Phase 3
Completed N=12
A Long-Term Safety Extension Study of WA19926 in Participants With Rheumatoid Arthritis
Source: ClinicalTrials.gov NCT01649804 ↗Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Sep 2016
Primary outcomePrimary: Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and AEs of Special Interest (AESIs) — 75; 0; 0 percentage of participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and AEs of Special Interest (AESIs) |
75; 0; 0 | — |
| SECONDARY Number of Participants With Remission, Low, Medium, and High Disease Activity, as Measured by Disease Activity Index 28 Erythrocyte Sedimentation Rate (DAS28-ESR) |
5; 1; 4; 2; 10; 1 | — |
| SECONDARY Number of Participants With Remission, Low, Medium, and High Disease Activity, as Measured by Simplified Disease Activity Index (SDAI) |
0; 6; 3; 3; 3; 7 | — |
| SECONDARY Number of Participants With Decreased, Unchanged, and Increased Tender Joint Count (TJC) |
5; 4; 2; 2; 2; 0 | — |
| SECONDARY Number of Participants With Decreased, Unchanged, and Increased Swollen Joint Count (SJC) |
3; 7; 1; 2; 2; 0 | — |
| SECONDARY Time to Rheumatoid Arthritis (RA) Flare |
— | — |
| SECONDARY Number of Participants With Decreased, Unchanged, and Increased Participants Global Assessment of Disease Activity |
6; 0; 5; 2; 0; 2 | — |
| SECONDARY Number of Participants With Decreased, Unchanged, and Increased Participant Global Assessment of Pain |
7; 4; 0; 2; 0; 2 | — |
| SECONDARY Health Assessment Questionnaire Disability Index (HAQ-DI) |
1.18 | — |
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
Data sourced from ClinicalTrials.gov (NCT01649804). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.