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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01662063




Registration number
NCT01662063
Ethics application status
Date submitted
30/07/2012
Date registered
10/08/2012
Date last updated
12/10/2016

Titles & IDs
Public title
A Long-Term Extension Study of WA22762 and NA25220 of Subcutaneous (SC) Tocilizumab (TCZ) in Moderate to Severe Rheumatoid Arthritis (RA)
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
ML28338
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: SC TCZ QW - Participants who received IV TCZ in the previous trial will be switched to SC TCZ 162 mg QW, and those who received SC TCZ will continue at their same dosage of SC TCZ 162 mg QW. Tocilizumab will be given for an additional 96 weeks in this open-label extension study.

Experimental: SC TCZ Q2W - Participants who received SC TCZ will continue at their same dosage of SC TCZ 162 mg Q2W. Tocilizumab will be given for an additional 96 weeks in this open-label extension study.


Treatment: Drugs: Tocilizumab
TCZ will be given as 162 mg SC QW or Q2W for up to 96 weeks.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants With at Least One Serious Adverse Event (SAE)
Timepoint [1] 0 0
From Baseline to 8 weeks after last dose; assessed continuously during treatment (up to 96 weeks) and up to 8 weeks after last dose (up to 2 years overall)
Primary outcome [2] 0 0
Percentage of Participants With at Least One SAE
Timepoint [2] 0 0
From Baseline to 8 weeks after last dose; assessed continuously during treatment (up to 96 weeks) and up to 8 weeks after last dose (up to 2 years overall)
Primary outcome [3] 0 0
Percentage of Participants With a Positive Anti-TCZ Antibody Assay at Any Timepoint
Timepoint [3] 0 0
From Baseline to 8 weeks after last dose; assessed at Baseline; Weeks 12, 24, 36, 48, 60, 72, 84, 96; and up to 8 weeks after last dose (up to 2 years overall)
Primary outcome [4] 0 0
Percentage of Participants With a Positive Anti-TCZ Antibody Assay at Baseline
Timepoint [4] 0 0
Baseline
Primary outcome [5] 0 0
Percentage of Participants With a Positive Anti-TCZ Antibody Assay Post-Baseline
Timepoint [5] 0 0
From Week 12 up to 8 weeks after last dose; assessed at Weeks 12, 24, 36, 48, 60, 72, 84, 96; and up to 8 weeks after last dose (up to 2 years overall)
Secondary outcome [1] 0 0
Percentage of Participants Who Correctly Administered All SC TCZ Doses
Timepoint [1] 0 0
From Baseline to last dose; assessed every 4 weeks during treatment (up to 96 weeks overall)
Secondary outcome [2] 0 0
Disease Activity Score Based on 28 Joints (DAS28) Score
Timepoint [2] 0 0
Baseline and Weeks 12, 24, 36, 48, 60, 72, 84
Secondary outcome [3] 0 0
Change From Baseline in DAS28 Score
Timepoint [3] 0 0
Baseline to Weeks 12, 24, 36, 48, 60, 72, 84
Secondary outcome [4] 0 0
Clinical Disease Activity Index (CDAI) Score
Timepoint [4] 0 0
Baseline and Weeks 12, 24, 36, 48, 60, 72, 84
Secondary outcome [5] 0 0
Change From Baseline in CDAI Score
Timepoint [5] 0 0
Baseline to Weeks 12, 24, 36, 48, 60, 72, 84
Secondary outcome [6] 0 0
Simplified Disease Activity Index (SDAI) Score
Timepoint [6] 0 0
Baseline and Weeks 12, 24, 36, 48, 60, 72, 84
Secondary outcome [7] 0 0
Change From Baseline in SDAI Score
Timepoint [7] 0 0
Baseline to Weeks 12, 24, 36, 48, 60, 72, 84
Secondary outcome [8] 0 0
Tender Joint Count (TJC) Score
Timepoint [8] 0 0
Baseline and Weeks 12, 24, 36, 48, 60, 72, 84
Secondary outcome [9] 0 0
Change From Baseline in TJC Score
Timepoint [9] 0 0
Baseline to Weeks 12, 24, 36, 48, 60, 72, 84
Secondary outcome [10] 0 0
Swollen Joint Count (SJC) Score
Timepoint [10] 0 0
Baseline and Weeks 12, 24, 36, 48, 60, 72, 84
Secondary outcome [11] 0 0
Change From Baseline in SJC Score
Timepoint [11] 0 0
Baseline to Weeks 12, 24, 36, 48, 60, 72, 84
Secondary outcome [12] 0 0
Number of Participants With a Disease-Modifying Anti-Rheumatic Drug (DMARD) Dose Reduction, Interruption, or Discontinuation
Timepoint [12] 0 0
From Baseline to last dose; assessed every 4 weeks during treatment (up to 96 weeks overall)
Secondary outcome [13] 0 0
Percentage of Participants With a DMARD Dose Reduction, Interruption, or Discontinuation
Timepoint [13] 0 0
From Baseline to last dose; assessed every 4 weeks during treatment (up to 96 weeks overall)
Secondary outcome [14] 0 0
Percentage of Reasons Given for DMARD Dose Reduction or Interruption
Timepoint [14] 0 0
From Baseline to last dose; assessed every 4 weeks during treatment (up to 96 weeks overall)
Secondary outcome [15] 0 0
Percentage of Reasons Given for DMARD Discontinuation
Timepoint [15] 0 0
From Baseline to last dose; assessed every 4 weeks during treatment (up to 96 weeks overall)
Secondary outcome [16] 0 0
Number of Participants With a Corticosteroid (CCS) Dose Reduction, Interruption, or Discontinuation
Timepoint [16] 0 0
From Baseline to last dose; assessed every 4 weeks during treatment (up to 96 weeks overall)
Secondary outcome [17] 0 0
Percentage of Participants With a CCS Dose Reduction, Interruption, or Discontinuation
Timepoint [17] 0 0
From Baseline to last dose; assessed every 4 weeks during treatment (up to 96 weeks overall)
Secondary outcome [18] 0 0
Percentage of Reasons Given for CCS Dose Reduction
Timepoint [18] 0 0
From Baseline to last dose; assessed every 4 weeks during treatment (up to 96 weeks overall)
Secondary outcome [19] 0 0
Percentage of Reasons Given for CCS Dose Interruption
Timepoint [19] 0 0
From Baseline to last dose; assessed every 4 weeks during treatment (up to 96 weeks overall)
Secondary outcome [20] 0 0
Percentage of Reasons Given for CCS Discontinuation
Timepoint [20] 0 0
From Baseline to last dose; assessed every 4 weeks during treatment (up to 96 weeks overall)
Secondary outcome [21] 0 0
Number of Participants Who Switched From the QW Regimen and Remained on the Q2W Regimen
Timepoint [21] 0 0
From Baseline to last dose; assessed every 4 weeks during treatment (up to 96 weeks overall)
Secondary outcome [22] 0 0
Percentage of Participants Who Switched From the QW Regimen and Remained on the Q2W Regimen
Timepoint [22] 0 0
From Baseline to last dose; assessed every 4 weeks during treatment (up to 96 weeks overall)
Secondary outcome [23] 0 0
Number of Participants Who Returned to the QW Regimen After Switching to the Q2W Regimen
Timepoint [23] 0 0
From Baseline to last dose; assessed every 4 weeks during treatment (up to 96 weeks overall)
Secondary outcome [24] 0 0
Time to Return to the QW Regimen After Switching to the Q2W Regimen
Timepoint [24] 0 0
From Baseline to last dose; assessed every 4 weeks during treatment (up to 96 weeks overall)
Secondary outcome [25] 0 0
Global Assessment of Disease Activity by the Participant According to Visual Analog Scale (VAS) Score
Timepoint [25] 0 0
Baseline and Weeks 12, 24, 36, 48, 60, 72, 84
Secondary outcome [26] 0 0
Change From Baseline in Global Assessment of Disease Activity by the Participant According to VAS Score
Timepoint [26] 0 0
Baseline to Weeks 12, 24, 36, 48, 60, 72, 84
Secondary outcome [27] 0 0
Global Assessment of Pain by the Participant According to VAS Score
Timepoint [27] 0 0
Baseline and Weeks 12, 24, 36, 48, 60, 72, 84
Secondary outcome [28] 0 0
Change From Baseline in Global Assessment of Pain by the Participant According to VAS Score
Timepoint [28] 0 0
Baseline to Weeks 12, 24, 36, 48, 60, 72, 84
Secondary outcome [29] 0 0
Heath Assessment Questionnaire-Disability Index (HAQ-DI) Score
Timepoint [29] 0 0
Baseline and Weeks 12, 24, 36, 48, 60, 72, 84
Secondary outcome [30] 0 0
Change From Baseline in HAQ-DI Score
Timepoint [30] 0 0
Baseline to Weeks 12, 24, 36, 48, 60, 72, 84
Secondary outcome [31] 0 0
Percentage of Participants With HAQ-DI Score <0.5
Timepoint [31] 0 0
Baseline and Weeks 12, 24, 36, 48, 60, 72, 84
Secondary outcome [32] 0 0
Number of Participants With Low Disease Activity According to DAS28, SDAI, and CDAI Criteria
Timepoint [32] 0 0
Baseline and Weeks 12, 24, 36, 48, 60, 72, 84
Secondary outcome [33] 0 0
Percentage of Participants With Low Disease Activity According to DAS28, SDAI, and CDAI Criteria
Timepoint [33] 0 0
Baseline and Weeks 12, 24, 36, 48, 60, 72, 84
Secondary outcome [34] 0 0
Number of Participants With Remission According to DAS28, SDAI, and Boolean Criteria
Timepoint [34] 0 0
Baseline and Weeks 12, 24, 36, 48, 60, 72, 84
Secondary outcome [35] 0 0
Percentage of Participants With Remission According to DAS28, SDAI, and Boolean Criteria
Timepoint [35] 0 0
Baseline and Weeks 12, 24, 36, 48, 60, 72, 84

Eligibility
Key inclusion criteria
* Completed the 97-week WA22762 (NCT01194414) or 96-week NA25220 (NCT01232569) core study on SC or IV TCZ and, based on the Investigator's judgment, may continue to benefit from TCZ treatment in this study investigating the SC formulation
* 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 as defined by protocol
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Premature withdrawal from WA22762 (NCT01194414) or NA25220 (NCT01232569) core studies for any reason
* History of severe allergic or anaphylactic reactions to human, humanized, or murine monoclonal antibodies
* Evidence of serious uncontrolled concomitant disease or disorder
* Known active current or history of recurrent bacterial, viral, fungal, mycobacterial, or other infections
* Any major episode of infection requiring hospitalization or treatment with IV antibiotics within 4 weeks of Screening or oral antibiotics within 2 weeks of Screening
* History of or currently active primary or secondary immunodeficiency
* Oral corticosteroids at greater than (>) 10 mg per day prednisone or equivalent, or non-steroidal anti-inflammatory drugs (NSAIDs) above the maximum recommended dose
* Intra-articular or parenteral corticosteroids within 4 weeks prior to Baseline
* Treatment with any investigational or commercially available biologic disease-modifying anti-rheumatic drug (DMARD) other than TCZ at any time between completion of the core study WA22762 (NCT01194414) or NA25220 (NCT01232569) and enrollment in the long-term extension study
* Pregnant or breastfeeding women
* History of alcohol, drug, or chemical abuse within 1 year prior to Screening

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
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
Parallel
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
1/08/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/06/2014
Sample size
Target
Accrual to date
Final
218
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Colorado
Country [5] 0 0
United States of America
State/province [5] 0 0
Connecticut
Country [6] 0 0
United States of America
State/province [6] 0 0
Florida
Country [7] 0 0
United States of America
State/province [7] 0 0
Georgia
Country [8] 0 0
United States of America
State/province [8] 0 0
Idaho
Country [9] 0 0
United States of America
State/province [9] 0 0
Illinois
Country [10] 0 0
United States of America
State/province [10] 0 0
Kansas
Country [11] 0 0
United States of America
State/province [11] 0 0
Louisiana
Country [12] 0 0
United States of America
State/province [12] 0 0
Maryland
Country [13] 0 0
United States of America
State/province [13] 0 0
Massachusetts
Country [14] 0 0
United States of America
State/province [14] 0 0
Michigan
Country [15] 0 0
United States of America
State/province [15] 0 0
Minnesota
Country [16] 0 0
United States of America
State/province [16] 0 0
Mississippi
Country [17] 0 0
United States of America
State/province [17] 0 0
Missouri
Country [18] 0 0
United States of America
State/province [18] 0 0
Nebraska
Country [19] 0 0
United States of America
State/province [19] 0 0
New Hampshire
Country [20] 0 0
United States of America
State/province [20] 0 0
New Jersey
Country [21] 0 0
United States of America
State/province [21] 0 0
New Mexico
Country [22] 0 0
United States of America
State/province [22] 0 0
New York
Country [23] 0 0
United States of America
State/province [23] 0 0
North Carolina
Country [24] 0 0
United States of America
State/province [24] 0 0
Ohio
Country [25] 0 0
United States of America
State/province [25] 0 0
Oklahoma
Country [26] 0 0
United States of America
State/province [26] 0 0
Pennsylvania
Country [27] 0 0
United States of America
State/province [27] 0 0
South Carolina
Country [28] 0 0
United States of America
State/province [28] 0 0
Tennessee
Country [29] 0 0
United States of America
State/province [29] 0 0
Texas
Country [30] 0 0
United States of America
State/province [30] 0 0
Washington
Country [31] 0 0
Puerto Rico
State/province [31] 0 0
Ponce

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Genentech, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This open-label extension study will evaluate the long-term safety and efficacy of SC TCZ in participants with moderate to severe RA who have completed the 97-week WA22762 (NCT01194414) or 96-week NA25220 (NCT01232569) core studies on SC or intravenous (IV) TCZ. Participants will receive TCZ 162 milligrams (mg) SC every week (QW) or every 2 weeks (Q2W) for up to 96 weeks.
Trial website
https://clinicaltrials.gov/study/NCT01662063
Trial related presentations / publications
Kivitz A, Wallace T, Olech E, Borofsky M, Devenport J, Pei J, Michalska M. Long-Term Safety and Efficacy of Subcutaneously Administered Tocilizumab for Adult Rheumatoid Arthritis: A Multicenter Phase 3b Long-term Extension Study. Rheumatol Ther. 2016 Dec;3(2):291-304. doi: 10.1007/s40744-016-0043-1. Epub 2016 Sep 24.
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
Genentech, Inc.
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/NCT01662063