 0 0
Change From Baseline in Total Swollen Joint Counts (28 Joints)
Timepoint [3] 0 0
Baseline, Weeks 12, 24, 36, 48, 56, 68, 80, 92, at end of study visit (Week 104), at early withdrawal (up to Week 104)
Secondary outcome [4] 0 0
Percentage of Participants With Drug-Free Remission
Timepoint [4] 0 0
Baseline up to Week 104 (assessed at Baseline, Weeks 12, 24, 36, 48, 56, 68, 80, 92, at end of study visit [Week 104], at early withdrawal [up to 104 weeks])
Secondary outcome [5] 0 0
Percentage of Participants With Clinical Remission
Timepoint [5] 0 0
Baseline up to Week 104 (assessed at Baseline, Weeks 12, 24, 36, 48, 56, 68, 80, 92, at end of study visit [Week 104], at early withdrawal [up to 104 weeks])
Secondary outcome [6] 0 0
Time to Rheumatoid Arthritis (RA) Flare in Participants Who Had Entered Drug-Free Remission
Timepoint [6] 0 0
Baseline up to Week 104 (assessed at Baseline, Weeks 12, 24, 36, 48, 56, 68, 80, 92, at end of study visit [Week 104], at early withdrawal [up to 104 weeks])
Secondary outcome [7] 0 0
Change From Baseline in Physician's Global Assessment (PGA) of Disease Activity Using Visual Analog Scale (VAS)
Timepoint [7] 0 0
Baseline, Weeks 12, 24, 36, 48, 56, 68, 80, 92, at end of study visit (Week 104), at early withdrawal (up to 104 weeks)
Secondary outcome [8] 0 0
Change From Baseline in PtGA of Disease Activity Using VAS
Timepoint [8] 0 0
Baseline, Weeks 12, 24, 36, 48, 56, 68, 80, 92, at end of study visit (Week 104), at early withdrawal (up to 104 weeks)
Secondary outcome [9] 0 0
Change From Baseline in Participant Assessment of Pain Using VAS
Timepoint [9] 0 0
Baseline, Weeks 12, 24, 36, 48, 56, 68, 80, 92, at end of study visit (Week 104), at early withdrawal (up to 104 weeks)
Secondary outcome [10] 0 0
Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI)
Timepoint [10] 0 0
Baseline, Weeks 12, 24, 36, 48, 56, 68, 80, 92, at end of study visit (Week 104), at early withdrawal (up to 104 weeks)

Eligibility
Key inclusion criteria
- Participants who complete WA19926 core study (visit at Week 104 and two follow-up
telephone visits) 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 the
study drug dose of tocilizumab 8 mg/kg at baseline visit

- Receiving treatment on an outpatient basis

- Females of child-bearing potential must agree to use at least one adequate method of
contraception as defined by protocol during the treatment period
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Pregnant women

- Participants who have prematurely withdrawn from the WA19926 study for any reason

- Treatment with any investigational agent or cell depleting therapies since last
administration of study drug in the WA19926 core study

- 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 the study drug in
the WA19926 core study

- Immunization with a live/attenuated vaccine since the last administration of study
drug in the WA19926 core study

- Diagnosis since visit at Week 104 of the core WA19926 study of rheumatic autoimmune
disease other than rheumatoid arthritis

- Diagnosis since visit at Week 104 of the core WA19926 study of inflammatory joint
disease other than rheumatoid arthritis

- Evidence of serious uncontrolled concomitant disease or disorder

- Known active or history of recurrent infection

- Current liver disease as determined by Investigator

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
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/07/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/02/2015
Sample size
Target
Accrual to date
Final
38
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
Poland
State/province [1] 0 0
Bytom
Country [2] 0 0
Poland
State/province [2] 0 0
Elblag
Country [3] 0 0
Poland
State/province [3] 0 0
Poznan
Country [4] 0 0
Poland
State/province [4] 0 0
Warszawa

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 long-term extension of study WA19926 will evaluate
the safety and efficacy of tocilizumab (RoActemra/Actemra) in participants with early,
moderate to severe rheumatoid arthritis who have completed the WA19926 core study. Eligible
participants will receive tocilizumab 8 mg/kg intravenously every 4 weeks for up to 104
weeks.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01665430
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01665430