Clinical trial NCT01649804: A Long-Term Safety Extension Study of WA19926 in Participants With 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: 2012-07-25
Enrollment: 12
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 extension study of WA19926 will assess the long-term safety and the efficacy of RoActemra/Actemra (tocilizumab) treatment in participants with rheumatoid arthritis. Participants who have completed the core study WA19926 are eligible to participate. Participants will receive RoActemra/Actemra 8 mg/kg intravenously every 4 weeks. The anticipated time on study drug is 104 weeks.


Eligibility criteria: Inclusion Criteria:

* Adult participants, \>/=18 years of age who have completed the core study WA19926 and according to the investigator may benefit from RoActemra/Actemra treatment
* No current or recent adverse event or laboratory finding preventing the use of the study drug dose at baseline
* Receiving treatment on an outpatient basis

Exclusion Criteria:

* Females who are pregnant
* Participants who have prematurely withdrawn from the core study WA19926 for any reason
* Treatment with any investigational drug since the last administration of the study drug in the core study WA19926
* Treatment with an anti-tumor necrosis (TNF), anti-interleukin 1 agent or T-cell costimulation modulator since the last administration of the study drug in the core study WA19926
* Immunization with live/attenuated vaccine since the last administration of the study drug in the core study WA19926
* Diagnosis since the last WA19926 visit of rheumatic autoimmune disease or inflammatory joint disease other than rheumatoid arthritis
* Abnormal laboratory values

Primary outcomes:
measure: Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and AEs of Special Interest (AESIs)
timeFrame: End of Study (Week 104 or early withdrawal)
Secondary outcomes:
measure: Number of Participants With Remission, Low, Medium, and High Disease Activity, as Measured by Disease Activity Index 28 Erythrocyte Sedimentation Rate (DAS28-ESR)
timeFrame: Screening and End of Study (Week 104 or early withdrawal)
measure: Number of Participants With Remission, Low, Medium, and High Disease Activity, as Measured by Simplified Disease Activity Index (SDAI)
timeFrame: Screening and End of Study (Week 104 or early withdrawal)
measure: Number of Participants With Decreased, Unchanged, and Increased Tender Joint Count (TJC)
timeFrame: Week 12 and Week 104
measure: Number of Participants With Decreased, Unchanged, and Increased Swollen Joint Count (SJC)
timeFrame: Week 12 and Week 104
measure: Time to Rheumatoid Arthritis (RA) Flare
timeFrame: End of Study (Week 104 or early withdrawal)
measure: Number of Participants With Decreased, Unchanged, and Increased Participants Global Assessment of Disease Activity
timeFrame: Week 12 and Week 104
measure: Number of Participants With Decreased, Unchanged, and Increased Participant Global Assessment of Pain
timeFrame: Week 12 and Week 104
measure: Health Assessment Questionnaire Disability Index (HAQ-DI)
timeFrame: End of Study (Week 104 or early withdrawal)
Other outcomes:
Locations:
city: Budapest
country: Hungary
city: Debrecen
country: Hungary
city: Eger
country: Hungary
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: