Clinical trial NCT01734993: A Long-Term Extension Study of WA22762 to Evaluate Safety and Efficacy of Subcutaneous Tocilizumab in Participants With Moderate to Severe Rheumatoid Arthritis (RA).
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Rheumatoid Arthritis
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2012-11-28
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

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

Primary outcomes:
measure: Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: Baseline up to approximately 142 weeks
measure: Percentage of Participants With AEs and SAEs Related to TCZ
timeFrame: Baseline up to approximately 142 weeks
measure: Percentage of Participants With Adverse Events of Special Interest (AESIs)
timeFrame: Baseline up to approximately 142 weeks
measure: Percentage of Participants With AESIs Related to TCZ
timeFrame: Baseline up to approximately 142 weeks
measure: Percentage of Participants With AEs Leading to TCZ Discontinuation, Interruption, or Dose Modification
timeFrame: Baseline up to approximately 142 weeks
measure: Percentage of Participants With Clinically Significant Physical Examinations and Vital Signs Abnormalities
timeFrame: Baseline up to approximately 142 weeks
measure: Percentage of Participants With Clinically Significant Laboratory Abnormalities
timeFrame: Baseline up to approximately 142 weeks
measure: Percentage of Participants With Anti-TCZ Antibodies
timeFrame: Baseline up to approximately 142 weeks
Secondary outcomes:
measure: Change From Baseline in Disease Activity Score 28 - Erythrocyte Sedimentation Rate (DAS28-ESR) Score
timeFrame: 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)
measure: Change From Baseline in Simplified Disease Activity Index (SDAI) Score
timeFrame: 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)
measure: Change From Baseline in TJC
timeFrame: 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)
measure: Change From Baseline in SJC
timeFrame: 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)
measure: Percentage of Participants With Clinical Remission
timeFrame: Week 48, 108
measure: Percentage of Participants With Concomitant Corticosteroid Discontinuation
timeFrame: Baseline up to approximately 142 weeks
measure: Percentage of Participants With Concomitant Corticosteroid Dose Reduction
timeFrame: Baseline up to approximately 142 weeks
measure: Time to Concomitant Corticosteroid Discontinuation
timeFrame: Baseline up to approximately 142 weeks
measure: Time to Concomitant Corticosteroid Dose Reduction
timeFrame: Baseline up to approximately 142 weeks
measure: Change From Baseline in PtGA of Disease Activity
timeFrame: 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)
measure: Change From Baseline in Patient's Assessment of Pain
timeFrame: 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)
measure: Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Total Score
timeFrame: 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)
measure: Change From Baseline in Physician's Global Assessment of Disease Activity
timeFrame: 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)
measure: Change From Baseline in ESR
timeFrame: 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)
measure: Change From Baseline in CRP
timeFrame: 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)
Other outcomes:
Locations:
city: Bordeaux
country: France
city: Montpellier
country: France
city: Nantes
country: France
city: Paris
country: France
city: Strasbourg
country: France
city: Toulouse
country: France
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: