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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01772316




Registration number
NCT01772316
Ethics application status
Date submitted
17/01/2013
Date registered
21/01/2013
Date last updated
6/11/2016

Titles & IDs
Public title
A Long-Term Extension Study of WA22763 and NA25220 of Subcutaneous RoActemra/Actemra (Tocilizumab) in Patients With Moderate to Severe Rheumatoid Arthritis
Scientific title
A Multicenter, Open-label, Long-term Extension Study of WA22762 and NA25220 to Evaluate Safety and Efficacy of Subcutaneous Tocilizumab in Patients With Moderate to Severe Rheumatoid Arthritis
Secondary ID [1] 0 0
2012-002632-87
Secondary ID [2] 0 0
ML28488
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 Subcutaneous (SC) - Participants received Tocilizumab 162 milligram (mg) given as 0.9 milliliter (mL) of a 180 milligram per milliliter (mg/mL) solution administered once a week (for participants entering from NCT01194414) or once every two weeks (for participants entering from NCT01232569) by SC injection and as a single fixed dose irrespective of body weight.


Treatment: Drugs: tocilizumab
162 mg subcutaneously weekly or every two weeks, 96 weeks
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants With an Adverse Event (AE)
Timepoint [1] 0 0
Baseline up to follow-up (Week 104)
Primary outcome [2] 0 0
Percentage of Participants Withdrawn From the Study Due to Lack of Therapeutic Response
Timepoint [2] 0 0
Baseline up to follow-up (Week 104)
Primary outcome [3] 0 0
Change From Baseline in Disease Activity Score 28 - Erythrocyte Sedimentation Rate (DAS28-ESR) at Week 48
Timepoint [3] 0 0
Baseline, Week 48
Primary outcome [4] 0 0
Change From Baseline in DAS28-ESR at Week 96
Timepoint [4] 0 0
Baseline, Week 96
Primary outcome [5] 0 0
Change From Baseline in Simplified Disease Activity Index (SDAI) at Week 48
Timepoint [5] 0 0
Baseline, Week 48
Primary outcome [6] 0 0
Change From Baseline in SDAI at Week 96
Timepoint [6] 0 0
Baseline, Week 96
Primary outcome [7] 0 0
Change From Baseline in Total Tender Joint Count (TJC) at Week 48
Timepoint [7] 0 0
Baseline, Week 48
Primary outcome [8] 0 0
Change From Baseline in Total TJC at Week 96
Timepoint [8] 0 0
Baseline, Week 96
Primary outcome [9] 0 0
Change From Baseline in Swollen Joint Count (SJC) at Week 48
Timepoint [9] 0 0
Baseline, Week 48
Primary outcome [10] 0 0
Change From Baseline in SJC at Week 96
Timepoint [10] 0 0
Baseline, Week 96
Secondary outcome [1] 0 0
Percentage of Participants With Remission (DAS28 <2.6 or SDAI </=3.3) at Weeks 48 and 96
Timepoint [1] 0 0
Week 48, Week 96
Secondary outcome [2] 0 0
Percentage of Participants With Disease-Modifying Antirheumatic Drugs (DMARDs)/Corticosteroid Dose Reductions and/or Discontinuation
Timepoint [2] 0 0
Randomization of first participant to clinical cutoff date (19MAY2015) (approximately 29 months)
Secondary outcome [3] 0 0
Patient Global Visual Analog Score (VAS) at Specified Time Points
Timepoint [3] 0 0
Baseline, Week 48, Week 96
Secondary outcome [4] 0 0
Patient Pain VAS Score at Specified Time Points
Timepoint [4] 0 0
Baseline, Week 48, Week 96
Secondary outcome [5] 0 0
Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Specified Time Points
Timepoint [5] 0 0
Baseline, Week 48, Week 96

Eligibility
Key inclusion criteria
* Adult participants, >/= 18 years of age
* Participants who have completed the 97-week WA22762 or 96-week NA25220 core study on subcutaneous or intravenous RoActemra/Actemra and based on the investigator's judgment may continue to benefit from RoActemra/Actemra treatment in this study investigating the subcutaneous formulation
* Oral corticosteroids and non-steroidal anti-inflammatory drugs (NSAIDS) up to the maximum recommended dose are permitted if on a stable dose regimen for >/= 4 weeks prior to baseline
* Permitted non-biological disease-modifying anti-rheumatic drugs (DMARDs) are allowed
* 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
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 or NA25220 core studies for any reason
* Previous treatment with any cell-depleting therapies, including investigational agents or approved therapies
* History of severe allergic or anaphylactic reactions to human, humanized or mural monoclonal antibodies
* Evidence of serious uncontrolled concomitant disease
* Current liver disease as determined by the principal investigator
* History of diverticulitis, diverticulosis requiring antibiotic treatment or chronic ulcerative lower gastrointestinal (GI) disease such as Crohn's disease, ulcerative colitis or other symptomatic lower GI conditions that might predispose to perforations
* Known active current or history of recurrent infections
* Any major episode of infection requiring hospitalization or treatment with intravenous (IV) antibiotics within 4 weeks of screening or oral antibiotics within 2 weeks prior to screening
* Active tuberculosis requiring treatment within the previous 3 years
* Primary or secondary immunodeficiency (history of or currently active)
* Pregnant or breast feeding women
* Body weight > 150 kilogram (kg)
* Inadequate renal, hepatic or hematologic function
* Positive for hepatitis B or hepatitis C

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
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
1/12/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/05/2015
Sample size
Target
Accrual to date
Final
47
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
Spain
State/province [1] 0 0
Badajoz
Country [2] 0 0
Spain
State/province [2] 0 0
Cantabria
Country [3] 0 0
Spain
State/province [3] 0 0
La Coruña
Country [4] 0 0
Spain
State/province [4] 0 0
Tenerife
Country [5] 0 0
Spain
State/province [5] 0 0
Valencia
Country [6] 0 0
Spain
State/province [6] 0 0
Vizcaya
Country [7] 0 0
Spain
State/province [7] 0 0
Madrid
Country [8] 0 0
Spain
State/province [8] 0 0
Malaga
Country [9] 0 0
Spain
State/province [9] 0 0
Sevilla

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 study will evaluate the safety and efficacy of RoActemra/Actemra (tocilizumab) in participants with moderate to severe rheumatoid arthritis who have completed the 97-week WA22762 or the 96-week NA25220 core study. Participants will receive RoActemra/Actemra 162 milligram (mg) subcutaneously weekly (for participants entering from WA22762) or every two weeks (for participants entering from NA25220) for 96 weeks, with telephone call follow-up visits at Weeks 100 and 104.
Trial website
https://clinicaltrials.gov/study/NCT01772316
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/study/NCT01772316