Clinical trial NCT01655381: A Long-Term Extension Study of WA19926 on the Safety of Tocilizumab (RoActemra/Actemra) in Participants With Early Moderate to Severe Rheumatoid Arthritis
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Rheumatoid Arthritis
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2012-08-01
Enrollment: 15
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 open-label, single arm, multicenter long-term extension study will evaluate the safety and efficacy of tocilizumab (RoActemra/Actemra) in participants with moderate to severe rheumatoid arthritis who have completed the 104-week WA19926 core study. Eligible participants will receive tocilizumab 8 mg/kg intravenously every 4 weeks for up to 104 weeks.


Eligibility criteria: Inclusion Criteria:

* Adult participants, \>/= 18 years of age
* Participants who complete their last WA19926 core study visit (Week 104) and who may benefit from study drug treatment, at baseline or later if they are in remission DAS28 at Week 104 of WA19926, 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
* Women of childbearing potential must agree to use adequate contraception as defined by protocol during and up to 3 months after treatment

Exclusion Criteria:

* Pregnant females
* Participants who have withdrawn prematurely from the WA19926 core study for any reason
* Treatment with any investigational agent or cell-depleting therapies since the last administration of study drug in WA19926
* Treatment with an anti-tumor necrosis factor (TNF) or anti-interleukin (IL) 1 agent, or a T-cell costimulation modulator since the last administration of study drug in WA19926
* Immunization with a live/attenuated vaccine since the last administration of study drug in WA19926
* Diagnosis since last WA19926 visit (Week 104) of rheumatic autoimmune disease other than rheumatoid arthritis
* Diagnosis since last WA19926 visit (Week 104) of inflammatory joint disease other than rheumatoid arthritis
* History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies, including tocilizumab and its excipients
* Evidence of severe uncontrolled concomitant disease or disorder
* Known active or history of recurrent infections
* Active tuberculosis requiring treatment in the previous 3 years
* History of alcohol, drug or chemical abuse since inclusion in the WA19926 study

Primary outcomes:
measure: Percentage of Participants With Any Adverse Event (AE)
timeFrame: Up to 160 weeks
Secondary outcomes:
measure: Percentage of Participants With at Least One Clinical Remission Period
timeFrame: Up to approximately 148 weeks
measure: Percentage of Participants With at Least One Drug-Free Period
timeFrame: Up to approximately 148 weeks
measure: Cumulative Time of Remission Per Participant Over the Extension Study Period
timeFrame: Up to approximately 148 weeks
measure: Percentage of Participants With at Least 1 Rheumatoid Arthritis (RA) Flare
timeFrame: Up to approximately 148 weeks
measure: Time to RA Flare Following Remission or Drug-Free Remission
timeFrame: Up to approximately 148 weeks
measure: Change From Day 1 in DAS28-ESR Scores Over Time
timeFrame: Day 1 and Weeks 12, 24, 36, 48, 56, 68, 80, 92, 104, 116, 128, 140
measure: Change From Day 1 in Simplified Disease Activity Index (SDAI) Scores Over Time
timeFrame: Day 1 and Weeks 12, 24, 36, 48, 56, 68, 80, 92, 104, 116, 128, 140
measure: Change From Day 1 in Tender Joint Count Based on 28 Joints (TJC28) Over Time
timeFrame: Day 1 and Weeks 12, 24, 36, 48, 56, 68, 80, 92, 104, 116, 128, 140
measure: Change From Day 1 in Swollen Joint Count Based on 28 Joints (SJC28) Over Time
timeFrame: Day 1 and Weeks 12, 24, 36, 48, 56, 68, 80, 92, 104, 116, 128, 140
measure: Erythrocyte Sedimentation Rate (ESR) Over Time
timeFrame: Day 1 and Weeks 12, 24, 36, 48, 56, 68, 80, 92, 104, 116, 128, 140
measure: C-reactive Protein (CRP) Level
timeFrame: Day 1 and Weeks 12, 24, 36, 48, 56, 68, 80, 92, 104, 116, 128, 140
measure: Participants' Global Assessment of Pain (VAS) Score
timeFrame: Day 1 and Weeks 12, 24, 36, 48, 56, 68, 80, 92, 104, 116, 128, 140
measure: Participants' Global Assessment of Disease Activity (VAS) Score
timeFrame: Day 1 and Weeks 12, 24, 36, 48, 56, 68, 80, 92, 104, 116, 128, 140
measure: Physicians' Global Assessment of Disease Activity (VAS) Score
timeFrame: Day 1 and Weeks 12, 24, 36, 48, 56, 68, 80, 92, 104, 116, 128, 140
measure: Percentage of Participants With Health Assessment Questionnaire Disability Index (HAQ-DI) Remission
timeFrame: Baseline and Weeks 12, 24, 36, 48, 56, 68, 80, 92, 104, 116, 128 140
measure: Percentage of Participants With Clinically Meaningful Improvement From Baseline in HAQ-DI
timeFrame: Weeks 12, 24, 36, 48, 56, 68, 80, 92, 104, 116, 128, 140
Other outcomes:
Locations:
city: Cahors
country: France
city: Montpellier
country: France
city: Mulhouse
country: France
city: Orleans
country: France
city: Paris
country: France
city: Toulouse
country: France
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: